Expired Study
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Minneapolis, Minnesota 55455


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

0009M64941


NCT ID:

NCT00176943


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

Phenotype and Cytokine Production Characteristics of T Cells From Alopecia Areata Scalp Skin Before and After Aldara 5% Cream Using Flow Cytometry


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Minnesota - Clinical and Translational Science Institute


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificatio


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:


Overall Contact Information

Official Name:Maria Hordinsky, MD
Principal Investigator
University of Minnesota - Clinical and Translational Science Institute

Study Dates

Start Date:October 2000
Completion Date:August 2002
Completion Type:Actual
Primary Completion Date:August 2002
Primary Completion Type:Actual
Verification Date:February 2014
Last Changed Date:February 13, 2014
First Received Date:September 12, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure: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.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To further characterize the functional potential of these cells using the nascent technology of intracellular cytokine staining.
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Aldara Cream 5%

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Hordinsky, Maria K., MD
Agency Class:Other
Agency Type:Collaborator
Agency Name:National Alopecia Areata Foundation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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