The efficacy of pimecrolimus 1% cream plus narrow-band ultraviolet B in the treatment of vitiligo: a double-blind, placebo-controlled clinical trial.

BACKGROUND: Recently, narrow-band ultraviolet B (NB-UVB) and topical immunomodulators have been successfully used in the treatment of vitiligo.

OBJECTIVE: To determine whether the combination of pimecrolimus with NB-UVB accelerates the response time and/or improves the degree of response in patients with vitiligo.

METHODS: Sixty-eight patients with vitiligo enrolled in this randomized, double-blind, placebo-controlled study. The patients were randomized into two groups and treated with NB-UVB plus either pimecrolimus or placebo for 3 months. Tri-weekly radiation was started at 280 mJ/cm(2), with 15% increments for each subsequent treatment until erythema was reported or a maximum of 800 mJ/cm was achieved. At baseline and 6 and 12 weeks after commencement of therapy, vitiliginous patches were measured.

RESULTS: Fifty patients completed the 3-month study. No significant side effects except self-limited erythema and pruritus were observed. After 12 weeks of treatment, repigmentation of the facial lesions was higher in patients treated with combined pimecrolimus and NB-UVB compared with the placebo plus NB-UVB group (64.3 vs 25.1%) (p < 0.05%). There was no statistically significant difference in the repigmentation rate between the two groups on other body areas.

CONCLUSION: On the face, NB-UVB works better if combined with pimecrolimus 1% cream rather than used alone.