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Plaquenil for Alopecia Areata, Alopecia Totalis

This study has been completed.

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

MedlinePlus related topics:   Hair Diseases and Hair Loss   

Drug Information available for:   Hydroxychloroquine    Hydroxychloroquine sulfate   

U.S. FDA Resources

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

Further study details as provided by University of Minnesota:

Primary Outcome Measures:
  • 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.

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)

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176982

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

Sponsors and Collaborators
Hordinsky, Maria K., MD

Investigators
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
First Received:   September 12, 2005
Last Updated:   February 6, 2008
ClinicalTrials.gov Identifier:   NCT00176982
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Minnesota:
treatment of alopecia areata  

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Alopecia Areata
Alopecia areata
Alopecia totalis
Skin Diseases
Hydroxychloroquine
Alopecia

Additional relevant MeSH terms:
Hair Diseases
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Hypotrichosis
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2008




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