Overview

Plaquenil for Alopecia Areata, Alopecia Totalis

Status:
Completed
Trial end date:
2008-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Hordinsky, Maria K., MD
Treatments:
Hydroxychloroquine
Criteria
Inclusion Criteria:

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

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, cancer
immunotherapy genetic immunodeficiency 4. Medications with potential interaction to
hydroxychloroquine (e.g. liver toxins, bone marrow toxins) 5. Pregnancy, or breast feeding
6. Women of child bearing potential not able or willing to use two methods of contraception
at least one of which is not a hypersensitivity to 4-aminoquinolone compounds (chloroquine
and hydroxychloroquine) 9. Glucose-6-phosphate deficiency.