This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA) (NCT01904721), a randomized phase 2 study. The primary outcome is Change From Baseline in Target Area Hair Count (TAHC).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01904721 |
| Phase | Phase 2 |
| Condition | Alopecia, Alopecia, Androgenetic, Baldness |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 244 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Allergan |
| Results posted | Yes |
2. Clinical Question
Population
Men with androgenic alopecia were enrolled. The primary outcome population was the Modified Intent-to-Treat group: randomized Stage 2 patients who received study medication and had both baseline and follow-up target area hair count measurements. This definition is narrower than all enrolled participants because it requires treatment and measurements at both time points.
Intervention
The trial evaluated Bimatoprost Solution 1 and Bimatoprost Solution 2. In Stage 1, each solution was applied to a pre-specified scalp area once or twice daily for 28 days. In Stage 2, each solution was applied twice daily for 6 months.
Comparator
Stage 2 included Bimatoprost Vehicle applied twice daily for 6 months. This allows the Stage 2 solution groups to be considered in relation to a vehicle group, but the registry record does not report an estimated comparison or its uncertainty. Stage 1 lists solution regimens and does not list a vehicle arm.
Primary question
The primary endpoint was change from baseline in target area hair count, measured in terminal hairs/cm2 from baseline to Month 6. The registry describes a positive change as an increase in terminal hairs and a negative change as a decrease. The posted results needed to establish the size and precision of any between-group difference are not reported in the registry record.
3. Trial Design
This was a Phase 2, randomized, triple-masked, parallel-group study sponsored by Allergan. The registry lists enrollment of 244 and a completed status. The recorded study dates are start 2013-08 and primary completion 2014-09. The conditions listed include alopecia, androgenetic alopecia, and baldness.
The study had two stages. In Stage 1, four groups received either Bimatoprost Solution 1 or Bimatoprost Solution 2, applied to a pre-specified scalp area once or twice daily for 28 days. In Stage 2, three groups received Bimatoprost Solution 1, Bimatoprost Solution 2, or vehicle, each applied twice daily for 6 months. These descriptions establish the regimens but do not explain how participants moved between stages or whether Stage 2 enrollment came from Stage 1. That information is not reported in the registry record.
Randomization assigns participants to treatment groups by chance; in general, this is intended to reduce systematic differences between groups. Triple masking indicates that the record classifies the study as triple-masked, but it does not identify which roles were masked or explain the procedures used to maintain masking. Those details are not reported in the registry record.
The registry lists six outcome measures, including the primary target area hair count measure and secondary outcomes concerning investigator and panel assessments, hair width, and hair darkness. The record does not report the primary endpoint estimates, group-level outcome summaries, or comparative statistical results. The design can therefore be described, but the efficacy question cannot be answered from the outcome information posted in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Only the first 6 of 7 groups are shown.
Overall Study
| Stage | Stage 1: Bimatoprost Solution 1 Twice Daily | Stage 1: Bimatoprost Solution 1 Once Daily | Stage 1: Bimatoprost Solution 2 Twice Daily | Stage 1: Bimatoprost Solution 2 Once Daily | Stage 2: Bimatoprost Solution 1 Twice Daily | Stage 2: Bimatoprost Solution 2 Twice Daily |
|---|---|---|---|---|---|---|
| STARTED | 13 | 13 | 12 | 12 | 65 | 65 |
| COMPLETED | 13 | 13 | 11 | 11 | 57 | 56 |
| NOT COMPLETED | 0 | 0 | 1 | 1 | 8 | 9 |
Reasons for not completing this period:
| Reason | Stage 1: Bimatoprost Solution 1 Twice Daily | Stage 1: Bimatoprost Solution 1 Once Daily | Stage 1: Bimatoprost Solution 2 Twice Daily | Stage 1: Bimatoprost Solution 2 Once Daily | Stage 2: Bimatoprost Solution 1 Twice Daily | Stage 2: Bimatoprost Solution 2 Twice Daily |
|---|---|---|---|---|---|---|
| Other Reasons | 0 | 0 | 1 | 1 | 2 | 2 |
| Personal Reasons | 0 | 0 | 0 | 0 | 2 | 3 |
| Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 3 |
| Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 |
| Adverse Event | 0 | 0 | 0 | 0 | 3 | 1 |
Analysis population for the primary outcome, as defined in the registry: Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Only the first 6 of 8 groups are shown.
