Plaquenil for Alopecia Areata, Alopecia Totalis

This study has been completed.
Sponsor:
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00176982
First received: September 12, 2005
Last updated: August 12, 2009
Last verified: August 2009

September 12, 2005
August 12, 2009
April 2002
December 2007   (final data collection date for primary outcome measure)
Percent hair regrowth in each quadrant of the scalp will be estimated and statistical analysis performed to determine if there was any significant regrowth compared to pre-treatment photographs.
Same as current
Complete list of historical versions of study NCT00176982 on ClinicalTrials.gov Archive Site
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Plaquenil for Alopecia Areata, Alopecia Totalis
Open Label Study of Hydroxychloroquine for Alopecia Areata, Alopecia Totalis

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Alopecia Areata
Drug: Hydroxychloroquine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
January 2008
December 2007   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00176982
0202M18141
Not Provided
Maria Hordinsky MD, University of Minnesota
Hordinsky, Maria K., MD
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Principal Investigator: Maria Hordinsky, MD University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Richard Kalish, MD, PhD State Universiyt of New York at Stony Brook
University of Minnesota - Clinical and Translational Science Institute
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP