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Characteristics of T Cells From Alopecia Areata Scalp Skin Before and After Treatment With Aldara 5%

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ClinicalTrials.gov Identifier: NCT00176943
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 14, 2014
Sponsor:
Collaborator:
National Alopecia Areata Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute ( Hordinsky, Maria K., MD )

Study Description
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Brief Summary:
It is thought that alopecia areata occurs as the result of an inappropriate response of the body's own immune system to certain substances in or around the hair follicle. We will be examining the efficacy of Aldara Cream 5% in treating extensive alopecia areata and observe its affect on the hair follicle.

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

Detailed Description:
We will examine how the application of Aldara Cream 5% daily for 6 months will affect the hair follicle and the inflammation present in the skin of patients with alopecia areata. In the study we will obtain additional scalp biopsies to examine how the drug affects the quality and state of activity of the immune cells in the biopsy specimens. This type of information will provide data about the behavior of these inflammatory cells in mediating the hair loss associated with alopecia areata and how this behavior may be effected by Aldara Cream 5% treatment. Such information may be valuable to the successful management of alopecia areata.

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)
Official Title: Phenotype and Cytokine Production Characteristics of T Cells From Alopecia Areata Scalp Skin Before and After Aldara 5% Cream Using Flow Cytometry
Study Start Date : October 2000
Actual Primary Completion Date : August 2002
Actual 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 phenotypic characteristics of T lymphocytes infiltrating scalp dermis and epidermis in patients with extensive alopecia areata before and after treatment with Aldara Cream 5% an immunomodulatory agent.

Secondary Outcome Measures :
  1. To further characterize the functional potential of these cells using the nascent technology of intracellular cytokine staining.

Eligibility Criteria
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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 be in good health.
  • No topical or systemic treatment for alopecia areata for at least 2 weeks prior to study initiation.
  • Must be at least 18 years of age and older
  • Will have to have extensive scalp alopecia areata (>95% involvement) of less than 2 years duration.
  • Willing to refrain from other alopecia areata treatments during the course of the study.
  • Will have to agree to shampoo their scalp daily with Free and Clear shampoo. Participant in "Aldara for the Treatment of Extensive Alopecia Areata" study.

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 to the patient
  • Significant abnormalities on screening clinical evaluation.
  • Previous use of Aldara Cream 5%.
  • A history of drug or alcohol abuse.
  • Use of UV 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.
  • Alterations in thyroid medication within 6 weeks of study initiation. Pregnant or nursing females. Not participating in the "Aldara for the Treatment of Extensive Alopecia Areata" study.
Contacts and Locations
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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): NCT00176943


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Hordinsky, Maria K., MD
National Alopecia Areata Foundation
Investigators
Principal Investigator: Maria Hordinsky, MD University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Marna Ericson, PhD University of Minnesota - Clinical and Translational Science Institute
More Information
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Responsible Party: Hordinsky, Maria K., MD
ClinicalTrials.gov Identifier: NCT00176943     History of Changes
Other Study ID Numbers: 0009M64941
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: February 14, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
 Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers