Aldara for the Treatment of Extensive Alopecia Areata - Tabular View

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

November 8, 2006

Start Date ^ICMJE

October 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00177021 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Aldara for the Treatment of Extensive Alopecia Areata

Official Title ^ICMJE

Aldara for the Treatment of Extensive Alopecia Areata

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Alopecia Areata

Intervention ^ICMJE

Drug: Aldara Cream 5%

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2002

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00177021

Responsible Party

Study ID Numbers ^ICMJE

9908M15841

Study Sponsor ^ICMJE

Hordinsky, Maria K., MD

Collaborators ^ICMJE

National Alopecia Areata Foundation
3M

Investigators ^ICMJE

Principal Investigator:	Maria Hordinsky, MD	University of Minnesota
Principal Investigator:	Marna Ericson, Ph D	University of Minnesota

Information Provided By

University of Minnesota

Verification Date

November 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP