Efficacy and safety of topical tacrolimus for the treatment of face and neck vitiligo

J Dermatol. 2010 Feb;37(2):125-9. doi: 10.1111/j.1346-8138.2009.00774.x.

Abstract

Vitiligo is a common acquired idiopathic hypomelanotic disorder characterized by circumscribed depigmented maculae. The conventional treatments are limited by their inconsistent and incomplete responses, relapse rate, inconvenience to apply, side-effects and especially long-term effects. The aim of the present study was to determine the efficacy and safety of topical tacrolimus as monotherapy for the treatment of face/neck vitiligo in Taiwan. This was a multicenter, open-label, non-comparative study. Patients were at least 16 years old and had vitiligo lesions with Vitiligo Index of Disease Activity score +1 or more on face or neck. Patients received a monotherapy with 0.1% of tacrolimus ointment twice daily for 12 weeks. The efficacy was measured by the percentage of repigmentation of target lesion, which was graded as minimal (1-25%), mild (26-50%), moderate (51-75%) or excellent (76-100%). Patients who had at least mild repigmentation were defined as responders. A total of 61 patients were enrolled in this investigation. Most of the patients showed repigmentation at week 4. At the end of treatment, all patients showed repigmentation and 45.9% of patients were responders. During the study, 15 adverse events related to the ointment were reported. All the reported adverse events were mild and similar to the well-known adverse effect of tacrolimus in the treatment of atopic dermatitis. Tacrolimus ointment is effective and well tolerated for the treatment of patients with vitiligo in Taiwan. It will be another drug of choice for persons with vitiligo who are unable to receive regular phototherapy and fear the side-effects of topical steroid in long-term use.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Administration, Cutaneous
  • Adolescent
  • Adult
  • Aged
  • Child
  • Dermatitis, Atopic / drug therapy
  • Face / pathology
  • Female
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / therapeutic use*
  • Male
  • Middle Aged
  • Neck / pathology
  • Prospective Studies
  • Skin Pigmentation / drug effects*
  • Tacrolimus / administration & dosage
  • Tacrolimus / adverse effects
  • Tacrolimus / therapeutic use*
  • Taiwan
  • Vitiligo / drug therapy*
  • Young Adult

Substances

  • Immunosuppressive Agents
  • Tacrolimus