Overview

Topical Bimatoprost Effect on Androgen Dependent Hair Follicles

Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Duke University
Treatments:
Androgens
Bimatoprost
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.