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.
RCT Entities:
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.
Authors: F Jason Duncan; Kathleen A Silva; Charles J Johnson; Benjamin L King; Jin P Szatkiewicz; Sonya P Kamdar; David E Ong; Joseph L Napoli; Jinshan Wang; Lloyd E King; David A Whiting; Kevin J McElwee; John P Sundberg; Helen B Everts Journal: J Invest Dermatol Date: 2012-09-27 Impact factor: 8.551