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Supplemental Data Tables and Figures for the Diagnosis and Treatment of Leishmaniasis 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Society of Tropical Medicine and Hygiene (ASTMH)Score SheetINTERVENTIONNUMBER PER ARMCOUNTRYSPECIATION PERFORMEDSPECIES 1SPECIES 2DIAGNOSTIC CRITERIAMETHODSORAL TREATMENTSLOCAL TREATMENTSPARENTERAL TREATMENTOUTCOMESCLINICAL ENDPOINTRESULTSAUTHORS' CONCLUSIONSSIMILARITY OF GROUPSLOSS TO FOLLOW-UP & FOLLOW-UP TIMEBLINDINGRANDOMIZATIONTOTAL QUALITY SCORENUMBER SCORESPECIATION SCOREDIAGNOSTIC SCOREENDPOINT SCORESIMILARITY SCOREFOLLOW-UP SCOREBLINDING SCORENEW WORLD CUTANEOUS LEISHMANIASIS???????????????????????????Hepburn 1994 ADDIN EN.CITE <EndNote><Cite><Author>Hepburn</Author><Year>1994</Year><RecNum>3007</RecNum><DisplayText>[1]</DisplayText><record><rec-number>3007</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">3007</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hepburn, N. C.</author><author>Tidman, M. J.</author><author>Hunter, J. A.</author></authors></contributors><auth-address>Royal Army Medical College, Millbank, London, UK.</auth-address><titles><title>Aminosidine (paromomycin) versus sodium stibogluconate for the treatment of American cutaneous leishmaniasis</title><secondary-title>Trans R Soc Trop Med Hyg</secondary-title><alt-title>Transactions of the Royal Society of Tropical Medicine and Hygiene</alt-title></titles><periodical><full-title>Trans R Soc Trop Med Hyg</full-title><abbr-1>Transactions of the Royal Society of Tropical Medicine and Hygiene</abbr-1></periodical><alt-periodical><full-title>Transactions of the Royal Society of Tropical Medicine and Hygiene</full-title></alt-periodical><pages>700-3</pages><volume>88</volume><number>6</number><edition>1994/11/01</edition><keywords><keyword>Adult</keyword><keyword>Animals</keyword><keyword>Antimony Sodium Gluconate/adverse effects/*therapeutic use</keyword><keyword>Humans</keyword><keyword>*Leishmania braziliensis</keyword><keyword>*Leishmania mexicana</keyword><keyword>Leishmaniasis, Cutaneous/*drug therapy</keyword><keyword>Male</keyword><keyword>Military Personnel</keyword><keyword>Paromomycin/adverse effects/*therapeutic use</keyword><keyword>Prospective Studies</keyword></keywords><dates><year>1994</year><pub-dates><date>Nov-Dec</date></pub-dates></dates><isbn>0035-9203 (Print)
0035-9203</isbn><accession-num>7886779</accession-num><urls></urls><remote-database-provider>Nlm</remote-database-provider><language>eng</language></record></Cite></EndNote>[1]PRM & SSG17Belize Speciation via isoenzyme typing (23/34)L. braziliensisL. mexicanaMicroscopy and cultureRCT; Participants British soldiers, treated in the UK N/AN/AT1(n=17): paromomycin 14 mg/kg IV daily (max 1 g/day) x 20 days; T2(n=17): SSG 20 mg/kg IV daily x 20 days Primary: % cure at 1.5 months; Secondary: adverse eventsCure defined as completely re-epithelialized with lack of induration.paromomycin cured 10 of 17 lesions; SSG cured 15 of 17 lesions.paromomycin was not as effective as SSG in the treatment of CL from Belize, particularly in cases due to L. braziliensis. It was, however, safe and well tolerated. A single course of SSG can cure 88% of patients.Differed in lesion duration and sizeLoss not mentioned; followed for 6 months Openstated but method not explained4011100.50Oster 1985 ADDIN EN.CITE <EndNote><Cite><Author>Oster</Author><Year>1985</Year><RecNum>3082</RecNum><DisplayText>[2]</DisplayText><record><rec-number>3082</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">3082</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Oster, C. N.</author><author>Chulay, J. D.</author><author>Hendricks, L. D.</author><author>Pamplin, C. L., 3rd</author><author>Ballou, W. R.</author><author>Berman, J. D.</author><author>Takafuji, E. T.</author><author>Tramont, E. C.</author><author>Canfield, C. J.</author></authors></contributors><titles><title>American cutaneous leishmaniasis: a comparison of three sodium stibogluconate treatment schedules</title><secondary-title>Am J Trop Med Hyg</secondary-title><alt-title>The American journal of tropical medicine and hygiene</alt-title></titles><periodical><full-title>Am J Trop Med Hyg</full-title></periodical><alt-periodical><full-title>The American journal of tropical medicine and hygiene</full-title></alt-periodical><pages>856-60</pages><volume>34</volume><number>5</number><edition>1985/09/01</edition><keywords><keyword>Antimony Sodium Gluconate/*administration & dosage/therapeutic use</keyword><keyword>Clinical Trials as Topic</keyword><keyword>Drug Administration Schedule</keyword><keyword>Gluconates/*administration & dosage</keyword><keyword>Humans</keyword><keyword>Infusions, Parenteral</keyword><keyword>Leishmania</keyword><keyword>Leishmaniasis/*drug therapy</keyword><keyword>Random Allocation</keyword></keywords><dates><year>1985</year><pub-dates><date>Sep</date></pub-dates></dates><isbn>0002-9637 (Print)
0002-9637</isbn><accession-num>2994500</accession-num><urls></urls><remote-database-provider>Nlm</remote-database-provider><language>eng</language></record></Cite></EndNote>[2]SSG12Brazil & PanamaSpeciation via isoenzyme typing (26/36)L. braziliensisL. mexicana, L. chagasiMicroscopy and cultureRCT; Participants were Americans who acquired CL while travelling, aged >18 yearsN/AN/AT1(n=12): SSG 600mg IV daily x 10 days; T2(n=12): SSG loading dose of 600 mg IV followed by 600mg/day continuous infusion x 9 days; T3(n=12): SSG loading dose of 600 mg IV followed by 200 mg q8h x 9 daysPrimary: % cure at 12 months; Secondary: adverse eventsCure defined as complete healing of the lesions and negative aspiration culture after the treatment. "Healing" not defined.The cure rate after the first course of treatment was 64%, but was higher for T1 (100%) than for T2 (50%) or T3 (42%) (P < 0.01).Giving the same total amount of sodium stibogluconate in three divided doses or by continuous infusion offers no advantage over standard, once daily treatmentNot comparedLoss not mentioned; followed for 12 monthsNot mentionedRandomized via predetermined randomization schedule3.5011000.50Correia 1996 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Db3JyZWlhPC9BdXRob3I+PFllYXI+MTk5NjwvWWVhcj48
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ADDIN EN.CITE.DATA [3] PEN & PRM & MA15Brazil Monoclonal antibody and isoenzymesL. braziliensis noneMicroscopy and intra-dermal skin testRCT; Participants aged 12-56, lesions < 6 months in duration, mean 1 lesionN/AN/AT1(n=15): Pentamidine 4 mg/kg IM q 2 days x 8 sessions; T2(n=15): paromomycin 20 mg/kg IM daily x 20 days; T3(n=16): MA 10mg/kg IM daily x 20 daysPrimary: % cure at 1 year; Secondary: adverse eventsFailure of therapy was defined as ulceration of the skin lesion four months after treatment.One year after treatment, there was no significant difference in cure rates between IM paromomycin and IM Pentamidine. AE were not statistically different between groups. Statistical significance of the results between the three schedules used was not verified. No conclusion provided in the abstract (article in Portuguese)Differed in number of lesionsLoss not mentioned; followed for 1 year.OpenRandomized but method not explained3011000.50Oliveira-Neto 1997 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5PbGl2ZWlyYS1OZXRvPC9BdXRob3I+PFllYXI+MTk5Nzwv
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ADDIN EN.CITE.DATA [4] MA12 & 11BrazilMonoclonal antibody L. braziliensis (18/23) noneMicroscopy or culture and intra-dermal skin test RCT; Participants aged 11-66, lesions 1-11 months in durationN/AN/AT1(n=12): MA 5mg/kg IV daily x 30 days; T2(n=11): MA 20mg/kg IV daily x 30 daysPrimary: % cure; Secondary: adverse eventsCure was defined as complete re-epithelialisation of the lesion.Cure was observed in 83% in T1 and 82% in T2. AE included arthralgias and myalgias, mostly observed in T2.Low-dose and high-dose antimony may be equally effective for treatment of CLDiffered in the number of lesionsLoss not mentioned; followed for 7 years.Not mentionedRandomized by the chief-nurse into the 2 treatment groups4.5011100.50Almeida 1999 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BbG1laWRhPC9BdXRob3I+PFllYXI+MTk5OTwvWWVhcj48
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ADDIN EN.CITE.DATA [5]GM-CSF & SSG10BrazilPrevious studiesL. braziliensis noneMicroscopy and detection of antigen via serology or intra-dermal skin test RCT; Participants aged 10-50, presence of single ulcer of < 60 days in durationN/AN/AT1(n=10): GM-CSF 200 mcg weekly x 2 injections & SSG 20mg/kg IV daily x 20 days; T2(n=10): placebo injections & SSG 20mg/kg IV daily x 20 daysPrimary: % cure at 20 days; Secondary: none; Tertiary: speed of healingCure was defined as complete re-epithelialisation of the lesion.GM-CSF and antimony-treated patients healed faster than patients who received antimony alone (49 +/- 32.8 vs. 110 +/- 61.6 days, p<0.05). No AE bined GM-CSF and antimony significantly increased the chance of lesion healing in 40 daysNo significant differencesLoss not mentioned; followed for 180 daysDouble blindRandomized but method not explained5001110.51Figueiredo 1999 MA24 & 19 (mix of patients with CL and MCL)BrazilNot performedN/AnoneClinically diagnosed by examinationRCT; CL and MCL patients, aged 15-60N/AN/AT1(n=24): MA 14mg/kg IV daily for 2 cycles of 20 days (CL) or 3 cycles of 30 days (MCL); T2(n=19): MA 28mg/kg IV daily x 10 days followed by placebo x 10 days (7 with MCL and 12 CL).Primary: % cure at 2 yearsN/ATwo years after treatment, there was no significant difference in cure rates between MA 14 mg/kg/day and MA 28 mg/kg/day. N/AN/A4 out of 43 (9.3%); total follow-up time unknownDouble blindRandomized but method not explained2000000.51Machado-Pinto 2002 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYWNoYWRvLVBpbnRvPC9BdXRob3I+PFllYXI+MjAwMjwv
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ADDIN EN.CITE.DATA [6]Vaccine & MA51BrazilEndemic, speciation not performedL. braziliensis noneMicroscopy and intra-dermal skin testRCT; Participants aged 5-65, with mean 1 lesion. N/AN/AT1(n=51): L. amazonensis strain vaccine injected daily & MA 8.5 mg/kg IM daily x 10 days with repeat cycles every 10 days if necessary; T2(n=51): placebo vaccine & MA 8.5 mg/kg IM x 10 days with repeat cycles every 10 days if necessaryPrimary: % cure; Secondary: adverse events; Tertiary: speed of healingCure defined as complete re-epithelialisation of all lesions without relapseComplete cure occurred in 92% and 7.8% of participants in the respective groups at the end of treatment (short-term primary outcome, excluded from analysis). (p<0.0001); no significant side effectsThe combination of a single-strain Leishmania (Leishmania) amazonensis vaccine with a half dose regimen of antimonial was highly effective for the treatment of ACLDiffered in age of participants6 out of 102 (6%); followed for 1 yearDouble blindRandomized but method not explained5.51011011Santos 2004 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TYW50b3M8L0F1dGhvcj48WWVhcj4yMDA0PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [7] GM-CSF & MA11BrazilEndemic, speciation not performedL. braziliensis noneMicroscopy and detection of antigen via serology or intra-dermal skin testRCT; Participants aged 15-50, lesions < 60 days in duration. N/AT1(n=11): GM-CSF 10 mcg/ml ointment 3x/week x 3 weeks & MA 20 mg/kg IV daily x 20 daysT2(n=11): MA 20 mg/kg IV daily x 20 days & placebo ointmentPrimary: % cure at 40 days; Secondary: adverse events; Tertiary: speed of healingCure was defined as complete re-epithelialisation of the ulcerComplete cure occurred in 91% (10/11) and 45.5% (5/11) of participants in the respectivegroups. The mean healing time was 43 +/- 14 days in the GM-CSF group, and 104 +/- 79 days in the placebo group (p=0.043). No significant ically applied GM-CSF was effective in the management of CLNo significant differences2 out of 22 (9%); followed for 1 yearDouble blindRandomized, by randomization tables performed by a statistician60011111Lobo 2006 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Mb2JvPC9BdXRob3I+PFllYXI+MjAwNjwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA [8] RFT & MA17 & 20BrazilEndemic, speciation not performedL. braziliensis noneMicroscopy and detection of antigen via serology or intra-dermal skin testRCT; Participants aged 18-67, < 2 cutaneous lesions and < 10 cm in sizeN/AT1(n=17): radiofrequency thermotherapy (50°C x 30 sec) x 1 session & MA 20mg/kg IV daily x 20 daysT2(n=20): MA 20 mg/kg IV daily x 20 daysPrimary: % cure at 1 month; Secondary: adverse effectsNot definedAt 28 days, 75% of lesions were healing or healed in the heat therapy group and 90% in the control group (p=0.1261); 8 patients complicated with secondary bacterial infection of the lesion in the heat therapy group.No difference in cure rates between heat therapy and Glucantime and Glucantime aloneDiffered in gender allocation and number of lesions1 out of 37 (2.7%); followed for 1 monthNot mentionedRandomized but method not explained2001000.50Nascimento 2010 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OYXNjaW1lbnRvPC9BdXRob3I+PFllYXI+MjAxMDwvWWVh
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ADDIN EN.CITE.DATA [9]Vaccine & MA27 & 8 & 9BrazilEndemic, speciation not performedL. braziliensis noneMicroscopyRCT; Participants aged 18-60, lesions < 6 months in duration, mean 1 lesionN/AN/AAll patients received MA. T1(n=27): LEISH-F1+MPL-SE vaccine (consisting of 5 (n=9), 10 (n=9), or 20 μg (n=9) recombinant Leishmania polyprotein LEISH-F1 antigen and 25 μg MPL-SE adjuvant monthly x 3 doses; T2(n=8): received adjuvant alone; T3(n=9): received saline placeboPrimary: determine the safety and tolerability of the LEISH-F1 and MPL-SE vaccine; Secondary: evaluate the immunogenicity and the effect of the vaccine on the clinical course of CL.Cure defined as complete re-epithelialized, the patient was considered clinically curedThe vaccine was safe and well tolerated at all doses. Nearly all vaccine recipients and no adjuvant-alone or placebo recipients demonstrated an IgG antibody response to LEISH-F1 at Day 84. Also at Day 84, 80% of vaccine recipients were clinically cured, compared to 50% and 38% of adjuvant-alone and placebo recipients.The LEISH-F1+MPL-SE vaccine was safe and immunogenic in CL patients and appeared to shorten their time to cure when used in combination with meglumine antimoniate chemotherapy.Differed in gender allocation3 out of 44 (6.8%); followed for 11 monthsDouble blindRandomized but method not explained5.50111011Machado 2010 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYWNoYWRvPC9BdXRob3I+PFllYXI+MjAxMDwvWWVhcj48
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ADDIN EN.CITE.DATA [10]MIL & MA60 & 30BrazilPCRL. braziliensis noneMicroscopy, culture, and intra-dermal skin testRCT; Participants aged 2-65, lesions < 3 months in duration, no prior treatmentT1(n=60): Miltefosine 2.5mg/kg PO daily x 28 daysN/AT2(n=30): MA 20mg/kg IV daily x 20 daysPrimary: % cure at 6 months; Secondary: adverse eventsCure defined as complete re-epithelialisation, without raised borders, infiltrations or crusts were considered healedCure was observed in 53.3% with MA and 75% with miltefosine (p?=?0.04). Miltefosine was more effective than MA for 13-65 year olds vs 2-12 year olds (78.9% versus 45%, p?=?0.02). AE included GI symptoms with miltefosine and myalgias with MAThis study demonstrates that miltefosine therapy was more effective than standard MA and safe for the treatment of CL caused by Leishmania braziliensis in Bahia, Brazil.Differed in gender allocation and number of lesions3 out of 90 (3%); followed for 6 monthsOpenRandomized via computer-generated system61111010Sousa 2011 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Tb3VzYTwvQXV0aG9yPjxZZWFyPjIwMTE8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [11]FLU8 & 14 & 6Brazil Endemic, speciation not performedL. braziliensis noneMicroscopy and cultureNot an RCT; Fluconazole used in individuals with contraindications to pentavalent antimonials (elderly, renal or cardiac disease, diabetes), participants aged 2-88T1(n=8): Fluconazole 5mg/kg daily x 4-12 weeks; T2(n=14): fluconazole 6.5mg/kg daily x 4-12 weeks; T3(n=6): fluconazole 8 mg/kg daily x 4-12 weeksN/AN/APrimary: % cure; Secondary: time to cure; Tertiary: adverse eventsCure not definedAs the dose of fluconazole increased, the cure rate increased and the time to cure shortened. Those treated with 5 mg/kg/day had a cure rate of 75%, and healing took a mean of 7.5 weeks. Of those treated with 8 mg/kg/day, 100% were cured, and the time to healing was 4 weeks. Fluconazole was well tolerated in all patients.Fluconazole was used successfully to treat L. braziliensis infection. The cure rate with fluconazole was high. The dosages of fluconazole used were higher than the ones used by others to treat CLDiffered in gender allocation and duration of lesionsLoss and follow-up time not mentionedNot mentionedNot randomized10010000Chrusciak-Talhari 2011 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DaHJ1c2NpYWstVGFsaGFyaTwvQXV0aG9yPjxZZWFyPjIw
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ADDIN EN.CITE.DATA [12]MIL & MA60 & 30BrazilPCR-RFLP and enzyme electrophoresis L. guyanensisnoneMicroscopyRCT; Participants 2-65, 1 -5 lesions of < 3 months in durationT1(n=60): Miltefosine 2.5 mg/kg PO daily x 28 daysN/AT2(n=30): MA 15-20mg/kg IV daily x 20 daysPrimary: % cure at 6 months; Secondary: safety of miltefosine compared to antimonyCure defined as complete re-epithelialisation of all ulcers and complete disappearance of inflammatory induration.Cure rates were 71.4% and 53.6% for miltefosine and antimonial respectively. No severe AE occurred.Miltefosine was safe and relatively well tolerated and cure rate was higher than antimony.No significant differences3.6% in T1 and 3.5% in T2; followed for 6 monthsOpenRandomized via 2:1 allocation for miltefosine71111110Neves 2011 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OZXZlczwvQXV0aG9yPjxZZWFyPjIwMTE8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [13]MA & PEN & AMB74 & 74 & 37Brazil PCR-RFLPL. guyanensis (88.7%)L. braziliensisMicroscopy and cultureRCT Participants aged 5 to 65, primarily men, N/AN/AT1(n=74): MA 15 mg/kg IV or IM daily x 20 days; T2(n=74): Pentamidine 4 mg/kg IM q72hours x 3 doses; T3(n=37): amphotericin B 1mg/kg IV daily x 20 days. Primary: cure at 6 months; Secondary: adverse eventsCure defined as complete re-epithelialisation of all ulcers and absence of any signs of inflammatory reaction at 2 months.Intention-to-treat analysis showed efficacy of 58.1% for pentamidine and 55.5% for meglumine (p=0.857). 75% of the Amphotericin group refused to continue the study. AE included arthralgia with meglumine, and local pain with pentamidine.Pentamidine and meglumine show similar efficacy in the treatment of ATL caused by L. guyanensis. Given the low efficacy of both drugs, there is an urgent need for new therapeutical approaches.Only differed in gender distribution for AMB group, however this group was excluded from the efficacy analysis.75.7% receiving AMB refused to continue in the study; 6.2% loss in the other groups; followed for 6 monthsOpenRandomized via list of random distribution6.5111110.50Newlove 2011 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OZXdsb3ZlPC9BdXRob3I+PFllYXI+MjAxMTwvWWVhcj48
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ADDIN EN.CITE.DATA [14]MA45Brazil Endemic, speciation not performedL. braziliensis noneIntra-dermal skin testingRCT; Participants aged 13-50, < 4 lesions of 15-60 days in duration. All patients had a helminth infection; study evaluated the difference between early vs deferred treatment of intestinal helminths in the treatment of CL. T1(n=45): albendazole 400 mg PO, ivermectin 200 μg/kg PO, and praziquantel 50 mg/kg PO at Days 0 and 30 and placebo at Day 60; T2(n=45): placebo on day 0 and 30, and appropriate antihelmintic treatment based on parasitology assay on day 60. N/AAll patients received MA 20 mg/kg IV daily x 20 daysPrimary: % cure at 3 months; Secondary: time to cureCure defined as complete re-epithelialisation at 3 months.At the 90-day study endpoint, 51.1% in the control group had persistent lesions, compared with 62.2% in the treatment group. Patients who received early anthelmintic treatment took longer to heal their lesions than their non-treated counterparts, although this result was not statistically significant (P = 0.13).Cutaneous leishmaniasis and co-existing helminth infection was associated with poor response to therapy. However, introduction of early anthelmintic treatment in co-infected patients did not lead to improvement in overall cure rates or time to cure for CL and was associated with a tendency for delayed lesion healing.No significant differencesNo losses; followed for 3 monthsDouble blindrandomization tables6.5100.51111Motta 2012 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb3R0YTwvQXV0aG9yPjxZZWFyPjIwMTI8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [15]AMB & MA16 & 19BrazilMonoclonal antibodyL. braziliensis L. amazonensis, L. vianniaMicroscopy, culture, and intra-dermal skin testNot an RCT, prospective non-randomized study; Participants mean age 25 years, predominantly male, lesions > 6 months in duration, < 7 lesionsN/AN/AT1(n=16): Liposomal amphotericin B 1.5 mg/kg IV daily x 5 days; T2(n=19): MA 20 mg/kg IV daily x 20 days.Primary: % cureCure defined as complete re-epithelialisation of the lesion at 3 months.In T1, 50% experienced a clinical cure. There was 100% clinical cure in T2. AE included myalgia, arthralgia, tachycardia, headache and Hexheimer’s reaction with MA.Liposomal amphotericin B seemed to be promising and safe for the treatment of American cutaneous leishmaniasis.Differed in number of lesions and speciationLoss not mentioned; followed for 12 monthsOpenNot randomized3.5011100.50Toledo 2014 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Ub2xlZG8gSnVuaW9yPC9BdXRob3I+PFllYXI+MjAxNDwv
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ADDIN EN.CITE.DATA [16]AZI & MA24BrazilPCRL. braziliensisnoneMicroscopy, culture, and intra-dermal skin testRCT; Participants aged 14-65, mean 1.6 lesions, mean duration 3 months, treatment-naiveT2(n=24): Azithromycin 500mg PO daily x 20 dayN/AT1(n=24): MA 15mg/kg IV/IM daily x 20 daysPrimary: % cure at 3 months; Secondary: adverse eventsCure defined as complete re-epithelialisation without inflammatory infiltration and erythema until 90 days after the treatment ended.The study was interrupted due to the high failure rate in the azithromycin group. The MA group had a higher cure rate, with the ITT and PP analyses that were 54.2% vs 20.8% and 72.2% vs 23.8%, respectively.Azithromycin was ineffective for CL treatment and does not seem to have a role in the therapeutic arsenal for CL.Differed in lesion duration6 out of 48 (12.5%); followed for 6 monthsOpenRandomized via 1:1 allocation4.5011100.50Soto 2008 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Tb3RvPC9BdXRob3I+PFllYXI+MjAwODwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA [17]MIL & MA41 & 16BoliviaEndemic, speciation not performedL. braziliensis noneMicroscopyRCT; Participants aged 25-30, median 1 lesionT1(n=41): Miltefosine 2.5 mg/kg PO daily x 28 daysN/AT2(n=16): MA 20mg/kg IM daily x 20 daysPrimary: % cure at 6 months; Secondary: adverse events; Tertiary: speed of healingCure was defined as complete epithelialisation of all lesions by 6 months after the end of therapy.Cure rates were of 88% with miltefosine and of 94% with MA. More rapid healing was observed with MA. AE included gastrointestinal side effects with miltefosine and arthralgias with MA.The two conclusions from this work are that oral miltefosine can be used for cutaneous disease in this part of Bolivia and that miltefosine was more effective for L. braziliensis in this region than for L. braziliensis in Guatemala.No significant differences between treatment arms5 out of 62 (8%); followed for 1 yearOpenRandomized but method not explained4.50011110Solomon 2013 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Tb2xvbW9uPC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48
