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

J Dermatolog Treat. 2009;20(1):14-8. doi: 10.1080/09546630802155057.

Abstract

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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Adolescent
  • Adult
  • Age Factors
  • Aged
  • Combined Modality Therapy
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Ointments
  • Probability
  • Prospective Studies
  • Risk Assessment
  • Severity of Illness Index
  • Sex Factors
  • Statistics, Nonparametric
  • Tacrolimus / analogs & derivatives*
  • Tacrolimus / therapeutic use
  • Treatment Outcome
  • Ultraviolet Therapy / methods*
  • Vitiligo / diagnosis*
  • Vitiligo / therapy*
  • Young Adult

Substances

  • Ointments
  • pimecrolimus
  • Tacrolimus