Trial · NCT01325337
Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia
NCT01325337, Phase 2, Completed, Allergan; results first posted 2014-04-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia. Trials, record NCT01325337. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01325337
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia
- NCT number
- NCT01325337
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 307 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Alopecia, Alopecia, Androgenetic, Baldness
- Interventions
- bimatoprost Formulation A, bimatoprost Formulation B, bimatoprost Formulation C, bimatoprost vehicle solution, minoxidil 5% solution
- First posted
- 2011-03-29
- Last updated
- 2014-04-10
- Other registries' IDs
- eudract:2011-000379-15
- Results first posted
- 2014-04-10
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). |
| Primary | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Baseline, 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 | Baseline, 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 | Baseline, 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). |
| 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). |
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 | Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure. | terminal hairs/cm^2 | MEAN |
| PRIMARY | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Baseline, Month 6 | Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Baseline, Month 6 | Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Baseline, Month 6 | Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Target Area Hair Width (TAHW) | Baseline, Month 6 | Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure. | mm/cm^2 | MEAN |
| SECONDARY | Change From Baseline in Target Area Hair Darkness (TAHD) | Baseline, Month 6 | Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure. | Intensity units | MEAN |
Source ClinicalTrials.gov
Results by group135
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) | Bimatoprost Formulation A | Baseline | 135.0 | Standard Deviation 58.80 | terminal hairs/cm^2 |
| Change From Baseline in Target Area Hair Count (TAHC) | Bimatoprost Formulation B | Baseline | 145.7 | Standard Deviation 57.25 | terminal hairs/cm^2 |
| Change From Baseline in Target Area Hair Count (TAHC) | Bimatoprost Formulation C | Baseline | 151.5 | Standard Deviation 60.40 | terminal hairs/cm^2 |
| Change From Baseline in Target Area Hair Count (TAHC) | Vehicle to Bimatoprost | Baseline | 143.7 | Standard Deviation 55.42 | terminal hairs/cm^2 |
| Change From Baseline in Target Area Hair Count (TAHC) | Minoxidil 5% Solution | Baseline | 132.7 | Standard Deviation 53.14 | terminal hairs/cm^2 |
| Change From Baseline in Target Area Hair Count (TAHC) | Bimatoprost Formulation A | Change from Baseline at Month 6 | 13.1 | Standard Deviation 21.69 | terminal hairs/cm^2 |
| Change From Baseline in Target Area Hair Count (TAHC) | Bimatoprost Formulation B | Change from Baseline at Month 6 | 6.1 | Standard Deviation 19.80 | terminal hairs/cm^2 |
| Change From Baseline in Target Area Hair Count (TAHC) | Bimatoprost Formulation C | Change from Baseline at Month 6 | 6.3 | Standard Deviation 22.05 | terminal hairs/cm^2 |
| Change From Baseline in Target Area Hair Count (TAHC) | Vehicle to Bimatoprost | Change from Baseline at Month 6 | 4.1 | Standard Deviation 15.59 | terminal hairs/cm^2 |
| Change From Baseline in Target Area Hair Count (TAHC) | Minoxidil 5% Solution | Change from Baseline at Month 6 | 21.9 | Standard Deviation 19.30 | terminal hairs/cm^2 |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bimatoprost Formulation A | 61 | |
| Overall Study | STARTED | Bimatoprost Formulation B | 61 | |
| Overall Study | STARTED | Bimatoprost Formulation C | 62 | |
| Overall Study | STARTED | Vehicle to Bimatoprost | 62 | |
| Overall Study | STARTED | Minoxidil 5% Solution | 61 | |
| Overall Study | COMPLETED | Bimatoprost Formulation A | 56 | |
| Overall Study | COMPLETED | Bimatoprost Formulation B | 52 | |
| Overall Study | COMPLETED | Bimatoprost Formulation C | 53 | |
| Overall Study | COMPLETED | Vehicle to Bimatoprost | 52 | |
| Overall Study | COMPLETED | Minoxidil 5% Solution | 53 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events45
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 | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Bimatoprost Formulation A | 5 | 61 | |
| other | Nasopharyngitis | Infections and infestations | Bimatoprost Formulation B | 7 | 61 | |
| other | Nasopharyngitis | Infections and infestations | Bimatoprost Formulation C | 4 | 62 | |
| other | Nasopharyngitis | Infections and infestations | Vehicle to Bimatoprost | 7 | 62 | |
| other | Nasopharyngitis | Infections and infestations | Minoxidil 5% Solution | 3 | 61 | |
| other | Application site pruritis | General disorders | Bimatoprost Formulation A | 1 | 61 | |
| other | Application site pruritis | General disorders | Bimatoprost Formulation B | 4 | 61 | |
| other | Application site pruritis | General disorders | Bimatoprost Formulation C | 0 | 62 | |
| other | Application site pruritis | General disorders | Vehicle to Bimatoprost | 0 | 62 | |
| other | Application site pruritis | General disorders | Minoxidil 5% Solution | 7 | 61 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bimatoprost Formulation A | ||
| Total, all-cause mortality | Bimatoprost Formulation B | ||
| Total, all-cause mortality | Bimatoprost Formulation C | ||
| Total, all-cause mortality | Vehicle to Bimatoprost | ||
| Total, all-cause mortality | Minoxidil 5% Solution | ||
| Total, other adverse events | Bimatoprost Formulation A | 6 | 61 |
| Total, other adverse events | Bimatoprost Formulation B | 11 | 61 |
| Total, other adverse events | Bimatoprost Formulation C | 4 | 62 |
| Total, other adverse events | Vehicle to Bimatoprost | 7 | 62 |
| Total, other adverse events | Minoxidil 5% Solution | 10 | 61 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
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.
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/NCT01325337
GET https://conductscience.org/api/trials/v1/NCT01325337/results?page=2