Alopecia, 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 2% solution in women with female pattern hair loss. All treatments will be provided in a double-blinded fashion except for minoxidil 2% 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 2% 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
FEMALE
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* Mild to moderate female pattern hair loss 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). A negative change from Baseline indicated worsening (decrease 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 the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs). A negative change from Baseline indicated worsening (decrease 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 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. | 61 |
| Vehicle to Bimatoprost Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months. | 61 |
| Minoxidil 2% Solution Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months. | 62 |
| Total | 306 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 3 | 3 | 1 | 2 |
| Overall Study | Did Not Receive Treatment | 0 | 1 | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 | 5 | 1 | 5 |
| Overall Study | Personal Reasons | 2 | 1 | 6 | 5 | 3 |
| Overall Study | Pregnancy | 0 | 0 | 1 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Bimatoprost Formulation A | Bimatoprost Formulation B | Bimatoprost Formulation C | Vehicle to Bimatoprost | Minoxidil 2% Solution | Total |
|---|---|---|---|---|---|---|
| Age, Customized 18 to 34 years | 12 Participants | 13 Participants | 12 Participants | 13 Participants | 12 Participants | 62 Participants |
| Age, Customized 35 to 59 years | 49 Participants | 48 Participants | 49 Participants | 48 Participants | 50 Participants | 244 Participants |
| Sex: Female, Male Female | 61 Participants | 61 Participants | 61 Participants | 61 Participants | 62 Participants | 306 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 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 | 17 / 61 | 17 / 60 | 15 / 60 | 20 / 61 | 24 / 61 |
| serious Total, serious adverse events | 4 / 61 | 4 / 60 | 3 / 60 | 1 / 61 | 1 / 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). A negative change from Baseline indicated worsening (decrease 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) | Baseline | 153.1 terminal hairs/cm^2 | Standard Deviation 54.78 |
| Bimatoprost Formulation A | Change From Baseline in Target Area Hair Count (TAHC) | Change from Baseline at Month 6 | -0.4 terminal hairs/cm^2 | Standard Deviation 17.1 |
| Bimatoprost Formulation B | Change From Baseline in Target Area Hair Count (TAHC) | Baseline | 161.1 terminal hairs/cm^2 | Standard Deviation 63.85 |
| Bimatoprost Formulation B | Change From Baseline in Target Area Hair Count (TAHC) | Change from Baseline at Month 6 | -3.5 terminal hairs/cm^2 | Standard Deviation 18.21 |
| Bimatoprost Formulation C | Change From Baseline in Target Area Hair Count (TAHC) | Baseline | 145.2 terminal hairs/cm^2 | Standard Deviation 63.42 |
| Bimatoprost Formulation C | Change From Baseline in Target Area Hair Count (TAHC) | Change from Baseline at Month 6 | 4.3 terminal hairs/cm^2 | Standard Deviation 16.82 |
| Vehicle to Bimatoprost | Change From Baseline in Target Area Hair Count (TAHC) | Change from Baseline at Month 6 | 1.1 terminal hairs/cm^2 | Standard Deviation 20.44 |
| Vehicle to Bimatoprost | Change From Baseline in Target Area Hair Count (TAHC) | Baseline | 163.0 terminal hairs/cm^2 | Standard Deviation 57.28 |
| Minoxidil 2% Solution | Change From Baseline in Target Area Hair Count (TAHC) | Baseline | 156.3 terminal hairs/cm^2 | Standard Deviation 55.46 |
| Minoxidil 2% Solution | Change From Baseline in Target Area Hair Count (TAHC) | Change from Baseline at Month 6 | 13.6 terminal hairs/cm^2 | Standard Deviation 18.72 |
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 | 3.4 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly 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 | Moderately Decreased | 1.7 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly Increased | 34.5 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately Increased | 17.2 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 | 20.7 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly Decreased | 19.0 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly Decreased | 11.7 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 | 33.3 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately Increased | 20.0 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly Increased | 3.3 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately Decreased | 8.3 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly Increased | 21.7 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 | Remained the Same | 38.9 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly Increased | 9.3 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately 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 | 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 | Slightly Decreased | 13.0 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately Decreased | 5.6 Percentage of participants |
| Bimatoprost Formulation C | 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 | Slightly Increased | 24.6 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly Decreased | 13.1 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately Increased | 18.0 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly Decreased | 3.3 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately Decreased | 8.2 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly Increased | 3.3 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 | 29.5 Percentage of participants |
| Minoxidil 2% Solution | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly Increased | 35.7 Percentage of participants |
| Minoxidil 2% Solution | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly Decreased | 1.8 Percentage of participants |
| Minoxidil 2% Solution | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately Decreased | 1.8 Percentage of participants |
| Minoxidil 2% Solution | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Slightly Decreased | 5.4 Percentage of participants |
| Minoxidil 2% Solution | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Moderately Increased | 28.6 Percentage of participants |
| Minoxidil 2% Solution | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Greatly Increased | 7.1 Percentage of participants |
| Minoxidil 2% Solution | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | Remained the Same | 19.6 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 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 | 95.63 Intensity units | Standard Deviation 23.837 |
| Bimatoprost Formulation A | Change From Baseline in Target Area Hair Darkness (TAHD) | Change from Baseline at Month 6 | 2.94 Intensity units | Standard Deviation 13.084 |
| Bimatoprost Formulation B | Change From Baseline in Target Area Hair Darkness (TAHD) | Baseline | 100.12 Intensity units | Standard Deviation 25.077 |
| Bimatoprost Formulation B | Change From Baseline in Target Area Hair Darkness (TAHD) | Change from Baseline at Month 6 | 4.22 Intensity units | Standard Deviation 13.159 |
| Bimatoprost Formulation C | Change From Baseline in Target Area Hair Darkness (TAHD) | Baseline | 92.76 Intensity units | Standard Deviation 19.433 |