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ADDIN EN.CITE.DATA [18]AMB & SSG34BoliviaPCRL. braziliensis noneMicroscopy or cultureNot a RCT, prospective study, Mean age 24, mean 2 lesions, most (94% and 88%) acquired in BoliviaN/AN/AT1(n=34): Liposomal amphotericin B 3 mg/kg x 5 days, and a 6th dose on day 10; T2(n=34): SSG 20 mg/kg IV daily x 3 weeksPrimary: % cure; Secondary: adverse outcomeCure was defined as 100% re-epithelialisation of the ulcer within 3 months of treatment completionWith L-AMB 85% had complete cure compared with 70% in those receiving SSG (though difference not statistically significant). Treatment interrupted in 65% SSG patients because of parison of L-AMB to SSG treatment for L (V) braziliensis showed that the former was effective, better tolerated, and more cost effective. L-AMB should therefore be considered as the first-line treatment option for cutaneous L (V) braziliensis infectionNo significant differencesloss not mentioned; followed for mean 29 months (range 10 to 85)OpenNot randomized; treatment group determine by who had insurance to cover for L-AMB5.5111110.50Soto 2004A PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Tb3RvPC9BdXRob3I+PFllYXI+MjAwNDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA [19]SSG & MA48 & 16 & 50Bolivia & ColombiaMonoclonal antibodyL. panamensisnoneMicroscopyRCT; Participants aged 18-65, average 1.8 lesions. From La Paz, Bolivia, or Uraba and Carmen de Chucuri, ColombiaN/AN/AT1(n=48): SSG (generic) 20 mg/kg IM daily x 20 days; T2(n=16): SSG (Pentostam) 20 mg/kg IV daily x 20 days; T3(n=50): MA 20 mg/kg IM daily x 20 daysPrimary: % cure at 6 months; Secondary: adverse eventsCure was defined as complete epithelialisation of all lesions by 6 months after the end of therapy.There was no significant difference in cure rates between IM SSG and IM MA. Per-protocol cure rates and intention-to-treat cure rates for all pentavalent antimonials were 86% and 79%. More AE were reported with MAThe efficacy and tolerance of inexpensive generic stibogluconate was comparable to branded formulations for the treatment of CLDiffered in gender allocation and ulcer size10 out of 114 (8.8%); followed for 6 monthsDouble blindRandomized by playing cards60111011Soto 2004B PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Tb3RvPC9BdXRob3I+PFllYXI+MjAwNDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA [20]MIL49 & 24 & 40 & 20Colombia & GuatemalaMonoclonal antibody and PCRL. panamensis (100% from Colombia)L. braziliensis (63% Guatemala) & L. mexicana (37% Guatemala)Microscopy or cultureRCT; Participants aged >12 years, predominantly male, mean 1 lesionColombia: T1(n=49): Miltefosine 50 mg PO x 28 days; T2(n=24): placebo PO x 28 days; Guatemala: T1(n=40): Miltefosine 50 mg PO x 28 days; T2(n=20): placebo PO x 28 daysN/AN/APrimary: % cure at 6 months; Secondary: % remission and adverse eventsCure was defined as complete healing of all lesions by 6 months after the end of therapy.Colombia: per-protocol cure rates for miltefosine and placebo were 91% and 38%. Guatemala: per-protocol cure rates for miltefosine and placebo were 53% and 21%. AE included including creatinine and LFTsMiltefosine cure rate was lower than historic antimony cure rates of >90%; Miltefosine is a useful PO agent against CL due to L. panamensis in Colombia, but not against L. braziliensis in GuatemalaNo significant differences8 out of 133 (6%); followed for 6 monthsDouble blindRandomized but method not explained6.50111111Martínez 1992 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYXJ0aW5lejwvQXV0aG9yPjxZZWFyPjE5OTI8L1llYXI+
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ADDIN EN.CITE.DATA [21]ALL & MA25 & 33 & 35 & 17ColombiaEndemic, speciation via isoenzyme typingL. panamensisnoneMicroscopy, culture, and intra-dermal skin testRCT; Participants aged 11-40, predominantly male, 1-3 lesionsT1(n=25): Allopurinol 20 mg/kg PO daily x 15 days; T3(n=35): Allopurinol 20 mg/kg PO daily x 15 days & MA 20 mg/kg IV daily x 15 days; N/AT2(n=33): MA 20 mg/kg IV daily x 15 days; T4(n=17)?: no treatmentPrimary: % cure at 1 year; Secondary: % remissionCure was defined as complete epithelialisation at 3 months without recurrence by 1 year.Cure rate in T2 was 36%. The addition of allopurinol in T3 increased cure rate to 74% (p<0.001). Cure rate with allopurinol alone (T1) was 80% (p<0.001). No cures in T4. Only minor AE were reported. Cure rates were significantly higher in the oral allopurinol groupcompared with the MA group. There was no significant differencein cure rates between oral allopurinol alone and oral allopurinol incombination with MA. The efficacy of allopurinol alone appears to be as good as in combination. The validity of these conclusions have been questioned PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYXJ0aW5lejwvQXV0aG9yPjxZZWFyPjE5OTI8L1llYXI+
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ADDIN EN.CITE.DATA [21]Differed in age of participantsLoss not mentioned; followed for 1 yearOpenNot all groups randomized; Allopurinol alone and the group that received no treatment were self-selected4011100.50Soto 1994 ADDIN EN.CITE <EndNote><Cite><Author>Soto</Author><Year>1994</Year><RecNum>5304</RecNum><DisplayText>[22]</DisplayText><record><rec-number>5304</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">5304</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Soto, J.</author><author>Buffet, P.</author><author>Grogl, M.</author><author>Berman, J.</author></authors></contributors><auth-address>Bogota Military Hospital, Colombia.</auth-address><titles><title>Successful treatment of Colombian cutaneous leishmaniasis with four injections of pentamidine</title><secondary-title>The American journal of tropical medicine and hygiene</secondary-title><alt-title>Am J Trop Med Hyg</alt-title></titles><periodical><full-title>The American journal of tropical medicine and hygiene</full-title></periodical><alt-periodical><full-title>Am J Trop Med Hyg</full-title></alt-periodical><pages>107-11</pages><volume>50</volume><number>1</number><edition>1994/01/01</edition><keywords><keyword>Adult</keyword><keyword>Cohort Studies</keyword><keyword>Colombia</keyword><keyword>Follow-Up Studies</keyword><keyword>Humans</keyword><keyword>Leishmaniasis, Cutaneous/*drug therapy/pathology</keyword><keyword>Middle Aged</keyword><keyword>Pentamidine/administration & dosage/adverse effects/*therapeutic use</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>1994</year><pub-dates><date>Jan</date></pub-dates></dates><isbn>0002-9637 (Print)
0002-9637 (Linking)</isbn><accession-num>8304565</accession-num><work-type>Clinical Trial
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ADDIN EN.CITE.DATA [23]ALL & SSG51ColombiaSpeciation via isoenzyme typingL. braziliensis noneMicroscopy or culture and intra-dermal skin test RCT; Participants aged 18-57, 47% were farmers, 35% weresoldiersT1(n=51): Allopurinol 20 mg/kg PO daily x 15 days & SSG 20 mg/kg IV daily x 15 days; N/AT2(n=49): SSG 20mg/kg IV daily x 15 daysPrimary: % cure at 1 year; Secondary: % remission and adverse effectsCure was defined as complete epithelialisation at 3 months without recurrence by 1 year.Cure was observed in 39% in T2. The addition of allopurinol (T1) increased the cure rate to 71% (p=0.005). AE included chemical hepatitis with allopurinol.The combination of allopurinol and SSG was significantly more effective than SSG alone. The data support the use of allopurinol as an inexpensive, orally administered agent that can be used as an adjunctNo significant differences3 out of 100 (3%); followed for 1 yearOpenRandomized via master list generated by computer71111110Vélez 1997 ADDIN EN.CITE <EndNote><Cite><Author>Velez</Author><Year>1997</Year><RecNum>3153</RecNum><DisplayText>[24]</DisplayText><record><rec-number>3153</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">3153</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Velez, I.</author><author>Agudelo, S.</author><author>Hendrickx, E.</author><author>Puerta, J.</author><author>Grogl, M.</author><author>Modabber, F.</author><author>Berman, J.</author></authors></contributors><auth-address>PECET, Universidad de Antioquia, Madellin, Colombia.</auth-address><titles><title>Inefficacy of allopurinol as monotherapy for Colombian cutaneous leishmaniasis. A randomized, controlled trial</title><secondary-title>Ann Intern Med</secondary-title><alt-title>Annals of internal medicine</alt-title></titles><periodical><full-title>Annals of internal medicine</full-title><abbr-1>Ann Intern Med</abbr-1></periodical><alt-periodical><full-title>Annals of internal medicine</full-title><abbr-1>Ann Intern Med</abbr-1></alt-periodical><pages>232-6</pages><volume>126</volume><number>3</number><edition>1997/02/01</edition><keywords><keyword>Adult</keyword><keyword>Allopurinol/adverse effects/*therapeutic use</keyword><keyword>Antimetabolites/adverse effects/*therapeutic use</keyword><keyword>Antimony/therapeutic use</keyword><keyword>Antiprotozoal Agents/adverse effects/*therapeutic use</keyword><keyword>Female</keyword><keyword>Follow-Up Studies</keyword><keyword>Humans</keyword><keyword>Leishmaniasis, Cutaneous/*drug therapy</keyword><keyword>Male</keyword><keyword>Meglumine/therapeutic use</keyword><keyword>Organometallic Compounds/therapeutic use</keyword><keyword>Treatment Failure</keyword></keywords><dates><year>1997</year><pub-dates><date>Feb 1</date></pub-dates></dates><isbn>0003-4819 (Print)
0003-4819</isbn><accession-num>9027276</accession-num><urls></urls><remote-database-provider>Nlm</remote-database-provider><language>eng</language></record></Cite></EndNote>[24]ALL & MA56ColombiaMonoclonal antibodyL. panamensis (84%)L. braziliensis (16%)Microscopy or cultureRCT; Participants aged 6-60, mean 3 lesions. T1(n=60): Allopurinol 300 mg PO x 28 days; T2(n=56): placebo PO x 28 daysN/AT3(n=66): MA 20 mg/kg IM daily x 20 daysPrimary: % cure at 1 year; Secondary: % remission and adverse effectsCure was defined as complete epithelialisation at 3 months without recurrence by 1 year.Cure was observed in 18/55 (33%) in T1, 17/46 (37%) in T2, 52/56 (93%) in T3 (P<0.001). AE included myalgias, arthralgias, anorexia, nausea, and headache in patients receiving MA. Allopurinol monotherapy had no effect on Colombian cutaneous disease primarily caused by L. panamensisNo significant differences30 out of 187 (16%); followed for 1 yearDouble-blinded (except patients in MA group)Randomized but method not explained7111110.51Soto 1998 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Tb3RvPC9BdXRob3I+PFllYXI+MTk5ODwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA [25]PRM & MA30ColombiaIsoenzyme typing (in the 69/150 positive cultures)L. braziliensis (20/69) L. panamensis (49/69) Microscopy or cultureRCT; Participants aged 18-60, mean of 1.4 lesionsN/AT1(n=59): 15% paromomycin sulphate in 12% MBCL x 10 days & MA 20 mg/kg IV daily x 7 days; T3(n=31): 15% paromomycin sulphate in 12% MBCL x 10 days & MA 20 mg/kg IV daily x 3 daysT2(n=30): MA 20 mg/kg IV daily x 7 days & topical placebo x 10 days; T4(n=31): MA 20 mg/kg IV daily x 20 daysPrimary: % cure at 1 yearCure defined as complete re-epithelialisation of all lesions without relapseCure rates were 58%, 53%, 20%, and 84% for T1, T2, T3, and T4 respectively.10 days of treatment with paromomycin/MBCL did not augment the response of CL compared to a short-course of treatment with meglumine antimoniateNo significant differences2 out of 150 (1.3%); followed for 1 yearDouble-blindedRandomized, assigned in unequal allocation(2:1:1:1)7.51111111Palacios 2001 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QYWxhY2lvczwvQXV0aG9yPjxZZWFyPjIwMDE8L1llYXI+
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ADDIN EN.CITE.DATA [26]MA68ColombiaMonoclonal antibody and isoenzyme typingL. panamensis (84/88)L. braziliensis (4/88)Microscopy or cultureRCT; Participants were predominantly pediatric, with a median of 2 lesionsN/AN/AT1(n=68): MA 20 mg/kg IM daily x 10 days; T2(n=68): MA 20 mg/kg IM days x 20 daysPrimary: % cure at 1 yearCure was defined as complete re-epithelialisation of the all lesions at 13 weeks without relapses at 1 year.Efficacy of MA for a 10 day treatment was 61% compared to 67% for 20 days; there was significantly lower clinical response for children <5 years in both the 10 day(11%) and 20 day (25%) groups, compared with patients aged 5-14 years (67% and 75%) and 15+ years (81% and 83%)Overall efficacy of 10 day vs 20 day MA was similar; low efficacy rates largely explained by poor response in children compared to adultsDiffered in lesion size and presence of adenopathy54 out of 136 (39.7%); followed for 1 yearSingle-blinded (examiners only)Randomized via permutedblock randomisation6111100.50.5Soto 2002 ADDIN EN.CITE <EndNote><Cite><Author>Soto</Author><Year>2002</Year><RecNum>3139</RecNum><DisplayText>[27]</DisplayText><record><rec-number>3139</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">3139</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Soto, J. M.</author><author>Toledo, J. T.</author><author>Gutierrez, P.</author><author>Arboleda, M.</author><author>Nicholls, R. S.</author><author>Padilla, J. R.</author><author>Berman, J. D.</author><author>English, C. K.</author><author>Grogl, M.</author></authors></contributors><auth-address>Consorcio de Investigaciones Bioclinicas CIBIC, Bogota, Colombia.</auth-address><titles><title>Treatment of cutaneous leishmaniasis with a topical antileishmanial drug (WR279396): phase 2 pilot study</title><secondary-title>Am J Trop Med Hyg</secondary-title><alt-title>The American journal of tropical medicine and hygiene</alt-title></titles><periodical><full-title>Am J Trop Med Hyg</full-title></periodical><alt-periodical><full-title>The American journal of tropical medicine and hygiene</full-title></alt-periodical><pages>147-51</pages><volume>66</volume><number>2</number><edition>2002/07/24</edition><keywords><keyword>Administration, Cutaneous</keyword><keyword>Adult</keyword><keyword>Aminoglycosides/administration & dosage/*therapeutic use</keyword><keyword>Antiprotozoal Agents/administration & dosage/*therapeutic use</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Leishmaniasis, Cutaneous/*drug therapy/pathology</keyword><keyword>Male</keyword><keyword>Pilot Projects</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2002</year><pub-dates><date>Feb</date></pub-dates></dates><isbn>0002-9637 (Print)
0002-9637</isbn><accession-num>12135285</accession-num><urls><related-urls><url>;[27] PRM33 & 12ColombiaMonoclonal antibody (only in 5/45)L. panamensis (detected in 5/45)noneClinically diagnosed by examination, culture (only 5/45 successful)RCT; Participants were all male soldiers, mean aged 25 years, mean 1.6 lesions, 26% had failed MAN/AT1(n=33): Paromomycin in WR279396 x 20 days; T2(n=12): topical placebo x 20 daysN/APrimary: % cure at 70 days; Secondary: adverse events; Tertiary: speed of healingCure was defined as 100% re-epithelialisation of the lesion without relapse by the 6-month follow-up17/28 (61%) of T1patients were cured; 5/9 (55%) of T2 patients were cured (p=0.9); mean time to lesion cure was 35 days in T1 and 56 days in T2 (p=0.04); WR-group, 55% hadmild local reactions for 3.6 days, while 33% in placebo-groupWR279396 (a topical formulation of aminoglycosides) significantly accelerated cure time, but was not statistically more effective than placeboDiffered in lesion size8 out of 45 (17.8%); followed for 6 monthsSingle-blinded (examiners only)Randomized via 2:1 allocation2.5000100.50.5Lopez-Jaramillo 2010 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Mb3Blei1KYXJhbWlsbG88L0F1dGhvcj48WWVhcj4yMDEw
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ADDIN EN.CITE.DATA [28]NO & MA90ColombiaEndemic, speciation not performedL. panamensisnoneMicroscopy or cultureRCT; Participants aged 19-50N/AT2(n=88): nitric oxide releasing patch & placebo IM x 20 days T1(n=90): MA 20 mg/kg IM daily and placebo patch x 20 daysPrimary: % cure at 3 months; Secondary: adverse eventsCure was defined as complete re-epithelialisation of the ulcer The cure rates were 94.8% for MA compared with 37.1% for NO. A significantly lower frequency of non-serious adverse events and abnormal serum markers were observed in patients treated with NO. Treatment of CL with NO resulted in a lower effectiveness compared with Glucantime; however, the low frequency of adverse events and the facility of topic administration justify the development of new generations of NO systems for the treatment of CL.No significant differences between treatment arms35 out of 178 (19.6%); followed for 3 monthsDouble blindRandomized via computer-generated system6.5101110.51Velez I 2010 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5WZWxlejwvQXV0aG9yPjxZZWFyPjIwMTA8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [29]MIL & MA143ColombiaPCR-RFLPL. panamensis (38%)L. braziliensis (62%)CultureRCT; Participants mean age 25 years, male soldiers, mean 1 lesionT1(n=145): Miltefosine 50 mg PO TID x 28 daysN/AT2(n=143): MA 20 mg/kg IM daily x 20 daysPrimary: % cure of 6 months; Secondary: assess safety of miltefosine compared to meglumine antimoniateCure defined as complete re-epithelialisation of all ulcers and complete disappearance of the induration up to 3 months, without relapse at 6 months.The efficacy of miltefosine by protocol was 69.8% and 58.6% by intention to treat. For meglumine antimoniate, the efficacy by protocol was 85.1% and 72% by intention to treat.The efficacy of MA was statistically superior to that of miltefosine in the treatment of CL in Colombia (P = 0.003). No differences were found in the response to treatment based on the species responsibleNo significant differences between treatment arms39 out of 288 (13.5%); followed for 6 monthsOpenRandomized via computerized block randomization6.5111110.50Lopez 2012 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Mb3BlejwvQXV0aG9yPjxZZWFyPjIwMTI8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [30]RFT & MA149ColombiaPCRL. panamensisL. braziliensisMicroscopy, culture, and intra-dermal skin testRCT; Participants all male soldiers (no other demographics provided)N/AT1(n=149): Thermotherapy (50°C x 30 seconds) x 1 session & fusidic acid ointment x 10 daysT2(n=143): MA 20?mg/kg IM daily x 20?daysPrimary: % cure at 6 months; Secondary: adverse eventsComplete re-epithelialisation of all ulcers and complete loss of induration up to three months after the end of treatmentThe efficacy of thermotherapy was 64% (86/134 patients) by protocol and 58% (86/149) by intention-to-treat. For the meglumine antimoniate group, efficacy by protocol was 85% (103/121 patients) and 72% (103/143) by intention-to-treat. Significant difference. Although the efficacy rate of meglumine antimoniate was greater than that of thermotherapy for the treatment of cutaneous leishmaniasis, the side effects were also greater. This makes us consider thermotherapy as a first line treatment for cutaneous leishmaniasis.No table provided (only mentioned that patients balanced, but data not in article)31 out of 292 (10.6%); followed for 6 monthsOpenRandomized via generated list in blocks of eight5.5111100.50Rubiano 2012 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SdWJpYW5vPC9BdXRob3I+PFllYXI+MjAxMjwvWWVhcj48
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ADDIN EN.CITE.DATA [31]MIL & MA58ColombiaMonoclonal antibodies or isoenzyme electrophoresisL. panamensis (68-76%)L. guyanensis (20-30%)Microscopy and cultureRCT; Participants all pediatric (ages 2-12)T2(n=58): Miltefosine 1.8-2.5 mg PO daily x 28 daysN/AT1(n=58): MA 20 mg/kg IM daily x 20 daysPrimary: % failure at 26 weeksCure was defined as complete re-epithelialisation and absence of inflammatory signs for all lesionsBy intention-to-treat analysis, failure rate was 17.2% for miltefosine and 31% for meglumine antimoniate (p=0.04); Adverse events were mild for both treatments.Miltefosine is non-inferior to meglumine antimoniate for treatment of pediatric CL secondary to L. Viannia sp.Differed only slightly in lymphatic involvement.5 out of 116 (4.3%); followed for 6 monthsOpenRandomized via computerized balanced block randomization scheme71111110Lopez 2013 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Mb3BlejwvQXV0aG9yPjxZZWFyPjIwMTM8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [32]MIL & RFT143 & 147ColombiaPCR-RFLPL. braziliensisL. panamensisMicroscopyRCT; Participants all male soldiers, aged 19-39, mean 1 lesion, mean 2-3 months durationT1(n=143): Miltefosine 50 mg PO TID x 28 daysT2(n=147): Thermotherapy (Thermomed?, 50°C x 30 seconds) x 1 sessionN/APrimary: % cure at 6 months; Secondary: adverse eventsCure defined as complete re-epithelialisation of all ulcers and disappearance of induration up to three months following treatmentThe efficacy of miltefosine by protocol and by intention to treat was 70% (85/122 patients) and 69% (85/145 patients), respectively. AE included gastrointestinal symptoms for T1 and local pain in T2.No statistically significant difference was found in the efficacy analysis (intention to treat and protocol) between the miltefosine and thermotherapy.No significant differences35 out of 290 (12.0%); followed for 6 monthsOpenRandomized via block of eight6.5111110.50Guderian 1991 ADDIN EN.CITE <EndNote><Cite><Author>Guderian</Author><Year>1991</Year><RecNum>2996</RecNum><DisplayText>[33]</DisplayText><record><rec-number>2996</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">2996</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Guderian, R. H.</author><author>Chico, M. E.</author><author>Rogers, M. D.</author><author>Pattishall, K. M.</author><author>Grogl, M.</author><author>Berman, J. D.</author></authors></contributors><auth-address>School of Medicine, Central University of Ecuador, Quito.</auth-address><titles><title>Placebo controlled treatment of Ecuadorian cutaneous leishmaniasis</title><secondary-title>Am J Trop Med Hyg</secondary-title><alt-title>The American journal of tropical medicine and hygiene</alt-title></titles><periodical><full-title>Am J Trop Med Hyg</full-title></periodical><alt-periodical><full-title>The American journal of tropical medicine and hygiene</full-title></alt-periodical><pages>92-7</pages><volume>45</volume><number>1</number><edition>1991/07/01</edition><keywords><keyword>Allopurinol/*analogs & derivatives/therapeutic use</keyword><keyword>Antimony Sodium Gluconate/*therapeutic use</keyword><keyword>Antiprotozoal Agents/*therapeutic use</keyword><keyword>Ecuador</keyword><keyword>Humans</keyword><keyword>Leishmaniasis/*drug therapy</keyword><keyword>Ribonucleosides/*therapeutic use</keyword></keywords><dates><year>1991</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>0002-9637 (Print)
