Trial · NCT01904721

A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)

NCT01904721, Phase 2, Completed, Allergan; results first posted 2015-12-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA). Trials, record NCT01904721. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01904721

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)
NCT number: NCT01904721
Status: Completed
Phases: Phase 2
Enrollment: 244 participants, actual
Lead sponsor: Allergan
Conditions: Alopecia, Alopecia, Androgenetic, Baldness
Interventions: Bimatoprost Solution 1, Bimatoprost Solution 2, Bimatoprost Vehicle
First posted: 2013-07-22
Last updated: 2016-03-22
Results first posted: 2015-12-09

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Target Area Hair Count (TAHC)	Baseline, Month 6	TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm\^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs).
Primary	Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score	Month 6	The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Secondary	Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score	Month 6	The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: "Since the start of the study, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Secondary	Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score	Month 6	At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: "Compared with the baseline image, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Secondary	Change From Baseline in Target Area Hair Width (TAHW)	Baseline, Month 6	Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm\^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs).
Secondary	Change From Baseline in Target Area Hair Darkness (TAHD)	Baseline, Month 6	Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the darkness of terminal hairs).

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Target Area Hair Count (TAHC)	Baseline, Month 6	Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements	terminal hairs/cm2	MEAN
PRIMARY	Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score	Month 6	Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements	Percentage of Participants	NUMBER
SECONDARY	Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score	Month 6	Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements	Percentage of Participants	NUMBER
SECONDARY	Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score	Month 6	Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements	Percentage of Participants	NUMBER
SECONDARY	Change From Baseline in Target Area Hair Width (TAHW)	Baseline, Month 6	Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements	mm/cm2	MEAN
SECONDARY	Change From Baseline in Target Area Hair Darkness (TAHD)	Baseline, Month 6	Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements	Intensity Units	MEAN

Source ClinicalTrials.gov

Results by group81

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Target Area Hair Count (TAHC)	Stage 2: Bimatoprost Solution 2 Twice Daily	Baseline	131.3	Standard Deviation 55.53	terminal hairs/cm2
Change From Baseline in Target Area Hair Count (TAHC)	Stage 2: Bimatoprost Solution 1 Twice Daily	Baseline	140.4	Standard Deviation 59.76	terminal hairs/cm2
Change From Baseline in Target Area Hair Count (TAHC)	Stage 2: Bimatoprost Vehicle Twice Daily	Baseline	129.0	Standard Deviation 57.42	terminal hairs/cm2
Change From Baseline in Target Area Hair Count (TAHC)	Stage 2: Bimatoprost Solution 2 Twice Daily	Change from Baseline at Month 6	9.3	Standard Deviation 23.09	terminal hairs/cm2
Change From Baseline in Target Area Hair Count (TAHC)	Stage 2: Bimatoprost Solution 1 Twice Daily	Change from Baseline at Month 6	12.7	Standard Deviation 26.39	terminal hairs/cm2
Change From Baseline in Target Area Hair Count (TAHC)	Stage 2: Bimatoprost Vehicle Twice Daily	Change from Baseline at Month 6	5.8	Standard Deviation 20.95	terminal hairs/cm2
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score	Stage 2: Bimatoprost Solution 2 Twice Daily	Greatly increased	4.8		Percentage of Participants
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score	Stage 2: Bimatoprost Solution 1 Twice Daily	Greatly increased	6.5		Percentage of Participants
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score	Stage 2: Bimatoprost Vehicle Twice Daily	Greatly increased	0.0		Percentage of Participants
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score	Stage 2: Bimatoprost Solution 2 Twice Daily	Moderately increased	25.4		Percentage of Participants

1 to 10 of 81Source ClinicalTrials.gov

See all 81 results by group

Participant flow21

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Stage 1: Bimatoprost Solution 1 Twice Daily	13
Overall Study	STARTED	Stage 1: Bimatoprost Solution 1 Once Daily	13
Overall Study	STARTED	Stage 1: Bimatoprost Solution 2 Twice Daily	12
Overall Study	STARTED	Stage 1: Bimatoprost Solution 2 Once Daily	12
Overall Study	STARTED	Stage 2: Bimatoprost Solution 1 Twice Daily	65
Overall Study	STARTED	Stage 2: Bimatoprost Solution 2 Twice Daily	65
Overall Study	STARTED	Stage 2: Bimatoprost Vehicle Twice Daily	64
Overall Study	COMPLETED	Stage 1: Bimatoprost Solution 1 Twice Daily	13
Overall Study	COMPLETED	Stage 1: Bimatoprost Solution 1 Once Daily	13
Overall Study	COMPLETED	Stage 1: Bimatoprost Solution 2 Twice Daily	11

1 to 10 of 21Source ClinicalTrials.gov

See all 21 participant flow

Adverse events238

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Atrioventricular Block First Degree	Cardiac disorders	Stage 1: Bimatoprost Solution 1 Twice Daily	0	13
other	Atrioventricular Block First Degree	Cardiac disorders	Stage 1: Bimatoprost Solution 1 Once Daily	2	13
other	Atrioventricular Block First Degree	Cardiac disorders	Stage 1: Bimatoprost Solution 2 Twice Daily	0	12
other	Atrioventricular Block First Degree	Cardiac disorders	Stage 1: Bimatoprost Solution 2 Once Daily	0	12
other	Atrioventricular Block First Degree	Cardiac disorders	Stage 2: Bimatoprost Solution 2 Twice Daily	1	65
other	Atrioventricular Block First Degree	Cardiac disorders	Stage 2: Bimatoprost Solution 1 Twice Daily	1	65
other	Atrioventricular Block First Degree	Cardiac disorders	Stage 2: Bimatoprost Vehicle Twice Daily	1	64
other	Influenza Like Illness	General disorders	Stage 1: Bimatoprost Solution 1 Twice Daily	2	13
other	Influenza Like Illness	General disorders	Stage 1: Bimatoprost Solution 1 Once Daily	0	13
other	Influenza Like Illness	General disorders	Stage 1: Bimatoprost Solution 2 Twice Daily	0	12

1 to 10 of 238Source ClinicalTrials.gov

See all 238 adverse events

Adverse event totals21

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Stage 1: Bimatoprost Solution 1 Twice Daily
Total, all-cause mortality	Stage 1: Bimatoprost Solution 1 Once Daily
Total, all-cause mortality	Stage 1: Bimatoprost Solution 2 Twice Daily
Total, all-cause mortality	Stage 1: Bimatoprost Solution 2 Once Daily
Total, all-cause mortality	Stage 2: Bimatoprost Solution 2 Twice Daily
Total, all-cause mortality	Stage 2: Bimatoprost Solution 1 Twice Daily
Total, all-cause mortality	Stage 2: Bimatoprost Vehicle Twice Daily
Total, other adverse events	Stage 1: Bimatoprost Solution 1 Twice Daily	5	13
Total, other adverse events	Stage 1: Bimatoprost Solution 1 Once Daily	4	13
Total, other adverse events	Stage 1: Bimatoprost Solution 2 Twice Daily	7	12

1 to 10 of 21Source ClinicalTrials.gov

See all 21 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01904721

GET https://conductscience.org/api/trials/v1/NCT01904721/results?page=2

API reference For AI assistants