Efficacy and Safety of Intralesional Triamcinolone Acetonide Alone and Its Combination With 5-fluorouracil in Keloids and Hypertrophic Scars

HYPOTHESIS Null hypothesis: There is no difference in the efficacy of intralesional triamcinolone acetonide alone and its combination with 5-flurouracil in the treatment of keloids and hypertrophic scars Alternate hypothesis: Combination of intralesional triamcinolone and 5- fluorouracil is more efficacious than intralesional triamcinolone alone in treatment of keloids and hypertrophic scars

METHODS

Sample size: Sample size:

This study considers a 95% confidence interval, 80% power to estimate sample size. According to the article published in the Clinical and experimental dermatology by Darougegh A et al in 2009 comparing the efficacy of Intralesional Triamcinolone alone versus combined with 5 FU in treatment of keloids, it was found that the patient reported good to excellent (> 50%) 30 | P a g e improvement in TAC alone group was 20% whereas that of the combination of TAC and 5-FU was 55% (22). Now using the sample size estimation formula for 2 proportions based on above study, n = {2p(1-p) (Zβ + Zα/2)2}/ (p1-p2)2 Where n= sample size for each group; p1 = 0.55; p2 = 0.2; p= (p1 +p2)/2; Zα/2=1.96 at 95% CI; Zβ = 0.842 at 80% power; using above formula, n= 30. Adding 10% in calculated value to consider the drop out, the minimum sample size in each group will be 30+3=33; Thus, a total sample size will be 66 The study is double blinded ,both participants and investigator( treatment provider/assessor) are blinded. Total of 66 patients are enrolled into the study , 33 in each groups allocated by block randomization through computer generated block randomization list. Patients with a clinical diagnosis of keloids or hypertrophic scars attending the outpatient department of dermatology at BPKIHS will be enrolled in the study. Written and understood informed consent will be taken prior to the enrollment and treatment. Detailed information of all the patients satisfying inclusion criteria will be recorded in preset pro forma. This will include personal data, past history, medical history, drug history, clinical data like site, size, number, distribution of lesions, complaints related to scar like pain, pruritus, erythema, scar score and cutaneous examination. Patients will be excluded according to the exclusion criteria. Photographs of the lesions will be taken before the first treatment session, in every treatment session and at the completion of treatment at 12th week. Only one lesion (preferably on the trunk or proximal extremity) will be treated per patient.

Study Treatments: