Topical Bimatoprost Effect on Androgen Dependent Hair Follicles

Phase 2

Completed

• Conditions: Male Pattern Hair Loss; Androgenetic Alopecia
• Interventions: Drug: Bimatoprost; Drug: Placebo

• Registration Number: NCT02170662
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-20
• Study First Posted: 2014-06-23
• Status Verified: 2014-07
• Results First Submitted: 2014-07-31
• Results First Submitted QC: 2014-07-31
• Results First Posted: 2014-08-20
• Last Update Submitted: 2014-08-27
• Last Update Posted: 2014-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active 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.
Placebo	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.
Active drug	Bimatoprost	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.
Placebo	Bimatoprost	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.

Primary Outcome Measures

Name	Time	Method
Percent Change in Target Area Total Hair Count	Baseline to week 17; and week 17 to week 34	The primary endpoint is the percent change in total hair count from the beginning and end of each part of the study.

Secondary Outcome Measures

Name	Time	Method
Percent Change in the Target Area Vellus Hair Count	Baseline to week 17; and week 17 to week 34	Vellus hairs are fine hairs that generally do not grow beyond 1 cm and do not contribute to overall hair density. For the most part, they have a diameter of \<40 um. They are increased in number in male pattern baldness
Percent Change in Hair Diameter	Baseline to week 17; Week 17 to week 34	The percent change in hair diameter is a recent addition to the methods of assessing efficacy of hair growth promoters. It is a measure of hair mass and does not separate out the effect on terminal and vellus hairs but rather combines the effect on both. Since it is only terminal hairs that contributes to normal hair density, this measure does not add anything to the measures of total, terminal and vellus hair counts in terms of overall effect on hair growth and is therefore not analyzed or reported here.
Percent Change in the Target Area Terminal Hair Count	Baseline to week 17; and week 17 to week 34	Terminal hairs are those which grow beyond a cm and contribute to overall hair density.