Topical Bimatoprost Effect on Androgen Dependent Hair Follicles

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Brief Title

Topical Bimatoprost Effect on Androgen Dependent Hair Follicles

Official Title

Topical Bimatoprost Effect on Androgen Dependent Hair Follicles

Brief Summary

      The purpose of this study is to determine the effect of bimatoprost solution on scalp hair
      growth. Bimatoprost 0.03% ophthalmic solution is currently approved by the FDA for treatment
      of glaucoma (Lumigan™) and for thickening of thin eyelashes (Latisse™). Bimatoprost 0.03% is
      not approved for the treatment of scalp hair loss and its use in this study is considered
      investigational which means it is still being tested in research studies.

      Thirty-three subjects were consented and screened, 9 entered and 9 completed the study.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Percent Change in Target Area Total Hair Count

Secondary Outcome

 Percent Change in the Target Area Terminal Hair Count

Condition

Male Pattern Hair Loss

Intervention

Bimatoprost

Study Arms / Comparison Groups

 Active drug
Description:  During Part I of the study, subjects will be randomized in a blinded fashion to either placebo (vehicle that does not contain active drug) or topical bimatoprost to apply to the scalp target area every day for 16 weeks. After a 10 day washout period, each group will be crossed over to the alternate topical preparation (Part II) to apply for 16 weeks.

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

33

Start Date

November 2009

Completion Date

May 2011

Primary Completion Date

May 2011

Eligibility Criteria

        Inclusion Criteria:

          1. Hamilton-Norwood patterns of baldness IIIV, IV, V, or VA.

          2. Subject's hair color must have adequate contrast against scalp color to allow hair
             counting on macrophotography.

          3. Good health with normal blood tests for hematological, renal, and liver function.

          4. Able to return to Duke for study visits.

        Exclusion Criteria:

          1. ECOG >1.

          2. Used topical or oral minoxidil in the past 6 months, oral finasteride in the past 12
             months or oral dutasteride in the past 24 months.

          3. Taken any warfarin, heparin, or retinoid for greater than 2 weeks during the past 6
             months and any in the past month.

          4. Taken any chemotherapy in the past 2 years.

          5. Used any over-the-counter (OTC) preparation that purports to help hair growth in the
             past four months.

          6. Used prostaglandins of any type in the past or currently.

          7. Any history of alopecia areata, cicatricial alopecia, radiation to the head, hair
             transplants, or scalp reductions.

          8. Any skin abnormalities in the target area that would effect hair growth.

          9. Any history of glaucoma or elevated intraocular pressure (IOP).

         10. Any cancer other than non-melanoma skin cancer (NMSC) in the past 2 years and all must
             be in remission.
      

Gender

Male

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

No

Contacts

Elise Olsen, MD, , 



Administrative Informations


NCT ID

NCT02170662

Organization ID

Pro00017573


Responsible Party

Sponsor

Study Sponsor

Duke University


Study Sponsor

Elise Olsen, MD, Principal Investigator, Duke University


Verification Date

July 2014