Aldara for the Treatment of Extensive Alopecia Areata

NCT ID: NCT00177021

Last Updated: 2006-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-10-31
• Study Completion Date: 2002-08-31

Brief Summary

We propose to examine the efficacy and tolerability of Aldara Cream 5% for the treatment of extensive alopecia areata. Aldara is a immune-response modifier. The drug induces the production of cytokines which are small, hormone-like proteins involved in cellular communication during immune responses. We hypothesize that this drug will effect the inflammatory cells present around hair follicles in patients with alopecia areata.

Detailed Description

Ten patients with extensive scalp alopecia areata (>95% hair loss)of less than 2 years duration will be invited to participate in this study. For six months each person will be asked to apply Aldara Cream 5% daily to the right half of the scalp. No drug will be applied to the left side. Skin biopsies will be taken of the right scalp before and at the completion of the therapy.

Conditions

Alopecia Areata

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Aldara Cream 5%

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Must give written informed consent.
• Must be 18 years of age, male or female of any race.
• Subjects must have extensive scalp alopecia areata (>95% involvement) of less than 2 years duration.
• In good general and mental health based on a medical history and physical exam.
• Patient must be willing to refrain from all other alopecia areata treatments during the course of the study.
• Must agree to shampoo daily with Free and Clear shampoo.

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 in administering the drug to the patient.
• Significant abnormalities on screening clinical examination.
• Previous use of Aldara Cream 5%
• History of drug or alcohol abuse.
• Use of ultraviolet 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.
• Use of a topical medication within six weeks prior to the study.
• Alterations in thyroid medication within 6 months of study initiation.
• Pregnant or nursing females.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Alopecia Areata Foundation

OTHER

Sponsor Role: collaborator

3M

INDUSTRY

Sponsor Role: collaborator

Hordinsky, Maria K., MD

INDIV

Sponsor Role: lead

Principal Investigators

Maria Hordinsky, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Marna Ericson, Ph D

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

9908M15841

Identifier Type: -

Identifier Source: org_study_id