A double-blind, randomized, placebo-controlled trial of topical tacrolimus 0.1% vs. clobetasol propionate 0.05% in childhood vitiligo.
Author(s): Ho N, Pope E, Weinstein M, Greenberg S, Webster C, Krafchik BR
Affiliation(s): Section of Dermatology, Department of Paediatric Medicine, The Hospital for Sick Children, University of Toronto, Toronto, ON M5G 1X8, Canada. email@example.com
Publication date & source: 2011-09, Br J Dermatol., 165(3):626-32. Epub 2011 Jun 30.
Publication type: Research Support, Non-U.S. Gov't
BACKGROUND: Both clobetasol propionate 0.05% (CP 0.05%) and tacrolimus 0.1% (T 0.1%) ointments have been shown to be efficacious and safe in treating vitiligo in the paediatric population. OBJECTIVES: To assess efficacy and safety of these two therapies compared with each other and with placebo. METHODS: In this prospective study, children aged 2-16 years with vitiligo, stratified into 'facial' (n = 55) and 'nonfacial' (n = 45) groups, were randomized into three arms: CP 0.05% ointment (n = 30), T 0.1% ointment (n = 31) and placebo (n = 29) for 6 months. Successful repigmentation, defined as > 50% improvement, was evaluated by comparing photographs taken at baseline and at 2, 4 and 6 months. RESULTS: In the facial group, 58% of the CP 0.05% group responded successfully compared with 58% of the T 0.1% group, and in the nonfacial group, 39% of the CP 0.05% group responded compared with 23% of the T 0.1% group (P > 0.05). There was a significant difference in response between the CP 0.05% group vs. placebo (P < 0.0001) and the T 0.1% group vs. placebo (P = 0.0004). Spontaneous repigmentation was evaluated as 2.4%. No significant clinical adverse events were noted in any group. CONCLUSIONS: Both CP 0.05% and T 0.1% ointments offer similar benefit in paediatric vitiligo, both facial and nonfacial. The facial lesions responded faster than the nonfacial ones. (c) 2011 The Authors. BJD (c) 2011 British Association of Dermatologists.