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A double-blind, randomized, placebo-controlled trial of topical tacrolimus 0·1% vs. clobetasol propionate 0·05% in childhood vitiligo

Authors

  • N. Ho,

    1. Section of Dermatology, Department of Paediatric Medicine, The Hospital for Sick Children, University of Toronto, Toronto, ON M5G 1X8, Canada
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  • E. Pope,

    1. Section of Dermatology, Department of Paediatric Medicine, The Hospital for Sick Children, University of Toronto, Toronto, ON M5G 1X8, Canada
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  • M. Weinstein,

    1. Section of Dermatology, Department of Paediatric Medicine, The Hospital for Sick Children, University of Toronto, Toronto, ON M5G 1X8, Canada
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  • S. Greenberg,

    1. Section of Dermatology, Department of Paediatric Medicine, The Hospital for Sick Children, University of Toronto, Toronto, ON M5G 1X8, Canada
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  • C. Webster,

    1. Section of Dermatology, Department of Paediatric Medicine, The Hospital for Sick Children, University of Toronto, Toronto, ON M5G 1X8, Canada
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  • B.R. Krafchik

    1. Section of Dermatology, Department of Paediatric Medicine, The Hospital for Sick Children, University of Toronto, Toronto, ON M5G 1X8, Canada
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  • 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.

  • Conflicts of interest
    None declared.

Nhung Ho.
E-mail: nhung.ho@utoronto.ca

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’ (= 55) and ‘nonfacial’ (= 45) groups, were randomized into three arms: CP 0·05% ointment (= 30), T 0·1% ointment (= 31) and placebo (= 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 (> 0·05). There was a significant difference in response between the CP 0·05% group vs. placebo (< 0·0001) and the T 0·1% group vs. placebo (= 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.

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