Status:
COMPLETED
Aldara for the Treatment of Extensive Alopecia Areata
Lead Sponsor:
Hordinsky, Maria K., MD
Collaborating Sponsors:
National Alopecia Areata Foundation
3M
Conditions:
Alopecia Areata
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
We propose to examine the efficacy and tolerability of Aldara Cream 5% for the treatment of extensive alopecia areata. Aldara is a immune-response modifier. The drug induces the production of cytokine...
Detailed Description
Ten patients with extensive scalp alopecia areata (\>95% hair loss)of less than 2 years duration will be invited to participate in this study. For six months each person will be asked to apply Aldara ...
Eligibility Criteria
Inclusion
- Must give written informed consent.
- Must be 18 years of age, male or female of any race.
- Subjects must have extensive scalp alopecia areata (\>95% involvement) of less than 2 years duration.
- In good general and mental health based on a medical history and physical exam.
- Patient must be willing to refrain from all other alopecia areata treatments during the course of the study.
- Must agree to shampoo daily with Free and Clear shampoo.
Exclusion
- History of any illness or condition that in the opinion of the investigator might confound the results of the study or pose additional risk in administering the drug to the patient.
- Significant abnormalities on screening clinical examination.
- Previous use of Aldara Cream 5%
- History of drug or alcohol abuse.
- Use of ultraviolet radiation, including tanning beds and PUVA therapy for treatment of acne, psoriasis, or any other skin condition within 2 months prior to study initiation.
- Use of systemic or topical glucocorticoids, corticosteroids. estrogenic, progestogenic, androgenic, or antiandrogen drugs, cyclosporine, FK506 or immunotherapy with DNCB, SADBE, or DCP within 6 months of study initiation.
- Use of a topical medication within six weeks prior to the study.
- Alterations in thyroid medication within 6 months of study initiation.
- Pregnant or nursing females.
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
End Date :
August 1 2002
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00177021
Start Date
October 1 2000
End Date
August 1 2002
Last Update
November 13 2006
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455