Characteristics of T Cells From Alopecia Areata Scalp Skin Before and After Treatment With Aldara 5%

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Brief Title

Characteristics of T Cells From Alopecia Areata Scalp Skin Before and After Treatment With Aldara 5%

Official Title

Phenotype and Cytokine Production Characteristics of T Cells From Alopecia Areata Scalp Skin Before and After Aldara 5% Cream Using Flow Cytometry

Brief Summary

      It is thought that alopecia areata occurs as the result of an inappropriate response of the
      body's own immune system to certain substances in or around the hair follicle. We will be
      examining the efficacy of Aldara Cream 5% in treating extensive alopecia areata and observe
      its affect on the hair follicle.
    

Detailed Description

      We will examine how the application of Aldara Cream 5% daily for 6 months will affect the
      hair follicle and the inflammation present in the skin of patients with alopecia areata. In
      the study we will obtain additional scalp biopsies to examine how the drug affects the
      quality and state of activity of the immune cells in the biopsy specimens. This type of
      information will provide data about the behavior of these inflammatory cells in mediating the
      hair loss associated with alopecia areata and how this behavior may be effected by Aldara
      Cream 5% treatment. Such information may be valuable to the successful management of alopecia
      areata.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

To determine the phenotypic characteristics of T lymphocytes infiltrating scalp dermis and epidermis in patients with extensive alopecia areata before and after treatment with Aldara Cream 5% an immunomodulatory agent.

Secondary Outcome

 To further characterize the functional potential of these cells using the nascent technology of intracellular cytokine staining.

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

Primary Completion Date

August 2002

Eligibility Criteria

        Inclusion Criteria:

          -  Must be in good health.

          -  No topical or systemic treatment for alopecia areata for at least 2 weeks prior to
             study initiation.

          -  Must be at least 18 years of age and older

          -  Will have to have extensive scalp alopecia areata (>95% involvement) of less than 2
             years duration.

          -  Willing to refrain from other alopecia areata treatments during the course of the
             study.

          -  Will have to agree to shampoo their scalp daily with Free and Clear shampoo.
             Participant in "Aldara for the Treatment of Extensive Alopecia Areata" study.

        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 to the patient

          -  Significant abnormalities on screening clinical evaluation.

          -  Previous use of Aldara Cream 5%.

          -  A history of drug or alcohol abuse.

          -  Use of UV 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.

          -  Alterations in thyroid medication within 6 weeks of study initiation. Pregnant or
             nursing females. Not participating in the "Aldara for the Treatment of Extensive
             Alopecia Areata" study.
      

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

NCT00176943

Organization ID

0009M64941


Responsible Party

Sponsor

Study Sponsor

Hordinsky, Maria K., MD

Collaborators

 National Alopecia Areata Foundation

Study Sponsor

Maria Hordinsky, MD, Principal Investigator, University of Minnesota


Verification Date

February 2014