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

BackgroundTopical calcineurin inhibitors are used off label in the treatment of vitiligo, and there is a lack placebo-controlled, blinded studies to support their use.ObjectiveThis study aimed compare efficacy tacrolimus 0.1% ointment with that vehicle for repigmentation adult patients facial vitiligo.DesignThis was 24-week multicenter randomized parallel double-blind post-treatment follow-up extension.PopulationParticipants included were recent vitiligo target lesions (<2 years) without changes pigmentation or size over previous 3 months.InterventionPatients received either twice daily.Main Outcomes MeasuresThe primary outcome therapeutic success, defined as change ≥75% lesion between baseline week 24, measured by ImageJ software. Secondary measures variation physicians’ global assessment scores patients’ satisfaction scores, safety data, rate relapse at 48.ResultsA total 42 included. Therapeutic success achieved 65% tacrolimus-treated versus 0% vehicle-treated 24 (P < 0.0001). Only 40% observed 48 weeks.Conclusions RelevanceTwice-daily showed superior through weeks intervention vitiligo.Trial RegistrationThis registered ClinicalTrials.gov (identifier: NCT02466997). Topical use. This vitiligo. extension. Participants months. Patients daily. The 48. A weeks. Twice-daily