Efficacy Study of Latanoprost and Bimatoprost Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata

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Brief Title

Efficacy Study of Latanoprost and Bimatoprost Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata

Official Title

Efficacy and Safety of Latanoprost (Xalatan) and Bimatoprost (Lumigan) Ophthalmic Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata

Brief Summary

      This is a single center, randomized, investigator-masked study to determine the efficacy and
      safety of latanoprost and bimatoprost ophthalmic solutions in promoting eyelash growth in
      patients who have lost their eyelashes due to alopecia areata. These medications are
      FDA-approved as eyedrops for patients with glaucoma who have been noted to grow longer,
      darker, and thicker eyelashes with their use. In this study, patients will be asked to apply
      these solutions to the affected eyelid margins of one eye with a sterile cotton-tipped
      applicator once a day.
    

Detailed Description

      This is a pilot, single-center, randomized, investigator-masked study to evaluate the
      efficacy and safety of latanoprost (Xalatan) ophthalmic solution compared to bimatoprost
      (Lumigan) ophthalmic solution in patients with eyelash loss due to alopecia areata. This is a
      collaborative study between the Departments of Dermatology and Ophthalmology at UCSF.
      Patients will be randomized to receive either latanoprost or bimatoprost. Patients will be
      instructed to apply latanoprost or bimatoprost to the affected eyelid margins of one eye
      using a sterile cotton-tipped applicator once a day (similar to the application of eyeliner).
      The untreated eye will serve as a control. When substantial eyelash growth is noted in the
      treated eye, patients will be instructed to decrease application to once a week. Patients
      will be seen every four weeks in the Department of Dermatology. In addition, eyelash growth
      will be assessed in the Beckman Vision Center where eyelash length will be measured, and
      photographs will be taken at baseline, 2 months, and 4 months. Intraocular pressure will be
      documented at baseline and at each visit to the Beckman Vision Center. The study will be
      conducted over four months.
    


Study Type

Interventional


Primary Outcome

Eyelash growth in response to topical application of latanoprost or bimatoprost to the eyelid margins of patients with alopecia areata; eyelid photographs and eyelash length will be documented at 8 week intervals.


Condition

Alopecia Areata

Intervention

Latanoprost (Xalatan)

Study Arms / Comparison Groups

 application to eyelid of latanoprost solution
Description:  Subject will apply latanoprost solution with applicator daily to affected eye lid(s)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

14

Start Date

June 2005

Completion Date

March 2006

Primary Completion Date

February 2006

Eligibility Criteria

        Inclusion Criteria:

          -  Males and females in good general health, ages 18-70.

          -  Patients with alopecia areata who have had 50% or more eyelash loss for 6 months or
             longer.

        Exclusion Criteria:

          -  Any pre-existing eye disorder that would preclude use of a topical agent around the
             eyes (e.g. infection, inflammation, recent surgery.)

          -  Subjects with limited close vision who cannot see their eyelid margin clearly.

          -  Immunosuppressed state.

          -  Women who are pregnant or who are trying to become pregnant, or are breast-feeding.

          -  Patients with known allergy to latanoprost or bimatoprost, other prostaglandin F-2a or
             related drugs, or to benzalkonium.

          -  Unable to read or follow instructions.
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Vera H. Price, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00187577

Organization ID

H7285-26596-01



Study Sponsor

University of California, San Francisco


Study Sponsor

Vera H. Price, M.D., Principal Investigator, Professor, University of California, San Francisco Department of Dermatology


Verification Date

June 2011