Efficacy and Safety of Tacrolimus 0.1% for the Treatment of Facial Vitiligo: A Multicenter Randomized, Double-Blinded, Vehicle-Controlled Study

Abstract Background Topical calcineurin inhibitors are used off-label in vitiligo, and there is a lack of placebo-controlled, blinded studies to support their use. Objective To compare the efficacy of tacrolimus 0.1% ointment versus vehicle for repigmentation in adult patients with facial vitiligo. Design 24-week multicenter randomized parallel double-blind study with a 24-week post-treatment follow-up extension. Population. Adult patients with recent facial vitiligo target lesions ( Intervention Patients received either tacrolimus 0.1% ointment or vehicle twice daily. Main Outcomes and Measures The primary outcome was therapeutic success, defined as a change in repigmentation of the target lesion ≥ 75% between baseline and week 24, measured by ImageJ software. Secondary outcome measures were variation of the physicians’ global assessment scores and patients’ satisfaction scores, safety data and the rate of relapse at week 48. Results 42 patients were included. Therapeutic success was achieved in 65% of tacrolimus-treated patients versus 0% in vehicle-treated patients at week 24 (p Conclusions and Relevance: Twice-daily tacrolimus 0.1% ointment showed superior efficacy, compared with vehicle, through 24 weeks of intervention and 24 weeks of follow-up in adult patients with facial vitiligo.