Topical Bimatoprost Effect on Androgen Dependent Hair Follicles

NCT ID: NCT02170662

Last Updated: 2014-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-05-31

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.

Conditions

Male Pattern Hair Loss; Androgenetic Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active drug

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.

Group Type: ACTIVE_COMPARATOR

Bimatoprost

Intervention Type: DRUG

Bimatoprost 0.03% ophthalmic solution as purchased from the manufacturer will be the active drug.

Placebo

Intervention Type: DRUG

Placebo

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.

Group Type: ACTIVE_COMPARATOR

Bimatoprost

Intervention Type: DRUG

Bimatoprost 0.03% ophthalmic solution as purchased from the manufacturer will be the active drug.

Placebo

Intervention Type: DRUG

Interventions

Bimatoprost

Bimatoprost 0.03% ophthalmic solution as purchased from the manufacturer will be the active drug.

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elise Olsen, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Other Identifiers

Pro00017573

Identifier Type: -

Identifier Source: org_study_id