Efficacy and safety of tacrolimus 0.1% for the treatment of facial vitiligo: a multicenter randomized, double-blinded, vehicle-controlled study.

Abstract

BACKGROUND\nTopical calcineurin inhibitors are used off-label in vitiligo, and there is a lack of placebo-controlled, blinded studies to support their use.\n\n\nOBJECTIVE\nTo compare the efficacy of tacrolimus 0.1% ointment versus vehicle for repigmentation in adult patients with facial vitiligo.\n\n\nDESIGN\n24-week multicenter randomized parallel double-blind study with a 24-week post-treatment follow-up extension.\n\n\nPOPULATION\nAdult patients with recent facial vitiligo target lesions (<2years) without changes in pigmentation or size over the prior 3 months.\n\n\nINTERVENTION\nPatients received either tacrolimus 0.1% ointment or vehicle twice daily.\n\n\nMAIN OUTCOMES AND MEASURES\nThe 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.\n\n\nRESULTS\n42 patients were included. Therapeutic success was achieved in 65% of tacrolimus-treated patients versus 0% in vehicle-treated patients at week 24 (p < 0.0001). Only 40% of relapse was observed at 48 weeks.\n\n\nCONCLUSIONS\nand 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.