Plaquenil for Alopecia Areata, Alopecia Totalis

NCT ID: NCT00176982

Last Updated: 2009-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2008-01-31

Brief 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.

Detailed 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.

Conditions

Alopecia Areata

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Hydroxychloroquine

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hordinsky, Maria K., MD

INDIV

Sponsor Role: lead

Responsible Party

University of Minnesota

Principal Investigators

Maria Hordinsky, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Richard Kalish, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

State Universiyt of New York at Stony Brook

Locations

University of Minnesota

Minneapolis, Minnesota, United States

State University of New York at Stony Brook

Stony Brook, New York, United States

Countries

United States

Other Identifiers

0202M18141

Identifier Type: -

Identifier Source: org_study_id