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

NCT00063076 | Completed Phase 2 DMC

• 1 other identifier: DM02-164
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Conditions

Alopecia Areata

Keywords

Alopecia Areata; Alopecia Totalis; Alopecia Universalis; Targretin Gel

Outcome Measures

Primary Outcomes (1)

• Response and toxicity of Targretin Gel 1% treatment for alopecia areata

  "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 = \[toxicity, response\].

  Baseline and at weeks 2,4,8,12,16,20,24 and at a 4-week follow-up

Study Arms (2)

Targretin®

EXPERIMENTAL

Targretin® (bexarotene) Gel 1%, treat half head

Drug: Targretin Gel 1%

Control

NO INTERVENTION

Half head untreated as control

Interventions

Targretin Gel 1% DRUG

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.

Also known as: Targretin

Targretin®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Ligand Pharmaceuticals: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Alopecia Areata; Alopecia universalis

Interventions

Bexarotene

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Madeleine Duvic, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2003
• First Posted: June 20, 2003
• Study Start: May 1, 2003
• Primary Completion: October 1, 2006
• Study Completion: May 1, 2007
• Last Updated: August 2, 2012

Record last verified: 2012-08

Locations

US (1)