Phase 2 N=9 Randomized Triple-blind Treatment

Topical Bimatoprost Effect on Androgen Dependent Hair Follicles

Male Pattern Hair Loss · Androgenetic Alopecia

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View on ClinicalTrials.gov: NCT02170662 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: Percent Change in Target Area Total Hair Count — -2.6; 27.4; 4.9; -5.8 percentage change in total hair count

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Bimatoprost (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: Duke University
Primary completion: May 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Target Area Total Hair Count	-2.6; 27.4; 4.9; -5.8	—
SECONDARY Percent Change in the Target Area Terminal Hair Count	-2.1; 12.1; -5.1; -8.3	—
SECONDARY Percent Change in the Target Area Vellus Hair Count	-2.6; 78.1; 5.1; 2.9	—
SECONDARY Percent Change in Hair Diameter	—	—

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.

Eligibility Criteria

Inclusion Criteria

Hamilton-Norwood patterns of baldness IIIV, IV, V, or VA.
Subject's hair color must have adequate contrast against scalp color to allow hair counting on macrophotography.
Good health with normal blood tests for hematological, renal, and liver function.
Able to return to Duke for study visits.

Exclusion Criteria

ECOG >1.
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.
Taken any warfarin, heparin, or retinoid for greater than 2 weeks during the past 6 months and any in the past month.
Taken any chemotherapy in the past 2 years.
Used any over-the-counter (OTC) preparation that purports to help hair growth in the past four months.
Used prostaglandins of any type in the past or currently.
Any history of alopecia areata, cicatricial alopecia, radiation to the head, hair transplants, or scalp reductions.
Any skin abnormalities in the target area that would effect hair growth.
Any history of glaucoma or elevated intraocular pressure (IOP).
Any cancer other than non-melanoma skin cancer (NMSC) in the past 2 years and all must be in remission.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02170662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.