Phase II Randomized Bilateral Comparison of Topical Targretin Gel 1% in Alopecia Areata
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|ClinicalTrials.gov Identifier: NCT00063076|
Recruitment Status : Completed
First Posted : June 20, 2003
Last Update Posted : August 2, 2012
The goal of this clinical research study is to find the most effective dose of Targretin® (bexarotene) Gel 1% that can be given to patients as a treatment for alopecia areata. The safety and tolerability of this drug will also be studied.
- Determine the safety and tolerability of Targretin® Gel 1% in the treatment of patients with alopecia areata.
- Determine the efficacy of Targretin® Gel 1% in the treatment of patients with alopecia areata.
|Condition or disease||Intervention/treatment||Phase|
|Alopecia Areata||Drug: Targretin Gel 1%||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Two Stage Phase II Randomized Bilateral Comparison of Topical Targretin® Gel 1% in Alopecia Areata|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||May 2007|
Targretin® (bexarotene) Gel 1%, treat half head
Drug: Targretin Gel 1%
Alopecia lesions on one-half of the head including facial hair treated, and other half on head serves as control (untreated). Starting dose once every day till Week 3 then escalate to twice a day.
Other Name: Targretin
No Intervention: Control
Half head untreated as control
- Response and toxicity of Targretin Gel 1% treatment for alopecia areata [ Time Frame: Baseline and at weeks 2,4,8,12,16,20,24 and at a 4-week follow-up ]"Response" defined as hair growth at PGA grade 3 or 4, and "toxicity" as vesiculation grade 3 or ulceration at grade 4 using design of Thall, Simon and Estey (1995, 1996). To monitor response and toxicity, four possible elementary outcomes are: 1 = [no toxicity, no response], 2 = [no toxicity, response], 3 = [toxicity, no response] , 4 = [toxicity, response].
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00063076
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Madeleine Duvic, MD||UT MD Anderson Cancer Center|