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

This study has been completed.
Sponsor:
Collaborator:
Ligand Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00063076
First received: June 19, 2003
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

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.

Condition Intervention Phase
Alopecia Areata
Drug: Targretin Gel 1%
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Two Stage Phase II Randomized Bilateral Comparison of Topical Targretin® Gel 1% in Alopecia Areata

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

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].


Enrollment: 46
Study Start Date: May 2003
Study Completion Date: May 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Targretin®
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of alopecia areata, alopecia totalis, or alopecia universalis.
  2. Patients must be 18 years of age to participate.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. Patients have signed the informed consent.

Exclusion Criteria:

  1. Must be off other topical treatment for alopecia areata or PUVA (psoralen + UVA) therapy for at least two weeks.
  2. 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.
  3. Women who are pregnant or breastfeeding are excluded. The pregnancy test will be sensitive to at least 25 mlU/ml.
  4. Patients with hepatitis, HIV or other serious infections are excluded.
  5. Known hypersensitivity to Targretin® drug or to any retinoid or to any ingredient in the study medication.
  6. Patients must not have participated in any other investigational drug study within 4 weeks of entry.
  7. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063076

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Ligand Pharmaceuticals
Investigators
Principal Investigator: Madeleine Duvic, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00063076     History of Changes
Other Study ID Numbers: DM02-164
Study First Received: June 19, 2003
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Alopecia Areata
Alopecia Totalis
Alopecia Universalis
Targretin Gel

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Bexarotene
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014