Alopecia, Alopecia, Androgenetic, Baldness
Conditions
Brief summary
This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5% solution which will be provided open-label.
Interventions
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
DRUGminoxidil 5% solution
Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year * Willingness to have micro-dot-tattoo applied to scalp * Willingness to maintain same hair style, length and hair color during study
Exclusion criteria
* Drug or alcohol abuse within 12 months * HIV positive * Received hair transplants or had scalp reductions * Use of hair weaves, hair extensions or wigs within 3 months * Oral or topical minoxidil treatment within 6 months * Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| 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). |
Countries
Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost Formulation A Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months. | 61 |
| Bimatoprost Formulation B Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months. | 61 |
| Bimatoprost Formulation C Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months. | 62 |
| Vehicle to Bimatoprost Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months. | 62 |
| Minoxidil 5% Solution Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months. | 61 |
| Total | 307 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 2 | 1 | 2 |
| Overall Study | Lost to Follow-up | 2 | 2 | 2 | 1 | 2 |
| Overall Study | Personal Reasons | 2 | 5 | 4 | 8 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Bimatoprost Formulation A | Bimatoprost Formulation B | Bimatoprost Formulation C | Vehicle to Bimatoprost | Minoxidil 5% Solution | Total |
|---|---|---|---|---|---|---|
| Age, Customized 18 to 34 years | 19 Participants | 18 Participants | 20 Participants | 18 Participants | 18 Participants | 93 Participants |
| Age, Customized 35 to 50 years | 42 Participants | 43 Participants | 42 Participants | 44 Participants | 43 Participants | 214 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 61 Participants | 61 Participants | 62 Participants | 62 Participants | 61 Participants | 307 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 61 | 11 / 61 | 4 / 62 | 7 / 62 | 10 / 61 |
| serious Total, serious adverse events | 0 / 61 | 1 / 61 | 1 / 62 | 1 / 62 | 0 / 61 |
Outcome results
Primary
Change From Baseline in Target Area Hair Count (TAHC)
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).
Time frame: Baseline, Month 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost Formulation A | Change From Baseline in Target Area Hair Count (TAHC) | Change from Baseline at Month 6 | 13.1 terminal hairs/cm^2 | Standard Deviation 21.69 |
| Bimatoprost Formulation A | Change From Baseline in Target Area Hair Count (TAHC) | Baseline | 135.0 terminal hairs/cm^2 | Standard Deviation 58.8 |
| Bimatoprost Formulation B | Change From Baseline in Target Area Hair Count (TAHC) | Change from Baseline at Month 6 | 6.1 terminal hairs/cm^2 | Standard Deviation 19.8 |
| Bimatoprost Formulation B | Change From Baseline in Target Area Hair Count (TAHC) | Baseline | 145.7 terminal hairs/cm^2 | Standard Deviation 57.25 |
| Bimatoprost Formulation C | Change From Baseline in Target Area Hair Count (TAHC) | Change from Baseline at Month 6 | 6.3 terminal hairs/cm^2 | Standard Deviation 22.05 |
| Bimatoprost Formulation C | Change From Baseline in Target Area Hair Count (TAHC) | Baseline | 151.5 terminal hairs/cm^2 | Standard Deviation 60.4 |
| Vehicle to Bimatoprost | Change From Baseline in Target Area Hair Count (TAHC) | Change from Baseline at Month 6 | 4.1 terminal hairs/cm^2 | Standard Deviation 15.59 |
| Vehicle to Bimatoprost | Change From Baseline in Target Area Hair Count (TAHC) | Baseline | 143.7 terminal hairs/cm^2 | Standard Deviation 55.42 |
| Minoxidil 5% Solution | Change From Baseline in Target Area Hair Count (TAHC) | Baseline | 132.7 terminal hairs/cm^2 | Standard Deviation 53.14 |
| Minoxidil 5% Solution | Change From Baseline in Target Area Hair Count (TAHC) | Change from Baseline at Month 6 | 21.9 terminal hairs/cm^2 | Standard Deviation 19.3 |
Primary
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
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.