0002-9637</isbn><accession-num>1651060</accession-num><urls></urls><remote-database-provider>Nlm</remote-database-provider><language>eng</language></record></Cite></EndNote>[33]ALL & PRB & SSG30 & 30 & 15EcuadorMonoclonal antibodyL. panamensisL. braziliensis & L. mexicana & L. guyanensisMicroscopy or cultureRCT; Participants mean age 29 years, lesions 3-4 months in durationT1(n=30): Allopurinol ribonucleoside 1500 mg PO QID & probenecid 500 mg PO QID x 28 daysN/AT2(n=30): SSG 20mg/kg IM daily x 20 days; T3(n=15): no treatmentPrimary: % cure at 1.5 monthsCure defined as >80% re-epithelialisation by 1.5 monthsMean reduction in lesion size for patients in T2 group was 61%, 23% and 11% after 1, 2, and 3 weeks; mean reduction in lesions size for patients in T3 group was 56%, 29%, and 25% after 1, 2, and 3 weeks; 41%, 100%, 75% cure for patients in T1, T2, and T3 groups Allopurinol will be an oral agent available to augment standard therapyNot compared14 out of 75 (18.67%); followed for 1 yearNot mentionedRandomized via 2:2:1 allocation4.5011100.50Armijos 2004 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Bcm1pam9zPC9BdXRob3I+PFllYXI+MjAwNDwvWWVhcj48
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ADDIN EN.CITE.DATA [34]PRM & MA40EcuadorNot performedN/AnoneMicroscopy or cultureRCT; Participants aged 5-60, 1-3 lesions, lesions > 4 months in durationN/AT1(n=40): 15% paromomycin in 12% MBCL ointment daily x 3 months; T2(n=40): 15% paromomycin in 10% urea daily x 30 daysT3(n=40): MA 20 mg/kg IM daily x 10 daysPrimary: % cure at 2 months; Secondary: adverse events; Tertiary: speed of healingThe complete healing of all lesions by week 12 after the start of treatment with no relapse observed during the 52-week follow-up period was defined as a clinically cured case.Cure rates were 47.5%, 47.5% and 70% at 2 months but at 12 weeks were 79.3%, 70%, and 91.7% in T1, T2, and T3 (p>0.05). MA-treated (T3) subjects had a faster healing time (29.5 days vs. 43.1 days). AE included burning, redness, inflammation, and sorenessAlthough the time required for clinical healing of ulcerated lesions takes longer, topical paromomycin may be an acceptable alternative in endemic areas where meglumine antimoniate is unavailable, too costly, or contraindicatedDiffered in lesion size25 out of 120 (20.83%); followed for 1 yearDouble blinded, except T3Randomized via Computer-generated random numbers table3.51010000.5D’Oliveira 1997 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EJmFwb3M7T2xpdmVpcmEgSnVuaW9yPC9BdXRob3I+PFll
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ADDIN EN.CITE.DATA [35]ALL & MA18 & 16El SalvadorUnclear if speciated or based on endemicityL. braziliensis noneMicroscopy and/or cultureRCT; Participants had never received previous treatment T1(n=18): Allopurinol 20mg/kg PO TID x 20 days;N/AT2(n=16): MA 10 mg/kg IV daily x 20 daysPrimary: % cure at 70 days; Secondary: recurrence at 3 monthsCure not defined; defined therapeutic failureStudy stopped because 0/9 on Allopurinol showed response at 1 month, and 2/18 developed mucosal diseaseAllopurinol should not be used.Differed slightly in number of lesionsLoss not mentioned; followed for 12 monthsOpenRandomized but method not explained3.5001010.50Arana 1994 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BcmFuYTwvQXV0aG9yPjxZZWFyPjE5OTQ8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [36] MA & IFN- γ22GuatemalaSpeciation method not mentionedL. braziliensisL. mexicanaCultureRCT; Participants all Guatemalan male soldiers, aged 18-20, mean 1.2 lesionsN/AN/AT1(n=22): MA 20 mg/kg IV daily x 20 days; T2(n=22): MA 20 mg/kg IV daily x 10 days followed by placebo IV x 10 days; T3(n=22): MA 20 mg/kg IV daily x 10 days & IFN- γ (1 ml solution containing 0.2 mg of recombinant IFN-γ /ml) S/C every other day x 5 dosesPrimary: % cure at 1 year; Secondary: recurrence rate Cure defined as complete re-epithelialisation of all lesions with no residual erythema. Test-of-cure cultures at the end of therapy and at the 9 week follow-upCure was observed in 90% of patients receiving meglumine for 20 days, 90% of patients receiving meglumine for 10 days, and 100% of patients receiving meglumine plus interferon-gamma.The high efficacy of our 10-day course of meglumine indicates that the currently recommended duration of 20 days may be unnecessary for infections caused by L. braziliensisNo significant differences4 out of 66 (4.5%); followed for 12 months Double blindRandomized but method not explained5.50011111Arana 2001 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BcmFuYTwvQXV0aG9yPjxZZWFyPjIwMDE8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [37]PRM35 & 33GuatemalaEndemic, speciation not performedL. braziliensisL. mexicanaMicroscopy and cultureRCT; Participants aged 10-60, excluded patient with previous antimony-containing treatmentsN/AT1(n =35): 15% paromomycin in 12% MBCL BID x 20 days; T2(n=33): topical placeboN/APrimary: % cure at 1 yearCure defined as complete re-epithelialisation w/ no inflammation or indurations and no reactivationCure was observed in 85.7% in the treatment group and 39.4% in the placebo group (P < or = 0.001).Our findings show that the combination of paromomycin with methylbenzethonium chloride for 20 days is a good alternative for antimonial treatments of cutaneous leishmaniasis in Guatemala.No significant differences8 out of 76 (10.5%); followed for 12 months Double blindRandomized but method not explained6101110.51Navin 1990 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OYXZpbjwvQXV0aG9yPjxZZWFyPjE5OTA8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [38] RFT & MA22Guatemala Endemic, speciation not performedL. braziliensisL. mexicanaMicroscopy and cultureRCT Participants all male soldiers, aged 18-60years, mean 1 lesionN/AT2(n=22): Thermotherapy (50?C for 30 sec) weekly x 3 treatmentsT1(n=22): MA 850 mg IM daily x 15 days; T3(n=22): placebo treatmentPrimary: % cure at 2 months; Secondary: adverse effectsCure defined as complete re-epithelialisation with no evidence of papules, inflammation or indurationCure was observed in 73% receiving meglumine antimoniate, 73% receiving heat therapy, and 27% receiving placebo. Speed of healing was slower with heat therapy.Although neither meglumine antimoniate nor heat therapy proved completely effective, both treatments were more effective than the placebo treatment. Heat treatment was not better than meglumine antimonite.Not comparedLoss not mentioned; followed for 52 weeksSingle blinded (patient)Randomized, but method not explained3.5001100.50.5Navin 1992 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OYXZpbjwvQXV0aG9yPjxZZWFyPjE5OTI8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [39]KET & SSG40Guatemala Speciation via isoenzyme typingL. braziliensis L. mexicana Microscopy and cultureRCT; Participants Guatemalan civilians and soldiers, aged 19-22, mean 1.5 lesionsT1(n=40): Ketoconazole 600 mg PO daily x 28 daysN/AT2(n=40): SSG 20 mg/kg IV daily x 20 days; T3(n=40): placebo (either saline infusions or placebo tablets)Primary: % cure at 2 months; Secondary: recurrence rate within 1 year Cure defined as complete re-epithelialisation and no evidence of inflammationAmong patients infected with L. braziliensis, 24/25 (96%) receiving SSG but 7/23 (30%) receiving ketoconazole were cured. Among L. mexicana infected patients, 4/7 (57%) receiving SSG but 8/9 (89%) receiving ketoconazole were cured.These differences emphasize the importance of speciation in the treatment of leishmaniasis. However, the small sample size for each strain limits these resultsDiffered in lesion size7 out of 120 (5.83%); followed for 52 weeks Single blinded Randomized via computer algorithm6.51111010.5Neva 1997 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OZXZhPC9BdXRob3I+PFllYXI+MTk5NzwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA [40]PRM23 & 30Honduras Speciation via isoenzyme typingL. chagasiL. mexicanaCultureRCT; Participants were inhabitants from the municipalities of San Juan Bautista and CoyolitoN/AT1(n=23): 15% paromomycin in 10% urea TID x 4 weeks; T2(n=30): topical placebo TID x 4 weeksN/APrimary: % cure at 3 months; Secondary: recurrence rate after 4-5 monthsCure not defined.The treatment was not effectiveTopical therapy with 15% paromomycin and 10% urea was not better than placebo in treating non-ulcerating cutaneous leishmaniasis. No table provided (only mentioned that patients balanced, but data not in article)Loss not mentioned; followed for 11 weeks Double blindRandomized by a computer algorithm4.5011000.51Balou 1987 SSG21 & 19PanamaMonoclonal antibody (23/40 patients)L. panamensisL. chagasiMicroscopy and cultureRCT; Participants were American soldiers on duty in Panama treated in Washington N/AN/AT1(n=21): SSG 10 mg/kg IV daily x 20 days; T2(n=19): SSG 20 mg/kg IV daily x 20 days.Primary: % cured at 1.5 months; Secondary: adverse eventsCure not defined.Nine weeks after starting treatment, all 19 patients treated with SSG 20 mg/kg/day were cured but 5/21 patients treated with SSG 10 mg/kg/day had persistent active disease (p < 0.05).Higher doses of sodium stibogluconate are both safe and efficacious at treating American cutaneous leishmaniasis. Lower doses are inadequate for some patients.No significant differencesLoss not mentioned; followed for 12 months Double blindRandomized but method not explained5011010.51Saenz 1987 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TYWVuejwvQXV0aG9yPjxZZWFyPjE5ODc8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [41]SSG & MA30 & 29PanamaN/AL. panamensisnoneMicroscopy and cultureRCT; Participants primarily male inhabitants of the provinces of Panama and ColonN/AN/AT1(n=30): SSG 20 mg/kg IM daily x 20 days; T2(n=30): MA 20 mg/kg IM daily x 20 days.Primary: % cured; Secondary: recurrence at 1 year & adverse eventsN/AN/A (Article only in Spanish)N/A (Article only in Spanish)N/A9 out of 59 (15.3%); followed for 12 monthsNot mentionedRandomized, method unknown (article only in Spanish)3101000.50Saenz 1990 ADDIN EN.CITE <EndNote><Cite><Author>Saenz</Author><Year>1990</Year><RecNum>5592</RecNum><DisplayText>[42]</DisplayText><record><rec-number>5592</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">5592</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Saenz, R. E.</author><author>Paz, H.</author><author>Berman, J. D.</author></authors></contributors><auth-address>Gorgas Memorial Institute, Panama City, Republic of Panama.</auth-address><titles><title>Efficacy of ketoconazole against Leishmania braziliensis panamensis cutaneous leishmaniasis</title><secondary-title>Am J Med</secondary-title><alt-title>Am J Med</alt-title></titles><periodical><full-title>Am J Med</full-title><abbr-1>The American journal of medicine</abbr-1></periodical><alt-periodical><full-title>Am J Med</full-title><abbr-1>The American journal of medicine</abbr-1></alt-periodical><pages>147-55</pages><volume>89</volume><number>2</number><edition>1990/08/01</edition><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Antimony Sodium Gluconate/adverse effects/*therapeutic use</keyword><keyword>Gluconates/*therapeutic use</keyword><keyword>Humans</keyword><keyword>Ketoconazole/adverse effects/*therapeutic use</keyword><keyword>Leishmaniasis/diagnosis/*drug therapy</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Randomized Controlled Trials as Topic</keyword><keyword>Testosterone/blood</keyword></keywords><dates><year>1990</year><pub-dates><date>Aug</date></pub-dates></dates><isbn>0002-9343 (Print)
0002-9343 (Linking)</isbn><accession-num>2166429</accession-num><work-type>Clinical Trial
Comparative Study
Randomized Controlled Trial</work-type><urls><related-urls><url>;[42] KET & MA22 & 19 & 11PanamaSpeciation via isoenzyme typing (31/41)L. panamensisL. mexicanaMicroscopy and cultureRCT; Participants all male, aged 16-67, mean 2.1 and 2.6 lesions per treatment arm. T1(n=22): Ketoconazole 600 mg PO daily x 28 days; T3(n=11): placebo PO daily x 28 days.N/AT2(n=19): MA 20 mg/kg IM (max 850 mg/day) daily x 20 daysPrimary: % cure at 3 months; Secondary: adverse events; Tertiary: speed of healingCure defined as complete re-epithelialisation and no clinical relapse in the f/u period Ketoconazole clinically cured 16/21 (76%). Pentostam cured 13/19 (68%). The placebo group had a 0% cure rate.Both ketoconazole and Pentostam were more effective than placebo against L. panamensis. Ketoconazole is comparable in efficacy to Pentostam.Significant difference in lesion size and durationLoss not mentioned; followed for 12 months Not mentionedRandomized via card drawing 4.5011100.50Sosa 2013 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Tb3RvPC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA [43]PRM15PanamaIsoenzyme electropheresis or PCRL. panamensisnoneMicroscopy and cultureRCT; Participants mean age 25 years, mean 2 lesions, mean 2-3 months durationN/AT1(n=15): topical WR 279,396 (15% paromomycin & 0.5% gentamicin) applied daily x 20 days; T2(n=15): 15% paromomycin daily x 20 daysN/APrimary: % cure at 6 months; Secondary: adverse eventsCure defined as complete re-epithelialisation of index lesion by nominal Day 63The index lesion cure rate after 6 months follow-up was 13 of 15 (87%) for WR 279,396 and 9 of 15 (60%) for Paromomycin Alone (P = 0.099). No significant AE.The increased final cure rate in the WR 279,396 group in this small Phase 2 study suggests that the combination product may provide greater clinical benefit than paromomycin monotherapy.Differed in lesion duration and sizeNo losses; followed for 6 monthsDouble blindRandomized via 1:1 allocation60111011Andersen 2005 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BbmRlcnNlbjwvQXV0aG9yPjxZZWFyPjIwMDU8L1llYXI+
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ADDIN EN.CITE.DATA [44]PEN & MA40PeruIsoenzyme electrophoresisL. braziliensis noneMicroscopy or cultureRCT; Participants aged 18-60, predominantly male, mean 2 lesionsN/AN/AT1(n=40): Pentamidine 2 mg/kg IV on alternate days x 7 doses; T2(n=40): MA 20 mg/kg IV daily x 20 daysPrimary: % cure at 6 months; Secondary: adverse events; Tertiary: histopathological cureClinical cure was defined as completely re-epithelialized by 6 months. Parasitological cure was defined as the inability to culture or stain parasites from the lesion78% cure rate in patients administered Glucantime (T2); 35% cure in patients administered Pentamidine (T1)Glucantime is more effective than pentamidine for treatment of L. braziliensis CL in Peru based on parasitological as well as clinical criteriaNo significant differences6 out of 80 (7.5%); followed for 6 monthsOpenRandomized via 1:1 allocation71111110Miranda-Verástegui 2005 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NaXJhbmRhLVZlcmFzdGVndWk8L0F1dGhvcj48WWVhcj4y
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ADDIN EN.CITE.DATA [45]IMQ & MA20PeruEndemic, speciation not performedL. braziliensis L. peruvianaMicroscopy, culture, and/or PCRRCT; Participants aged 1-78, predominantly pediatric; history of one or more failed courses of treatment with MA N/AT1(n=20): 5% imiquimod cream applied every other day x 20 days & MA 20 mg/kg IM daily x 20 days; T2(n=20): MA 20 mg/kg IM daily x 20 days & topical placebo creamPrimary: % cure at 1 year; Secondary: adverse eventsCure was defined as complete re-epithelialisation without signs of inflammationLesions resolved more rapidly in imiquimod group: 50% cure at 1 month vs 15% for control group (p=0.02), 61% at 2 months vs. 25% (p=0.03), and 72% cure at 3 months vs. 35% (p=0.02); erythema occurred more often in T1 (p=0.02); One year after treatment, there was no significantdifference in cure rates btw both armsCombined antimony plus imiquimod treatment was well tolerated, accelerated lesion healing, and improved scar quality; this therapy may have particular advantages for subjects with facial lesionsDiffered in lesion duration2 out of 40 (5%); followed for 1 yearDouble blindRandomized but method not explained4.50011011Arévalo 2007 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BcmV2YWxvPC9BdXRob3I+PFllYXI+MjAwNzwvWWVhcj48
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ADDIN EN.CITE.DATA [46]IMQ & MA6PeruEndemic, speciation not performedL. braziliensis L. peruviana & L. mexicana & L. amazonensiMicroscopy, culture, and/or PCRRCT; Participants aged 18-87N/AT1(n=6): 7.5% imiquimod cream applied every other day x 20 days; T2(n=7): 7.5% imiquimod cream applied every other day x 20 days & MA 20 mg/kg IV daily x 20 days; T3(n=7): MA 20 mg/kg IV daily x 20 daysPrimary: % cure at 3 months; Secondary: adverse eventsClinical cure was defined as complete re-epithelialisation without signs of inflammation.Although several patients showed initial resolution with imiquimod alone (T1), all relapsed after treatment discontinuation; 57% of those receiving meglumine alone (T3) and 100% of those receiving combination treatment (T2) were cured; combination treatment was more effective (p<0.05)Combination therapy with imiquimod and meglumine is a promising regimen for initial treatment of CL and warrants additional larger studiesDiffered in lesion size, location, and durationLoss not disclosed; Followed for 3 yearNot mentionedRandomized but method not explained3001100.50Llanos-Cuentas 2008 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5MbGFub3MtQ3VlbnRhczwvQXV0aG9yPjxZZWFyPjIwMDg8
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ADDIN EN.CITE.DATA [47]SSG127PeruPCRL. peruviana (49.6%)L. braziliensis (22.8) & L. guyanensis (21.3%), other sp. (6.3%)Microscopy, culture, and intra-dermal skin testNot an RCT, prospective case-control study; Participants aged 2-51, mean 2 lesionsN/AN/AT1(n = 127): SSG 20mg/kg IV or IM daily x 20 daysPrimary: % failure at 6 monthsClinical cure was defined as complete wound closure and re-epithelialisation without inflammation or infiltrationFailure rate at 6 months was 24.4%, with 96% of the failures occurring in the first 3 months; clinical risk factors associated with failure were younger age, a shorter stay in an area of disease acquisition, shorter duration of disease, additional lesions, and infection with L. peruviana or L. braziliensisThe identification of parasite species and clinical risk factors for antimonial treatment failure should lead to improved management of CL in PeruSingle treatment armLoss not mentioned; followed for 6 monthsOpenNot randomized4.5111100.50Miranda-Verastegui 2009 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NaXJhbmRhLVZlcmFzdGVndWk8L0F1dGhvcj48WWVhcj4y
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ADDIN EN.CITE.DATA [48]IMQ & MA39 & 36PeruPCRL. peruvianaL. braziliensis & L. guyanensisMicroscopy, culture, and/or PCRRCT; Participants aged 5–65, lesions > 4 weeks in duration, acquired lesions primarily in the jungleN/AT1(n=39): Imiquimod cream applied 3x/week x 9 applications; T2(n=36): placebo cream applied 3x/week x 9 applications.All participants in T1 and T2 also received MA 20 mg/kg IV daily x 20 daysPrimary: % cure at 12 months; Secondary: adverse eventscure defined as complete re-epithelialisation with no inflammation assessed during the 12 months post-treatment period.The cure rate at 12-month for the ITT analysis was 75% (30/40) in T1 and 58% (23/40) in T2 (p = 0.098). Subgroup analyses suggested that combination treatment benefits were most often observed with L. braziliensis infections. Over the study period, only one adverse event (rash) was recorded, in the experimental arm.The combination treatment of imiquimod plus pentavalent antimony performed better than placebo plus pentavalent antimony, but the difference was not statistically significant.No significant differences between treatment arms5 out of 80 (6.25%); followed for 6 monthsDouble blindRandomized but method not explained7.51111111van der Meide 2009 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj52YW4gZGVyIE1laWRlPC9BdXRob3I+PFllYXI+MjAwOTwv
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ADDIN EN.CITE.DATA [49]PEN23SurinamePCR-RFLPL. guyanensisnoneMicroscopy or smearNot RCT, prospective single arm study; Participants aged 17-65, mean 2 lesions of median 7 weeks in durationN/AN/AT1(n=23): pentamidine isethionate 300 mg IM weekly x 3-4 dosesPrimary: patient compliance to treatment; Secondary: % cure at 10 weekslesion was judged on the following criteria: re-epithelialisation and degree of contraction, decrease in necrotic tissue, and decrease in border activity.A lower cure rate (76-78%) was estimated than that obtained previously (90%), and only 50% of the recruited CL patients finished the complete treatment schedule.As one-half of the CL patients were treated insufficiently, a much shorter treatment protocol should be considered to improve the inadequate follow-upSingle treatment arm8 out of 23 (34.9%); followed for 2.5 monthsOpenNot randomized3.5011100.50Convit 1987 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Db252aXQ8L0F1dGhvcj48WWVhcj4xOTg3PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [50]Vaccine & MA124 & 51VenezuelaMono- or poly-clonal antibody and PCRL. braziliensis noneMicroscopy, culture, and intra-dermal skin testRCT; Participants aged >12 years, lesions < 12 months in durationN/AN/AT1(n=44): MA 50 mg/kg IM daily x 20 days for 2-3 courses with 15 day intervals; T2(n=58): vaccine (L. mexicana amazonensis with BCG), the amount used in 1st dose depended on response to TBST, a 2nd dose was given at 6-8 weeks, and a 3rd dose at 12-18 weeks Primary: % cure at 6 months; Secondary: adverse events; Tertiary: speed of healing, development of cell-mediated immunityClinical cure defined as complete healing of the lesion without evidence of infiltration or lymphangitis.The vaccine gave a similar cure rate (94%) to three 20-day courses of MA. AE were few with the vaccine, and with MA. AE included myalgias, headache, fever, hypotension, cardiac arrhythmia, and paresthesia.Immunotherapy is a low-cost, low-risk alternative to chemotherapy in localised CLNo significant differences between treatment arms8 out of 102 (7.8%); followed for 40 weeksSingle blind (examiner)Randomized but method not explained61110110.5Convit 1989 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Db252aXQ8L0F1dGhvcj48WWVhcj4xOTg5PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [51]Vaccine & MA124 & 51 & 42 VenezuelaMono- or poly-clonal antibody and PCRL. braziliensis noneMicroscopy and cultureRCT; Participants aged > 12 years, lesions < 12 months in duration N/AN/AT1(n=124): vaccine (L. mexicana amazonensis with BCG) q6-8weeks x 3 doses; T2(n=51): MA 50 mg/kg IM daily x 20 days, for 2-3 courses with 15 day intervals; T3(n=42): intradermal BCG q6-8weeks x 3 dosesPrimary: % cure at 6 months; Secondary: adverse events; Tertiary: speed of healingClinical cure defined as complete healing of the lesion and absence of peripheral infiltration/inflammation, satellite lesions, adenopathy, lymphangitis, or new lesions.In T1 and T2, there was a 90% cure rate, with an average time to healing of 16-18 weeks.T3 had significantly lower cure rates. AE included arrhythmia, severe myalgias, colic, paresthesia with bined vaccine is efficacious for American CL; provides a strong rationale for studying vaccine effectiveness in prophylactic trialsNo significant differences between treatment armsLoss not mentioned; followed for 2 yearsSingle blind (examiner)Randomized via random sequence generation6111010.50.5INTERNATIONAL TRIALS???????????????????0???????Wortmann 2010 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Xb3J0bWFubjwvQXV0aG9yPjxZZWFyPjIwMTA8L1llYXI+
