Aldara for the Treatment of Extensive Alopecia Areata

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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 4

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

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

Condition

Alopecia Areata

Intervention

Aldara Cream 5%


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

Drug

Estimated Enrollment

20

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

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Maria Hordinsky, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00177021

Organization ID

9908M15841



Study Sponsor

Hordinsky, Maria K., MD

Collaborators

 National Alopecia Areata Foundation

Study Sponsor

Maria Hordinsky, MD, Principal Investigator, University of Minnesota


Verification Date

November 2006