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

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00176943
• Other study ID #: 0009M64941
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: February 13, 2014
• Start date: October 2000
• Est. completion date: August 2002

Study information

• Verified date: February 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2002
• Est. primary completion date: August 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• Aldara Cream 5%

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Hordinsky, Maria K., MD	National Alopecia Areata Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To further characterize the functional potential of these cells using the nascent technology of intracellular cytokine staining.