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.


CONCLUSIONS
This design cannot differentiate between drug-induced and spontaneous regrowth.


CONCLUSIONS
Topical bexarotene 1% application is well tolerated and possibly effective. A randomized placebo-controlled trial should be conducted.
Talpur
Rakhshandra
R
Division of Internal Medicine, Department of Dermatology, University of Texas M.D. Anderson Cancer Center, Houston, Texas 77030-4095, USA.
Vu
Jenny
J
Bassett
Roland
R
Stevens
Victor
V
Duvic
Madeleine
M
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000506:Alopecia Areata / Q000188:drug therapy*; D016588:Anticarcinogenic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000077610:Bexarotene; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D012535:Scalp / Q000187:drug effects; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
D016588:Anticarcinogenic Agents; D005782:Gels; D013764:Tetrahydronaphthalenes; D000077610:Bexarotene