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Veronica Lepe, MD; Benjamin Moncada, MD; Juan Pablo Castanedo-Cazares, MD; Maria Bertha Torres-Alvarez, MD; Carlos A. Ortiz; Antonio B. Torres-Rubalcava, MD

Arch Dermatol. 2003;139:581-585.

Objective  To assess the safety and efficacy of topical 0.1% tacrolimus vs 0.05% clobetasol propionate.

Design  Randomized double-blind trial.

Setting  Department of Dermatology, Hospital Central "Dr Ignacio Morones Prieto," San Luis Potosí, México.

Participants  From 20 children with vitiligo, 2 symmetrical lesions of about the same size and evolution time were selected. They were devoid of any topical or systemic therapy for 2 months prior to inclusion.

Interventions  Treatment with topical tacrolimus and clobetasol for a 2-month period.

Main Outcomes Measures  The grade of repigmentation was evaluated by color slides at baseline and again at every 2-week visit. The slides were analyzed by 2 clinicians unrelated to the study and by a morphometric digitalized computer program. Characteristics of pigment, time of response, symptoms, telangiectasias, and atrophy were evaluated every 2 weeks.

Results  Eighteen (90%) of the 20 patients experienced some repigmentation. The mean percentage of repigmentation was 49.3% for clobetasol and 41.3% for tacrolimus. Lesions in 3 patients using clobetasol presented atrophy, and 2 lesions incurred telangiectasias; tacrolimus caused a burning sensation in 2 lesions.

Conclusions  Tacrolimus proved almost as effective as clobetasol propionate to restore skin color in lesions of vitiligo in children. Because it does not produce atrophy or other adverse effects, tacrolimus may be very useful for younger patients and for sensitive areas of the skin such as eyelids, and it should be considered in other skin disorders currently treated with topical steroids for prolonged periods.

From the Dermatology Department, Hospital Central "Dr Ignacio Morones Prieto" (Drs Lepe, Moncada, Castanedo-Cazares, and Torres-Alvarez), Public Health Department (Dr Torres-Rubalcava), School of Medicine, and the Graphic Design School (Mr Ortiz), Universidad Autónoma de San Luis Potosí, San Luis Potosí, Mexico. The authors have no relevant financial interest in this article.

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