Time frame: Baseline, Month 6
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly Increased | 0.0 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Remained the Same | 43.1 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly Increased | 31.0 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly Decreased | 0.0 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately Decreased | 3.4 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly Decreased | 13.8 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately Increased | 8.6 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly Decreased | 15.3 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly Increased | 1.7 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately Increased | 11.9 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly Increased | 23.7 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Remained the Same | 40.7 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately Decreased | 5.1 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly Decreased | 1.7 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately Decreased | 6.7 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly Decreased | 20.0 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately Increased | 11.7 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly Decreased | 3.3 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Remained the Same | 41.7 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly Increased | 16.7 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly Increased | 0.0 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly Increased | 19.0 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Remained the Same | 51.7 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly Decreased | 19.0 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly Increased | 1.7 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly Decreased | 0.0 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately Decreased | 1.7 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately Increased | 6.9 Percentage of participants |
| Minoxidil 5% Solution | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly Decreased | 0.0 Percentage of participants |
| Minoxidil 5% Solution | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately Decreased | 1.7 Percentage of participants |
| Minoxidil 5% Solution | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Remained the Same | 22.4 Percentage of participants |
| Minoxidil 5% Solution | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly Decreased | 8.6 Percentage of participants |
| Minoxidil 5% Solution | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately Increased | 27.6 Percentage of participants |
| Minoxidil 5% Solution | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly Increased | 34.5 Percentage of participants |
| Minoxidil 5% Solution | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly Increased | 5.2 Percentage of participants |
Secondary
Change From Baseline in Target Area Hair Darkness (TAHD)
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).
Time frame: Baseline, Month 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost Formulation A | Change From Baseline in Target Area Hair Darkness (TAHD) | Baseline | 106.88 Intensity units | Standard Deviation 19.282 |
| Bimatoprost Formulation A | Change From Baseline in Target Area Hair Darkness (TAHD) | Change from Baseline at Month 6 | 1.19 Intensity units | Standard Deviation 12 |
| Bimatoprost Formulation B | Change From Baseline in Target Area Hair Darkness (TAHD) | Baseline | 103.85 Intensity units | Standard Deviation 21.95 |
| Bimatoprost Formulation B | Change From Baseline in Target Area Hair Darkness (TAHD) | Change from Baseline at Month 6 | 2.92 Intensity units | Standard Deviation 14.686 |
| Bimatoprost Formulation C | Change From Baseline in Target Area Hair Darkness (TAHD) | Baseline | 100.81 Intensity units | Standard Deviation 18.041 |
| Bimatoprost Formulation C | Change From Baseline in Target Area Hair Darkness (TAHD) | Change from Baseline at Month 6 | 4.04 Intensity units | Standard Deviation 11.061 |
| Vehicle to Bimatoprost | Change From Baseline in Target Area Hair Darkness (TAHD) | Change from Baseline at Month 6 | 0.65 Intensity units | Standard Deviation 10.626 |
| Vehicle to Bimatoprost | Change From Baseline in Target Area Hair Darkness (TAHD) | Baseline | 104.03 Intensity units | Standard Deviation 17.863 |
| Minoxidil 5% Solution | Change From Baseline in Target Area Hair Darkness (TAHD) | Baseline | 99.57 Intensity units | Standard Deviation 28.139 |
| Minoxidil 5% Solution | Change From Baseline in Target Area Hair Darkness (TAHD) | Change from Baseline at Month 6 | 3.40 Intensity units | Standard Deviation 12.888 |
Secondary
Change From Baseline in Target Area Hair Width (TAHW)
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).
Time frame: Baseline, Month 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost Formulation A | Change From Baseline in Target Area Hair Width (TAHW) | Baseline | 7.83 mm/cm^2 | Standard Deviation 3.879 |
| Bimatoprost Formulation A | Change From Baseline in Target Area Hair Width (TAHW) | Change from Baseline at Month 6 | 0.76 mm/cm^2 | Standard Deviation 1.39 |
| Bimatoprost Formulation B | Change From Baseline in Target Area Hair Width (TAHW) | Baseline | 8.34 mm/cm^2 | Standard Deviation 3.716 |
| Bimatoprost Formulation B | Change From Baseline in Target Area Hair Width (TAHW) | Change from Baseline at Month 6 | 0.25 mm/cm^2 | Standard Deviation 1.185 |
| Bimatoprost Formulation C | Change From Baseline in Target Area Hair Width (TAHW) | Baseline | 8.59 mm/cm^2 | Standard Deviation 3.668 |
| Bimatoprost Formulation C | Change From Baseline in Target Area Hair Width (TAHW) | Change from Baseline at Month 6 | 0.12 mm/cm^2 | Standard Deviation 1.228 |
| Vehicle to Bimatoprost | Change From Baseline in Target Area Hair Width (TAHW) | Change from Baseline at Month 6 | 0.13 mm/cm^2 | Standard Deviation 0.839 |
| Vehicle to Bimatoprost | Change From Baseline in Target Area Hair Width (TAHW) | Baseline | 8.35 mm/cm^2 | Standard Deviation 3.494 |
| Minoxidil 5% Solution | Change From Baseline in Target Area Hair Width (TAHW) | Baseline | 7.82 mm/cm^2 | Standard Deviation 3.436 |
| Minoxidil 5% Solution | Change From Baseline in Target Area Hair Width (TAHW) | Change from Baseline at Month 6 | 1.29 mm/cm^2 | Standard Deviation 1.117 |
Secondary
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
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.
