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

Alopecia Areata Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

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 patients will begin applications of twice a day applications if tolerated. Patients will continue BID dosing, if tolerated, unless the investigator determines a further increase in application frequency may benefit the patient and the patient agrees to comply.

Patients will be seen at baseline and at weeks 2, 4, 8, 12, 16, 20, 24 and at a 4-week follow-up. Telephone evaluations will be done at week 1 and as needed.

Study visits for evaluation of safety and efficacy will be made at Week 2 and 4 after the start of treatment and then every 4 weeks up until Week 24. Telephone safety evaluations will also be made at Week 1 and other times as needed.

Skin irritation or changes in health during the study may require participants to stop treatment or withdraw from the study.

At withdrawal from the study, about 4 teaspoons of blood will be drawn. The total study duration is 24 Weeks with a 4-week follow-up period. At the 4-week follow-up visit, a physical exam, including measurement of vital signs and weight will be performed. An evaluation of both treated and untreated sides of the head will be performed.

Patients who show a response at 6 months (24 weeks) will be given the option to continue therapy for an additional 6 months and will be able to apply the medication to both sides of the head. Patients will come every 2 months (3 additional visits) and will have the same examination as they have had during the study with evaluation of irritation, hair loss, hair thickness, measurement of lesions, and the physician's global assessment, which is the evaluation of hair re-growth. The same dose adjustment and withdrawal from treatment will be applied during this 6-month period. Every 2 months, blood (about 2 tablespoons) will be drawn for pregnancy tests and to look at your triglycerides (fat) levels and complete blood cell counts.

This is an investigational study. Targretin® Gel 1% is commercially available and approved by the FDA for use in the treatment of cutaneous lesions in patients with CTCL. Initially up to 42 participants will be enrolled in the study. All will be enrolled at M. D. Anderson. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

• NCT number: NCT00063076
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 2003
• Completion date: May 2007