Aldara for the Treatment of Extensive Alopecia Areata

Alopecia Areata Clinical Trial

Official title:

Aldara for the Treatment of Extensive Alopecia Areata

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00177021
• Other study ID #: 9908M15841
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: November 8, 2006
• Start date: October 2000
• Est. completion date: August 2002

Study information

• Verified date: November 2006
• 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

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.

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.

Recruitment information / eligibility

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

Eligibility

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.

Study Design

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

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 (3)

Lead Sponsor	Collaborator
Hordinsky, Maria K., MD	3M, National Alopecia Areata Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the efficacy of Aldara Cream 5% for the treatment of extensive alopecia areata
Secondary	Assess changes in the hair follicle differentiation oand perifollicular inflammation before and after treatment with Aldara Cream5%