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ADDIN EN.CITE.DATA [52]AMB20Iraq (5), Afghanistan (5), Peru (1), French Guiana (1), Honduras (2), Colombia (6)Isoenzyme electrophoresisL. braziliensis (3), L. guyanensis (3)L. panamensis (4), L. tropica (2), L. major (3)Microscopy and cultureNot an RCT, retrospective study; Participants predominantly male soldiers, mean age 29 years, mean 1 lesionN/AN/AT1(n=20): Liposomal amphotericin B 3mg/kg IV daily x 10 doses given within a 21-day periodPrimary: % cure; Secondary: adverse eventsNot defined16/19 experienced a cure with the initial treatment regimen. 3 patients needed additional doses to achieve cure. Acute infusion-related reactions occurred in 25%, and mild renal toxicity occurred in 45% of patients. Although the optimum dosing regimen is undefined and the cost and toxicity may limit widespread use, liposomal amphotericin B is a viable treatment alternative.Single treatment arm1 out of 20 (5%); followed for mean 4 monthsOpenNot randomized30110010Harms 2011 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IYXJtczwvQXV0aG9yPjxZZWFyPjE5OTE8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [53]AMB & MA13 & 8 & 2Bolivia, Brazil, Costa Rica, Ecuador, French Guiana, Peru PCR-RFLPL. braziliensisnoneMicroscopy and/or cultureNot an RCT, retrospective study of German travelers to Central and South America, treated in GermanyT2(n=8): miltefosine 2.5 mg/kg PO daily TID x 28 days; N/AT1(n=13): Liposomal amphotericin B 3 mg/kg IV on days 1-5 and day 10; T3(n=2): MA 20 mg/kg IV daily x 21 days Primary: % cure; Secondary: adverse eventsCure defined as completely re-epithelialized without inflammation.Cure achieved with amphotericin B in 11/13 patients, miltefosine in 5/8, and meglumine antimoniate in 2/2. Of the patients who failed initial therapy, four were cured with meglumine antimoniate and one with amphotericin B.Amphotericin B, miltefosine, and meglumine antimoniate proved to be effective. Conventional meglumine antimoniate showed high efficacy as a first-line treatment.Patient demographics individually listed, but not comparedLoss not mentioned; followed for 12 month OpenNot randomized3.5011100.50Morizit 2013 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb3Jpem90PC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48
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ADDIN EN.CITE.DATA [54]AMB & MIL & MA168InternationalPCR-RFLPmanymanyMicroscopy and/or cultureNot an RCT, retrospective analysis of data on returned travelers collected by experts with the French leishmaniasis reference center. N/ATreated via a stepwise algorithm: in situation 1, wound care measures are employed; in situation 2, local therapy is employed (cryotherapy, IL MA, or topical paromomycin)Treated via a stepwise algorithm: in situation 3, systemic therapy is employed (MA, Amphotericin B, or miltefosine) Primary: % cure at 3 months; Secondary: adverse eventsCure defined as positive outcome at 42-60 days23/25 (92%) with wound care alone had positive outcome (mostly L. major, L. tropica, L. aethiopia). 37/47 (79%) had positive outcome with local therapy; 4/19 (21%) with L. braziliensis or L. panamensis. 22/37 (60%) receiving systemic therapy had positive outcome.Stepwise therapy as per the French guidelines allows for safe and reasonable patient outcome at 42-60 daysNot comparedLoss not mentioned; followed for 2 monthsOpenNot randomized3.5111000.50OLD WORLD CUTANEOUS LEISHMANIASIS???????????????????0???????Reithinger 2005 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SZWl0aGluZ2VyPC9BdXRob3I+PFllYXI+MjAwNTwvWWVh
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ADDIN EN.CITE.DATA [56]SSG172AfghanistanPCR-RFLPL. majornoneMicroscopyNot an RCT, case series by the Dutch militaryN/AT1(n=172): SSG IL q 1-3 days until clinical improved. If no improvement, alternative treatments were startedN/APrimary: % cure at 6 monthsCure defined as complete re-epithelialisationSatisfactory response to IL SSG +/- cryotherapy in 77%; 19.5% treated with miltefosine. 6 month cure 77%.Natural evolution played a role in this observational study, which showed cure of all patients at six months. Management of CL was feasible under field conditions.Single arm studyLoss 9.6%; followed for 6 monthsOpenNot randomized51111010van Thiel 2010B PEVuZE5vdGU+PENpdGU+PEF1dGhvcj52YW4gVGhpZWw8L0F1dGhvcj48WWVhcj4yMDEwPC9ZZWFy
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ADDIN EN.CITE.DATA [57]MIL34 AfghanistanPCR-RFLPL. majornoneMicroscopy and/or cultureNot an RCT, observational study; Participants aged 19-49, predominantly male Dutch military personnelT1(n=34): miltefosine 50 mg PO TID x 28 daysN/AN/APrimary: % cure; Secondary: adverse eventCure defined as re-epithelialisation at 6 monthsAll patients had experienced clinical improvement at the end of treatment, but no cure. At 6 months, 28 patients had definite cure. AE included diminution of ejaculate volumeMiltefosine efficacious for L. major. Single arm studyNo losses; followed for 6 monthsOpenNot randomized51111010Safi 2012 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TYWZpPC9BdXRob3I+PFllYXI+MjAxMjwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA [58]RFT & ILMA195AfghanistanEndemic, speciation not performedL. tropicanoneMicroscopyRCT; Participants aged 5-75, primarily pediatric N/AT1(n=195): radiofrequency thermotherapy (50°C x 30 sec) x 1 session; T2(n=195): MA IL weekly x 5 dosesN/APrimary: % cure at 6 monthsCure defined as complete re-epithelialisation Cure was observed in 83% in T1 compared to 74% in T2; outcomes were better if the lesion smaller or nodularA single treatment with thermotherapy was more effective than 5 days of intralesional Glucantime. It is also more cost-effective and has fewer side effects.No significant differences5 out of 390 (1%); followed for 6 monthsOpenRandomized via picking pieces out of a hat61011110Jebran 2014 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5KZWJyYW48L0F1dGhvcj48WWVhcj4yMDE0PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [59]EC & MWT73 & 62AfghanistanPCR-RFLPL. tropicanoneMicroscopy and/or cultureRCT; Participants aged 5-66, lesions 1-12 months in durationN/AT1(n=73): Bipolar high frequency electro-cauterization followed by MWT with polyacrylate hydrogel and sodium chlorite applied daily; T2(n=62): Bipolar high frequency electro-cauterization, followed by MWT with polyacrylate hydrogel without sodium chlorite applied dailyN/APrimary: % cure at 6 monthsCure defined as complete re-epithelialisationCure in both groups was more rapid than historical cure time by IL MA, but no different between T1 and T2 (43 and 42 days respectively).Bipolar high frequency electro-cauterization (EC) followed by daily moist-wound-treatment leads to rapid wound healing.No significant differences22 out of 135 (16.3%); followed for 6 monthsDouble blindRandomized via computer algorithm7.5111110.51Stahl 2014 ADDIN EN.CITE <EndNote><Cite><Author>Stahl</Author><Year>2014</Year><RecNum>3143</RecNum><DisplayText>[60]</DisplayText><record><rec-number>3143</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">3143</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Stahl, H. C.</author><author>Ahmadi, F.</author><author>Schleicher, U.</author><author>Sauerborn, R.</author><author>Bermejo, J. L.</author><author>Amirih, M. L.</author><author>Sakhayee, I.</author><author>Bogdan, C.</author><author>Stahl, K. W.</author></authors></contributors><titles><title>A randomized controlled phase IIb wound healing trial of cutaneous leishmaniasis ulcers with 0.045% pharmaceutical chlorite (DAC N-055) with and without bipolar high frequency electro-cauterization versus intralesional antimony in Afghanistan</title><secondary-title>BMC Infect Dis</secondary-title><alt-title>BMC infectious diseases</alt-title></titles><periodical><full-title>BMC Infect Dis</full-title><abbr-1>BMC infectious diseases</abbr-1></periodical><alt-periodical><full-title>BMC Infectious Diseases</full-title></alt-periodical><pages>619</pages><volume>14</volume><edition>2014/11/26</edition><dates><year>2014</year></dates><isbn>1471-2334</isbn><accession-num>25420793</accession-num><urls></urls><custom2>Pmc4258014</custom2><electronic-resource-num>10.1186/s12879-014-0619-8</electronic-resource-num><remote-database-provider>Nlm</remote-database-provider><language>eng</language></record></Cite></EndNote>[60]SSG & EC & MWT24 & 32 & 31 AfghanistanPCR-RFLPL. tropicaL. majorMicroscopy or smearRCT; Participants aged 19-40, lesions 7-11 months in durationN/AT1(n=24): SSG IL twice weekly x 4 weeks; T2(n=32): high-frequency electro-cauterization and MWT with 0.045% DAC N-055; T3(n=31): MWT with 0.045% DAC N-055N/APrimary: ratio of closed versus open wounds 2.5 monthsCure defined as complete re-epithelialisationPP analysis of 69 (79%) patients revealed complete epithelialisation before day 75 in 65% in T1, 100% in T2, and 87% T3 (p = 0.004). Re-ulceration occurred 17%, 13%, 30% respectively.Treatment of CL ulcers with EC followed by MWT with 0.045% DAC N-055 or with DAC N-055 alone showed shorter wound closure times than with the standard SSG therapy.No significant differences10 out of 87 (11.5%); followed for 6 monthsOpenRandomized via 1:1:1 allocation5.5011110.50Negera 2012 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OZWdlcmE8L0F1dGhvcj48WWVhcj4yMDEyPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [61]CRY & SSG103 & 20EthiopiaPCR-RFLPL. aethiopicanoneMicroscopy and/or cultureNot an RCT, prospective non-randomized study; Participants mean age 20.6 years in T1 and 18.4 years in T2, lesions mean 8.5 months in durationN/AT2(n=103): Cryotherapy (liquid nitrogen) x 3-4 sessions/lesion weekly until cure; T3(n=10): untreated lesions, selected among the participants in T2T1(n=20): SSG 20 mg/kg (max 850 mg) daily x 30 daysPrimary: % cure at 6 monthsCure defined by lesions showing complete scarring and disappearance of inflammatory signs by 3 monthsCure was observed in 83/89 (94%) receiving cryotherapy, and in 85% receiving SSG. Both methods were equally effective at treating CL due to L. aethiopica.Not reported15 out of 123 (15%); followed for 6 monthsOpenNot randomized3.5011100.50Dogra 1990 ADDIN EN.CITE <EndNote><Cite><Author>Dogra</Author><Year>1990</Year><RecNum>2971</RecNum><DisplayText>[62]</DisplayText><record><rec-number>2971</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">2971</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Dogra, J.</author><author>Aneja, N.</author><author>Lal, B. B.</author><author>Mishra, S. N.</author></authors></contributors><auth-address>Department of Medicine and Dermatology, S.P. Medical College, Bikaner, India.</auth-address><titles><title>Cutaneous leishmaniasis in India. Clinical experience with itraconazole (R51 211 Janssen)</title><secondary-title>Int J Dermatol</secondary-title><alt-title>International journal of dermatology</alt-title></titles><periodical><full-title>Int J Dermatol</full-title><abbr-1>International journal of dermatology</abbr-1></periodical><alt-periodical><full-title>International Journal of Dermatology</full-title></alt-periodical><pages>661-2</pages><volume>29</volume><number>9</number><edition>1990/11/01</edition><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Animals</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>India/epidemiology</keyword><keyword>Itraconazole</keyword><keyword>Ketoconazole/administration & dosage/*analogs & derivatives/therapeutic use</keyword><keyword>Leishmania tropica</keyword><keyword>Leishmaniasis/diagnosis/*drug therapy/epidemiology</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Rural Health</keyword></keywords><dates><year>1990</year><pub-dates><date>Nov</date></pub-dates></dates><isbn>0011-9059 (Print)
0011-9059</isbn><accession-num>2177041</accession-num><urls></urls><remote-database-provider>Nlm</remote-database-provider><language>eng</language></record></Cite></EndNote>[62]ITR15 & 5IndiaNot performedN/AnoneMicroscopyRCT; Participants with lesions 4-11 weeks in duration, <6 lesions totalT1(n=15): Itraconazole 4 mg/kg (max 200 mg) PO daily x 6 weeks; T2(n=5): no treatmentN/AN/APrimary: % cure at 3 months; Secondary: adverse events; Tertiary: parasite cureCure defined as complete disappearance of induration or redness if nodular, complete healing of ulcer, and negative smear; definition of healing not specifiedCure observed in 10/15 (67%) receiving itraconazole and 0/5 on no treatment. AE included mild headache with itraconazoleSmall study. Itraconazole had some efficacy compared to observed cohortNot reportedLoss not mentioned; followed for 3 monthsOpenRandomized, method unknown (full article not available)2001000.50Dogra 1991 ADDIN EN.CITE <EndNote><Cite><Author>Dogra</Author><Year>1991</Year><RecNum>2970</RecNum><DisplayText>[63]</DisplayText><record><rec-number>2970</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">2970</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Dogra, J.</author></authors></contributors><auth-address>Department of Medicine (Dermatology Section), S.P. Medical College, Bikaner, India.</auth-address><titles><title>A double-blind study on the efficacy of oral dapsone in cutaneous leishmaniasis</title><secondary-title>Trans R Soc Trop Med Hyg</secondary-title><alt-title>Transactions of the Royal Society of Tropical Medicine and Hygiene</alt-title></titles><periodical><full-title>Trans R Soc Trop Med Hyg</full-title><abbr-1>Transactions of the Royal Society of Tropical Medicine and Hygiene</abbr-1></periodical><alt-periodical><full-title>Transactions of the Royal Society of Tropical Medicine and Hygiene</full-title></alt-periodical><pages>212-3</pages><volume>85</volume><number>2</number><edition>1991/03/01</edition><keywords><keyword>Administration, Oral</keyword><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Dapsone/*administration & dosage/therapeutic use</keyword><keyword>Double-Blind Method</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Leishmaniasis/*drug therapy</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword></keywords><dates><year>1991</year><pub-dates><date>Mar-Apr</date></pub-dates></dates><isbn>0035-9203 (Print)
0035-9203</isbn><accession-num>1887473</accession-num><urls></urls><remote-database-provider>Nlm</remote-database-provider><language>eng</language></record></Cite></EndNote>[63]DAP60IndiaNot performedN/AnoneMicroscopyRCT; Participants aged > 12 years, no prior treatment, lesions < 4 months in durationT1(n=60): Dapsone 100 mg PO BID x 6 weeks; T2(n=60): placebo tablet PO BID x 6 weeksN/AN/APrimary: % cure at 1 month; Secondary: adverse events; Tertiary: parasite cureCure defined as complete disappearance of induration of nodules or re-epithelialisation if ulcer, and 3 negative smearsCure was observed in 49/60 (71%) in dapsone treated patients and 0/60 with placebo. AE included dapsone related hemolysis (3 patients), and nauseaDapsone for 6 weeks had some efficacy in treatment of CL compared to placeboNo table provided (only mentioned that patients balanced)Loss not mentioned; followed for 1 monthDouble blindRandomized but method not explained4.51011001Dogra 1992 ADDIN EN.CITE <EndNote><Cite><Author>Dogra</Author><Year>1992</Year><RecNum>6124</RecNum><DisplayText>[64]</DisplayText><record><rec-number>6124</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">6124</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Dogra, J.</author></authors></contributors><titles><title>Current therapies for treatment of cutaneous leishmaniasis in India</title><secondary-title>Infection</secondary-title><alt-title>Infection</alt-title></titles><periodical><full-title>Infection</full-title></periodical><alt-periodical><full-title>Infection</full-title></alt-periodical><pages>189-91</pages><volume>20</volume><number>4</number><edition>1992/07/01</edition><keywords><keyword>Antifungal Agents/therapeutic use</keyword><keyword>Antiprotozoal Agents/therapeutic use</keyword><keyword>Dapsone/therapeutic use</keyword><keyword>Fluorescent Antibody Technique</keyword><keyword>Humans</keyword><keyword>Itraconazole</keyword><keyword>Ketoconazole/analogs & derivatives/therapeutic use</keyword><keyword>Leishmaniasis, Cutaneous/diagnosis/*drug therapy/prevention & control</keyword><keyword>Protozoan Vaccines/standards</keyword><keyword>Skin Tests</keyword></keywords><dates><year>1992</year><pub-dates><date>Jul-Aug</date></pub-dates></dates><isbn>0300-8126 (Print)
0300-8126 (Linking)</isbn><accession-num>1325946</accession-num><work-type>Review</work-type><urls><related-urls><url>;[64] ITR & DAP20IndiaNot performedN/AnoneMicroscopyRCT; Participants aged 15- >55, no further demographics providedT1(n=20): Itraconazole 4mg/kg (max 200 mg) PO daily x 6 weeks; T2( n=20): dapsone 4mg/kg PO BID x 6 weeks; T3(n=20): placeboN/AN/APrimary: % cure; Secondary: adverse eventsCure defined as complete disappearance of induration in nodular lesions or re-epithelialisation of ulcer, and 3 monthly negative smearsItraconazole cured 15/20 (75%), dapsone 18/20 (90%), and placebo 2/20 (10%). AE included nausea and increased LFTsDapsone was more efficacious than itraconazole. Not reportedLoss not mentioned; followed for 3 monthsNot mentionedRandomized, but method not explained3001100.50Dogra 1996 ADDIN EN.CITE <EndNote><Cite><Author>Dogra</Author><Year>1996</Year><RecNum>2972</RecNum><DisplayText>[65]</DisplayText><record><rec-number>2972</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">2972</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Dogra, J.</author><author>Saxena, V. N.</author></authors></contributors><auth-address>C.G.H.S. Jaipur, India.</auth-address><titles><title>Itraconazole and leishmaniasis: a randomised double-blind trial in cutaneous disease</title><secondary-title>Int J Parasitol</secondary-title><alt-title>International journal for parasitology</alt-title></titles><periodical><full-title>Int J Parasitol</full-title><abbr-1>International journal for parasitology</abbr-1></periodical><alt-periodical><full-title>Int J Parasitol</full-title><abbr-1>International journal for parasitology</abbr-1></alt-periodical><pages>1413-5</pages><volume>26</volume><number>12</number><edition>1996/12/01</edition><keywords><keyword>Antiprotozoal Agents/adverse effects/*therapeutic use</keyword><keyword>Double-Blind Method</keyword><keyword>Humans</keyword><keyword>India</keyword><keyword>Itraconazole/adverse effects/*therapeutic use</keyword><keyword>Leishmaniasis, Cutaneous/*drug therapy</keyword><keyword>Liver Function Tests</keyword></keywords><dates><year>1996</year><pub-dates><date>Dec</date></pub-dates></dates><isbn>0020-7519 (Print)
0020-7519</isbn><accession-num>9024895</accession-num><urls></urls><remote-database-provider>Nlm</remote-database-provider><language>eng</language></record></Cite></EndNote>[65] ITR10IndiaNot performedN/AnoneMicroscopyRCT; Participants aged >18 years, no prior treatment, lesion < 4 months in durationT1(n=10): Itraconazole 200 mg PO daily x 6 weeks; T2(n=10): placebo 2 tablets PO daily x 6 weeksN/AN/APrimary: % cure at 3 months; Secondary: adverse events; Tertiary: parasite cureCure defined as complete disappearance of nodular lesions or re-epithelialisation of ulcers and 3 negative smearsItraconazole healed 7/10 (70%) and placebo 1/10 (10%). AE included nausea and increased LFTsItraconazole could be a preferred choice over pentavalent antimonials (systemic/peri-lesional) for the initial therapy of CL. No table provided (only mentioned that patients balanced)Loss not mentioned; followed for 3 monthsDouble blindRandomized, but method not explained4001100.51Kochar 2000 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Lb2NoYXI8L0F1dGhvcj48WWVhcj4yMDAwPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [66]RIF23IndiaNot performedN/AnoneMicroscopyRCT; Participants aged 1-60, mean 2 lesions, median duration 2 months durationT1(n=23): Rifampin 600 mg PO BID x 4 weeks; T2(n=23): placeboN/AN/APrimary: % cure; Secondary: adverse events; Tertiary: parasite cureCure defined as complete healing at 4 weeks; definition of healing not specifiedRifampin cured 73.9% while placebo cured on 4%. There were no AE Rifampin demonstrated better cure rates than placebo, however it needs to be studied over a longer time period.Significant differences in lesion size, number and duration4 out of 50 (8%); followed for 1 month Double blindNot randomized2.5001000.51Kochar 2006 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Lb2NoYXI8L0F1dGhvcj48WWVhcj4yMDA2PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [67]RIF25IndiaNot performedN/AnoneMicroscopyRCT; Participants predominantly pediatric, lesions < 3 months in duration, 50% with nodular lesionsT1(n=25): Rifampin 600 mg PO BID and omeprazole 20 mg PO daily x 6 weeks; T2(n=25): placebo x 6 weeksN/AN/APrimary: % cure; Second: adverse eventsCure defined as complete healing and disappearance of lesion; definition of healing not specifiedRifampin cured 6/25 (24%) while placebo cured 3/25 (12%) by ITT. No AE reportedOnly modest cure rates were observed with rifampin as compared to placebo.No significant differences6 out of 50 (12%); followed for 1.5 monthsDouble blindRandomized, but method not explained5101010.51Aara 2013 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BYXJhPC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA [68]RIF & ILSSG & RFT & CRY361 & 297 & 185 & 96 & 19IndiaPCR-RFLPL. tropicanoneMicroscopyNot an RCT, consecutive case series presenting to hospital in Rajasthan over 10 years; Treated on a case to case basis.T4(n=96): Rifampin PO x 4-6 weeksT1(n=361): SSG IL biweekly x 5-7 sessions; T2(n=297): SSG IL weekly x 5-7 sessions; T3(n=185): Thermotherapy (50°C x 30–60 sec) x 1 session; T5(n=19): CryotherapyN/APrimary: % cure at 6-24 weeksCure defined as total re-epithelialisation and absence of amastigotes on smearT1 cure 92% at 24 weeks, T2 92% at 24 weeks, T3 98% at 24 weeks, T4 84% at 6 weeks, and T5 84% at 24 weeksMost modalities are associated with cure by 16-24 weeksNot reported406 out of 1379 (29%); followed for 18 months OpenNot randomized3.5011100.50Bumb 2013 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CdW1iPC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA [69]RFT & ILSSG50IndiaPCR-RFLPL. tropicanoneMicroscopyRCT; Participants aged 4-60, ≤ 4 lesions, 1-18 months in durationN/AT1(n=50): Thermotherapy (50°C x 30-60 sec) x 1 session; T2(n=50): SSG IL biweekly x 7 sessions N/APrimary: % cure at 6 months; Secondary: time to cure; Tertiary: adverse eventsCure defined as complete re-epithelialisationCure rates in the heat therapy and SSG groups were 98% and 94% respectively. AE included local infections with heat therapyA single application of radiofrequency heat therapy is safe, cosmetically acceptable and effective in inducing a long-term cure of CL.No significant differencesNo losses; followed for 12 monthsOpenRandomized via 1:1 allocation71111110Agarwal 2014 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BZ3Jhd2FsPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48
