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

Author(s): Talpur R, Vu J, Bassett R, Stevens V, Duvic M

Affiliation(s): Division of Internal Medicine, Department of Dermatology, University of Texas M.D. Anderson Cancer Center, Houston, Texas 77030-4095, USA.

Publication date & source: 2009-10, J Am Acad Dermatol., 61(4):592.e1-9. Epub 2009 Aug 14.

Publication type: Clinical Trial, Phase I; Clinical Trial, Phase II; Comparative Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't

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.