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

This study has been completed.

Sponsor:

Collaborator:

National Alopecia Areata Foundation

Information provided by (Responsible Party):

University of Minnesota - Clinical and Translational Science Institute ( Hordinsky, Maria K., MD )

ClinicalTrials.gov Identifier:

NCT00176943

First received: September 12, 2005

Last updated: February 13, 2014

Last verified: February 2014

History of Changes

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.

Condition	Intervention	Phase
Alopecia Areata	Drug: Aldara Cream 5%	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Imiquimod

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:

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:

To further characterize the functional potential of these cells using the nascent technology of intracellular cytokine staining.


Estimated Enrollment:	20
Study Start Date:	October 2000
Study Completion Date:	August 2002
Primary Completion Date:	August 2002 (Final data collection date for primary outcome measure)

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	Hordinsky, Maria K., MD
ClinicalTrials.gov Identifier:	NCT00176943 History of Changes
Other Study ID Numbers:	0009M64941
Study First Received:	September 12, 2005
Last Updated:	February 13, 2014
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 23, 2016

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