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ADDIN EN.CITE.DATA [70]RIF & DAP & ILSSG & RFT58 & 14 & 50 & 3 & 5IndiaPCRL. tropicaN/AMicroscopy, culture, and/or PCRNot an RCT, case series of 151 pediatric patients. Participants aged 0-5 years, mostly single facial lesions, mean 4.5 months in duration, mean 2.4 cm in sizeT3(n=50): Rifampin 20 mg/kg PO daily x 4-6 weeks; T4(n=3): Dapsone 20 mg/kg daily PO x 4-6 weeks; T5(n=11): Rifampin 20 mg/kg PO daily & Dapsone 20 mg/kg PO daily x 4-6 weeksT1(n=58): SSG IL once to twice per week x 5-7 session; T2(n=14): Thermotherapy (50°C x 30 seconds); T6(n=12): SSG IL once to twice per week x 5-7 session & rifampin 20 mg/kg PO daily x 4-6 weeksN/APrimary: % cure at 3 monthsCure was defined as total re-epithelialisation of the lesion and a negative skin plete cure with local therapies (SSG IL and RFT) was observed in 84.4% and 91.8%, respectively. Rifampicin, dapsone, and a combination of both, complete healing was recorded in 82%, 66.67%, and 90.1% respectively. The combination of SSG IL and rifampicin was effective in 100% of cases.Relatively good success rates with variable treatment regimens. Not compared9 out of 151 (6.0%); followed for 3 monthsOpenNot randomized40111010Aronson 2010 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Bcm9uc29uPC9BdXRob3I+PFllYXI+MjAxMDwvWWVhcj48
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ADDIN EN.CITE.DATA [71]RFT & SSG27Iraq & KuwaitPCR-RFLP and enzyme electrophoresis L. majornoneMicroscopyRCT; Participants aged 18-57, predominantly male, median 2-3 lesions of median 4 months durationN/AT2(n=27): Thermotherapy (50°C x 30 sec) x 1 sessionT1(n=27): SSG 20 mg/kg IV daily x 10 daysPrimary: % cure at 2 months; Secondary: adverse eventsCure defined as complete re-epithelialisation In an ITT analysis, the per subject efficacy was 54% SSG and 48% TM (p = 0.78), and the per lesion efficacy was 59% SSG and 73% TM (p = 0.053). Local AE were recorded with TM, and myalgias, increased LFTs and cytopenias with SSG.L. major treated with heat by TM had similar cure rates as IV SSG, and was associated with fewer side effectsNo significant differencesNo losses; followed for 12 monthsSingle blind (examiner)Randomized via computer algorithm7.51111110.5Asilian 1995 ADDIN EN.CITE <EndNote><Cite><Author>Asilian</Author><Year>1995</Year><RecNum>2930</RecNum><DisplayText>[72]</DisplayText><record><rec-number>2930</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">2930</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Asilian, A.</author><author>Jalayer, T.</author><author>Whitworth, J. A.</author><author>Ghasemi, R. L.</author><author>Nilforooshzadeh, M.</author><author>Olliaro, P.</author></authors></contributors><auth-address>Department of Dermatology, School of Medicine, Isfahan University of Medical Sciences, Iran.</auth-address><titles><title>A randomized, placebo-controlled trial of a two-week regimen of aminosidine (paromomycin) ointment for treatment of cutaneous leishmaniasis in Iran</title><secondary-title>Am J Trop Med Hyg</secondary-title><alt-title>The American journal of tropical medicine and hygiene</alt-title></titles><periodical><full-title>Am J Trop Med Hyg</full-title></periodical><alt-periodical><full-title>The American journal of tropical medicine and hygiene</full-title></alt-periodical><pages>648-51</pages><volume>53</volume><number>6</number><edition>1995/12/01</edition><keywords><keyword>Administration, Topical</keyword><keyword>Adolescent</keyword><keyword>Anti-Bacterial Agents/administration & dosage/adverse effects/*therapeutic use</keyword><keyword>Child</keyword><keyword>Child, Preschool</keyword><keyword>Double-Blind Method</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Iran</keyword><keyword>Leishmaniasis, Cutaneous/*drug therapy</keyword><keyword>Male</keyword><keyword>Ointments</keyword><keyword>Paromomycin/administration & dosage/adverse effects/*therapeutic use</keyword></keywords><dates><year>1995</year><pub-dates><date>Dec</date></pub-dates></dates><isbn>0002-9637 (Print)
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ADDIN EN.CITE.DATA [73]HRB & MA86 & 85IranNot performedN/AnoneMicroscopyRCT; participants with lesion < 4 months in duration, mean < 2 lesionsN/AT1(n=86): Herbal extract in black paste to lesion daily x 5 days & placebo saline injections daily x 20 days T2(n=85): MA 15-20 mg/kg IM daily x 20 days & placebo black paste to lesions daily x 5 daysPrimary: % cure at 6 weeks; Secondary: adverse eventsCure defined as complete healing and re-epithelialisation of lesionHerbal extract paste healed 64/86 (74%) and MA 23/85 (27%). Adverse events included urticarial and generalized pruritus in the MA cohortHerbal extract paste was more effective for healing of CL than MA in this studyNot reportedLoss not mentioned; followed for 6 monthsDouble blindRandomized, but method not explained5101100.51Gholami 2000 Garlic96 & 75IranNot performedN/AnoneNot specifiedRCT; Participants aged > 5 years, lesions < 100 days in duration, no facial lesions includedN/AT1(n=96): 5% garlic cream BID q3days x 40 days; T2(n=75): placeboN/APrimary: % cured at 40 daysCure defined as complete healing; definition of healing not specifiedGarlic cream healed 18/96 and placebo 15/755% garlic cream was not effective in the treatment of CLNo significant differences26 out of 197 (13.2%); followed for 2 monthsDouble blindRandomized, method unknown (full article not available)4100010.51Salmanpour 2001 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TYWxtYW5wb3VyPC9BdXRob3I+PFllYXI+MjAwMTwvWWVh
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ADDIN EN.CITE.DATA [74]KET & ILMA64 & 36IranNot performedN/AnoneMicroscopyRCT; Participants aged > 3 yearsT1(n=64): Ketoconazole 600 mg (adults) or 10 mg/kg (children) daily x 30 days T2(n=36): MA IL q2weeks x 6-8 sessionsN/APrimary: % cure at 6 weeks; Secondary: adverse eventsCure defined as complete re-epithelialisation of ulcer with little or no scarKetoconazole healed 57/64 (89%) of lesions, and ILMA healed 23/32 (72%). AE included elevated LFTs with ketoconazole and local irritation with ILMA.Ketoconazole was more effective than ILMA in this studyNo table provided (only mentioned that patients balanced, but data not in article)Loss not mentioned; followed for 6 months Not mentionedRandomized, but method not explained4101100.50Esfandiarpour 2002 ADDIN EN.CITE <EndNote><Cite><Author>Esfandiarpour</Author><Year>2002</Year><RecNum>2983</RecNum><DisplayText>[75]</DisplayText><record><rec-number>2983</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">2983</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Esfandiarpour, I.</author><author>Alavi, A.</author></authors></contributors><auth-address>Kerman University of Medical Sciences and Health Services, Kerman, Iran. irajesfandayar@</auth-address><titles><title>Evaluating the efficacy of allopurinol and meglumine antimoniate (Glucantime) in the treatment of cutaneous leishmaniasis</title><secondary-title>Int J Dermatol</secondary-title><alt-title>International journal of dermatology</alt-title></titles><periodical><full-title>Int J Dermatol</full-title><abbr-1>International journal of dermatology</abbr-1></periodical><alt-periodical><full-title>International Journal of Dermatology</full-title></alt-periodical><pages>521-4</pages><volume>41</volume><number>8</number><edition>2002/09/05</edition><keywords><keyword>Administration, Oral</keyword><keyword>Adolescent</keyword><keyword>Allopurinol/*therapeutic use</keyword><keyword>Antiprotozoal Agents/*therapeutic use</keyword><keyword>Drug Therapy, Combination</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Injections, Intramuscular</keyword><keyword>Iran</keyword><keyword>Leishmaniasis, Cutaneous/*drug therapy</keyword><keyword>Male</keyword><keyword>Meglumine/*therapeutic use</keyword><keyword>Organometallic Compounds/*therapeutic use</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2002</year><pub-dates><date>Aug</date></pub-dates></dates><isbn>0011-9059 (Print)
0011-9059</isbn><accession-num>12207774</accession-num><urls></urls><remote-database-provider>Nlm</remote-database-provider><language>eng</language></record></Cite></EndNote>[75]ALL & MA50IranNot performedN/AnoneMicroscopyRCT; Participants mean age 14, mean 1 lesion, mean 8 months durationT1(n=50): Allopurinol 15 mg/kg PO divided TID x 3 weeks; T3(n=50): allopurinol 15 mg/kg PO divided TID x 3 weeks & MA 30 mg/kg IM x 2 weeksN/AT2(n=50): MA 30 mg/kg IM daily x 2 weeksPrimary: % cure; Secondary: adverse eventsCure defined as reduction of inflammation, edema, and flattening on scarAllopurinol was associated with cure in 9/50 (18%), MA in 12/50 (24%) and Allopurinol & MA in 23/50 (46%). AE in allopurinol included nausea, heartburn, and elevated LFTsCombined allopurinol and MA was more effective than either therapy alone, however none of these treatments demonstrated good efficacy No significant differencesLoss not mentioned; followed for 1 monthNot mentionedRandomized but method not explained3.51010100Momeni 2002 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb21lbmk8L0F1dGhvcj48WWVhcj4yMDAyPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [76]ALL & MA36IranMonoclonal antibodies or isoenzyme electrophoresisL. major noneMicroscopyRCT; Participants aged > 5, no prior treatments, lesion < 4 months in durationT1(n=36): Allopurinol 20 mg/kg daily & MA 30 mg/kg IM daily x 20 daysN/AT2(n=36): MA 60 mg/kg IM daily x 20 days Primary: % cure at 2 monthsCure defined as all lesions healed and negative amastigotes on smears; definition of healing not specifiedLow dose MA with allopurinol cured 25/36 (72%) while MA alone cured 26/36 (75%). AE included abdominal pain, nausea, skin eruption, myalgiasCombination low dose MA with allopurinol showed similar efficacy compared to full dose MA, and had less toxicityNo significant differences6 out of 62 (9.7%); followed for 2 monthsOpenRandomized but method not explained5.51110110Faghihi 2003 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5GYWdoaWhpPC9BdXRob3I+PFllYXI+MjAwMzwvWWVhcj48
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ADDIN EN.CITE.DATA [77]PRM & ILMA48IranNot performedN/AnoneMicroscopyRCT; Participants aged 1–48, mean 16 years old, ≤ 3 lesions, no ulcerating lesions includedN/AT1(n=48): 15% paromomycin sulfate in 10% urea ointment BID x 45 days; T2(n=48): MA 15g/5ml IL weekly x maximum 12 injectionsN/APrimary: % cure after 2 months; Secondary: % relapses over 1 yearCure defined as return to normal tissue texture in < 2 monthsTopical paromomycin ointment healed 8/48 (17%) of lesions at 2 months and ILMA healed 20/48 (42%).Neither performed well, but ILMA was superior than topical paromomycin.Groups not compared, only listed number of lesions in each group and locationloss not mentioned; followed for 12 monthsOpenRandomized via a stratified blocked randomization method3.5101000.50Momeni 2003A ADDIN EN.CITE <EndNote><Cite><Author>Momeni</Author><Year>2003</Year><RecNum>3056</RecNum><DisplayText>[78]</DisplayText><record><rec-number>3056</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">3056</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Momeni, A. Z.</author><author>Aminjavaheri, M.</author><author>Omidghaemi, M. R.</author></authors></contributors><auth-address>Isfahan University of Medical Sciences, PO Box 81465/1191, Isfahan, Iran. azmomeni@</auth-address><titles><title>Treatment of cutaneous leishmaniasis with ketoconazole cream</title><secondary-title>J Dermatolog Treat</secondary-title><alt-title>The Journal of dermatological treatment</alt-title></titles><periodical><full-title>J Dermatolog Treat</full-title><abbr-1>The Journal of dermatological treatment</abbr-1></periodical><alt-periodical><full-title>J Dermatolog Treat</full-title><abbr-1>The Journal of dermatological treatment</abbr-1></alt-periodical><pages>26-9</pages><volume>14</volume><number>1</number><edition>2003/05/15</edition><keywords><keyword>Administration, Cutaneous</keyword><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Antifungal Agents/administration & dosage/*therapeutic use</keyword><keyword>Child</keyword><keyword>Double-Blind Method</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Ketoconazole/administration & dosage/*therapeutic use</keyword><keyword>Leishmaniasis, Cutaneous/*drug therapy/pathology</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2003</year><pub-dates><date>Jan</date></pub-dates></dates><isbn>0954-6634 (Print)
0954-6634</isbn><accession-num>12745852</accession-num><urls></urls><remote-database-provider>Nlm</remote-database-provider><language>eng</language></record></Cite></EndNote>[78]KET49 & 55IranNot performedN/AnoneMicroscopyRCT; Participants aged > 5 years, lesion < 4 months in durationN/AT1(n=49): 2% ketoconazole cream BID x 21 days; T2(n=55): placebo cream BID x 21 daysN/APrimary: % cure at 2 months; Secondary: adverse eventsCure defined as healed lesions by day 51 and negative amastigotes on smearKetoconazole cream healed 11/49 (22%) and placebo cream 6/55 (11%). AE included pruritus at lesion site.The low response rate in patients receiving ketoconazole cream indicates that it cannot be used as the single agent.No significant differences17 out of 90 (17.9%); followed for 1.5 monthsOpenRandomized but method not explained5101010.51Momeni 2003 B ADDIN EN.CITE <EndNote><Cite><Author>Momeni</Author><Year>2003</Year><RecNum>6142</RecNum><DisplayText>[79]</DisplayText><record><rec-number>6142</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">6142</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Momeni, A. Z.</author><author>Aminjavaheri, M.</author></authors></contributors><auth-address>Aminjavaheri Medical Lab. P.O. Box 1191, 81465 Isfahan, Iran. azmomeni@</auth-address><titles><title>Successful treatment of non-healing cases of cutaneous leishmaniasis, using a combination of meglumine antimoniate plus allopurinol</title><secondary-title>Eur J Dermatol</secondary-title><alt-title>Eur J Dermatol</alt-title></titles><periodical><full-title>Eur J Dermatol</full-title><abbr-1>European journal of dermatology : EJD</abbr-1></periodical><alt-periodical><full-title>Eur J Dermatol</full-title><abbr-1>European journal of dermatology : EJD</abbr-1></alt-periodical><pages>40-3</pages><volume>13</volume><number>1</number><edition>2003/03/01</edition><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Allopurinol/*administration & dosage</keyword><keyword>Antimony/*administration & dosage</keyword><keyword>Antiprotozoal Agents/*administration & dosage</keyword><keyword>Drug Therapy, Combination</keyword><keyword>Humans</keyword><keyword>Leishmaniasis, Cutaneous/*drug therapy/pathology</keyword><keyword>Male</keyword><keyword>Meglumine/*administration & dosage</keyword><keyword>Organometallic Compounds/*administration & dosage</keyword></keywords><dates><year>2003</year><pub-dates><date>Jan-Feb</date></pub-dates></dates><isbn>1167-1122 (Print)
1167-1122 (Linking)</isbn><accession-num>12609780</accession-num><work-type>Case Reports
Clinical Trial</work-type><urls><related-urls><url>;[79]ITR70IranIsoenzyme electrophoresisL. majornoneMicroscopy and/or cultureRCT; Participants aged >12 years, no prior treatment, no facial lesions, < 4 months in durationT1(n=70): Itraconazole 7 mg/kg (max 400 mg) PO daily x 3 weeks; T2(n=70): placebo x 3 weeksN/AN/APrimary: % cure at 2 months; Secondary: adverse eventsCure defined as all lesions healed with negative smears; definition of healing not specifiedCure observed in 36/51 (59%) receiving itraconazole and in 27/61 (44%) receiving placebo.Itraconazole was not significantly more effective than placebo when given for 3 weeksNo significant differences9 out of 140 (6.4%); followed for 1.5 monthsDouble blindRandomized, method unknown71110111Asilian 2004B PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Bc2lsaWFuPC9BdXRob3I+PFllYXI+MjAwNDwvWWVhcj48
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ADDIN EN.CITE.DATA [80]CO2 & MA123 & 110IranNot performedN/AnoneMicroscopyRCT; Participants aged 7-70, < 5 lesions, < 4 months in durationN/AT1(n=123): CO2 laser (Sonic 500 machine) x 1 session & topical 2% erythromycinT2(n=110): MA 50 mg/kg IM daily x 15 days, rest 5 days, resume for additional 15 days Primary: % cure at 1.5 months; Secondary: speed of healing; Tertiary: scar prevention; Quaternary: adverse eventsCure defined as complete re-epithelialisation, flattening and negative amastigotes on smearCO2 laser cured 104/111 lesions while MA cured 176/210 lesions, RR1.12Similar efficacy between a single session of CO2 laser and a 30 day treatment of MADiffered in number of lesions59 out of 233 (25%); followed for 6 monthsNot mentionedRandomized via coin flip4.5101100.50Asilian 2003 ADDIN EN.CITE <EndNote><Cite><Author>Asilian</Author><Year>2003</Year><RecNum>2929</RecNum><DisplayText>[81]</DisplayText><record><rec-number>2929</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">2929</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Asilian, A.</author><author>Jalayer, T.</author><author>Nilforooshzadeh, M.</author><author>Ghassemi, R. L.</author><author>Peto, R.</author><author>Wayling, S.</author><author>Olliaro, P.</author><author>Modabber, F.</author></authors></contributors><auth-address>Department of Dermatology, School of Medicine, University of Medical Sciences, Isfahan, Islamic Republic of Iran.</auth-address><titles><title>Treatment of cutaneous leishmaniasis with aminosidine (paromomycin) ointment: double-blind, randomized trial in the Islamic Republic of Iran</title><secondary-title>Bull World Health Organ</secondary-title><alt-title>Bulletin of the World Health Organization</alt-title></titles><periodical><full-title>Bulletin of the World Health Organization</full-title><abbr-1>Bull World Health Organ</abbr-1></periodical><alt-periodical><full-title>Bulletin of the World Health Organization</full-title><abbr-1>Bull World Health Organ</abbr-1></alt-periodical><pages>353-9</pages><volume>81</volume><number>5</number><edition>2003/07/12</edition><keywords><keyword>Antiprotozoal Agents/administration & dosage/*therapeutic use</keyword><keyword>Child</keyword><keyword>Double-Blind Method</keyword><keyword>Humans</keyword><keyword>Iran</keyword><keyword>Leishmaniasis, Cutaneous/*drug therapy</keyword><keyword>*Ointments</keyword><keyword>Paromomycin/administration & dosage/*therapeutic use</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2003</year></dates><isbn>0042-9686 (Print)
0042-9686</isbn><accession-num>12856053</accession-num><urls></urls><custom2>Pmc2572463</custom2><remote-database-provider>Nlm</remote-database-provider><language>eng</language></record></Cite></EndNote>[81]PRM117 & 116IranNot performedN/AnoneMicroscopyRCT; Participants with single lesion, < 4 months in duration, < 5 cm in size, no prior treatmentN/AT1(n=117): 15% paromomycin in 10% urea ointment BID x 4 weeks; T2(n=116): 15% paromomycin BID x 2 weeks followed by paraffin ointment BID x 2 weeks N/APrimary: % cure at 2.5 months; Secondary: adverse events; Tertiary: parasite cureCure defined as complete epithelialisation of lesion4 weeks of topical paromomycin ointment healed 58/117, while 2 weeks healed 43/116. RR 1.34. No AE reportedHigher healing rates and parasite cure were observed with 4 weeks of topical paromomycin in urea ointmentNo significant differences87 out of 233 (37%); followed for 3.5 monthsDouble blindRandomized but method not explained6.5101110.51Asilian 2004A PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Bc2lsaWFuPC9BdXRob3I+PFllYXI+MjAwNDwvWWVhcj48
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ADDIN EN.CITE.DATA [82]CRY100 & 200 & 160IranNot performedN/AnoneMicroscopyRCT; Participants with lesions < 8 weeks in durationN/AT1(n=100): cryotherapy and MA IL q2weeks x 6 weeks; T2(n=200): cryotherapy q2weeks x 6 weeks; T3(n=160): MA IL q2weeks x 6 weeksN/APrimary: % cure at 6 months; Secondary: adverse events, remission duration, relapse rate; Tertiary: parasite cureCure defined as complete re-epithelialisation of ulcer with loss of edema, induration and absence of amastigotes on smearCryotherapy & ILMA healed 120/149 (91%) of lesions; cryotherapy healed 120/230 (57%) of lesions; ILMA healed 84/160 (56%) of lesionsCombined cryotherapy and intralesional meglumine antimoniate was more effective than either cryotherapy or ILMA aloneNo significant differences30 out of 400 (7.5%); followed for 6 months Not mentionedRandomized, but method not explained5.51011110Iraji 2004 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5JcmFqaTwvQXV0aG9yPjxZZWFyPjIwMDQ8L1llYXI+PFJl
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ADDIN EN.CITE.DATA [83]ILMA & ZnSO435 & 31IranNot performedN/AnoneMicroscopyRCT; Participants aged 2-67, lesions < 12 weeks in duration, < 4 lesionsN/AT1(n=35): MA IL q2weeks x 6 weeks; T2(n=31): 2% ZnSO4 IL q2weeks x 6 weeksN/APrimary: % cure at 1.5 months; Secondary: adverse eventsCure defined using the Sharquie grading system, where 4 represented total clearance of lesion and parasiteHealing at 6 weeks was noted in 84% IL Zinc Sulfate and in 60% of ILMA. AE included pain and vasovagal episodes with Zinc Sulfate and local irritation with ILMA.No statistical difference in efficacy between IL Zinc Sulfate and ILMA.No significant differences38 out of 104 (36.5%); followed for 1.5 monthsDouble blindRandomized, but method not explained6101110.51Nilforoushzadeh 2004 (source only cochrane review) PRM & ILMA & CRY81 & 76IranNot performedN/AnoneMicroscopyRCT; Participants aged 1-20, lesion < 2 months in duration, max 3 lesionsN/AT1(n=81): MA IL biweekly x 6 weeks; T2(n=76): MA IL biweekly x 6 weeks & 15% paromomycin in 10% urea ointment BID x 4 weeks & cryotherapy q 2 weeks x 3 sessionsN/APrimary: % cure at 2 monthsNot definedTriple therapy healed 68/81 (89.5%) while ILMA healed 57/76 (70%) at 6 weeks post bined cryotherapy, topical paromomycin and ILMA was more effective than ILMA alone.No table provided (only mentioned that patients were balanced)53 out of 210 (25%); followed for 1.5 monthsOpenRandomized, method unknown3.5101000.50Shazad 2005 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGF6YWQ8L0F1dGhvcj48WWVhcj4yMDA1PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [84]PRM & ILMA30IranNot performedN/AnoneMicroscopyRCT; Participants all male soldiers, no prior treatment, 1-3 lesions total, 77% ulcerating lesionsN/AT1(n=30): 15% paromomycin in 10% urea ointment BID x 20 days; T2(n=30): MA IL daily x 20 daysN/APrimary: % cure at 1 month; Secondary: adverse eventsCure defined as complete re-epithelialisation of all lesions18/30 (60%) receiving topical paromomycin and 20/30 (66%) receiving ILMA were cured. AE included urticarial, pain, lymphadenitis, not specified to which groups Topical paromomycin and ILMA showed similar effectivenessOnly differed in number of lesions38 out of 104 (36.5%); followed for 1.5 monthsOpenRandomized, method unknown (full article not available)4101100.50Asilian 2006 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Bc2lsaWFuPC9BdXRob3I+PFllYXI+MjAwNjwvWWVhcj48