Time frame: Baseline, Month 6
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Greatly Decreased | 0.0 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Remained the Same | 71.9 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Greatly Increased | 0.0 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Moderately Decreased | 0.0 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Moderately Increased | 3.5 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly Decreased | 7.0 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly Increased | 17.5 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly Increased | 10.7 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Remained the Same | 73.2 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Moderately Increased | 1.8 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Greatly Decreased | 0.0 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Greatly Increased | 0.0 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Moderately Decreased | 0.0 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly Decreased | 14.3 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Greatly Increased | 0.0 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Moderately Increased | 0.0 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly Increased | 8.6 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Remained the Same | 74.1 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly Decreased | 17.2 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Moderately Decreased | 0.0 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Greatly Decreased | 0.0 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Moderately Decreased | 0.0 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly Decreased | 16.1 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Moderately Increased | 0.0 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly Increased | 8.9 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Greatly Increased | 0.0 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Remained the Same | 75.0 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Greatly Decreased | 0.0 Percentage of participants |
| Minoxidil 5% Solution | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Remained the Same | 50.0 Percentage of participants |
| Minoxidil 5% Solution | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Greatly Decreased | 0.0 Percentage of participants |
| Minoxidil 5% Solution | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Greatly Increased | 0.0 Percentage of participants |
| Minoxidil 5% Solution | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Moderately Decreased | 1.7 Percentage of participants |
| Minoxidil 5% Solution | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly Decreased | 3.4 Percentage of participants |
| Minoxidil 5% Solution | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly Increased | 39.7 Percentage of participants |
| Minoxidil 5% Solution | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Moderately Increased | 5.2 Percentage of participants |
Secondary
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
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.
Time frame: Baseline, Month 6
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Greatly Increased | 0.0 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Greatly Decreased | 0.0 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Moderately Decreased | 0.0 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly Increased | 29.3 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Moderately Increased | 12.1 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Remained the Same | 48.3 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly Decreased | 10.3 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly Decreased | 3.4 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Remained the Same | 55.9 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Moderately Increased | 6.8 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Greatly Increased | 5.1 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Moderately Decreased | 0.0 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly Increased | 28.8 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Greatly Decreased | 0.0 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Remained the Same | 63.9 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Greatly Increased | 0.0 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Moderately Increased | 4.9 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly Increased | 23.0 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly Decreased | 8.2 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Moderately Decreased | 0.0 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Greatly Decreased | 0.0 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly Increased | 25.9 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly Decreased | 3.4 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Moderately Increased | 6.9 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Greatly Decreased | 0.0 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Moderately Decreased | 0.0 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Greatly Increased | 0.0 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Remained the Same | 63.8 Percentage of participants |
| Minoxidil 5% Solution | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly Increased | 15.5 Percentage of participants |
| Minoxidil 5% Solution | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Greatly Decreased | 0.0 Percentage of participants |
| Minoxidil 5% Solution | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Moderately Decreased | 0.0 Percentage of participants |
| Minoxidil 5% Solution | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly Decreased | 6.9 Percentage of participants |
| Minoxidil 5% Solution | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Moderately Increased | 24.1 Percentage of participants |
| Minoxidil 5% Solution | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Greatly Increased | 8.6 Percentage of participants |
| Minoxidil 5% Solution | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Remained the Same | 44.8 Percentage of participants |