| Bimatoprost Formulation C | Change From Baseline in Target Area Hair Darkness (TAHD) | Change from Baseline at Month 6 | 2.11 Intensity units | Standard Deviation 14.674 |
| Vehicle to Bimatoprost | Change From Baseline in Target Area Hair Darkness (TAHD) | Change from Baseline at Month 6 | 2.07 Intensity units | Standard Deviation 11.486 |
| Vehicle to Bimatoprost | Change From Baseline in Target Area Hair Darkness (TAHD) | Baseline | 96.90 Intensity units | Standard Deviation 22.678 |
| Minoxidil 2% Solution | Change From Baseline in Target Area Hair Darkness (TAHD) | Baseline | 93.07 Intensity units | Standard Deviation 20.667 |
| Minoxidil 2% Solution | Change From Baseline in Target Area Hair Darkness (TAHD) | Change from Baseline at Month 6 | 2.12 Intensity units | Standard Deviation 11.561 |
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 the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs). A negative change from Baseline indicated worsening (decrease 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 | 8.92 mm/cm^2 | Standard Deviation 3.444 |
| Bimatoprost Formulation A | Change From Baseline in Target Area Hair Width (TAHW) | Change from Baseline from Month 6 | 0.13 mm/cm^2 | Standard Deviation 1.198 |
| Bimatoprost Formulation B | Change From Baseline in Target Area Hair Width (TAHW) | Baseline | 9.64 mm/cm^2 | Standard Deviation 3.308 |
| Bimatoprost Formulation B | Change From Baseline in Target Area Hair Width (TAHW) | Change from Baseline from Month 6 | -0.19 mm/cm^2 | Standard Deviation 1.067 |
| Bimatoprost Formulation C | Change From Baseline in Target Area Hair Width (TAHW) | Baseline | 8.86 mm/cm^2 | Standard Deviation 3.977 |
| Bimatoprost Formulation C | Change From Baseline in Target Area Hair Width (TAHW) | Change from Baseline from Month 6 | 0.30 mm/cm^2 | Standard Deviation 1.263 |
| Vehicle to Bimatoprost | Change From Baseline in Target Area Hair Width (TAHW) | Change from Baseline from Month 6 | 0.07 mm/cm^2 | Standard Deviation 1.183 |
| Vehicle to Bimatoprost | Change From Baseline in Target Area Hair Width (TAHW) | Baseline | 10.13 mm/cm^2 | Standard Deviation 4.165 |
| Minoxidil 2% Solution | Change From Baseline in Target Area Hair Width (TAHW) | Baseline | 9.76 mm/cm^2 | Standard Deviation 3.698 |
| Minoxidil 2% Solution | Change From Baseline in Target Area Hair Width (TAHW) | Change from Baseline from Month 6 | 0.87 mm/cm^2 | Standard Deviation 1.315 |
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 | Remained the Same | 87.3 Percentage of participants |
| 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 | Moderately Decreased | 0.0 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly Increased | 0.0 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Moderately Increased | 1.8 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 | Slightly Decreased | 10.9 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly Decreased | 11.9 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Remained the Same | 81.4 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Moderately Increased | 0.0 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 Increased | 6.8 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Remained the Same | 81.3 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 | 2.1 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly Increased | 6.3 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly Decreased | 10.4 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 | Slightly Increased | 6.6 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly Decreased | 3.3 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Moderately Increased | 1.6 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 |
| 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 | 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 | 88.5 Percentage of participants |
| Minoxidil 2% Solution | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly Increased | 17.0 Percentage of participants |
| Minoxidil 2% Solution | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Greatly Decreased | 0.0 Percentage of participants |
| Minoxidil 2% Solution | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Moderately Decreased | 1.9 Percentage of participants |
| Minoxidil 2% Solution | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Slightly Decreased | 1.9 Percentage of participants |
| Minoxidil 2% Solution | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Moderately Increased | 0.0 Percentage of participants |
| Minoxidil 2% Solution | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Greatly Increased | 0.0 Percentage of participants |
| Minoxidil 2% Solution | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | Remained the Same | 79.2 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 | 5.2 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 | 3.4 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly Increased | 24.1 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 | 39.7 Percentage of participants |
| Bimatoprost Formulation A | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly Decreased | 15.5 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly Decreased | 10.0 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Remained the Same | 40.0 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Moderately Increased | 10.0 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Greatly Increased | 3.3 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Moderately Decreased | 1.7 Percentage of participants |
| Bimatoprost Formulation B | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly Increased | 35.0 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 | 51.9 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Greatly Increased | 7.4 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Moderately Increased | 11.1 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly Increased | 25.9 Percentage of participants |
| Bimatoprost Formulation C | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly Decreased | 3.7 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 | 23.0 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly Decreased | 6.6 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Moderately Increased | 14.8 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 | 1.6 Percentage of participants |
| Vehicle to Bimatoprost | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Remained the Same | 54.1 Percentage of participants |
| Minoxidil 2% Solution | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly Increased | 37.5 Percentage of participants |
| Minoxidil 2% Solution | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Greatly Decreased | 0.0 Percentage of participants |
| Minoxidil 2% Solution | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Moderately Decreased | 0.0 Percentage of participants |
| Minoxidil 2% Solution | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Slightly Decreased | 3.6 Percentage of participants |
| Minoxidil 2% Solution | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Moderately Increased | 16.1 Percentage of participants |
| Minoxidil 2% Solution | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Greatly Increased | 1.8 Percentage of participants |
| Minoxidil 2% Solution | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | Remained the Same | 41.1 Percentage of participants |