Aldara for the Treatment of Extensive Alopecia Areata - Tabular View

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Aldara for the Treatment of Extensive Alopecia Areata

This study has been completed.

Study NCT00177021. Last updated on November 8, 2006. Information provided by University of Minnesota

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Aldara for the Treatment of Extensive Alopecia Areata

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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

Condition ^†

Alopecia Areata

Intervention ^†

Drug: Aldara Cream 5%

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

October 2000

Completion Date

August 2002

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00177021

Organization ID

9908M15841

Secondary IDs ^††

Study Sponsor ^†

Hordinsky, Maria K., MD

Collaborators ^††

National Alopecia Areata Foundation
3M

Investigators ^†

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

First Received Date ^†

September 9, 2005

Last Updated Date

November 8, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.