Phase I/II randomized bilateral half-head comparison of topical bexarotene 1% gel for alopecia areata

Background: Alopecia areata, hair loss caused by perifollicular T-cell infiltrates, is refractory to therapy. Bexarotene, a retinoid X receptor is a selective retinoid, induces T-cell apoptosis. Objective: We sought to determine the safety, including the dose-limiting toxicities with adverse events, and efficacy, ie, response rate, of bexarotene in alopecia areata. Methods: We conducted a phase I/II randomized, half-head trial of 1% bexarotene gel applied twice daily for 6 months. Results: In all, 42 patients (11 male and 31 female) with alopecia totalis (n = 3), alopecia universalis (n = 5), or alopecia areata (n = 34) applied 1% bexarotene gel for 24 weeks. Five of 42 (12%) had 50% or more partial hair regrowth on the treated side, and 6 of 42 (14%) on both sides including 3 complete responders. In all, 31 patients had mild irritation; 4 had grade-3 irritation. Limitations: This design cannot differentiate between drug-induced and spontaneous regrowth. Conclusion: Topical bexarotene 1% application is well tolerated and possibly effective. A randomized placebo-controlled trial should be conducted.