Plaquenil for Alopecia Areata, Alopecia Totalis

August 12, 2009 updated by: Hordinsky, Maria K., MD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • New York
      • Stonybrook, New York, United States, 11790
        • State University of New York at Stony Brook

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hordinsky, Maria K., MD

Investigators

  • Principal Investigator: Richard Kalish, MD, PhD, State Universiyt of New York at Stony Brook

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

August 13, 2009

Last Update Submitted That Met QC Criteria

August 12, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0202M18141

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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