Phase II Randomized Bilateral Comparison of Topical Targretin Gel 1% in Alopecia Areata - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center Ligand Pharmaceuticals
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00063076

Purpose

The rationale for the use of bexarotene in alopecia areata comes from the drugs' immunomodulatory effects. It has been shown to be effective in inflammatory dermatoses, many of which are known to have T-cell mediated mechanisms. Alopecia areata is an organ-specific autoimmune reaction mediated by perifollicular T lymphocytes that clear upon resolution of disease. Therefore, since bexarotene is able to reduce or clear T-cell from the skin in CTCL lesions, we hypothesize that it may be effective in alopecia areata in eliminating the T-cells around the hair follicles.

Condition	Intervention	Phase
Alopecia Areata	Drug: Targretin Gel 1%	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Two Stage Phase II Randomized Bilateral Comparison of Topical Targretin® Gel 1% in Alopecia Areata

Resource links provided by NLM:

MedlinePlus related topics: Hair Diseases and Hair Loss

Drug Information available for: Bexarotene

U.S. FDA Resources

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

Estimated Enrollment:	42
Study Start Date:	May 2003
Estimated Study Completion Date:	May 2007

Eligibility

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

Criteria

Inclusion:

Clinical diagnosis of alopecia areata, alopecia totalis, or alopecia universalis
Patients must be ≥ 18 years of age to participate.
All patients must signed informed consent.
Must have at least two distinct alopecia areata patches >1.0 cm in diameter located on the right and left sides 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.

Patient must agree to treat only one side of the scalp with drug, to have photos taken, and to return for follow-up visits

Women of childbearing potential must use an effective method of contraceptive (hormonal, IUD, double barrier or abstinence) to prevent pregnancy and agree to do so for one month after their last application of Targretin® gel
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 H & E and immunohistochemistry of T-cells). However, failure to consent to biopsies will not exclude them from the study.

Exclusion:

Must be off other topical treatment for alopecia areata or PUVA (psoralen and ultraviolet A) 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 mIU/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, WBC <2,500, Platelets <100K, TSH>5.5 or <0.5, T4 <0.9 or 1.8, or fasting triglyceride level >350mg/dl will not be eligible to participate in the study

Contacts and Locations

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

No publications provided

Study ID Numbers:	DM02-164
Study First Received:	June 19, 2003
Last Updated:	May 31, 2007
ClinicalTrials.gov Identifier:	NCT00063076 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Alopecia Areata
Alopecia Totalis
Alopecia Universalis
Targretin Gel

Study placed in the following topic categories:

Anticarcinogenic Agents
Alopecia Universalis
Pathological Conditions, Anatomical
Alopecia Areata
Hypotrichosis

Skin Diseases
Bexarotene
Alopecia
Alopecia Totalis

Additional relevant MeSH terms:

Hair Diseases
Pathological Conditions, Anatomical
Anticarcinogenic Agents
Hypotrichosis
Skin Diseases
Antineoplastic Agents
Physiological Effects of Drugs

Protective Agents
Pharmacologic Actions
Alopecia Areata
Bexarotene
Alopecia
Therapeutic Uses

ClinicalTrials.gov processed this record on July 02, 2009