Phase II Randomized Bilateral Comparison of Topical Targretin Gel 1% in Alopecia Areata
This study has been completed.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: June 19, 2003
Last updated: August 1, 2012
Last verified: August 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.
Drug: Targretin Gel 1%
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Two Stage Phase II Randomized Bilateral Comparison of Topical Targretin® Gel 1% in Alopecia Areata
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
"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].
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2006 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Clinical diagnosis of alopecia areata, alopecia totalis, or alopecia universalis.
- Patients must be 18 years of age to participate.
- Patients with alopecia areata must have at least two distinct alopecia areata patches >1.0 cm diameter, one located on the right and left sides each of the scalp. Patients with alopecia totalis or universalis will not have distinct alopecia patches but will have complete or total alopecia on both the sides of the scalp. Patients with alopecia totalis or universalis will have one side of the scalp treated. The patient must agree to treat only one side of the scalp with drug, to have photos taken, and to return for follow-up visits.
- They must also agree to practice two reliable forms of contraception (hormonal, IUD, double barrier) to be used simultaneously unless abstinence is the chosen method during the entire period of treatment and for at least one month after treatment is discontinued.
- Men with sexual partners who are of childbearing potential or pregnant must use condoms during sexual intercourse during Targretin® gel therapy and for one month after the last application.
- Patients will be asked to voluntarily contribute pre- and post biopsies for research studies (3 mm punch biopsies for hematoxylin and eosin (H&E) staining and immunohistochemistry of T-cells). However, failure to consent to biopsies will not exclude them from the study.
- Patients have signed the informed consent.
- Must be off other topical treatment for alopecia areata or PUVA (psoralen + UVA) therapy for at least two weeks.
- Must have discontinued intralesional steroids or any systemic therapies that are immunosuppressive or that may affect alopecia areata for at least four weeks. Patients who are on chronic oral steroids are not eligible for the study.
- Women who are pregnant or breastfeeding are excluded. The pregnancy test will be sensitive to at least 25 mlU/ml.
- Patients with hepatitis, HIV or other serious infections are excluded.
- Known hypersensitivity to Targretin® drug or to any retinoid or to any ingredient in the study medication.
- Patients must not have participated in any other investigational drug study within 4 weeks of entry.
- Patients with Hbg < 9.5 g/dL, WBC < 2,500 K/ul, Platelets < 100 K/ul, TSH > 5.5 or < 0.5 mcU/mL, T4 < 0.9 or > 1.8 g/dl, or fasting triglyceride level > 350 mg/dl will not be eligible to participate in the study.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00063076
|UT MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center
||Madeleine Duvic, MD
||UT MD Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 19, 2003
||August 1, 2012
||United States: Food and Drug Administration
Keywords provided by M.D. Anderson Cancer Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 26, 2014
Pathological Conditions, Anatomical
Physiological Effects of Drugs