Eyebrow Hypotrichosis
Conditions
Brief summary
This study will evaluate the safety and efficacy of bimatoprost solution compared with vehicle in the treatment of eyebrow hypotrichosis (inadequate eyebrows).
Interventions
DRUGbimatoprost solution
Bimatoprost solution once a day or twice a day applied to each eyebrow for 7 months.
DRUGVehicle to bimatoprost solution
Vehicle to bimatoprost solution once or twice a day applied to each eyebrow for 7 months.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Adult participants with eyebrow hypotrichosis (inadequate eyebrow growth).
Exclusion criteria
* Patients with disease, infection, or abnormality of the eyebrow area * Patients with permanent eyebrow loss due to over-grooming
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale | Baseline, Month 7 | The physician evaluated eyebrow fullness using the 4-point GEBA Scale where: 1=very sparse, 2=sparse, 3=full and 4=very full. The percentage of participants with at least a 1-grade increase from Baseline is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA) | Baseline, Month 7 | Photographs were taken of the eyebrows. Eyebrow fullness was measured by DMSIA for both eyes and averaged. Eyebrow fullness was reported in millimeters squared (mm\^2). A positive change from Baseline indicated fuller eyebrows (improvement). |
| Change From Baseline in Eyebrow Darkness as Measured Using DMSIA | Baseline, Month 7 | Photographs were taken of the eyebrows. Eyebrow darkness (intensity) was measured by DMSIA for both eyes and averaged. Eyebrow darkness was reported in intensity units. A negative change from Baseline indicated darker eyebrows (improvement). |
| Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6 | Month 7 | ESS Item #6 measured the participant's satisfaction with eyebrow treatment: Overall, how satisfied are you with the way the eyebrow treatment makes your eyebrows look right now? using a 5-point scale where: 1=very satisfied, 2=mostly satisfied, 3=neither dissatisfied nor satisfied, 4=mostly dissatisfied and 5=very dissatisfied. The percentage of participants 'very satisfied' or 'mostly satisfied' is reported. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost Solution BID Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months. | 118 |
| Bimatoprost Solution QD Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months. | 118 |
| Vehicle to Bimatoprost Solution BID Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months. | 121 |
| Total | 357 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Treatment Period | Adverse Event | 1 | 2 | 1 |
| Treatment Period | Lost to Follow-up | 0 | 3 | 2 |
| Treatment Period | Other Miscellaneous Reasons | 1 | 2 | 2 |
| Treatment Period | Personal Reasons | 1 | 2 | 1 |
Baseline characteristics
| Characteristic | Bimatoprost Solution BID | Bimatoprost Solution QD | Vehicle to Bimatoprost Solution BID | Total |
|---|---|---|---|---|
| Age, Customized 18 to <45 years | 18 Participants | 19 Participants | 22 Participants | 59 Participants |
| Age, Customized ≥45 years | 100 Participants | 99 Participants | 99 Participants | 298 Participants |
| Sex: Female, Male Female | 114 Participants | 112 Participants | 112 Participants | 338 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 9 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 118 | 5 / 118 | 7 / 121 |
| serious Total, serious adverse events | 2 / 118 | 0 / 118 | 5 / 121 |
Outcome results
Primary
Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale
The physician evaluated eyebrow fullness using the 4-point GEBA Scale where: 1=very sparse, 2=sparse, 3=full and 4=very full. The percentage of participants with at least a 1-grade increase from Baseline is reported.
Time frame: Baseline, Month 7
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimatoprost Solution BID | Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale | 83.9 percentage of participants |
| Bimatoprost Solution QD | Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale | 77.1 percentage of participants |
| Vehicle to Bimatoprost Solution BID | Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale | 43.0 percentage of participants |
Secondary
Change From Baseline in Eyebrow Darkness as Measured Using DMSIA
Photographs were taken of the eyebrows. Eyebrow darkness (intensity) was measured by DMSIA for both eyes and averaged. Eyebrow darkness was reported in intensity units. A negative change from Baseline indicated darker eyebrows (improvement).
Time frame: Baseline, Month 7
Population: Participants from the Intent-to-treat population, all randomized participants, with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost Solution BID | Change From Baseline in Eyebrow Darkness as Measured Using DMSIA | Change from Baseline at Month 7 | -4.53 intensity units | Standard Deviation 3.294 |
| Bimatoprost Solution BID | Change From Baseline in Eyebrow Darkness as Measured Using DMSIA | Baseline | 53.90 intensity units | Standard Deviation 6.314 |
| Bimatoprost Solution QD | Change From Baseline in Eyebrow Darkness as Measured Using DMSIA | Baseline | 53.59 intensity units | Standard Deviation 7.688 |
| Bimatoprost Solution QD | Change From Baseline in Eyebrow Darkness as Measured Using DMSIA | Change from Baseline at Month 7 | -3.76 intensity units | Standard Deviation 3.212 |
| Vehicle to Bimatoprost Solution BID | Change From Baseline in Eyebrow Darkness as Measured Using DMSIA | Baseline | 52.87 intensity units | