Trial Outcomes & Findings for Safety and Efficacy Study of Bimatoprost in the Treatment of Women With Female Pattern Hair Loss (NCT NCT01325350)
NCT ID: NCT01325350
Last Updated: 2014-04-09
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
306 participants
Primary outcome timeframe
Baseline, Month 6
Results posted on
2014-04-09
Participant Flow
Participant milestones
| Measure |
Bimatoprost Formulation A
Approximately one milliliter (mL) of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Bimatoprost Formulation B
Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Bimatoprost Formulation C
Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Vehicle to Bimatoprost
Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Minoxidil 2% Solution
Approximately one mL of minoxidil 2% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
61
|
61
|
61
|
61
|
62
|
|
Overall Study
COMPLETED
|
55
|
56
|
44
|
52
|
50
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
17
|
9
|
12
|
Reasons for withdrawal
| Measure |
Bimatoprost Formulation A
Approximately one milliliter (mL) of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Bimatoprost Formulation B
Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Bimatoprost Formulation C
Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Vehicle to Bimatoprost
Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Minoxidil 2% Solution
Approximately one mL of minoxidil 2% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
3
|
1
|
2
|
|
Overall Study
Pregnancy
|
0
|
0
|
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
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Did Not Receive Treatment
|
0
|
1
|
1
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy Study of Bimatoprost in the Treatment of Women With Female Pattern Hair Loss
Baseline characteristics by cohort
| Measure |
Bimatoprost Formulation A
n=61 Participants
Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Bimatoprost Formulation B
n=61 Participants
Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Bimatoprost Formulation C
n=61 Participants
Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Vehicle to Bimatoprost
n=61 Participants
Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Minoxidil 2% Solution
n=62 Participants
Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
|
Total
n=306 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
18 to 34 years
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
62 Participants
n=30 Participants
|
|
Age, Customized
35 to 59 years
|
49 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
50 Participants
n=31 Participants
|
244 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
61 Participants
n=7 Participants
|
62 Participants
n=31 Participants
|
306 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: 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.
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).
Outcome measures
| Measure |
Bimatoprost Formulation A
n=61 Participants
Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Bimatoprost Formulation B
n=60 Participants
Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Bimatoprost Formulation C
n=60 Participants
Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Vehicle to Bimatoprost
n=61 Participants
Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Minoxidil 2% Solution
n=61 Participants
Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Target Area Hair Count (TAHC)
Baseline
|
153.1 terminal hairs/cm^2
Standard Deviation 54.78
|
161.1 terminal hairs/cm^2
Standard Deviation 63.85
|
145.2 terminal hairs/cm^2
Standard Deviation 63.42
|
163.0 terminal hairs/cm^2
Standard Deviation 57.28
|
156.3 terminal hairs/cm^2
Standard Deviation 55.46
|
|
Change From Baseline in Target Area Hair Count (TAHC)
Change from Baseline at Month 6
|
-0.4 terminal hairs/cm^2
Standard Deviation 17.10
|
-3.5 terminal hairs/cm^2
Standard Deviation 18.21
|
4.3 terminal hairs/cm^2
Standard Deviation 16.82
|
1.1 terminal hairs/cm^2
Standard Deviation 20.44
|
13.6 terminal hairs/cm^2
Standard Deviation 18.72
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: 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.
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.
Outcome measures
| Measure |
Bimatoprost Formulation A
n=58 Participants
Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Bimatoprost Formulation B
n=60 Participants
Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Bimatoprost Formulation C
n=54 Participants
Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Vehicle to Bimatoprost
n=61 Participants
Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Minoxidil 2% Solution
n=56 Participants
Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
|
|---|---|---|---|---|---|
|
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Greatly Increased
|
3.4 Percentage of participants
|
3.3 Percentage of participants
|
9.3 Percentage of participants
|
3.3 Percentage of participants
|
7.1 Percentage of participants
|
|
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Moderately Increased
|
17.2 Percentage of participants
|
20.0 Percentage of participants
|
16.7 Percentage of participants
|
18.0 Percentage of participants
|
28.6 Percentage of participants
|
|
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Slightly Increased
|
34.5 Percentage of participants
|
21.7 Percentage of participants
|
16.7 Percentage of participants
|
24.6 Percentage of participants
|
35.7 Percentage of participants
|
|
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Remained the Same
|
20.7 Percentage of participants
|
33.3 Percentage of participants
|
38.9 Percentage of participants
|
29.5 Percentage of participants
|
19.6 Percentage of participants
|
|
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Slightly Decreased
|
19.0 Percentage of participants
|
11.7 Percentage of participants
|
13.0 Percentage of participants
|
13.1 Percentage of participants
|
5.4 Percentage of participants
|
|
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Moderately Decreased
|
1.7 Percentage of participants
|
8.3 Percentage of participants
|
5.6 Percentage of participants
|
8.2 Percentage of participants
|
1.8 Percentage of participants
|
|
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Greatly Decreased
|
3.4 Percentage of participants
|
1.7 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
1.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: 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.
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.
Outcome measures
| Measure |
Bimatoprost Formulation A
n=58 Participants
Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Bimatoprost Formulation B
n=60 Participants
Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Bimatoprost Formulation C
n=54 Participants
Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Vehicle to Bimatoprost
n=61 Participants
Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Minoxidil 2% Solution
n=56 Participants
Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
|
|---|---|---|---|---|---|
|
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Greatly Increased
|
5.2 Percentage of participants
|
3.3 Percentage of participants
|
7.4 Percentage of participants
|
1.6 Percentage of participants
|
1.8 Percentage of participants
|
|
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Moderately Increased
|
12.1 Percentage of participants
|
10.0 Percentage of participants
|
11.1 Percentage of participants
|
14.8 Percentage of participants
|
16.1 Percentage of participants
|
|
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Slightly Increased
|
24.1 Percentage of participants
|
35.0 Percentage of participants
|
25.9 Percentage of participants
|
23.0 Percentage of participants
|
37.5 Percentage of participants
|
|
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Remained the Same
|
39.7 Percentage of participants
|
40.0 Percentage of participants
|
51.9 Percentage of participants
|
54.1 Percentage of participants
|
41.1 Percentage of participants
|
|
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Slightly Decreased
|
15.5 Percentage of participants
|
10.0 Percentage of participants
|
3.7 Percentage of participants
|
6.6 Percentage of participants
|
3.6 Percentage of participants
|
|
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Moderately Decreased
|
3.4 Percentage of participants
|
1.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Greatly Decreased
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: 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.
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.
Outcome measures
| Measure |
Bimatoprost Formulation A
n=55 Participants
Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Bimatoprost Formulation B
n=59 Participants
Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Bimatoprost Formulation C
n=48 Participants
Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Vehicle to Bimatoprost
n=61 Participants
Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Minoxidil 2% Solution
n=53 Participants
Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
|
|---|---|---|---|---|---|
|
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Greatly Increased
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Moderately Increased
|
1.8 Percentage of participants
|
0.0 Percentage of participants
|
2.1 Percentage of participants
|
1.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Slightly Increased
|
0.0 Percentage of participants
|
6.8 Percentage of participants
|
6.3 Percentage of participants
|
6.6 Percentage of participants
|
17.0 Percentage of participants
|
|
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Remained the Same
|
87.3 Percentage of participants
|
81.4 Percentage of participants
|
81.3 Percentage of participants
|
88.5 Percentage of participants
|
79.2 Percentage of participants
|
|
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Slightly Decreased
|
10.9 Percentage of participants
|
11.9 Percentage of participants
|
10.4 Percentage of participants
|
3.3 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Moderately Decreased
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Greatly Decreased
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: 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.
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).
Outcome measures
| Measure |
Bimatoprost Formulation A
n=61 Participants
Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Bimatoprost Formulation B
n=60 Participants
Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Bimatoprost Formulation C
n=60 Participants
Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Vehicle to Bimatoprost
n=61 Participants
Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Minoxidil 2% Solution
n=61 Participants
Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Target Area Hair Width (TAHW)
Change from Baseline from Month 6
|
0.13 mm/cm^2
Standard Deviation 1.198
|
-0.19 mm/cm^2
Standard Deviation 1.067
|
0.30 mm/cm^2
Standard Deviation 1.263
|
0.07 mm/cm^2
Standard Deviation 1.183
|
0.87 mm/cm^2
Standard Deviation 1.315
|
|
Change From Baseline in Target Area Hair Width (TAHW)
Baseline
|
8.92 mm/cm^2
Standard Deviation 3.444
|
9.64 mm/cm^2
Standard Deviation 3.308
|
8.86 mm/cm^2
Standard Deviation 3.977
|
10.13 mm/cm^2
Standard Deviation 4.165
|
9.76 mm/cm^2
Standard Deviation 3.698
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: 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.
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).
Outcome measures
| Measure |
Bimatoprost Formulation A
n=61 Participants
Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Bimatoprost Formulation B
n=60 Participants
Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Bimatoprost Formulation C
n=60 Participants
Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Vehicle to Bimatoprost
n=61 Participants
Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Minoxidil 2% Solution
n=61 Participants
Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Target Area Hair Darkness (TAHD)
Change from Baseline at Month 6
|
2.94 Intensity units
Standard Deviation 13.084
|
4.22 Intensity units
Standard Deviation 13.159
|
2.11 Intensity units
Standard Deviation 14.674
|
2.07 Intensity units
Standard Deviation 11.486
|
2.12 Intensity units
Standard Deviation 11.561
|
|
Change From Baseline in Target Area Hair Darkness (TAHD)
Baseline
|
95.63 Intensity units
Standard Deviation 23.837
|
100.12 Intensity units
Standard Deviation 25.077
|
92.76 Intensity units
Standard Deviation 19.433
|
96.90 Intensity units
Standard Deviation 22.678
|
93.07 Intensity units
Standard Deviation 20.667
|
Adverse Events
Bimatoprost Formulation A
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Bimatoprost Formulation B
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Bimatoprost Formulation C
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Vehicle to Bimatoprost
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Minoxidil 2% Solution
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bimatoprost Formulation A
n=61 participants at risk
Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Bimatoprost Formulation B
n=60 participants at risk
Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Bimatoprost Formulation C
n=60 participants at risk
Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Vehicle to Bimatoprost
n=61 participants at risk
Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Minoxidil 2% Solution
n=61 participants at risk
Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
|
|---|---|---|---|---|---|
|
General disorders
Death
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
1.7%
1/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
1.7%
1/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
1.7%
1/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
1.7%
1/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.3%
2/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
1.7%
1/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
1.7%
1/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
1.7%
1/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
1.6%
1/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
1.6%
1/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
1.7%
1/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
|
Nervous system disorders
Syncope
|
1.6%
1/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.6%
1/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
Other adverse events
| Measure |
Bimatoprost Formulation A
n=61 participants at risk
Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Bimatoprost Formulation B
n=60 participants at risk
Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Bimatoprost Formulation C
n=60 participants at risk
Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Vehicle to Bimatoprost
n=61 participants at risk
Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
|
Minoxidil 2% Solution
n=61 participants at risk
Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
|
|---|---|---|---|---|---|
|
General disorders
Application site pruritis
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
5.0%
3/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
3.3%
2/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
8.2%
5/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
|
General disorders
Application site dryness
|
1.6%
1/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
1.7%
1/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
3.3%
2/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
6.6%
4/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.8%
6/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
8.3%
5/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
1.6%
1/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
3.3%
2/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
|
Infections and infestations
Nasopharyngitis
|
1.6%
1/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
3.3%
2/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
3.3%
2/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
9.8%
6/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
11.5%
7/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.3%
2/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
1.7%
1/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
5.0%
3/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
3.3%
2/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
1.6%
1/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
|
Nervous system disorders
Headache
|
1.6%
1/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
1.7%
1/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
6.7%
4/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
8.2%
5/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
1.6%
1/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
8.2%
5/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
1.7%
1/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
1.6%
1/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
4.9%
3/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
|
Vascular disorders
Hypertension
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
5.0%
3/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
1.6%
1/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
0.00%
0/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
|
Infections and infestations
Sinusitis
|
1.6%
1/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
5.0%
3/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
1.7%
1/60
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
3.3%
2/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
1.6%
1/61
The Safety Population (all participants who received at least 1 dose of study treatment) was used to calculate the number of participants at risk for treatment-emergent Serious Adverse Events and treatment-emergent Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER