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

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

Study Description

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

• 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

Arms and Interventions

Outcome Measures

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

• 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

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
• First Posted: September 15, 2005
• 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