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Home > "P" Clinical Trials Conditions > Phase II randomized bilateral comparison of topical targretin gel 1% in alopecia areata  Phase II randomized bilateral comparison of topical targretin gel 1% in alopecia areata
Phase II randomized bilateral comparison of topical targretin gel 1% in alopecia areata
For Condition: Alopecia Areata
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , Ligand Pharmaceuticals
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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. 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 two acceptable methods of contraception 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 applicationP - 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 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>10 or <0.05, T4 <0.7 or 1.5, or fasting triglyceride level >350mg/dl will not be eligible to participate in the study
Total Enrollment: 42
Location and Contact Information:
Overall Study Official:
MadeleineDuvic, Principal Investigator, UT MD Anderson Cancer Center
UT MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Rakhshandra Talpur 713-792-4578
Additional Information:
Study ID Numbers: DM02-164;
Study Start Date: May 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063076
Other Alopecia Areata Studies:
1. Phase II randomized bilateral comparison of topical targretin gel 1% in alopecia areata
2. Alopecia Areata Registry
Related Studies:
Other Alopecia Areata Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Phase II randomized bilateral comparison of topical targretin gel 1% in alopecia areata
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