Aldara for the Treatment of Extensive Alopecia Areata

This study has been completed.

First Received on September 9, 2005. Last Updated on November 8, 2006 History of Changes

Sponsor:	Hordinsky, Maria K., MD
Collaborators:	National Alopecia Areata Foundation 3M
Information provided by:	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT00177021

Purpose

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.

Condition	Intervention	Phase
Alopecia Areata	Drug: Aldara Cream 5%	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Aldara for the Treatment of Extensive Alopecia Areata

Resource links provided by NLM:

Genetics Home Reference related topics: androgenetic alopecia

Drug Information available for: S 26308

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:

To determine the efficacy of Aldara Cream 5% for the treatment of extensive alopecia areata

Secondary Outcome Measures:

Assess changes in the hair follicle differentiation oand perifollicular inflammation before and after treatment with Aldara Cream5%

Estimated Enrollment:	20
Study Start Date:	October 2000
Estimated Study Completion Date:	August 2002

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177021

Locations

United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

Hordinsky, Maria K., MD

National Alopecia Areata Foundation

Investigators

Principal Investigator:	Maria Hordinsky, MD	University of Minnesota - Clinical and Translational Science Institute
Principal Investigator:	Marna Ericson, Ph D	University of Minnesota - Clinical and Translational Science Institute

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00177021 History of Changes
Other Study ID Numbers:	9908M15841
Study First Received:	September 9, 2005
Last Updated:	November 8, 2006
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Imiquimod

Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on February 12, 2012