| Characteristic | Unit | Stage 1: Bimatoprost Solution 1 Twice Daily | Stage 1: Bimatoprost Solution 1 Once Daily | Stage 1: Bimatoprost Solution 2 Twice Daily | Stage 1: Bimatoprost Solution 2 Once Daily | Stage 2: Bimatoprost Solution 2 Twice Daily | Stage 2: Bimatoprost Solution 1 Twice Daily |
|---|---|---|---|---|---|---|---|
| Participants analysed | 13 | 13 | 12 | 12 | 65 | 65 | |
| Age, Customized: ≥18 to <35 years | Participants | 8 | 0 | 3 | 3 | 17 | 18 |
| Age, Customized: 35 to 49 years | Participants | 5 | 13 | 9 | 9 | 48 | 47 |
| Sex/Gender, Customized: Male | Participants | 13 | 13 | 12 | 12 | 65 | 65 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Target Area Hair Count (TAHC), measured over Baseline, Month 6.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | terminal hairs/cm2 |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was change from baseline in target area hair count (TAHC), expressed in terminal hairs/cm2, from baseline to Month 6. Digital imaging analysis was used to measure the count in a designated scalp area. The registry defines positive change as an increase in terminal hairs and negative change as a decrease.
A change score describes how a measured value differs from its baseline value. In general, this can help characterize the direction and magnitude of change over follow-up. A hair count is a continuous measure: it can take a range of values rather than placing each participant into a small set of categories. The endpoint focuses on terminal hairs within the target area, rather than on an overall clinical impression.
The primary analysis population was defined as randomized Stage 2 patients who received study medication and had both baseline and follow-up TAHC measurements. This means the endpoint population excludes people without the required treatment exposure or measurements, according to the registry definition. The registry record does not report the observed mean change, standard deviation, group-level results, or between-group estimate. It therefore describes what was measured but not the outcome magnitude or precision.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies change in target area hair count from baseline to Month 6 as the primary outcome. It also specifies how to interpret the direction of change: a positive value represents an increase in terminal hairs, while a negative value represents a decrease. However, the registry record does not report the outcome values for the treatment groups. Without those values, it is not possible to describe the observed changes, compare the solutions with vehicle, or assess the precision of a difference.
The outcome is defined as a mean, with standard deviation as its dispersion measure. In general, a group mean describes the average measured change among participants included in that group’s analysis, while a standard deviation describes variation among individual measurements. Neither measure alone establishes whether groups differ. A comparative estimate and its uncertainty would be needed to characterize the size and precision of a treatment contrast. Those results are not reported in the registry record.
The record lists the primary outcome population as Stage 2 randomized patients who received medication and had both baseline and follow-up measurements. This restriction matters for interpretation: the primary result, if reported, would apply to that defined analysis population rather than automatically representing every randomized participant. The registry does not report how many participants contributed primary endpoint data or how missing measurements were handled.
The record lists 0 analyses. This does not establish that no statistical work was performed; it means no analyses are listed in the registry record. The primary endpoint result and any inferential comparison are not reported there. Consequently, no p-value, confidence interval, or claim of statistical significance can be assessed from the posted results.
The secondary outcomes include response categories from the Investigator Global Assessment and Global Panel Review, along with changes in target area hair width and darkness. These could provide different kinds of information: categorical assessments classify response, whereas width and darkness are measured as continuous changes. Their listed presence does not establish their results. Values and comparisons for these outcomes are not reported in the registry record.
