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| Sponsored by: |
Hordinsky, Maria K., MD |
|---|---|
| Information provided by: | University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00176982 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alopecia Areata |
Drug: Hydroxychloroquine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Open Label Study of Hydroxychloroquine for Alopecia Areata, Alopecia Totalis |
| Estimated Enrollment: | 16 |
| Study Start Date: | April 2002 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, New York | |
| State University of New York at Stony Brook | |
| Stonybrook, New York, United States, 11790 | |
| Principal Investigator: | Maria Hordinsky, MD | University of Minnesota |
| Principal Investigator: | Richard Kalish, MD, PhD | State Universiyt of New York at Stony Brook |
More Information
| Responsible Party: | University of Minnesota ( Maria Hordinsky MD ) |
| Study ID Numbers: | 0202M18141 |
| Study First Received: | September 12, 2005 |
| Last Updated: | February 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00176982 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
treatment of alopecia areata |
|
Pathological Conditions, Anatomical Alopecia Areata Antimalarials Hypotrichosis Skin Diseases |
Hydroxychloroquine Alopecia Alopecia Totalis Antirheumatic Agents |
|
Hair Diseases Pathological Conditions, Anatomical Anti-Infective Agents Antiprotozoal Agents Hypotrichosis Skin Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Pharmacologic Actions Alopecia Areata Antimalarials Antiparasitic Agents Alopecia Hydroxychloroquine Therapeutic Uses Antirheumatic Agents |
