Aldara for the Treatment of Extensive Alopecia Areata
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|ClinicalTrials.gov Identifier: NCT00177021|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 13, 2006
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|Condition or disease||Intervention/treatment||Phase|
|Alopecia Areata||Drug: Aldara Cream 5%||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Aldara for the Treatment of Extensive Alopecia Areata|
|Study Start Date :||October 2000|
|Study Completion Date :||August 2002|
- To determine the efficacy of Aldara Cream 5% for the treatment of extensive alopecia areata
- Assess changes in the hair follicle differentiation oand perifollicular inflammation before and after treatment with Aldara Cream5%
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00177021
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Maria Hordinsky, MD||University of Minnesota|
|Principal Investigator:||Marna Ericson, Ph D||University of Minnesota|
|Other Study ID Numbers:||
|First Posted:||September 15, 2005 Key Record Dates|
|Last Update Posted:||November 13, 2006|
|Last Verified:||November 2006|
Pathological Conditions, Anatomical
Physiological Effects of Drugs