Any planning illustration based on an observed effect must be distinguished from the trial’s results. Sample-size calculations are planning tools that estimate the number of participants needed under stated assumptions; they do not show that a study had a particular probability of detecting an effect after the fact. The registry record does not report the primary observed effect needed to interpret such an illustration, and no planning output should be read as an observed trial finding.
9. Statistical Methods Explained
Randomization, masking, outcome measurement, and statistical analysis address different sources of uncertainty and bias. The registry classifies this study as randomized, triple-masked, and parallel-group. In general, randomization uses chance to allocate participants to groups and can reduce systematic differences in prognostic characteristics. It does not guarantee that groups will be identical, especially in a finite study. Masking can reduce the influence of expectations on care, measurement, or assessment, but the record does not identify the roles masked or the procedures used. A parallel-group design means participants are assigned to treatment groups for comparison rather than being described as crossing through each treatment as their own comparator. The detailed allocation and masking procedures are not reported in the registry record.
What does the primary endpoint summarize?
TAHC is a continuous outcome measured in terminal hairs/cm2. The primary endpoint is change from baseline to Month 6. For a continuous outcome, a mean summarizes the average value or change in a group. The standard deviation describes how widely individual observations vary around that mean. These measures answer different questions: the mean describes the group’s average, and the standard deviation describes within-group variability. The registry names these summary measures but does not report their observed values.
A change score uses each participant’s baseline measurement as a reference. In general, this can account for where measurements began, but interpretation still depends on the group summaries and the comparative analysis. A positive change is defined in the registry as an increase in terminal hair count; a negative change is defined as a decrease. The target area and digital imaging method provide a specified measurement approach, though the record does not provide details about image acquisition, quality control, or measurement reliability.
Why is a comparison and its uncertainty needed?
When two groups are compared, the estimated difference describes the observed contrast, while an uncertainty interval describes the range of values compatible with the data under the statistical model. In general, a confidence interval helps readers judge precision; a narrow interval indicates more precise estimation than a wide interval. A p-value addresses compatibility with a specified null hypothesis under the analysis assumptions, but it does not measure effect size or clinical importance. No group comparison, confidence interval, or p-value for the primary outcome is reported in the registry record, so these features cannot be interpreted for this trial.
General statistical methods for continuous outcomes may include comparing group means or modeling the outcome while accounting for baseline values. The method used in this trial is not reported in the registry record. It would be inappropriate to infer an adjusted or unadjusted analysis, covariate set, model form, or testing procedure from the endpoint definition alone.
What can the analysis population tell us?
The registry defines a Modified Intent-to-Treat population for the primary outcome. It includes randomized Stage 2 patients who received study medication and had baseline and follow-up TAHC measurements. In general, analysis populations determine which participants contribute to a result, and different definitions can lead to different interpretations. Excluding participants without follow-up measurements can create bias if missingness is related to outcomes or treatment. The registry does not report the number of participants with endpoint data, reasons for missingness, or methods used to address missing data.
The registry lists 0 analyses. This is a statement about what analyses are recorded, not proof that the investigators conducted no analysis outside the registry entry. The statistical analysis plan, including the model, significance threshold, handling of multiple outcomes, and any planned interim analyses, is not reported in the registry record.
How should planning calculations be read?
General sample-size calculations depend on assumptions about the effect to detect, outcome variability, significance level, allocation, and statistical method. The planning assumptions recorded for the illustration specify a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. The illustration is described as planning based on the observed effect, not as the trial’s original design justification. For non-time-to-event outcomes, the stated convention is participants per arm; time-to-event calculations use a total event count. These planning calculations are not observed power and do not replace the missing endpoint results. The registry record does not report the trial’s own sample-size justification or statistical plan.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary endpoint and secondary outcomes that include response categories for the Investigator Global Assessment and Global Panel Review, plus change from baseline in target area hair width and darkness. Multiple outcomes or comparisons raise a general statistical issue: when many hypotheses are tested, the chance of at least one apparently unusual result can increase. Common approaches include prespecifying a hierarchy, adjusting significance thresholds, or treating secondary findings as exploratory. The registry record does not report a multiplicity strategy, outcome hierarchy, or which comparisons were intended to support confirmatory conclusions.