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ADDIN EN.CITE.DATA [85]5-ALA & PRM20IranNot performedN/AnoneMicroscopyRCT; Participants aged 5-59, ≤ 2 lesions of < 2 months duration, no prior treatmentsN/AT1(n=20): 10% 5-aminolaevulinic acid (5-ALA) hydrochloride cream followed by irradiation via visible red light at 100 J/cm weekly x 4 weeks; T2(n=20): 15% paromomycin in 12% MBL ointment BID x 28 days; T3(n=20): placebo ointment BID x 28 days N/APrimary: % cure at 2 months; Secondary: adverse events; Tertiary: parasite cureCure defined as loss of induration, complete re-epithelialisation, negative amastigotes smearCure at 2 months post-treatment occurred in 29/31(93.5%) receiving PDT, 14/31 (41%) receiving topical paromomycin, and 4/30 receiving placebo. AE included itch, burning, redness, edema, painPDT was more effective than topical paromomycin; both treatments were better than placebo ointmentNo significant differences3 out of 60 (5%); followed for 2 monthsDouble blindRandomized via computer-based randomization60011111Firooz 2006 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5GaXJvb3o8L0F1dGhvcj48WWVhcj4yMDA2PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [86]IMQ & MA59 & 60IranNot performedN/AnoneMicroscopy and/or cultureRCT; Participants age 12-60, lesion < 6 months in duration, < 5 lesions totalN/AT1(n=59): 5% imiquimod cream 3x/week x 28 days & MA 20 mg/kg IM daily x 14 days; T2(n=60): MA 20 mg/kg IM daily x 14 days & placebo petrolatum cream 3x/week x 28 daysPrimary: % cure at 3.5 months; Secondary: adverse eventsCure defined as >75% re-epithelialisation of lesion compared to baselineIn the imiquimod/MA group 26/59 lesions were healed, while in the MA/placebo arm 24/60 were healed, RR 1.10No beneficial effect of combining a 4-week course of treatment with 5% imiquimod cream and a standard course of meglumine antimoniate.No significant differences30 out of 119 (25%); followed for 3.5 monthsDouble blindRandomized via a simple randomization block design6.5101110.51Nilforoushzadeh 2006 ADDIN EN.CITE <EndNote><Cite><Author>Nilforoushzadeh</Author><Year>2006</Year><RecNum>6179</RecNum><DisplayText>[87]</DisplayText><record><rec-number>6179</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">6179</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Nilforoushzadeh, M.</author></authors></contributors><titles><title>Comparative Effect of Topical Trichloroacetic Acid and Intralesional Meglumine Antimoniate in the Treatment of Acute Cutaneous Leishmaniasis</title><secondary-title>International journal of pharmacology</secondary-title></titles><periodical><full-title>International journal of pharmacology</full-title></periodical><pages>3</pages><volume>2</volume><number>6</number><section>633</section><dates><year>2006</year></dates><urls><related-urls><url>;[87]TCA & ILMA40IranNot performedN/AnoneMicroscopyRCT; Participants aged 5-75, lesions < 12 weeks in duration, < 5 lesions total, no prior treatmentN/AT1(n=40): 50% trichloroacetic acid applied q2weeks x 3 sessions; T2(n=40): MA IL weekly x 6 weeks N/APrimary: % cure at 6 weeks; Secondary: adverse events; Tertiary: parasite cure Cure defined as complete re-epithelialisation of lesionHealing at 6 weeks was 26/38 (68%) with trichloroacetic acid , 23/35 (66%) with IL MA. AE included pruritus and mild erythema with MASimilar effectiveness between trichloroacetic acid and IL MA in this studyNo significant differences7 out of 80 (8.7%); followed for 3 monthsOpenRandomized, but method not explained5.51011110Sadeghian 2006 A ADDIN EN.CITE <EndNote><Cite><Author>Sadeghian</Author><Year>2006</Year><RecNum>6180</RecNum><DisplayText>[88]</DisplayText><record><rec-number>6180</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">6180</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Sadeghian, G.</author></authors></contributors><titles><title>A comparison between intralesional hypertonic sodium chloride solution and meglomine antimoniate in the treatment of cutaneous leishmaniasis</title><secondary-title>Egyptian Dermatology Online Journal</secondary-title></titles><periodical><full-title>Egyptian Dermatology Online Journal</full-title></periodical><pages>8</pages><volume>2</volume><number>1</number><dates><year>2006</year></dates><urls><related-urls><url>;[88]NS & ILMA36IranNot performedN/AnoneMicroscopyRCT; Participants aged > 5 years, no facial lesionsN/AT1(n=36): 5% NS IL weekly x 6-10 weeks; T2(n=36): MA IL weekly x 6-10 weeksN/APrimary: % cure at 6 months; Secondary: adverse events Cure defined as re-epithelialisation, decreased induration, ulcer size, negative smearCure at 6 weeks was 33% with ILMA, 25% with 5% NS; cure at 6 months was 52% with ILMA and 25% with 5% NSAt end of treatment neither ILMA or IL NS was very effective; at 6 months ILMA had better efficacy than IL 5% NSNo significant differencesLoss not mentioned; followed for 6 monthsDouble blindRandomized, but method not explained6101110.51Sadeghian 2006B PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TYWRlZ2hpYW48L0F1dGhvcj48WWVhcj4yMDA2PC9ZZWFy
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ADDIN EN.CITE.DATA [89]PTX & MA32IranNot performedN/AnoneMicroscopyRCT; Participants aged 14-46, lesions < 2 months in durationT1(n=32): Pentoxifylline 400 mg PO TID x 20 days & MA 20 mg/kg IM daily x 20 days; N/AT2(n=32): MA 20 mg/kg IM daily x 20 days & placebo PO TID x 20 daysPrimary: % cure at 3 months; Secondary: adverse eventsCure defined as complete improvement 3 months after treatment; definition of improvement not specified Complete cure was observed in 81.3% in the trial group and 51.6% in the control group. No AE resulted from bined therapy with Glucantime and pentoxifylline is more effective than Glucantime alone (P < 0.05).No significant differences1 out of 64 (1.5%); followed for 3 monthsDouble blindRandomized but method not explained5.51010111Salmanpour 2006 CRY & ILMA20IranNot performedN/AnoneMicroscopyRCT; Participants aged > 3 yearsN/AT1(n=20): Cryotherapy weekly x 6 weeks; T2(n=20): Cryotherapy & MA IL weekly x 6-8 weeks; T3(n=20): MA IL weekly x 6-8 weeksN/APrimary: % cure, time not reportedNot definedILMA healed 15/20 patients (75%), Cryotherapy healed 14/20 (68%) and Cryotherapy & ILMA healed 18/20 (89%)Combined cryotherapy and ILMA had higher effectiveness than either treatment aloneNot reportedLoss not mentioned; follow-up duration not mentionedNot mentionedRandomized, but method not explained1.50010000Layegh 2007 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5MYXllZ2g8L0F1dGhvcj48WWVhcj4yMDA3PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [90]AZI & MA22 & 27Iran Not performedN/AnoneMicroscopyRCT; Participants aged 4-70, lesion < 6 months in durationT1(n=22): Azithromycin 500 mg PO x 5 days/month, repeat monthly up to 4 months (pediatric dose 10mg/kg)N/AT2(n=27): MA 60 mg/kg IM daily x 20 daysPrimary: % cure at 3 months; Secondary: adverse eventsCure defined as decreased induration by >75%, full re-epithelialisation, or negative amastigotes on smearCure observed in 3/35 (10%) recieving azithromycin and 20/58 (34%) receiving IMMA. AE included myalgias and local erythema with IMMA, and GI intolerance with azithromycinIMMA was more effective than azithromycinNo significant differences2 out of 49 (4.1%); followed for 3 monthsOpenRandomized, but method not explained4.50011110Mohebali 2007 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb2hlYmFsaTwvQXV0aG9yPjxZZWFyPjIwMDc8L1llYXI+
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ADDIN EN.CITE.DATA [91]MIL & MA32 & 31IranPCR-RFLP and enzyme electrophoresis L. majornoneMicroscopyRCT; Participants mean ages 20.2 and 16.8 between groups, mean < 2 lesions, no prior treatmentsT1(n=32): Miltefosine 2.5 mg/kg PO daily x 28 daysN/AT2(n=31): MA 20 mg/kg IM daily x 14 daysPrimary: % cure at 3 months; Secondary: % relapse at 6 months; Tertiary: adverse eventsCure defined as complete re-epithelialisation and disappearance of induration at 3 monthsMiltefosine cured 26/32 (81%) and MA cured 25/31 (81%), RR 1.01. AE included nausea, vomiting with miltefosine; mild elevation in LFTs in both groupsBoth drugs are equally effective in treating CL, but early nausea and vomiting with miltefosine led to >10% withdrawal from the study.Differed in lesion size5 out of 63 (8%); followed for 6 monthsOpenRandomized via balanced block method5111010Nilforoushzadeh 2007 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OaWxmb3JvdXNoemFkZWg8L0F1dGhvcj48WWVhcj4yMDA3
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ADDIN EN.CITE.DATA [93]RFT & ILMA57 & 60IranNot performedN/AnoneMicroscopyRCT, aged >5 years, no facial lesions, no prior treatmentN/AT1(n=57): Thermotherapy weekly x 4 weeks; T2(n=60): MA IL weekly x 4 weeksN/APrimary: % cure at 6 months; Secondary: % relapse and adverse eventsCure assessed by examining for flattened lesion, no induration, re-appearance of epidermal creasesHeat therapy healed 46/57 (81%) of lesions, ILMA healed 52/94 (55%). AE included erythema, edema and pruritus with ILMAHeat therapy was more effective than 4 doses of ILMANo significant differencesLoss not mentioned; followed for 6 monthsSingle-blinded (examiners only)Randomized via random number list5101010.50.5Layegh 2009 ADDIN EN.CITE <EndNote><Cite><Author>Layegh</Author><Year>2009</Year><RecNum>3033</RecNum><DisplayText>[94]</DisplayText><record><rec-number>3033</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">3033</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Layegh, P.</author><author>Pezeshkpoor, F.</author><author>Soruri, A. H.</author><author>Naviafar, P.</author><author>Moghiman, T.</author></authors></contributors><auth-address>Qaem Hospital, Mashad University of Medical Sciences, Mashad, Iran. pouran_layegh@</auth-address><titles><title>Efficacy of cryotherapy versus intralesional meglumine antimoniate (glucantime) for treatment of cutaneous leishmaniasis in children</title><secondary-title>Am J Trop Med Hyg</secondary-title><alt-title>The American journal of tropical medicine and hygiene</alt-title></titles><periodical><full-title>Am J Trop Med Hyg</full-title></periodical><alt-periodical><full-title>The American journal of tropical medicine and hygiene</full-title></alt-periodical><pages>172-5</pages><volume>80</volume><number>2</number><edition>2009/02/05</edition><keywords><keyword>Antiprotozoal Agents/*therapeutic use</keyword><keyword>Child</keyword><keyword>Child, Preschool</keyword><keyword>*Cryotherapy</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Injections, Intralesional</keyword><keyword>Iran</keyword><keyword>Leishmaniasis, Cutaneous/*drug therapy/parasitology/*therapy</keyword><keyword>Male</keyword><keyword>Meglumine/*therapeutic use</keyword><keyword>Organometallic Compounds/*therapeutic use</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2009</year><pub-dates><date>Feb</date></pub-dates></dates><isbn>0002-9637</isbn><accession-num>19190206</accession-num><urls></urls><remote-database-provider>Nlm</remote-database-provider><language>eng</language></record></Cite></EndNote>[94]CRY & ILMA40 & 39IranNot performedN/Anonepositive smearRCT; Participants all children ≤ 13 years, lesions < 12 weeks in durationN/AT1(n=40): Cryotherapy weekly x 3-6 weeks; T2(n=39): MA IL x 4-6 weeksN/APrimary: % cureCure defined as complete re-epithelialisation and negative amastigotes on smearITT analysis: cryotherapy better than ILMA. Cryotherapy cured 52.5% vs 25% with ILMA.Because of its simplicity, lower cost, low rate of serious complications, and greater tolerability, cryotherapy is an appropriate treatment for childrenNo significant differences7 our of 79 (8.8%); followed for 6 months OpenRandomized, but method not explained5.51011110Emad 2011 ADDIN EN.CITE <EndNote><Cite><Author>Emad</Author><Year>2011</Year><RecNum>2980</RecNum><DisplayText>[95]</DisplayText><record><rec-number>2980</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">2980</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Emad, M.</author><author>Hayati, F.</author><author>Fallahzadeh, M. K.</author><author>Namazi, M. R.</author></authors></contributors><titles><title>Superior efficacy of oral fluconazole 400 mg daily versus oral fluconazole 200 mg daily in the treatment of cutaneous leishmania major infection: a randomized clinical trial</title><secondary-title>J Am Acad Dermatol</secondary-title><alt-title>Journal of the American Academy of Dermatology</alt-title></titles><periodical><full-title>J Am Acad Dermatol</full-title><abbr-1>Journal of the American Academy of Dermatology</abbr-1></periodical><alt-periodical><full-title>Journal of the American Academy of Dermatology</full-title></alt-periodical><pages>606-8</pages><volume>64</volume><number>3</number><edition>2011/02/15</edition><keywords><keyword>Adult</keyword><keyword>Female</keyword><keyword>Fluconazole/*administration & dosage/adverse effects/therapeutic use</keyword><keyword>Humans</keyword><keyword>Leishmania major/drug effects</keyword><keyword>Leishmaniasis, Cutaneous/*drug therapy</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword></keywords><dates><year>2011</year><pub-dates><date>Mar</date></pub-dates></dates><isbn>0190-9622</isbn><accession-num>21315963</accession-num><urls></urls><electronic-resource-num>10.1016/j.jaad.2010.04.014</electronic-resource-num><remote-database-provider>Nlm</remote-database-provider><language>eng</language></record></Cite></EndNote>[95]FLU60IranPCR-RFLP L. majornoneMethod not mentionedRCT; Participants aged > 12, lesions < 4months in durationT1(n=60): Fluconazole 100 mg PO BID x 6 weeks; T2(n=60): fluconazole 200 mg PO BID x 6 weeksN/AN/APrimary: % cure at 1.5 months; Secondary: adverse eventsCure defined as complete re-epithelialisationIn T1, no patients showed cure at 4 weeks, but 29 of 60 patients (48.3%) were cured by 6 weeks. 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ADDIN EN.CITE.DATA [96]MA56IranEndemic, speciation not performedL. tropicanoneMicroscopyNot an RCT, prospective observational study; Participants divided into groups based on age (< or > 15 years), lesions < 3 months in durationN/AN/AT1(n=56): MA 20 mg/kg IM daily x 20 days (all participants aged ≤ 15 years); T2(n=56): MA 20 mg/kg IM daily x 20 days (all participants aged > 15 years)Primary: % cure at 1.5 monthsCure defined as complete re-epithelialisation with negative amastigotes on smearPer-protocol analysis showed a significantly lower response in the children group 20 and 45 days after initiation of the treatment (P = 0.0001)Children with CL do not respond as well as adults when treated with IMMASignificant difference in age between treatment arms12 out of 112 (11%); followed for 1.5 monthsOpenNot randomized3.5101100.50Meymandi 2011 ADDIN EN.CITE <EndNote><Cite><Author>Meymandi</Author><Year>2011</Year><RecNum>4836</RecNum><DisplayText>[97]</DisplayText><record><rec-number>4836</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">4836</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Meymandi, S</author><author>Zandi, S, </author><author>Aghaie H, </author><author>Heshmatkhah A.</author></authors></contributors><titles><title>Efficacy of CO(2) laser for treatment of anthroponotic cutaneous leishmaniasis, compared with combination of cryotherapy and intralesional meglumine antimoniate.</title></titles><dates><year>2011</year></dates><urls><related-urls><url>;[97]CO2 & CRY & ILMA80IranEndemic, speciation not performedL. tropicanoneMicroscopyRCT; Participants aged 7–60 yearsN/AT1(n=80): CO2 laser therapy x 3-5 sessions; T2(n=80): Cryotherapy biweekly x 12 weeks & MA IL biweekly x 12 weeksN/APrimary: % cure; Secondary: adverse eventCure defined as total re-epithelialisation of the lesion with negative amastigotes on smearCure rates in T1 were 97% vs 78% in T2. Similar rates AECO2 laser was more effective for CL than combined MA IL with cryotherapyNo significant differences31 out of 160 (19.3%); followed for 4 monthsNot mentionedRandomized via randomization tables5.5101110.50Dastgheib 2012PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EYXN0Z2hlaWI8L0F1dGhvcj48WWVhcj4yMDEyPC9ZZWFy
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ADDIN EN.CITE.DATA [98]AZI & ALL & MA36 & 35IranEndemic, PCR on only negative smearsL. majornoneMicroscopyRCT; Participants aged > 12, lesion < 3 months in duration, < 5 lesions totalT1(n=36): Azithromycin 10 mg/kg (max 500 mg) PO daily and allopurinol 10 mg/kg (max 800 mg) PO daily x 2 monthsN/A T2(n=35): MA 20 mg/kg IM daily x 20 days Primary: % cure at 2 monthsCure defined as complete re-epithelialisationCure observed in 39% in T1 and 40% in T2 at 2 months post end of treatment. AE included GI intoleranceComparable efficacy with both regimens, neither highly efficacious.No significant differences14 out of 86 (16%); followed for 2 monthsOpenRandomized via even and odd number allocation5.5101110.50Jowkar 2012 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Kb3drYXI8L0F1dGhvcj48WWVhcj4yMDEyPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [99] CRY & NaNO236 & 27IranPCR-RFLPL. tropica (89%)L major (11%)MicroscopyRCT; Participants aged > 11 years, lesions < 4 months in durationN/AT1(n=36): Cryotherapy weekly and 2 creams (3% salicylic and 3% Na nitrite); T2(n=27): Cryotherapy weekly and 2 creams (3% salicylic with placebo)N/APrimary: % cure; Secondary: adverse events Cure defined as complete re-epithelialisation of the lesion83% cure in T1 vs 74% with placebo. More local AE in the Na nitrite groupNo more effectiveness from combining a 12-week treatment with 3% nitric oxide cream and weekly cryotherapy in comparison with cryotherapy and placeboNo significant differences37 out of 100 (37%); followed for 3 monthsDouble blindRandomized, but method not explained7111110.51Khatami 2012 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LaGF0YW1pPC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48
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ADDIN EN.CITE.DATA [100]MIL & ILMA63 & 75IranNot performedN/AnoneMicroscopyRCT; Participants aged 12-50T1(n=63): Miltefosine 2.5 mg/kg PO daily x 4 weeks;T2(n=75): MA IL x 14 daysN/APrimary: % cure at 2 months; Secondary: adverse events Not definedNo difference in cure rates. More AE in T1 (p=0.001)Cure with miltefosine vs ILMA not different. Miltefosine has more AENot reported73 out of 138 (53%); followed for 2 monthsOpenRandomized, method unknown (full article not available)3.5101000.50Maleki 2012 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYWxla2k8L0F1dGhvcj48WWVhcj4yMDEyPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA [101]ZnSO4 & ILMA24 & 10IranNot performednonenoneMicroscopyRCT; Participants aged 7-60, ≤ 3 lesions, < 12 weeks in duration, only "dry" lesionsN/AT1(n=24): 2% ZnSO4 IL 2x/week x 2 weeks; T2(n=10): MA IL weekly x 6 weeks N/APrimary: % cure at 8 weeks Cure defined as per the Sharquie score: 1-5 with 5 representing complete healing and negative smear, and 1 representing partial reduction of erythema and edemaComplete cure observed in 33% receiving ZnSO4, and 80% in those receiving ILMA. Many local AE.ILMA is superior to IL ZnS04. AE seen with both modalitiesNo significant differences11 out of 45 (24%); followed for 2 monthsOpenRandomized, but method not explained4001110.50Nilforoushzadeh 2012 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OaWxmb3JvdXNoemFkZWg8L0F1dGhvcj48WWVhcj4yMDEy
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ADDIN EN.CITE.DATA [102] TCA16IranEndemic, speciation not performedL. majornoneMicroscopyNot an RCT, case series; Participants aged 6-60, lesions < 5 cm, < 12 weeks in durationN/AT1(n=16): 5% trichloroacetic acid (TCA) cream applied BID x 8 weeksN/APrimary: % cure at 8 weeksCure defined as complete re-epithelialisation and negative amastigotes on smear16/16 cured at 8 weeks. No withdrawals due to AEDecreasing the scar size and the low cost are two promising aspects in introducing 5% TCA cream as a potential alternative for intralesional Glucantime.Single arm studyLoss not mentioned; followed for 2 month OpenNot randomized2.5001100.50Khatami 2013 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LaGF0YW1pPC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48
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ADDIN EN.CITE.DATA [103] ILMA & MA38 & 95IranEndemic, speciation not performedL. majorL. tropicaMicroscopyNot an RCT, case series; Participants mean age 30.8. T1 included lesions < 3 cm, ≤ 3 lesions. T2 included lesions > 3 cm, >3 lesions, or lesions located on the face or joints.N/AT1(n=38): MA IL 2x/week x 6-15 sessionsT2(n=95): MA 10-20 mg/kg IM in 2-3 divided doses x 14 days (L. major) or x 20 days (L. tropica)Primary: % cure at 1 monthCure defined as negative smear, and reduced indurationThe failure rate for patients treated with one course of Glucantime was 22.6% overall. The only association with failure was previous exposure to MADiffered in lesion size and number16 out of 133 (12%); followed for 1 monthOpenNot randomized21010000Goyonlo 2014 ADDIN EN.CITE <EndNote><Cite><Author>Goyonlo</Author><Year>2014</Year><RecNum>2995</RecNum><DisplayText>[104]</DisplayText><record><rec-number>2995</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">2995</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Goyonlo, V. M.</author><author>Vosoughi, E.</author><author>Kiafar, B.</author><author>Nahidi, Y.</author><author>Momenzadeh, A.</author><author>Taheri, A. R.</author></authors></contributors><auth-address>Department of Dermatology, Cutaneous Leishmaniasis Research Center, School of Medicine, Imam Reza Hospital, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.</auth-address><titles><title>Efficacy of intralesional amphotericin B for the treatment of cutaneous leishmaniasis</title><secondary-title>Indian J Dermatol</secondary-title><alt-title>Indian journal of dermatology</alt-title></titles><alt-periodical><full-title>Indian Journal of Dermatology</full-title></alt-periodical><pages>631</pages><volume>59</volume><number>6</number><edition>2014/12/09</edition><dates><year>2014</year><pub-dates><date>Nov</date></pub-dates></dates><isbn>0019-5154</isbn><accession-num>25484415</accession-num><urls></urls><custom2>Pmc4248523</custom2><electronic-resource-num>10.4103/0019-5154.143571</electronic-resource-num><remote-database-provider>Nlm</remote-database-provider><language>eng</language></record></Cite></EndNote>[104]ILAMB93IranNot performedN/AnoneMicroscopy or smearNot an RCT, prospective study. Participants mean age 20.8 years, lesions mean ≥6 months in duration, 85% unresponsive to MA ILN/AT1(n=93): Amphotericin B IL weekly until lesion cureN/APrimary: % cure; Secondary: adverse eventsCure defined as more than 90% reduction in size and induration of the lesions.At 12 weeks, 61.4% were recovered completely, 21.6% had partial remission, and 17% had less than 60% reduction. Recurrence in 9%. No significant AE's.Weekly intralesional injection of amphotericin B looks promising, considering that most of the patients in this study were resistant to antimoniates.Single treatment armLoss not mentioned; followed for 3 monthsOpenNot randomized2.5101000.50Jaffary 2014 ADDIN EN.CITE <EndNote><Cite><Author>Jaffary</Author><Year>2014</Year><RecNum>3013</RecNum><DisplayText>[105]</DisplayText><record><rec-number>3013</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">3013</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Jaffary, F.</author><author>Nilforoushzadeh, M. A.</author><author>Tavakoli, N.</author><author>Zolfaghari, B.</author><author>Shahbazi, F.</author></authors></contributors><auth-address>Skin Diseases and Leishmaniasis Research Center, Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Skin and Stem Cell Research Center, Department of Dermatology, Tehran University of Medical Sciences, Tehran, Iran.
Skin and Stem Cell Research Center, Department of Dermatology, Tehran University of Medical Sciences, Tehran, Iran.
