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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 B.R.
Publication year - 2011
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/j.1365-2133.2011.10351.x
Subject(s) - medicine , vitiligo , placebo , clobetasol propionate , tacrolimus , adverse effect , randomized controlled trial , population , dermatology , mometasone furoate , surgery , corticosteroid , transplantation , alternative medicine , environmental health , pathology
Summary 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.