The primary outcome population is defined as randomized Stage 2 patients who received study medication and had both baseline and follow-up TAHC measurements. This definition requires observed measurements at both time points. The registry record does not report how many participants lacked measurements, why data were missing, or whether imputation or other missing-data methods were used. In general, missing-data methods rely on assumptions about why observations are unavailable; conclusions can depend on whether those assumptions are plausible.
The record does not report a complete-case sensitivity analysis, an alternative analysis population, or an analysis plan. The number of analyses listed in the registry is 0. This limits assessment of multiplicity and missing-data handling; it does not establish that analyses were not conducted outside the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Stage 1: Bimatoprost Solution 1 Twice Daily | 0 | 13 | 0.0% |
| Stage 1: Bimatoprost Solution 1 Once Daily | 0 | 13 | 0.0% |
| Stage 1: Bimatoprost Solution 2 Twice Daily | 0 | 12 | 0.0% |
| Stage 1: Bimatoprost Solution 2 Once Daily | 0 | 12 | 0.0% |
| Stage 2: Bimatoprost Solution 2 Twice Daily | 1 | 65 | 1.5% |
| Stage 2: Bimatoprost Solution 1 Twice Daily | 2 | 65 | 3.1% |
| Stage 2: Bimatoprost Vehicle Twice Daily | 0 | 64 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Stage 1: Bimatoprost Solution 1 Twice Daily | 5 of 13 |
| Stage 1: Bimatoprost Solution 1 Once Daily | 4 of 13 |
| Stage 1: Bimatoprost Solution 2 Twice Daily | 7 of 12 |
| Stage 1: Bimatoprost Solution 2 Once Daily | 1 of 12 |
| Stage 2: Bimatoprost Solution 2 Twice Daily | 25 of 65 |
| Stage 2: Bimatoprost Solution 1 Twice Daily | 25 of 65 |
Most frequent serious adverse event terms
| Event term | Organ system | Stage 1: Bimatoprost Solution 1 Twice Daily | Stage 1: Bimatoprost Solution 1 Once Daily | Stage 1: Bimatoprost Solution 2 Twice Daily | Stage 1: Bimatoprost Solution 2 Once Daily | Stage 2: Bimatoprost Solution 2 Twice Daily | Stage 2: Bimatoprost Solution 1 Twice Daily |
|---|---|---|---|---|---|---|---|
| Coronary Artery Occlusion | Cardiac disorders | 0 of 13 | 0 of 13 | 0 of 12 | 0 of 12 | 0 of 65 | 1 of 65 |
| Myocardial Infarction | Cardiac disorders | 0 of 13 | 0 of 13 | 0 of 12 | 0 of 12 | 0 of 65 | 1 of 65 |
| Clavicle Fracture | Injury, poisoning and procedural complications | 0 of 13 | 0 of 13 | 0 of 12 | 0 of 12 | 1 of 65 | 0 of 65 |
| Road Traffic Accident | Injury, poisoning and procedural complications | 0 of 13 | 0 of 13 | 0 of 12 | 0 of 12 | 1 of 65 | 0 of 65 |
| Scapula Fracture | Injury, poisoning and procedural complications | 0 of 13 | 0 of 13 | 0 of 12 | 0 of 12 | 1 of 65 | 0 of 65 |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 0 of 13 | 0 of 13 | 0 of 12 | 0 of 12 | 1 of 65 | 0 of 65 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Stage 1: Bimatoprost Solution 1 Twice Daily | Stage 1: Bimatoprost Solution 1 Once Daily | Stage 1: Bimatoprost Solution 2 Twice Daily | Stage 1: Bimatoprost Solution 2 Once Daily | Stage 2: Bimatoprost Solution 2 Twice Daily | Stage 2: Bimatoprost Solution 1 Twice Daily |
|---|---|---|---|---|---|---|---|
| Hypertrichosis | Skin and subcutaneous tissue disorders | 0 of 13 | 0 of 13 | 0 of 12 | 0 of 12 | 5 of 65 | 6 of 65 |
| Growth of Eyelashes | Eye disorders | 0 of 13 | 0 of 13 | 0 of 12 | 0 of 12 | 10 of 65 | 0 of 65 |
