Rajiv Gandhi University of Health Sciences



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE.

ANNEXURE – II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

|1. |Name of the candidate and address (in block |DR L SUJANA |

| |letters) |POSTGRADUATE STUDENT, |

| | |DEPARTMENT OF DERMATOLOGY |

| | |S. NIJALINGAPPA MEDICAL COLLEGE, |

| | |BAGALKOT - 587102 |

|2. |Name of the institution |S. NIJALINGAPPA MEDICAL COLLEGE AND HANAGAL SHRI KUMARESHWAR HOSPITAL AND RESEARCH |

| | |CENTRE , |

| | |NAVANAGAR, BAGALKOT – 587102 |

|3. |Course of the study and subject | |

| | |MD DERMATOLOGY ,VENEREOLOGY AND LEPROLOGY. |

|4. |Date of admission to the course |31ST MAY 2013 |

|5. |Title of the Topic |A COMPARATIVE STUDY OF FRACTIONAL CO2 LASER AND COMBINATION OF FRACTIONAL |

| | |CO2 LASER WITH AUTOLOGOUS PLATELET RICH PLASMA IN POST ACNE SCARS. |

| | | |

|6. |Brief resume of the intended work |

| |6.1 |Need for the study |

| | |Acne vulgaris is a common chronic inflammatory disorder of pilosebaceous unit affecting adolescents and young adults |

| | |psychologically. Untreated acne especially the inflammatory type results in often distressing and difficult to treat scars.|

| | |This presents as a considerable challenge to the dermatologist. It is so because of the disfigurement it produces on the |

| | |face, which is socially and psychologically the most significant body part. |

| | |Causes of acne scar formation can be broadly categorized as either the result of increased tissue formation or more |

| | |commonly, loss or damage of local tissue.1 Clinical manifestations of acne scars as well as severity of scarring are |

| | |generally related to the degree of inflammatory reaction ,to tissue damage, and to time lapsed since the onset of tissue |

| | |inflammation.2,3 The incidence of acne scarring is not well defined. |

| | | |

| | |Broadly, acne scars are classified as atrophic and hypertrophic scars. Atrophic acne scars have been further classified as |

| | |ice pick, rolling and boxcar.4 The patients undergo psycho-social disturbances like poor quality of life &social |

| | |dysfunction. In addition to having to suffer acne, the actual presence of acne scars is a risk factor for suicide 5 and is |

| | |linked to low self-esteem, anxiety, depression, anger, altered social interactions, decreased academic performance, and |

| | |unemployment.1,6-7 |

| | | |

| | |Dermatologists are frequently encountered with challenge of evaluating and proving treatment recommendations to patients |

| | |with acne scars. There are various modalities to treat acne scars like chemical peels, dermabrasion, subcision, punch |

| | |excision, punch grafting, micro-needling and lasers. Effective treatment of facial acne scarring presents a major |

| | |challenge. However, with the advent of fractional CO2 laser and platelet rich plasma (PRP) therapy for atrophic scars, new|

| | |avenues for treatment of acne scars can be explored. Platelet rich plasma on the other hand provides with various growth |

| | |factors which aid in quick wound healing. |

| | | |

| | |So to find the efficacy of CO2 laser alone versus CO2 laser and Platelet rich plasma therapy is needed in treatment of acne|

| | |scars and for relief of patients from various emotional stress & psychosocial disturbances. |

| | | |

| |6.2 |Review of Literature |

| | |Fractional photothermolysis or Fractional CO2 laser is a technology developed by Anderson and Manstein that removes |

| | |fractions of skin instead of wiping away the entire skin.8 Immediate effect of which is ablation (or vaporization) of the |

| | |epidermis and sometimes the superficial papillary dermis. There is also thermal damage to a band of underlying dermis, |

| | |together with collagen denaturation and contraction. In the healing period, re-epithelialization occurs from surrounding |

| | |epidermis and from adnexal structures. This is followed by the formation of a band of upper dermal fibrosis, often referred|

| | |to in the cosmetic literature as ‘collagen remodelling’ The CO2 laser produces light (10 600 nm) that is relatively poorly |

| | |absorbed by the chromophore, water, and which therefore penetrates relatively deeply (30 μm). |

| | |A study conducted by Cho SB et al for 6 months on 20 korean patients, one patient had clinical improvement of 76% to 100%,|

| | |nine had improvements of 51% to 75%, seven had moderate improvements of 26% to 50%, and three had minimal to no |

| | |improvements.9 |

| | |A study for 6 month on nine Chinese patients (skin types III and IV,mean age 44.8)was conducted by Chan NPY et al. |

| | |Statistically significant improvements were seen for skin texture, skin laxity, wrinkles, enlarged pores, and acne scars. |