Department of Pharmacology, Isfahan University of Medical Sciences, Isfahan, Iran.</auth-address><titles><title>The efficacy of Achilles millefolium topical gel along with intralesional injection of glucantime in the treatment of acute cutaneous leishmaniasis major</title><secondary-title>Adv Biomed Res</secondary-title><alt-title>Advanced biomedical research</alt-title></titles><periodical><full-title>Adv Biomed Res</full-title><abbr-1>Advanced biomedical research</abbr-1></periodical><alt-periodical><full-title>Adv Biomed Res</full-title><abbr-1>Advanced biomedical research</abbr-1></alt-periodical><pages>111</pages><volume>3</volume><edition>2014/05/08</edition><dates><year>2014</year></dates><isbn>2277-9175</isbn><accession-num>24804185</accession-num><urls></urls><custom2>Pmc4009745</custom2><electronic-resource-num>10.4103/2277-9175.129717</electronic-resource-num><remote-database-provider>Nlm</remote-database-provider><language>eng</language></record></Cite></EndNote>[105]Yarrow & ILMA30IranEndemicL. majornoneMicroscopy and cultureRCT; participants mean age 25 years, predominantly male, mean 1.5 lesions, 3 months in durationN/AT1(n=30): 5% yarrow (Achilles millefolium) gel BID & MA 20mg/kg IL weekly x 4 weeks; T2(n=30): placebo gel BID & MA 20mg/kg IL weekly x 4 weeksN/APrimary: % cure at 3 months; Secondary: adverse eventsNot defined, only mentioned that cure was assessed by visual analog scaleNo significant difference in complete and relative cure rates between the two groups (P = 0.35) using Visual Analog Scale (VAS). AE included local erythema, pruritus, and increased wound secretion in T1.There is no significant difference in cure rates of lesions between yarrow and placebo topical gels as an adjuvant drugs with intralesional Glucantime.No significant differencesLoss not mentioned; followed for 3 monthsDouble blindRandomized via a random allocation computer software5.5101010.51Nilforoushzadeh 2014 ADDIN EN.CITE <EndNote><Cite><Author>Nilforoushzadeh</Author><Year>2014</Year><RecNum>3075</RecNum><DisplayText>[106]</DisplayText><record><rec-number>3075</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">3075</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Nilforoushzadeh, M. A.</author><author>Minaravesh, S.</author><author>Jaffary, F.</author><author>Siadat, A. H.</author><author>Haftbaradaran, E.</author></authors></contributors><auth-address>Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.
General Physician, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.
Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.</auth-address><titles><title>Comparison the efficacy of ablative CO2 laser and fractional CO2 laser on the healing of cutaneous leishmaniasis scars</title><secondary-title>Adv Biomed Res</secondary-title><alt-title>Advanced biomedical research</alt-title></titles><periodical><full-title>Adv Biomed Res</full-title><abbr-1>Advanced biomedical research</abbr-1></periodical><alt-periodical><full-title>Adv Biomed Res</full-title><abbr-1>Advanced biomedical research</abbr-1></alt-periodical><pages>259</pages><volume>3</volume><edition>2015/01/28</edition><dates><year>2014</year></dates><isbn>2277-9175</isbn><accession-num>25625098</accession-num><urls></urls><custom2>Pmc4298882</custom2><electronic-resource-num>10.4103/2277-9175.148231</electronic-resource-num><remote-database-provider>Nlm</remote-database-provider><language>eng</language></record></Cite></EndNote>[106]CO260 & 60IranNot performedN/AnoneNot specifiedRCT; Participants age 6-45 (mean 27), mean 1 lesion N/AT1(n=60): Ablative CO2 laser x 1 session; T2(n=60): Fractional CO2 laser q3weeks x 6 sessionsN/APrimary: % cure at 6 months; Secondary: adverse eventsScar depth was monitored, with a reduction of >75% consistent with very good improvement.?Use of ablative?CO2 demonstrated 44% improvement at 6 months vs. 76.7% ?with the fractional laser. AE were similar (rash).Fractional?CO2 ?laser therapy ?is?better?than?ablative?CO2 ?laser?in?diminishing size of?leishmaniasis?scars. Not comparedLoss not mentioned; followed for 6 monthsSingle blinded Randomized but method not explained2.5100000.50.5Sharquie 1997 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGFycXVpZTwvQXV0aG9yPjxZZWFyPjE5OTc8L1llYXI+
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ADDIN EN.CITE.DATA [107]ZnSO4 & NS19 & 17 & 18 & 9IraqNot performedN/AnoneMicroscopy and/or cultureRCT; Participants aged 3 months to 65 year, lesions < 12 weeks in duration, mean 2 lesionsN/AT1(n=19): 2% ZnSO4 IL; T2(n=17): 7% NS IL; T3(n=18): SSG IL; T4(n=9): no interventionN/APrimary: % cure at 1.5 months; Secondary: speed of healing, scar prevention, adverse eventsCure defined as marked and total clearance: total clearance defined as negative smear, and marked defined as reduction of 60% in lesion and negative smearIL ZnS04 healed 36 lesions (96%), IL hypertonic NS healed 34 (85%), IL SSG healed 31 (89%) and the no intervention group was associated with no healing.The results show that the three treatments gave comparable cure rates by the end of the follow-up period. However, zinc sulphate gave a high cure rate (94.8%) usually with a single injection. No significant differences 22 out of 85 (26%); followed for 2 monthsOpenRandomized via simple random distribution4.5001110.50Sharquie 2011 CRY & ILMA100 & 200 & 160IraqNot performedN/AnoneMicroscopy and/or cultureRCT; Participants with lesions < 12 weeks in duration, > 5 lesions, size > 4 cm, no prior treatmentN/AT1(n=100): Cryotherapy and MA IL q2weeks x 6 weeks; T2(n=200): Cryotherapy q2weeks x 6 weeks; T3(n=160): MA IL q2weeks x 6 weeksN/APrimary: % cure; Secondary: adverse events; Tertiary: parasite cureCure defined as complete re-epithelialisation of lesion with loss of edema, induration and absence of amastigotesCryotherapy and ILMA healed 120 of 149 (91%) lesions, cryotherapy healed 120 of 230 (57%) lesions and ILMA healed 84 of 160 (56%) bined cryotherapy and intralesional meglumine antimoniate was more effective than either cryotherapy or ILMA aloneNo significant differences30 out of 400 (7.5%); followed for 6 monthsNot mentionedRandomized, method unknown61011110Sharquie 2001 ADDIN EN.CITE <EndNote><Cite><Author>Sharquie</Author><Year>2001</Year><RecNum>3122</RecNum><DisplayText>[108]</DisplayText><record><rec-number>3122</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">3122</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Sharquie, K. E.</author><author>Najim, R. A.</author><author>Farjou, I. B.</author><author>Al-Timimi, D. J.</author></authors></contributors><auth-address>Department of Dermatology, College of Medicine, University of Baghdad, Baghdad, Iraq.</auth-address><titles><title>Oral zinc sulphate in the treatment of acute cutaneous leishmaniasis</title><secondary-title>Clin Exp Dermatol</secondary-title><alt-title>Clinical and experimental dermatology</alt-title></titles><periodical><full-title>Clin Exp Dermatol</full-title><abbr-1>Clinical and experimental dermatology</abbr-1></periodical><alt-periodical><full-title>Clin Exp Dermatol</full-title><abbr-1>Clinical and experimental dermatology</abbr-1></alt-periodical><pages>21-6</pages><volume>26</volume><number>1</number><edition>2001/03/22</edition><keywords><keyword>Administration, Oral</keyword><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Astringents/*administration & dosage</keyword><keyword>Child</keyword><keyword>Child, Preschool</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Infant</keyword><keyword>Leishmaniasis, Cutaneous/diagnosis/*drug therapy</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Treatment Outcome</keyword><keyword>Wound Healing</keyword><keyword>Zinc Sulfate/*administration & dosage</keyword></keywords><dates><year>2001</year><pub-dates><date>Jan</date></pub-dates></dates><isbn>0307-6938 (Print)
0307-6938</isbn><accession-num>11260171</accession-num><urls></urls><remote-database-provider>Nlm</remote-database-provider><language>eng</language></record></Cite></EndNote>[108]ZnSO439 & 37 & 39 & 15IraqNot performedN/AnoneMicroscopy and/or cultureRCT; Participants aged 4 months to 65 years, lesion < 3 months in duration, size > 4 cm, no prior treatmentT1(n=39): ZnSO4 2.5 mg/kg PO divided TID x 45 days; T2(n=37): ZnSO4 5 mg/kg PO divided TID x 45 days; T3(n=39): ZnSO4 10 mg/kg PO divided TID x 45 days T4(n=15): no intervention N/AN/APrimary: % cure at 2 months; Secondary: speed of healing, scar prevention, adverse eventsCure defined as total clearance of lesion, negative amastigotes on smear; definition of clearance not specifiedZnSO4 2.5mg/kg cured 16/39 (41%), 5mg/kg cured 23/37 (62%), and 10mg/kg cured 29/39 (74%). T4 had no participants who had cured lesions. AE included nausea, vomiting with higher doses, macular rashThere appeared to be a dose effect using ZnSO4 with higher doses associated with higher rates of cure (74% ITT), but more GI toxicity.No significant differences26 out of 130 (20%); followed for 1.5 monthsOpenRandomized, but method not explained3001010.50Enk 2014 ADDIN EN.CITE <EndNote><Cite><Author>Enk</Author><Year>2014</Year><RecNum>2982</RecNum><DisplayText>[109]</DisplayText><record><rec-number>2982</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">2982</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Enk, C. D.</author><author>Nasereddin, A.</author><author>Alper, R.</author><author>Dan-Goor, M.</author><author>Jaffe, C. L.</author><author>Wulf, H. C.</author></authors></contributors><auth-address>Department of Dermatology, Hadassah Medical Organization, The Hebrew University Medical School, Jerusalem, Israel.</auth-address><titles><title>Cutaneous leishmaniasis responds to daylight-activated photodynamic therapy: proof of concept for a novel self-administered therapeutic modality</title><secondary-title>Br J Dermatol</secondary-title><alt-title>The British journal of dermatology</alt-title></titles><periodical><full-title>Br J Dermatol</full-title><abbr-1>The British journal of dermatology</abbr-1></periodical><alt-periodical><full-title>Br J Dermatol</full-title><abbr-1>The British journal of dermatology</abbr-1></alt-periodical><edition>2014/11/05</edition><dates><year>2014</year><pub-dates><date>Nov 1</date></pub-dates></dates><isbn>0007-0963</isbn><accession-num>25363817</accession-num><urls><related-urls><url>;[109]5-ALA & PDT31IsraelPCRL tropicaL majorMicroscopy or smearNot an RCT, case series. Participants with > 1 lesion, < 1.5 cm in sizeN/AT1(n=31): 16% methyl aminolevulinate applied to lesion followed by Daylight-activated photodynamic therapy (administered either at home or in hospital) for 2.5 hours weekly until cureN/APrimary: % cureCure defined as flattening of lesion with complete epithelialisation, and microbiological confirmation.The overall cure rate for hospital-based and self-administered DA-PDT was 88.9% (ITT cure rate 77.4%); hospital-based treatment demonstrated 85.7% cure, and self-administered treatment 92.3% cure.DA-PDT is effective in the treatment of CL caused by L. major and L. tropica. The majority of the patients were treated according to a self-administered protocol, suggesting that DA-PDT can be adopted in areas lacking technological infrastructure.Data not yet available [Epub ahead of print]4 out of 33 (12%); followed for 18 monthsOpenNot randomized4.5111100.50Solomon 2014 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Tb2xvbW9uPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48
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ADDIN EN.CITE.DATA [110]AMB & ILSSG21 & 24IsraelPCRL. tropicanoneMicroscopyNot an RCT, retrospective case series. Participants aged 1-15 years, mean 2.6 lesions, 36 had received topical therapy prior to systemic therapyN/AT1(n=21): SSG IL x 1-5 injectionsT2(n=24): Liposomal amphotericin B 3-5 mg/kg IV daily x 5 days with 6th dose on day 10 of treatmentPrimary: % cure at 3 months; Secondary: adverse eventsCure defined as 100% re-epithelialisation of the ulcer (or of the non-ulcerative lesions, regression of the lesion) within 3 months after treatment.Of those receiving IL SSG, 14/21 (66.6%) were cured within 3 months. AE included injection site erythema and edema. Among the L-AMB-treated patients, 18 (75%) showed a complete response and 2 (8.3%), a partial response. AE included increased LFTs and leukopenia.In our experience, liposomal amphotericin B treatment in children is safe and effective and is required for a considerably shorter duration than treatment with pentavalent antimony.Not comparedNo losses; followed for 3 monthsOpenNot randomized40111010Al-Fouzan 1991 ADDIN EN.CITE <EndNote><Cite><Author>al-Fouzan</Author><Year>1991</Year><RecNum>2912</RecNum><DisplayText>[111]</DisplayText><record><rec-number>2912</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">2912</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>al-Fouzan, A. S.</author><author>al Saleh, Q. A.</author><author>Najem, N. M.</author><author>Rostom, A. I.</author></authors></contributors><auth-address>Department of Dermatology, Al-Sabah Hospital, Safat, Kuwait.</auth-address><titles><title>Cutaneous leishmaniasis in Kuwait. Clinical experience with itraconazole</title><secondary-title>Int J Dermatol</secondary-title><alt-title>International journal of dermatology</alt-title></titles><periodical><full-title>Int J Dermatol</full-title><abbr-1>International journal of dermatology</abbr-1></periodical><alt-periodical><full-title>International Journal of Dermatology</full-title></alt-periodical><pages>519-21</pages><volume>30</volume><number>7</number><edition>1991/07/01</edition><keywords><keyword>Administration, Oral</keyword><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Antifungal Agents/administration & dosage/*therapeutic use</keyword><keyword>Capsules</keyword><keyword>Child</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Itraconazole</keyword><keyword>Ketoconazole/administration & dosage/*analogs & derivatives/therapeutic use</keyword><keyword>Kuwait</keyword><keyword>Leishmaniasis, Cutaneous/*drug therapy</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Placebos</keyword></keywords><dates><year>1991</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>0011-9059 (Print)
0011-9059</isbn><accession-num>1663089</accession-num><urls></urls><remote-database-provider>Nlm</remote-database-provider><language>eng</language></record></Cite></EndNote>[111]ITR15 & 9KuwaitNot performedN/AnoneMicroscopyRCT; Participants aged 12-52, lesion duration 1-14 monthsT1(n=15): Itraconazole 200 mg PO BID x 6-8 weeks; T2(n=9): placebo PO BID x 6-8 weeksN/AN/APrimary: % cure at 2 months; Secondary: AE, % recurrenceNot definedCure observed in 11/15 (73%) receiving Itraconazole, and in 0% receiving placebo, RR 14.38. AE included nausea, headache, mild increased LFTsIn this small study, itraconazole was markedly superior to placebo, and associated adverse effects were mildPartially reportedLoss not mentioned; followed for 2 monthsNot mentionedRandomized, method unknown (full article not available)2001000.50Alsaleh 1995 ADDIN EN.CITE <EndNote><Cite><Author>Alsaleh</Author><Year>1995</Year><RecNum>6146</RecNum><DisplayText>[112]</DisplayText><record><rec-number>6146</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">6146</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Alsaleh, Q. A.</author><author>Dvorak, R.</author><author>Nanda, A.</author></authors></contributors><auth-address>Department of Dermatology, Al-Sabah Hospital, Kuwait.</auth-address><titles><title>Ketoconazole in the treatment of cutaneous leishmaniasis in Kuwait</title><secondary-title>International Journal of Dermatology</secondary-title><alt-title>Int J Dermatol</alt-title></titles><periodical><full-title>International Journal of Dermatology</full-title></periodical><alt-periodical><full-title>Int J Dermatol</full-title><abbr-1>International journal of dermatology</abbr-1></alt-periodical><pages>495-7</pages><volume>34</volume><number>7</number><edition>1995/07/01</edition><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Antifungal Agents/*therapeutic use</keyword><keyword>Dose-Response Relationship, Drug</keyword><keyword>Drug Administration Schedule</keyword><keyword>Female</keyword><keyword>Follow-Up Studies</keyword><keyword>Humans</keyword><keyword>Ketoconazole/administration & dosage/adverse effects/*therapeutic use</keyword><keyword>Kuwait</keyword><keyword>Leishmaniasis, Cutaneous/diagnosis/*drug therapy</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>1995</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>0011-9059 (Print)
0011-9059 (Linking)</isbn><accession-num>7591417</accession-num><work-type>Clinical Trial
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ADDIN EN.CITE.DATA [113]ILMA49 & 55PakistanNot performedN/AnoneMicroscopyRCT; Participants predominantly pediatric, average 1-2 lesions, ≤5 lesions totalN/AT1(n=49): MA IL weekly x 8 weeks or until cure; T2(n=55): MA IL q 2 weeks x 8 weeks or until cureN/APrimary: % cure at 2 months; Secondary: speed of healing, adverse events, scar prevention Cure defined as 100% improvement; improvement not specifiedHealing at 2 months post treatment was 102/11(92%) for weekly ILMA, and 89/104 (86%) for every 2 weeks ILMA; RR 1.07 ILMA is effective and can be given at 2 week intervals with similar Responses to weekly. AE included transient pain at the injection siteNo significant differences8 out of 104 (7.7%); followed for 2 monthsOpenRandomized, but method not explained4.51010110Mashood 2001 ADDIN EN.CITE <EndNote><Cite><Author>Mashood</Author><Year>2001</Year><RecNum>6181</RecNum><DisplayText>[114]</DisplayText><record><rec-number>6181</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">6181</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Mashood, A</author></authors></contributors><titles><title>Efficacy of allopurinol compared with pentostam in the treatment of old worlds cutaneous leishmaniasis</title><secondary-title>Journal of College of Physicians and Surgeons-Pakistan</secondary-title></titles><periodical><full-title>Journal of College of Physicians and Surgeons-Pakistan</full-title></periodical><pages>3</pages><volume>11</volume><number>6</number><section>367</section><dates><year>2001</year></dates><urls></urls></record></Cite></EndNote>[114]ALL & SSG20PakistanNot performedN/AnoneMicroscopyRCT; Participants all male soldiers, aged 20-40, no prior treatmentT1(n=20): allopurinol 20 mg/kg divided TID or QID x 15 daysN/AT2(n=20): SSG 20 mg/kg IV daily x 15 daysPrimary: % cure at end of treatment; Secondary: adverse eventsCure defined as 80% decrease in size of lesion or re-epithelialisationCure observed in 17/20 (85%) receiving SSG and 14/20 (70%) with allopurinol. AE included nausea, vomiting, anorexia, myalgias, increased LFTs, and rashBoth treatments were associated with good efficacy. Allopurinol is an effective treatment of CL in PakistanNo significant differencesLoss not mentioned; followed for 3 monthsNot mentionedRandomized, method unknown (full article not available)4001110.50Munir 2008 ADDIN EN.CITE <EndNote><Cite><Author>Munir</Author><Year>2008</Year><RecNum>3063</RecNum><DisplayText>[115]</DisplayText><record><rec-number>3063</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">3063</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Munir, A.</author><author>Janjua, S. A.</author><author>Hussain, I.</author></authors></contributors><auth-address>Combined Military Hospital, Kharian Cantt., Lalamusa, Pakistan.</auth-address><titles><title>Clinical efficacy of intramuscular meglumine antimoniate alone and in combination with intralesional meglumine antimoniate in the treatment of old world cutaneous leishmaniasis</title><secondary-title>Acta Dermatovenerol Croat</secondary-title><alt-title>Acta dermatovenerologica Croatica : ADC</alt-title></titles><periodical><full-title>Acta Dermatovenerol Croat</full-title><abbr-1>Acta dermatovenerologica Croatica : ADC</abbr-1></periodical><alt-periodical><full-title>Acta Dermatovenerol Croat</full-title><abbr-1>Acta dermatovenerologica Croatica : ADC</abbr-1></alt-periodical><pages>60-4</pages><volume>16</volume><number>2</number><edition>2008/06/11</edition><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Injections, Intralesional</keyword><keyword>Injections, Intramuscular</keyword><keyword>Leishmaniasis, Cutaneous/*drug therapy/pathology</keyword><keyword>Male</keyword><keyword>Meglumine/*administration & dosage/adverse effects</keyword><keyword>Middle Aged</keyword><keyword>Organometallic Compounds/*administration & dosage/adverse effects</keyword><keyword>Prospective Studies</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2008</year></dates><isbn>1330-027X (Print)
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ADDIN EN.CITE.DATA [117]MA40Saudi ArabiaNot performedN/AnoneMicroscopyRCT; Participants aged 13-42, predominantly male, 1-3 lesions, ≤ 6 months in duration, no prior treatmentN/AT2(n=40): MA IL q 2 days x 30 days T1(n=40): MA 15 mg/kg (max 850 mg) IM daily x 6 days/week for a total of 12 injectionsPrimary: % cure at 1 month; Secondary: adverse events, scar preventionCure defined as lesions completely healed and negative amastigotes on smear; definition of healing not specified46 (68%) of the 68 lesions of those treated with IMMA had healed completely, compared to 48/66 (73%) lesions of those treated with ILMASimilar efficacy was observed using 12 doses of IMMA or daily ILMA for a monthNo significant differences13 out of 80 (16%); followed for 1 monthSingle blind (examiner)Randomized but method not explained41010100.5Alrajhi 2002 ADDIN EN.CITE <EndNote><Cite><Author>Alrajhi</Author><Year>2002</Year><RecNum>24</RecNum><DisplayText>[118]</DisplayText><record><rec-number>24</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">24</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Alrajhi, A. A.</author><author>Ibrahim, E. A.</author><author>De Vol, E. B.</author><author>Khairat, M.</author><author>Faris, R. M.</author><author>Maguire, J. H.</author></authors></contributors><auth-address>Department of Immunology and Infectious Diseases, Harvard School of Public Health, Brigham and Women's Hospital, Boston, MA, USA.</auth-address><titles><title>Fluconazole for the treatment of cutaneous leishmaniasis caused by Leishmania major</title><secondary-title>N Engl J Med</secondary-title></titles><periodical><full-title>N Engl J Med</full-title></periodical><pages>891-5</pages><volume>346</volume><number>12</number><keywords><keyword>Adult</keyword><keyword>Animals</keyword><keyword>Antifungal Agents/administration & dosage/*therapeutic use</keyword><keyword>Double-Blind Method</keyword><keyword>Endemic Diseases</keyword><keyword>Female</keyword><keyword>Fluconazole/administration & dosage/*therapeutic use</keyword><keyword>Follow-Up Studies</keyword><keyword>Humans</keyword><keyword>*Leishmania major</keyword><keyword>Leishmaniasis, Cutaneous/*drug therapy/epidemiology/parasitology</keyword><keyword>Male</keyword><keyword>Multivariate Analysis</keyword><keyword>Proportional Hazards Models</keyword><keyword>Saudi Arabia/epidemiology</keyword><keyword>Time Factors</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2002</year><pub-dates><date>Mar 21</date></pub-dates></dates><isbn>1533-4406 (Electronic)
