Completed

Topical Bimatoprost Effect on Androgen Dependent Hair Follicles

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Bimatoprost

+ Placebo

Drug
Who is being recruted

Alopecia+4

+ Hair Diseases

+ Hypotrichosis

From 18 to 45 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 2009
See protocol details

Summary

Principal SponsorDuke University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2009

Actual date on which the first participant was enrolled.

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.

Official TitleTopical Bimatoprost Effect on Androgen Dependent Hair Follicles
NCT02170662
Principal SponsorDuke University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

33 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AlopeciaHair DiseasesHypotrichosisSkin DiseasesPathological Conditions, Signs and SymptomsSkin and Connective Tissue DiseasesPathological Conditions, Anatomical

Criteria

4 inclusion criteria required to participate
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.
10 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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 II

Active Comparator
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers