Study on Tacrolimus 0.1% Ointment for Facial Vitiligo

France: Twice-daily tacrolimus 0.1% ointment over a 6-month course was found to be highly effective for the treatment of facial vitiligo, according to a recent study in the Journal of Investigative Dermatology.

Relapses occurred in 40% of the included patients highlighting the need for maintenance therapy following treatment success.

Topical calcineurin inhibitors are widely used off label in vitiligo. However, there is a lack of placebo-controlled, blinded studies that support their use. Considering this, Khaled Ezzedine, UPEC-Université Paris-Est Créteil, France, and colleagues aimed to compare the efficacy of tacrolimus 0.1% ointment versus vehicle for repigmentation in adult patients with facial vitiligo.

For the purpose, the researchers performed a 24-week multicenter randomized parallel double-blind study with a 24-week post-treatment follow-up extension. It included 42 adult patients with recent facial vitiligo target lesions (<2 years) without changes in pigmentation or size over the prior 3 months.

The patients were randomized to receive either tacrolimus 0.1% ointment or vehicle twice daily.

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.

Key Findings of the Study

• Therapeutic success was achieved in 65% of tacrolimus-treated patients versus 0% in vehicle-treated patients at week 24.
• Only 40% of relapse was observed at 48 weeks.
• Side effects were negligible, consistent with more than 20 years of data regarding overall tacrolimus treatment.

"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," wrote the authors. "Maintenance intermittent treatment was justified because relapses occurred over 6 months in 40% of the included patients."

The study titled, "Efficacy and safety of tacrolimus 0.1% for the treatment of facial vitiligo: a multicenter randomized, double-blinded, vehicle-controlled study," is published in the Journal of Investigative Dermatology.

DOI: https://www.jidonline.org/article/S0022-202X(21)00077-4/fulltext