Clinical trial NCT00176943: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alopecia Areata
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Alopecia Areata Foundation
First posted: 2005-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.

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 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.

Primary outcomes:
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.
Secondary outcomes:
measure: To further characterize the functional potential of these cells using the nascent technology of intracellular cytokine staining.
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Maria Hordinsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Marna Ericson, PhD
role: PRINCIPAL_INVESTIGATOR
References: