Efficacy of topical tacrolimus 0.03% monotherapy in the treatment of non-segmental vitiligo: a randomized, controlled trial

Abstract

Background: Topical tacrolimus is increasingly used nowadays in the treatment of vitiligo.

Objective: We evaluated therapeutic outcomes of tacrolimus 0.03% in non-segmental vitiligo (NSV).

Patients and methods: Sixty-three patients with NSV were divided into groups A and B. Group A received 0.03% tacrolimus ointment (n = 31) and group B received 1% hydrocortisone acetate ointment (n = 32) for 24 weeks. Vitiligo area and severity index (VASI) and repigmentation rates were determined at baseline and 4-week intervals.

Results: In group A, 24-week VASI [0.5 (0.3, 1.95)] was significantly lower than baseline VASI [0.75 (0.5, 2.1); p = 0.030]. In group B, 24-week VASI [0.75 (0.4, 2.3)] was not significantly different from baseline VASI [0.73 (0.4, 2.1); p = 0.111]. Repigmentation was observed in 14/31 (45.2%) of patients in group A versus 0/32 (0.0%) in group B (p < 0.001). Repigmentation was graded as poor in 6/31 (19.4%), fair in 4/31 (12.9%), good in 1/31 (3.2%), and excellent in 3/31 (9.7%).

Conclusion: Repigmentation was achieved in 45% of patients with NSV following treatment with tacrolimus 0.03% monotherapy for 24 weeks. Tacrolimus-induced repigmentation is more likely in patients with vitiligo vulgaris, head and neck lesions, skin phototype III, and young age.

Keywords: and severity index; monotherapy; non-segmental vitiligo; randomized-controlled trial; tacrolimus 0.03%; vitiligo area.