| Hair Growth Abnormal | Skin and subcutaneous tissue disorders | 0 of 13 | 0 of 13 | 1 of 12 | 0 of 12 | 6 of 65 | 2 of 65 |
| Application Site Erythema | General disorders | 0 of 13 | 0 of 13 | 0 of 12 | 0 of 12 | 3 of 65 | 5 of 65 |
| Upper Respiratory Tract Infection | Infections and infestations | 0 of 13 | 0 of 13 | 2 of 12 | 1 of 12 | 1 of 65 | 2 of 65 |
| Application Site Pruritus | General disorders | 1 of 13 | 0 of 13 | 1 of 12 | 0 of 12 | 1 of 65 | 2 of 65 |
| Headache | Nervous system disorders | 0 of 13 | 2 of 13 | 0 of 12 | 0 of 12 | 0 of 65 | 3 of 65 |
| Application Site Discoloration | General disorders | 0 of 13 | 0 of 13 | 0 of 12 | 0 of 12 | 1 of 65 | 4 of 65 |
| Atrioventricular Block First Degree | Cardiac disorders | 0 of 13 | 2 of 13 | 0 of 12 | 0 of 12 | 1 of 65 | 1 of 65 |
| Back Pain | Musculoskeletal and connective tissue disorders | 1 of 13 | 0 of 13 | 2 of 12 | 0 of 12 | 0 of 65 | 0 of 65 |
Serious events with the highest arm-level rate: coronary artery occlusion (1.5%), myocardial infarction (1.5%), clavicle fracture (1.5%), road traffic accident (1.5%), scapula fracture (1.5%).
The adverse-event record lists serious and other adverse events separately for each treatment group. The serious-event figures are counts among the participants recorded as at risk in that group. Stage 1 lists 0 serious events for each of its four groups. Stage 2 lists 1 serious event for Bimatoprost Solution 2 twice daily, 2 for Bimatoprost Solution 1 twice daily, and 0 for vehicle twice daily. These are descriptive counts, not adjusted comparisons.
For other adverse events, the record lists 5 affected participants in Stage 1 Solution 1 twice daily, 4 in Stage 1 Solution 1 once daily, 7 in Stage 1 Solution 2 twice daily, and 1 in Stage 1 Solution 2 once daily. Stage 2 lists 25 affected participants in each solution group and 7 in the vehicle group. The at-risk counts are recorded separately for each group; the figures should not be combined across stages or interpreted as comparative risks without an analysis.
The serious-event terms listed are coronary artery occlusion, myocardial infarction, clavicle fracture, road traffic accident, scapula fracture, and pneumothorax, each with a recorded percentage of 1.5%. The registry record does not identify the group attribution for these terms in this listing. Death counts are not reported in the registry record. These safety entries do not establish causation or provide a complete comparative safety assessment.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, triple-masked, parallel-group Phase 2 study of bimatoprost solutions and vehicle in men with androgenic alopecia was completed. It describes treatment schedules, the primary endpoint, the defined primary analysis population, secondary outcomes, and adverse-event counts. Those details explain what the study was designed to assess and what information is recorded about safety.
The record does not report the primary TAHC results or comparative statistical estimates. It therefore does not establish the size, direction, or precision of the difference between either bimatoprost solution and vehicle. It also does not provide the basis for judging whether an observed difference would be statistically significant or clinically meaningful. This is a limitation of the results recorded, not evidence for either a benefit or a lack of benefit.
