Deana Funaro1, Audrey Lovett2, Nathalie Leroux3, Julie Powell4. 1. Department of Dermatology, Ste-Justine Hospital, University of Montreal, Montreal, Quebec, Canada; Vulvar Disease Division, Ste-Justine Hospital, University of Montreal, Montreal, Quebec, Canada; Department of Dermatology, Centre Hospitalier de l'Université de Montréal, University of Montreal, Montreal, Quebec, Canada. Electronic address: rouleaufunaro@videotron.ca. 2. Department of Dermatology, Centre Hospitalier de l'Université de Montréal, University of Montreal, Montreal, Quebec, Canada. 3. Department of Gynecology, Ste-Justine Hospital, University of Montreal, Montreal, Quebec, Canada. 4. Department of Dermatology, Ste-Justine Hospital, University of Montreal, Montreal, Quebec, Canada.
Abstract
BACKGROUND:Vulvar lichen sclerosus is a chronic condition usually responsive to topical corticosteroids. OBJECTIVE: We sought to evaluate the efficacy (reduction of signs and symptoms) and safety of clobetasol propionate 0.05% and tacrolimus 0.1% in the treatment of vulvar lichen sclerosus. METHOD: This double-blind, randomized study comparing 2 treatments over a 3-month period, enrolled 58 female patients with newly diagnosed vulvar lichen sclerosus or untreated vulvar lichen sclerosus for at least 1 month. RESULTS: In all, 55 patients were included in the statistical analysis. A total of 28 patients were assigned to the tacrolimusgroup and 27 patients to the clobetasol group. Both groups showed a significant difference in the decrease of symptoms and signs of lichen sclerosus. At the end of the study, 28 participants (19 tacrolimus and 9 clobetasol) still had some clinical signs of lichen sclerosus (χ(2) = 6.56, P = .015). However, a significantly higher number of patients in the clobetasol group (n = 15) had absence of signs and symptoms of lichen sclerosus (χ(2) = 10.35, P = .002; χ(2) = 10.35, P = .002). No adverse events were reported. LIMITATIONS: Short length of trial and recruitment through our vulvar disease referral center are limitations. CONCLUSION: This study showed that topical clobetasol propionate was significantly more effective in treating vulvar lichen sclerosus than topical tacrolimus.
RCT Entities:
BACKGROUND: Vulvar lichen sclerosus is a chronic condition usually responsive to topical corticosteroids. OBJECTIVE: We sought to evaluate the efficacy (reduction of signs and symptoms) and safety of clobetasol propionate 0.05% and tacrolimus 0.1% in the treatment of vulvar lichen sclerosus. METHOD: This double-blind, randomized study comparing 2 treatments over a 3-month period, enrolled 58 female patients with newly diagnosed vulvar lichen sclerosus or untreated vulvar lichen sclerosus for at least 1 month. RESULTS: In all, 55 patients were included in the statistical analysis. A total of 28 patients were assigned to the tacrolimus group and 27 patients to the clobetasol group. Both groups showed a significant difference in the decrease of symptoms and signs of lichen sclerosus. At the end of the study, 28 participants (19 tacrolimus and 9 clobetasol) still had some clinical signs of lichen sclerosus (χ(2) = 6.56, P = .015). However, a significantly higher number of patients in the clobetasol group (n = 15) had absence of signs and symptoms of lichen sclerosus (χ(2) = 10.35, P = .002; χ(2) = 10.35, P = .002). No adverse events were reported. LIMITATIONS: Short length of trial and recruitment through our vulvar disease referral center are limitations. CONCLUSION: This study showed that topical clobetasol propionate was significantly more effective in treating vulvar lichen sclerosus than topical tacrolimus.
Authors: Sara Mazzilli; Laura Diluvio; Monia Di Prete; Piero Rossi; Augusto Orlandi; Luca Bianchi; Elena Campione Journal: J Int Med Res Date: 2018-07-29 Impact factor: 1.671
Authors: Firuz G Feturi; Matthias Weinstock; Wenchen Zhao; Wei Zhang; Jonas T Schnider; Vasil E Erbas; Sinan Oksuz; Jan A Plock; Lisa Rohan; Alexander M Spiess; Lydia M Ferreira; Mario G Solari; Raman Venkataramanan; Vijay S Gorantla Journal: Front Surg Date: 2018-05-09