0028-4793 (Linking)</isbn><accession-num>11907288</accession-num><urls><related-urls><url>;[118]FLU106 & 103Saudi ArabiaIsoenzyme electrophoresisL. majornoneMicroscopy and/or cultureRCT; Participants aged > 12, predominantly male, no facial or ear lesionsT1(n=106): Fluconazole 200 mg PO daily x 6 weeks; T2(n=103): placebo 200 mg daily x 6 weeksN/AN/APrimary: % cure at 3 months; Secondary: adverse eventsCure described as complete healing; definition of healing not specifiedFluconazole cured 59% vs 22% with placebo. Time to healing was 8.5 weeks in fluconazole and 11.2 weeks for placebo. AE were not describedFluconazole was safe and hastened healing in 37% as compared to placebo. No significant differences64 out of 209 (31%); followed for 12 monthsDouble blindRandomized via random-number table6.5111010.51Jaffar 2006 ADDIN EN.CITE <EndNote><Cite><Author>Jaffar</Author><Year>2006</Year><RecNum>6182</RecNum><DisplayText>[119]</DisplayText><record><rec-number>6182</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">6182</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Jaffar, H</author></authors></contributors><titles><title>Rifampicin in cutaneous leishmaniasis- a therapeutic trial in Saudi Arabia</title><secondary-title>Journal of Pakistan Association of Dermatologists</secondary-title></titles><periodical><full-title>Journal of Pakistan Association of Dermatologists</full-title></periodical><pages>5</pages><volume>16</volume><section>4</section><dates><year>2006</year></dates><urls></urls></record></Cite></EndNote>[119]RIF46 & 16Saudi ArabiaNot performedN/AnoneMicroscopyRCT; Participants aged 3-65, lesions mean 2.6 months in duration, 30% facial lesionsT1(n=46): Rifampin 10 mg/kg divided BID x 4-6 weeks; T2(n=16): placebo BID x 4-6 weeksN/AN/APrimary: % cure at 3 months; Secondary: % recurrence, adverse eventsCure defined as complete healing at the end of 3 months; definition of healing not specifiedRifampin cured 46% and placebo cured 19%, RR 2.43. AE included elevated LFTsRifampin compared to placebo showed modest efficacy.Not reported21 out of 62 (34%); followed for 3 months Double blindRandomized, but method not explained3001000.51Ranawaka 2010 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SYW5hd2FrYTwvQXV0aG9yPjxZZWFyPjIwMTA8L1llYXI+
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ADDIN EN.CITE.DATA [120]NS & ILSSG87 & 67Sri LankaPCR, culture not routinely doneL. donovaninoneMicroscopyRCT, study of safety and efficacy of IL NS 7% vs ILSSG; Participants mean age 32 yearsN/AT1(n=87): 7% NS IL weekly x 3 weeks, then q 2 weeks x 2 sessions, then monthly until cure; T2(n=67): SSG IL weekly x 3 sessions, then q 2 weeks x 2 sessions, then monthly until cureN/APrimary: % cureCure defined as clearance of lesion without palpable lesion100% cure with IL SSG (1-6 injections) vs 61% cure with hypertonic saline (1-10 injections). No systemic AE; local pain and hyperpigmentationIL SSG was more efficacious than IL hypertonic saline.No significant differences7 out of 154 (4.5%); followed for 18 monthsDouble blindRandomized, but method not explained61010111Ranawaka 2011 ADDIN EN.CITE <EndNote><Cite><Author>Ranawaka</Author><Year>2011</Year><RecNum>3092</RecNum><DisplayText>[121]</DisplayText><record><rec-number>3092</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">3092</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Ranawaka, R. R.</author><author>Weerakoon, H. S.</author><author>Opathella, N.</author></authors></contributors><auth-address>Department of Dermatology, Teaching Hospital Anuradhapura, Sri Lanka. ranthilaka37@</auth-address><titles><title>Liquid nitrogen cryotherapy on Leishmania donovani cutaneous leishmaniasis</title><secondary-title>J Dermatolog Treat</secondary-title><alt-title>The Journal of dermatological treatment</alt-title></titles><periodical><full-title>J Dermatolog Treat</full-title><abbr-1>The Journal of dermatological treatment</abbr-1></periodical><alt-periodical><full-title>J Dermatolog Treat</full-title><abbr-1>The Journal of dermatological treatment</abbr-1></alt-periodical><pages>241-5</pages><volume>22</volume><number>4</number><edition>2010/09/08</edition><keywords><keyword>*Cryotherapy/adverse effects</keyword><keyword>Humans</keyword><keyword>*Leishmania donovani</keyword><keyword>Leishmaniasis, Cutaneous/parasitology/*therapy</keyword><keyword>Nitrogen</keyword></keywords><dates><year>2011</year><pub-dates><date>Aug</date></pub-dates></dates><isbn>0954-6634</isbn><accession-num>20818996</accession-num><urls><related-urls><url>;[121]NO65Sri LankaEndemic, speciation not performedL. donovaninoneMicroscopyNot an RCT, single arm study; Participants aged 6-71, lesions 1-36 months in durationN/AT1(n=65): Liquid nitric oxide weekly x 1-3 weeks, then q2weeks x 4-5 weeks, then monthly until cureN/APrimary: % cure; Secondary: time to cure; Tertiary: adverse eventsCure defined as clearance of lesion without palpable lesion; definition of clearance not specified91.7% cure within 1-7 sessions, mean 3.5 sessions. AE included local pain, ulceration and secondary infectionLiquid nitric oxide is an effective alternative to the historical use of IL antimonialsSingle arm study5 out of 65 (8%); followed for 6 monthsOpenNot randomized31010010Ranawaka 2015 ADDIN EN.CITE <EndNote><Cite><Author>Ranawaka</Author><Year>2015</Year><RecNum>3091</RecNum><DisplayText>[122]</DisplayText><record><rec-number>3091</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">3091</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Ranawaka, R. R.</author><author>Weerakoon, H. S.</author><author>de Silva, S. H.</author></authors></contributors><auth-address>Department of Dermatology, Anuradhapura Teaching Hospital, Anuradhapura, Sri Lanka.</auth-address><titles><title>Randomized, double-blind, controlled, comparative study on intralesional 10% and 15% hypertonic saline versus intralesional sodium stibogluconate in Leishmania donovani cutaneous leishmaniasis</title><secondary-title>Int J Dermatol</secondary-title><alt-title>International journal of dermatology</alt-title></titles><periodical><full-title>Int J Dermatol</full-title><abbr-1>International journal of dermatology</abbr-1></periodical><alt-periodical><full-title>International Journal of Dermatology</full-title></alt-periodical><edition>2015/01/21</edition><dates><year>2015</year><pub-dates><date>Jan 20</date></pub-dates></dates><isbn>0011-9059</isbn><accession-num>25600472</accession-num><urls><related-urls><url>;[122]NS & ILSSG170 & 192 & 82 Sri LankaNot performedL. donovaninoneMicroscopy or smearRCT; Participants aged 14 months to 88 years (mean 32.7), mean 1 lesionN/AT1(n=170): SSG IL up to 7 injections; T2(n=192): 10% NS IL weekly up to 10 injections; T3(n=82): 15% NS IL weekly up to 10 injectionsN/APrimary: % cure at 18 months; Secondary: adverse effects; Tertiary: duration of treatmentCure defined as >80% re-epithelialisation of the lesion and parasitological cure.IL SSG demonstrated 96.3% cure with 3.6 injections (6 weeks of treatment), 10% NS demonstrated 93.0% cure with mean 5.28 injections (9.3 weeks of treatment), and 15% NS demonstrated 93.6% cure with mean 5.3 injection (11 weeks of treatment). AE included cutaneous necrosis in 30.6% receiving 15% hypertonic saline.This study found 10% HS to be an effective and safe alternative to SSG. Treatment with HS at concentrations of 15% or above was not safe as a result of cutaneous necrosis. Data not yet available [Epub ahead of print]17 out of 444 (3.8%); followed for 18 monthsSingle blinded Randomized via 2:2:1 ratio5.51011010.5Lynen 1992 ADDIN EN.CITE <EndNote><Cite><Author>Lynen</Author><Year>1992</Year><RecNum>6176</RecNum><DisplayText>[123]</DisplayText><record><rec-number>6176</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">6176</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Lynen, L.</author><author>Van Damme, W.</author></authors></contributors><titles><title>Local application of diminazene aceturate: an effective treatment for cutaneous leishmaniasis?</title><secondary-title>Annales de la Societe belge de medecine tropicale</secondary-title><alt-title>Ann Soc Belg Med Trop</alt-title></titles><periodical><full-title>Annales de la Societe belge de medecine tropicale</full-title><abbr-1>Ann Soc Belg Med Trop</abbr-1></periodical><alt-periodical><full-title>Annales de la Societe belge de medecine tropicale</full-title><abbr-1>Ann Soc Belg Med Trop</abbr-1></alt-periodical><pages>13-9</pages><volume>72</volume><number>1</number><edition>1992/03/01</edition><keywords><keyword>Antiprotozoal Agents/*therapeutic use</keyword><keyword>Cetrimonium Compounds/*therapeutic use</keyword><keyword>Child</keyword><keyword>Chlorhexidine/therapeutic use</keyword><keyword>Diminazene/*analogs & derivatives/therapeutic use</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Leishmaniasis, Cutaneous/*drug therapy</keyword><keyword>Male</keyword></keywords><dates><year>1992</year><pub-dates><date>Mar</date></pub-dates></dates><isbn>0772-4128 (Print)
0772-4128 (Linking)</isbn><accession-num>1567264</accession-num><work-type>Clinical Trial
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ADDIN EN.CITE.DATA [53]ILMA & IFN-γ20SyriaNot performedN/AnoneMicroscopy and/or cultureRCT; Participants aged 6-60, up to 3 lesionsN/AT1(n=20): MA IL weekly x 5 weeks; T2(n=20): Lyophilized rIFN-γ 25ug (1 mL) IL weekly x 5 weeksN/APrimary: % cure at 1 month; Secondary: adverse events; Tertiary: parasite cureCure defined as lesions completely healed with smooth scar and parasite smear negative; definition of healed not specifiedCure observed in 29/38 lesions (76%) receiving ILMA and 1/37 lesions (3%) for rIFNγ . AE with ILMA included pain and local. AE with IFN include pain and headache (1/20)ILMA was more effective than rIFNγ, which had no treatment effectNo significant differencesLoss not mentioned; followed for 2.5 monthsOpenRandomized via random numbers table3.5001010.50Dandashli 2005 ADDIN EN.CITE <EndNote><Cite><Author>Dandashli</Author><Year>2005</Year><RecNum>6183</RecNum><DisplayText>[124]</DisplayText><record><rec-number>6183</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">6183</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Dandashli, A</author></authors></contributors><titles><title>Treatment of cutaneous leishmaniasis with fluconazole: a randomized double-blind, placebo-controlled trial</title><secondary-title>Journal of the European Academy of Dermatology and Venerology</secondary-title></titles><periodical><full-title>Journal of the European Academy of Dermatology and Venerology</full-title></periodical><pages>1</pages><volume>19</volume><number>2</number><section>43</section><dates><year>2005</year></dates><urls></urls></record></Cite></EndNote>[124]FLU46 & 19SyriaPerformed, but method not mentionedL. tropicanoneNot specifiedRCT; no participant demographics providedT1(n=46): fluconazole 200 mg PO daily x 6 weeks; T2(n=19): placebo PO daily x 6 weeksN/AN/A Primary: % cure; Secondary: adverse eventsCure defined as complete recovery; definition of recover not specifiedFluconazole cured 28.4% and placebo cured 9.8%. AE were mildA six week course of fluconazole is a safe and useful treatment for CL caused by L. tropica. Not reported14 out of 79 (18%); unknown follow-up timeDouble blindRandomized, but method not explained200.500001Ben Salah 1995 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CZW4gU2FsYWg8L0F1dGhvcj48WWVhcj4xOTk1PC9ZZWFy
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ADDIN EN.CITE.DATA [125]PRM57 & 58TunisiaIsoenzyme electrophoresisL. majornoneMicroscopy and/or cultureRCT; Participants aged 2-60, single lesion, no prior treatment, lesions <5cm size and <4 months in durationN/AT1(n=57): 15% paromomycin in 10% urea BID x 14 days; T2(n=58): placebo ointment (10% urea in soft white paraffin) BID x 14 daysN/APrimary: % cure at 2.5 months; Secondary: adverse eventsCure defined as 50% reduction in lesion, some re-epithelialisation by day 45, and complete re-epithelialisation by day 105Cure was seen in 40/57 receiving paromomycin and 40/58 receiving placebo, RR1. AE included local inflammation, rash, pain, redness in the paromomycin arm. Topical paromomycin was no better than placebo. There appeared to be high rates of self cure in this study No significant differences17 out of 132 (13%); followed for 3.5 monthsDouble blindRandomized via random numbers allocation7.5111110.51Ben Salah 2009 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CZW4gU2FsYWg8L0F1dGhvcj48WWVhcj4yMDA5PC9ZZWFy
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ADDIN EN.CITE.DATA [126]PRM49 & 41TunisiaIsoenzyme electropheresis or PCRL. major (97%)L. tropica, L. infantumMicroscopy and/or cultureRCT, multi-center study; Participants aged 5-75, ulcerating lesions, no previous treatments in last 3 months, < 5 lesionsN/AT1(n=49): Paromomycin in gentamicin ointment applied BID x 20 days; T2(n=41): placebo cream applied BID x 20 daysN/APrimary: % cure at 6 monthsCure defined as complete re-epithelialisation by day 50 or >50% re-epithelialisation at day 50 with full epithelialisation by day 100Cure observed in 94% receiving paromomycin with gentamicin ointment, vs 71% in those receiving placebo. No significant AE. Paromomycin with gentamicin ointment is a simple, safe, and effective option for CL due to L. major.Differed in age2 out of 92 (2.2%); followed for 6 monthsDouble blindRandomized via 1:1 computer algorithm71111011Ben Salah 2013 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CZW4gU2FsYWg8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFy
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ADDIN EN.CITE.DATA [127]PRM125TunisiaPerformed, but method not mentionedL. majornoneMicroscopy and/or cultureRCT; Participants aged 5-65, ulcerating lesions, < 5 lesionsN/AT1(n=125): Paromomycin in gentamicin (WR279,396) applied daily x 20 days; T2(n=125): Paromomycin alone applied daily x 20 days; T3(n=125): Vehicle control daily x 20 daysN/APrimary: % cureCure defined as at least 50% decrease in size of index lesion by day 42, with complete re-epithelialisation by day 98Cure observed in 81% for T1, vs 82% for T2, vs 58% for T3. Similar cure rate between T1 and T2 at 42 days. AE mostly local site irritationParomomycin alone or paromomycin combined with gentamicin are both effective for ulcerative CL due to L. majorNo significant differences5 out of 375 (1.3%); followed for 6 monthsOpenRandomized but method not explained610.511110Ozgoztasi 1997 ADDIN EN.CITE <EndNote><Cite><Author>Ozgoztasi</Author><Year>1997</Year><RecNum>3083</RecNum><DisplayText>[128]</DisplayText><record><rec-number>3083</rec-number><foreign-keys><key app="EN" db-id="2tafwvxz0fver0ev9enpd5s125ze2ws9fptv">3083</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Ozgoztasi, O.</author><author>Baydar, I.</author></authors></contributors><auth-address>Department of Dermatology and Infectious Diseases, Gaziantep University, Turkey.</auth-address><titles><title>A randomized clinical trial of topical paromomycin versus oral ketoconazole for treating cutaneous leishmaniasis in Turkey</title><secondary-title>Int J Dermatol</secondary-title><alt-title>International journal of dermatology</alt-title></titles><periodical><full-title>Int J Dermatol</full-title><abbr-1>International journal of dermatology</abbr-1></periodical><alt-periodical><full-title>International Journal of Dermatology</full-title></alt-periodical><pages>61-3</pages><volume>36</volume><number>1</number><edition>1997/01/01</edition><keywords><keyword>Administration, Oral</keyword><keyword>Administration, Topical</keyword><keyword>Amebicides/*therapeutic use</keyword><keyword>Animals</keyword><keyword>Child</keyword><keyword>Child, Preschool</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Ketoconazole/*therapeutic use</keyword><keyword>*Leishmania tropica</keyword><keyword>Leishmaniasis, Cutaneous/*drug therapy/parasitology/physiopathology</keyword><keyword>Male</keyword><keyword>Paromomycin/*therapeutic use</keyword><keyword>Trypanocidal Agents/*therapeutic use</keyword></keywords><dates><year>1997</year><pub-dates><date>Jan</date></pub-dates></dates><isbn>0011-9059 (Print)
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ADDIN EN.CITE.DATA [129]KET & ILSSG & SSG10YemenNot performedN/AnoneMicroscopy and/or cultureRCT; Participants aged 12-50, lesions 2-8 months in durationT3(n=10): Ketoconazole 200 mg PO TID x 4 weeks & SSG IL q 2 days x 3 sessionsT1(n=10): SSG IL q 2 days x 3 sessionsT2(n=10): SSG 20 mg/kg IM q 2 days x 3 sessions & SSG IL q 2 days x 3 sessionsPrimary: % cure at 3 months; Secondary: adverse eventsCure defined as complete re-epithelialisation, no edema, induration and negative amastigotes on smearCure observed in 58% in T1, 93% in T2, and 92% in T3. AE included local bination of IL SSG and either ketoconazole or SSG is better than IL SSG alone.No significant differencesNo losses; followed for 6 monthsOpenRandomized but method not explained4.50011110Explanation for each Section Study TitleInterventionStudy Publication DateNumberNumber ScoreCountrySpeciation PerformedSpeciation ScoreSpecies 1Species 2Study title. Studies are listed alphabetically by country and chronologically by year of publication.Abbreviations of all treatments for easier search through the table.Year of publication.Number of patients per treatment arm. If the number of patients per arm is not the same, then each arm is listed separately.Full point (1) if each treatment arm has at least 25 patients. If one arm had < 25 patients, no point was allocated. Country where participants contracted CL, not necessarily the country where they were treated.Method by which the parasite was speciated. Full point (1) if speciation was performed and method employed was mentioned in the study. No point if not speciated or if speciation method not described. Primary organism studied.Any secondary organisms studied.Diagnostic CriteriaDiagnostic ScoreMethodsOral TreatmentLocal TreatmentParenteral TreatmentOutcomeClinical EndpointEndpoint ScoreResultsMethod by which the diagnosis of cutaneous leishmaniasis was made.Full point (1) if diagnostic method was mentioned. No point if method not mentioned.Type of trial and information on the population studied, including age range, number of lesions, size, duration, and location.Description of the treatment arms where the intervention employed was an oral agent. If more than one route was given to a single arm, that treatment arm was classified according to the primary modality being studied. Description of the treatment arms where the intervention employed was a local treatment (local injections, creams, ointments, etc.). If more than one route was given to a single arm, that treatment arm was classified according to the primary modality being studied. Description of the treatment arms where the intervention employed was an intravenous agent. If more than one route was given to a single arm, that treatment arm was classified according to the primary modality being studied. List of the primary, secondary, and tertiary outcomes (if applicable) of the study. Definition of cure as provided in the study.Full point (1) if definition includes the mention of at least 75% re-epithelialization of the lesions. No point if no or incomplete definition provided.Brief summary of the efficacy of the treatments studied and any significant adverse events (AE). ConclusionsSimilarity of GroupsSimilarity ScoreLoss to Follow-up and Follow-up TimeFollow-up ScoreBlindingBlinded ScoreRandomizationRandomization ScoreQualityConcluding statement of the study, typically as provided in the abstract. A review of Table 1 to determine if the participants were successfully randomized or if significant differences existed between treatment arms. If significant differences, these were mentioned. Full point (1) is treatment arms were successfully randomized. No point (0) if the arms differed after randomization, or groups were not compared or the study only had a single treatment arm.Number of participants lost to follow-up (if mentioned), and the total number of months the participants were followed.Full point (1) if < 10% of participants lost to follow-up and participants followed for at least 1 month after the end of treatment. Half point (0.5) if only one of these categories is met, and no point (0) if neither are met.Whether the study was an open study, single blinded study, or double blinded study. If single blinded, the group that was blinded was mentioned. Full point (1) if double blinded, half point (0.5) if single blinded, and no point (0) if not blinded.Whether the study was randomized, and by what method.Full point (1) if the study was randomized and the method used was mentioned. Half point (0.5) if the randomization method was not mentioned. No point (0) if the study was not randomized.Total score List of AcronymsMiscellaneous AbbreviationsBCGBacillus Calmette–GuérinBIDTwice per dayDA-PDT Daylight-activated photodynamic therapyDAC N-055Pharmaceutical sodium chlorite solutionILIntra-lesionalILHS Isochorismatase-related hydrolasesIMIntra-muscularIVIntra-venousLCF-RFLocalized current field-radio frequency MBCLMethylbenzethonium chlorideMPL-SEMonophosphoryl lipid A plus squalenePCRPolymerase chain reactionPCR-RFLPPolymerase Chain Reaction - Restriction Fragment Length PolymorphismPOPer os qEveryqdDailyQT-NASBAReal-time quantitative nucleic acid sequence-based amplificationRx MedicationsS/CSubcutaneous TBSTTuberculin skin testTIDThree times per dayAbbreviations of Medications5-ALA5-aminolaevulinic acidALBAlbendazoleALLAllopurinolAMIAminosidine - (paromomycin)AMBAmphotericin BAZIAzithromycinBERBerelinCLOClotrimazoleCO2CO2 laserCRYCryotherapyDAP?DapsoneECElectro-cauterizationFLUFluconazoleGarlicGarlicGM-CSFGranulocyte-colony stimulating factor?HoneyHoneyHRB?Herbal extractIFN-γInterferon gammaILAMBIL Amphotericin BILMAIL Meglumine antimoniate ILSSGIL Sodium StibogluconateIMQImiquimodITRItraconazoleIVMIvermectinKETKetoconazoleMA Meglumine antimoniate MEFMefloquineMICMiconazoleMILMiltefosineMWTMoist wound treatmentNSSodium Chloride/Normal SalineNaNO2Sodium NitriteNONitric oxidePDTPhotodynamic therapyPENPentamidinePRAPraziquantelPRBProbenecidPRMParomomycin (aminosidine)PTXPentoxifyllineRFT Radiofrequency thermotherapyRIFRifampinSAVSavlanSSGSodium StibogluconateTCATrichloroacetic acidVaccineVaccineYarrowYarrow (Achilles millefolium)ZnSO4Zinc sulfateMeasurementdDaykgKilogramsmcg/mlMicrogram per mililiter mgMilligramsmg/kgMiligrams per kilogrammg/kg/dMiligram per kilogram per dayminMinutesmosMonthswksWeekyrsYearsLaboratory measuresCBCComplete blood countCreatCreatinine ECGElectrocardiogramLFTs Liver function testsPltsPlateletsWBCWhite blood cells VariousabnlAbnormalACLAmerican cutaneous leishmaniasisADLAdenolymphangitisAEAdverse eventsATLAmerican tegumentary leishmaniasis BFingBreastfeeding btwBetweenbxBiopsy??CCRComplete clinical responseCL Cutaneous leishmaniasis CN8Cranial nerve 8 decrDecreaseddivDividedDxDiagnosisExclExcluded GIGastro-intestinal GrpGroupHxHistory inclIncludedinfxInfectionITTIntention to treat lactLactatating??LbL. braziliensis leishLeishmaniamaxMaximum MCLMucocutaneous leishmaniasisNNumber of participants N/A Not applicable posPositivePPPer-protocolprgPregnantpxPatients/ParticipantsRCT Randomized clinical trial re-epRe-epithelialization RRRelative riskSESide effectsSig Significant signifSignificantsxSymptomsTTreatment armtxTreatment UKUnited KingdomvsversusWHOWorld Health Organizationw/inWithinw/oWithout WRAMCWalter Reed Army Medical Center ZCLZoonotic cutaneous leishmaniasis List of TreatmentOral treatmentsAllopurinolAllopurinol ribonucleosideAzithromycinDapsoneKetoconazoleItraconazoleMefloquineMiltefosineProbenecidRifampinZnSO4Topical treatments0.045% DAC N-055BerelinClotrimazole creamCO2 laserGarlicHerbal extracthigh frequency electrocauterizationImiquimodlyophilized rIFNγKetoconazoleMeglumine antimoniateMiconazole creamSodium Chloride 5% solutionSodium Chloride 7% solutionSodium nitrite creamNitric oxideParomomycinSavlanSilver dressingsSodium stibogluconateThermotherapyTopical honeyTrichloroacetic acidYarrow (Achilles millefolium)Zinc sulfate (ZnSO4)Parenteral treatmentsAminosidineAminosidine sulphate Amphotericin BGM-CSF IFN- γMeglumine antimoniateSodium stibogluconatePentamidineVaccineReferences ADDIN EN.REFLIST 1.Hepburn NC, Tidman MJ, Hunter JA. 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