A Darougheh1, A Asilian, F Shariati. 1. Skin Diseases and Leishmaniasis Research Centre, and Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran. darougheh@resident.mui.ac.ir
Abstract
BACKGROUND: Keloids and hypertrophic scars are benign growths of dermal collagen that can cause physical and psychological (cosmetic) problems for patients. METHODS: In this 12-week, double-blind, clinical trial, 40 patients were randomized into two study groups. Patients in group 1 were given intralesional triamcinolone acetonide (TAC), and patients in group 2 were given a combination of TAC and 5-fluorouracil (5-FU); both groups received injections at weekly intervals for 8 weeks. Lesions were assessed for erythema, pruritus, pliability, height, length and width. RESULTS: Four patients in group 1 and three patients in group 2 failed to complete the study. At the 8-week and 12-week follow-up visits, both groups showed an acceptable improvement in nearly all parameters, but these were more significant in the TAC + 5-FU group (P < 0.05 for all except pruritus and percentage of itch reduction). Good to excellent (> 50%) improvement were reported by 20% of the patients in group 1 and 55% of the patients in group 2, which was significantly different (P = 0.02). Good to excellent responses was reported by trained observers as 15% in group 1 and 40% in group 2. Their difference was not significant (P = 0.08). CONCLUSION: The overall efficacy of TAC + 5-FU was comparable with TAC, but the TAC + 5-FU combination was more acceptable to patients and produced better results.
RCT Entities:
BACKGROUND: Keloids and hypertrophic scars are benign growths of dermal collagen that can cause physical and psychological (cosmetic) problems for patients. METHODS: In this 12-week, double-blind, clinical trial, 40 patients were randomized into two study groups. Patients in group 1 were given intralesional triamcinolone acetonide (TAC), and patients in group 2 were given a combination of TAC and 5-fluorouracil (5-FU); both groups received injections at weekly intervals for 8 weeks. Lesions were assessed for erythema, pruritus, pliability, height, length and width. RESULTS: Four patients in group 1 and three patients in group 2 failed to complete the study. At the 8-week and 12-week follow-up visits, both groups showed an acceptable improvement in nearly all parameters, but these were more significant in the TAC + 5-FU group (P < 0.05 for all except pruritus and percentage of itch reduction). Good to excellent (> 50%) improvement were reported by 20% of the patients in group 1 and 55% of the patients in group 2, which was significantly different (P = 0.02). Good to excellent responses was reported by trained observers as 15% in group 1 and 40% in group 2. Their difference was not significant (P = 0.08). CONCLUSION: The overall efficacy of TAC + 5-FU was comparable with TAC, but the TAC + 5-FU combination was more acceptable to patients and produced better results.
Authors: Xiao-E Chen; Juan Liu; Afzaal Ahmed Bin Jameel; Maya Valeska; Jia-An Zhang; Yang Xu; Xing-Wu Liu; Hong Zhou; Dan Luo; Bing-Rong Zhou Journal: Exp Ther Med Date: 2017-05-08 Impact factor: 2.447
Authors: Shayan M Sarrami; Anna J Skochdopole; Andrew M Ferry; Edward P Buchanan; Larry H Hollier; Robert F Dempsey Journal: Semin Plast Surg Date: 2021-06-08 Impact factor: 2.314