Clinical Trial: Phase II Randomized Bilateral Comparison of Topical Targretin Gel 1% in Alopecia Areata

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Two Stage Phase II Randomized Bilateral Comparison of Topical Targretin® Gel 1% in Alopecia Areata

Brief Summary:

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.

Objectives:

  1. Determine the safety and tolerability of Targretin® Gel 1% in the treatment of patients with alopecia areata.
  2. Determine the efficacy of Targretin® Gel 1% in the treatment of patients with alopecia areata.

Detailed Summary:

Targretin® (bexarotene) Gel 1% a synthetic vitamin A compound that is approved for the topical treatment and oral treatment of cutaneous T cell lymphoma (CTCL). Vitamin A compounds can influence the growth of skin cells, and can cause the death of T-cells. Researchers hope that the bexarotene may get rid of T-cells around the hair follicles in AA (alopecia areata) lesions.

Before treatment starts, patients will have a complete medical history and a brief physical exam. Researchers will ask about alopecia disease history, date of first diagnosis, and earlier treatments and responses. Blood test (about 4 teaspoons) will be performed before and after the end of treatment. Additional blood tests will be done if needed. Women able to have children must have a negative blood pregnancy test within 7 days before the start of treatment. Blood pregnancy test must be repeated once a month while receiving treatment.

Participants in this study will be randomly assigned (as in the toss of a coin) to treat alopecia areata lesions on only one half of their head. Half of the participants will have the left side treated while the other half will have the right side treated. Sealed envelopes will be given to participants, telling them which side of the head to treat. The other half of the head will remain untreated and serve as the control.

Patients will treat alopecia lesions on one-half of the head including facial hair as designated by the investigator. The other half of the head will have control (untreated) alopecia lesions. Up to 5 index lesions for treatment and 5 control lesions will be designated at baseline to follow and measure during the study. Patients will be treated with Targretin® gel 1% in a dose escalation regimen starting at once every day. At the start of Week 3
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: 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].


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: June 19, 2003
Date Started: May 2003
Date Completion:
Last Updated: August 1, 2012
Last Verified: August 2012