The endpoint is a target-area measurement of terminal hair count from baseline to Month 6. Its definition does not by itself show what happened to participants, whether groups changed similarly, or how individual experiences varied. The registry’s modified intent-to-treat definition also means the target population for the primary analysis requires treatment exposure and measurements at both time points. The number included and the handling of absent measurements are not reported.
Safety figures are descriptive group counts. They identify serious events and other events recorded in the registry, but do not establish that study medication caused an event or that one regimen had a different safety profile from another. The record does not report deaths or provide a complete inferential comparison of safety outcomes.
In general, a trial’s design and registry entries should be distinguished from its outcome evidence. Here, the design is described, but the primary efficacy results and statistical analyses are not reported in the registry record. Any conclusion about treatment effects would go beyond what these posted results establish.
13. Why This Trial Matters Statistically
This trial illustrates why a clear endpoint definition is not the same as a report of the endpoint result. The registry specifies a digital imaging measure of terminal hair count in a target area and defines the direction of improvement. It also names the time frame and analysis population. These details make the intended measurement understandable, but without group summaries and comparative estimates, they do not show the observed effect or its precision.
The trial also highlights the importance of separating design features from analysis details. Randomization, masking, and a parallel-group structure are recorded, but the registry does not describe allocation procedures, the roles masked, the statistical model, or the approach to missing data. In general, these details help readers judge how treatment comparisons were generated and how robust they may be. Their absence in the registry record limits methodological appraisal.
Multiplicity is relevant because several secondary outcomes are listed alongside the primary endpoint. Without a reported hierarchy or adjustment strategy, readers cannot determine how confirmatory claims across outcomes were controlled. Missing data also matter because the primary population requires baseline and follow-up measurements. The record does not describe the amount or handling of missingness.
Finally, the listed adverse-event counts should be read as descriptive rather than causal or comparative evidence. Together, these features show why a registry record can be useful for understanding a trial’s structure while remaining insufficient to assess its efficacy findings. Transparent reporting of estimates, uncertainty, analysis populations, and analysis methods is needed for a statistical interpretation.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation for interpretation is that the registry record does not report the primary outcome values or statistical comparisons. There are no reported group means, standard deviations, treatment contrasts, confidence intervals, or p-values for the Month 6 TAHC endpoint. The registry lists 0 analyses, so the posted record does not support an assessment of the primary result’s magnitude or precision.
The analysis population is restricted to randomized Stage 2 patients who received medication and had baseline and follow-up measurements. The record does not state how many participants contributed to the endpoint or how missing measurements were handled. This makes it difficult to assess the consequences of the population definition or the possibility of bias due to missing data.
The registry does not report the statistical analysis plan, including the method for comparing groups, any baseline adjustment, the multiplicity approach for secondary outcomes, or whether interim analyses were planned. It also does not explain the Stage 1 to Stage 2 participant flow. Masking is classified as triple, but the masked roles and procedures are not described.
The adverse-event listing gives group counts but does not provide a comparative analysis or establish causation. Death counts are not reported in the registry record. The serious-event terms are listed with percentages but without group attribution in that listing. These gaps limit the safety interpretation as well as the efficacy interpretation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA) — NCT01904721.
- Registry record last updated 2016-03-22; status last verified 2016-02.
- Results first posted 2015-12-09.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
This completed Phase 2 trial randomized men with androgenic alopecia to bimatoprost solution regimens or vehicle. It is recorded as triple-masked and parallel-group, with enrollment of 244. Stage 1 regimens lasted 28 days; Stage 2 regimens lasted 6 months.
The primary endpoint was change from baseline to Month 6 in digitally measured target area hair count, expressed in terminal hairs/cm2. The primary population required treatment and both baseline and follow-up measurements. Secondary outcomes included investigator and panel response categories and changes in hair width and darkness.
The registry record does not report primary endpoint results, comparative analyses, or the statistical analysis plan. Adverse-event counts are recorded by group, but they do not provide a causal or inferential safety comparison.