Plaquenil for Alopecia Areata, Alopecia Totalis

Last updated: August 12, 2009
Sponsor: Hordinsky, Maria K., MD
Overall Status: Completed

Phase

4

Condition

Hair Loss

Alopecia

Treatment

N/A

Clinical Study ID

NCT00176982
0202M18141
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Alopecia areata is an autoimmune condition resulting in hair loss and complete baldness (alopecia totalis). Published evidence says that it is mediated by T-lymphocytes. Plaquenil is an anti-inflammatory drug approved by the FDA for malaria, lupus erythematosus, and rheumatoid arthritis. It has an effect on T-lymphocyte mediated inflammation, making it a logical choice for a treatment trail for alopecia areata.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Severe alopecia areata: >75% loss of scalp hair or alopecia areata totalis: 100% loss ofscalp hair above with or without loss of body hair (alopecia universalis) 2. Group I (8subjects): Duration of disease less than 1 year 3. Group II (8 subjects): Duration ofdisease greater than 1 year 4. At least 18 years old 5. Able to give consent.

Exclusion

Exclusion Criteria:

  1. Coexisting significant systemic disease that would increase risk of hydroxychloroquine (e.g. renal disease, liver disease, alcoholism, anemia, blood dyscrasia, psoriasis,porphyria) 2. Systemic immunosuppressive therapy within 3 weeks (e.g. prednisone,cyclosporin, azathioprine) 3. Immunosuppressive conditions (e.g. HIV infection, cancerimmunotherapy genetic immunodeficiency 4. Medications with potential interaction tohydroxychloroquine (e.g. liver toxins, bone marrow toxins) 5. Pregnancy, or breast feeding
  2. Women of child bearing potential not able or willing to use two methods of contraceptionat least one of which is not a hypersensitivity to 4-aminoquinolone compounds (chloroquineand hydroxychloroquine) 9. Glucose-6-phosphate deficiency.

Study Design

Total Participants: 16
Study Start date:
April 01, 2002
Estimated Completion Date:
January 31, 2008

Study Description

Alopecia areata is a high prevalence autoimmune disease with significant consequences. Alopecia areata is a tissue restricted autoimmune disease directed at the hair follicle, resulting in hair loss. Patients frequently suffer severe psychiatric consequences. This is especially true of girls and young women who become bald. The incidence of alopecia areata in the USA (Minnesota is 20.2 per 100,000 person-years with a lifetime risk of approximately 1.7%. There is no significant gender difference. The disease is often chronic with a remitting, relapsing course. Although it responds to immunosuppression, generalized immunosuppression has significant morbidity and treatment is frequently frustrating and not successful. New treatment options are essential. With evidence that alopecia areata is a T-lymphocyte mediated autoimmune condition it has become a model system for the study of pathogenesis and treatment of T-cell mediated autoimmunity and as such is a model for a host of additional T-cell mediated autoimmune conditions.

Connect with a study center

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • State University of New York at Stony Brook

    Stonybrook, New York 11790
    United States

    Site Not Available

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