Funding sources This self-initiated study was supported by a research grant from Astellas, Canada. This clinical study remained self directed. Astellas had no involvement in study design, data collection, data analysis, manuscript and publication decisions.
A double-blind, randomized, placebo-controlled trial of topical tacrolimus 0·1% vs. clobetasol propionate 0·05% in childhood vitiligo
Version of Record online: 30 JUN 2011
© 2011 The Authors. BJD © 2011 British Association of Dermatologists
British Journal of Dermatology
Volume 165, Issue 3, pages 626–632, September 2011
How to Cite
Ho, N., Pope, E., Weinstein, M., Greenberg, S., Webster, C. and Krafchik, B.R. (2011), A double-blind, randomized, placebo-controlled trial of topical tacrolimus 0·1% vs. clobetasol propionate 0·05% in childhood vitiligo. British Journal of Dermatology, 165: 626–632. doi: 10.1111/j.1365-2133.2011.10351.x
Conflicts of interest None declared.
- Issue online: 28 AUG 2011
- Version of Record online: 30 JUN 2011
- Accepted manuscript online: 1 APR 2011 10:31AM EST
- Accepted for publication 21 March 2011
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.