| | |The postinflammatory hyperpigmentation rate was 55.5% and 11.1% at 1 and 6 months post-treatment, respectively.Eighty-six |

| | |percent of patients were overall satisfied to very satisfied with the treatment.10 |

| | | |

| | |At the same time PRP has been used for various surgical and medical fields. Face and neck rejuvenation is a field that is |

| | |currently being explored. |

| | |A three month study conducted by Alessio Radaelli, on PRP with 23 patients was found to be promising in face and neck |

| | |rejuvenation and scar attenuation.11 |

| | |In another study by Dae Hun Kim et al, autologous PRP was found to stimulate fibroblasts growth and thereby helping in scar|

| | |healing.12 |

| | |A split -face trial was conducted by Lee JW et al in 14 Korean participants with acne scars. Six months after the final |

| | |treatment, overall degree of clinical improvement was significantly better on the experimental side than on the control |

| | |side.13 |

| | |A study done by Fabbrocini G et al found that PRP combined with dermaroller was more effective in acne scars than |

| | |dermaroller alone.14 |

| | | |

| |6.3 |Objectives of the study |

| | |To evaluate the efficacy of fractional CO2 laser alone and in combination with platelet rich plasma in treating post |

| | |acne scars. |

| | |2. To evaluate the safety of fractional CO2 laser and platelet rich plasma |

|7 | |Materials and methods |

| | |Eighty patients with post acne scars attending dermatology out patient department of Hanagal Shree Kumareshwar hospital, |

| | |Bagalkot will be included in the study. |

| |7.1 |Source of data |

| | |Inclusion criteria: |

| | |Patients with acne scars |

| | |Patients above 18 yrs |

| | |Patients willing for procedure |

| | |Exclusion criteria: |

| | |Patients with active acne |

| | |Patients below 18 yrs |

| | |Patients not willing for procedure |

| | |Predisposition to keloid formation |

| | |Patients active herpes infection |

| | |Pregnant and lactating mothers |

| | |Patients who has taken isotretinoin within previous 6 months |

| | |Patients with high expectations |

| | |Platelet dysfunction patients |

| | |Patients with HIV, HBV infection. |

| | | |

| |7.2 |Methods of collection of data |

| | |Study period: One year |

| | |Sample size: Eighty patients. Forty patients in each group. |

| | |Calculation done using open epi software according to the study done by Lee JW et al.13Overall degree of clinical |

| | |improvement in CO2 laser with PRP is 2.7[pic]0.7 and in CO2 alone is 2.3[pic]0.5. |

| | |At 95% confidence interval 5%error corresponds to Ƶα=1.96. power of the study (1-β)=80%, |

| | |Ƶβ=0.84 |

| | |The sample size calculated using the formula |

| | | |

| | |N= 2{Ƶα+Ƶβ}2[pic]2 |

| | |Δ2 |

| | |Δ=clinically significant difference, σ=common standard deviation. |

| | |The sample size calculated is 37 in each group. |

| | | |

| | |Sampling: It will be done by simple random sampling using random number tables. |

| | |Methods: Each of the participant will be followed for a period of 6 months. The objective parameters will be estimated at |

| | |the end of 6 months using Goodman’s quantitative global acne scarring grading system. Eighty patients presenting with acne |

| | |scars to the Dermatology outpatient department Hanagal Shree Kumareshwar hospital, Bagalkot will be taken up for study. |

| | |First the patients will be elaborately explained about the procedure and consent will be taken. Then the patient will be |

| | |thoroughly evaluated & grading of the acne scars will be done using Goodman’s quantitative global acne grading system. |

| | |Written informed consent will be obtained from all study participants. The patient will be explained about the fraction CO2|

| | |and PRP therapy, the cost factor involved, benefits, duration of the treatment, possible side effects and the prognosis of |

| | |the treatment. Digital photographs of face will be taken before and 4weeks after procedure. Before procedure, all treatment|

| | |areas will be gently cleansed and a topical anesthetic cream EMLA will be applied for 45 minutes. Out of 80 participants, |

| | |fourty participant’s will be given CO2 laser therapy alone and is named as group A. And remaining fourty will be treated by|

| | |both CO2 laser and PRP therapy and this constitutes group B. A total of 6 similar sittings will be done at intervals of 4 |

| | |weeks each. At the end of the treatment duration the scars will be graded using grading system as used in the beginning, |

| | |The photographs will be taken before treatment and after sixth sitting and compared. |

| | | |

| | |Statistical analysis: Data will be analyzed statistically by Chi square test and t tests,appropriate statistical tests will|

| | |be applied using SPSS version 15. p value ................
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