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

NCT00176943 | Completed Phase 4

• 1 other identifier: 0009M64941
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (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 Outcomes (1)

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

Interventions

Aldara Cream 5% DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hordinsky, Maria K., MD: lead
• National Alopecia Areata Foundation: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Maria Hordinsky, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Marna Ericson, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: October 1, 2000
• Primary Completion: August 1, 2002
• Study Completion: August 1, 2002
• Last Updated: February 14, 2014

Record last verified: 2014-02

Locations

US (1)