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Bexarotene 1% Gel Shows Efficacy for Alopecia Areata: Presented at AAD
By Bruce Sylvester
SAN ANTONIO, TX -- February 7, 2008 -- Topical bexarotene 1% treatment produced a 30% hair growth response among patients with alopecia areata (AA), according to research presented here at the American Academy of Dermatology 66th Annual Meeting (AAD).
"Currently, there is no cure for alopecia, and it is often refractory to treatment. So new treatment possibilities are especially welcome," said lead investigator Rakhshandra Talpur, MD, Instructor, Division of Internal Medicine, University of Texas M. D. Anderson Cancer Center, Houston, Texas.
"We had a good response rate in this first-of-its-kind study. The treatment was well tolerated," she noted during a poster session on February 4.
As background to the study, Dr. Talpur and colleagues explain that bexarotene, induces T-cell apoptosis and is effective for the treatment of cutaneous T-cell lymphoma (CTCL). "We previously observed that bexarotene reversed alopecia in CTCL patients and therefore conducted a phase II study of topical targretin gel for AA."
The trial included 11 men and 31 women with three categories of alopecia: patchy scalp hair loss (AA; n = 34); total loss of scalp hair (alopecia totalis, AT; n = 3); and loss of all hair (alopecia universalis, AU; n = 5).
Patients were randomised to application of 1% topical bexarotene gel to one half of the scalp once daily for 2 weeks, then twice daily for 24 weeks. Patients who responded to treatment at 24 weeks then applied the gel to both sides of the scalp for another 24 weeks.
The researchers assessed subjects each month for index lesions, hair density, laboratory tests, and adverse events.
At week 24, 39 subjects were evaluable for response.
Twelve subjects (30.7%) achieved a greater than 50% partial hair regrowth. Six subjects achieved improvement to both sides of the scalp, including 1 patient with AT. Six patients achieved a response limited to one side of the scalp.
Twenty subjects showed stable disease, and 7 progressed during the study. Three patients withdrew after 2 weeks of the study.
Twenty-six subjects experienced erythema, scaling, and/or itching at the drug application site, and 8 required decreased application frequency.
Five of the12 responders continued treatment for 48 weeks, and 3 achieved complete hair regrowth, 1 had bilateral partial response, and 1 had a complete response on one side and stable disease on the other side.
The authors concluded, "Topical bex [bexarotene] 1% is generally well tolerated with mild irritation and was associated with a 30% response in AA."
[Presentation title: A Phase II Randomized Bilateral Comparison Study of Bexarotene 1% Gel in Alopecia Areata. Poster 1411]
By Bruce Sylvester
SAN ANTONIO, TX -- February 7, 2008 -- Topical bexarotene 1% treatment produced a 30% hair growth response among patients with alopecia areata (AA), according to research presented here at the American Academy of Dermatology 66th Annual Meeting (AAD).
"Currently, there is no cure for alopecia, and it is often refractory to treatment. So new treatment possibilities are especially welcome," said lead investigator Rakhshandra Talpur, MD, Instructor, Division of Internal Medicine, University of Texas M. D. Anderson Cancer Center, Houston, Texas.
"We had a good response rate in this first-of-its-kind study. The treatment was well tolerated," she noted during a poster session on February 4.
As background to the study, Dr. Talpur and colleagues explain that bexarotene, induces T-cell apoptosis and is effective for the treatment of cutaneous T-cell lymphoma (CTCL). "We previously observed that bexarotene reversed alopecia in CTCL patients and therefore conducted a phase II study of topical targretin gel for AA."
The trial included 11 men and 31 women with three categories of alopecia: patchy scalp hair loss (AA; n = 34); total loss of scalp hair (alopecia totalis, AT; n = 3); and loss of all hair (alopecia universalis, AU; n = 5).
Patients were randomised to application of 1% topical bexarotene gel to one half of the scalp once daily for 2 weeks, then twice daily for 24 weeks. Patients who responded to treatment at 24 weeks then applied the gel to both sides of the scalp for another 24 weeks.
The researchers assessed subjects each month for index lesions, hair density, laboratory tests, and adverse events.
At week 24, 39 subjects were evaluable for response.
Twelve subjects (30.7%) achieved a greater than 50% partial hair regrowth. Six subjects achieved improvement to both sides of the scalp, including 1 patient with AT. Six patients achieved a response limited to one side of the scalp.
Twenty subjects showed stable disease, and 7 progressed during the study. Three patients withdrew after 2 weeks of the study.
Twenty-six subjects experienced erythema, scaling, and/or itching at the drug application site, and 8 required decreased application frequency.
Five of the12 responders continued treatment for 48 weeks, and 3 achieved complete hair regrowth, 1 had bilateral partial response, and 1 had a complete response on one side and stable disease on the other side.
The authors concluded, "Topical bex [bexarotene] 1% is generally well tolerated with mild irritation and was associated with a 30% response in AA."
[Presentation title: A Phase II Randomized Bilateral Comparison Study of Bexarotene 1% Gel in Alopecia Areata. Poster 1411]