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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
Sponsor:
Collaborators:
National Alopecia Areata Foundation
3M
Information provided by:
University of Minnesota

Study Description
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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 cytokines which are small, hormone-like proteins involved in cellular communication during immune responses. We hypothesize that this drug will effect the inflammatory cells present around hair follicles in patients with alopecia areata.

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: Aldara Cream 5% Phase 4

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 Cream 5% daily to the right half of the scalp. No drug will be applied to the left side. Skin biopsies will be taken of the right scalp before and at the completion of the therapy.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aldara for the Treatment of Extensive Alopecia Areata
Study Start Date : October 2000
Study Completion Date : August 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. To determine the efficacy of Aldara Cream 5% for the treatment of extensive alopecia areata

Secondary Outcome Measures :
  1. Assess changes in the hair follicle differentiation oand perifollicular inflammation before and after treatment with Aldara Cream5%

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Hordinsky, Maria K., MD
National Alopecia Areata Foundation
3M
Investigators
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Principal Investigator: Maria Hordinsky, MD University of Minnesota
Principal Investigator: Marna Ericson, Ph D University of Minnesota
More Information
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ClinicalTrials.gov Identifier: NCT00177021    
Other Study ID Numbers: 9908M15841
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 13, 2006
Last Verified: November 2006
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
 Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers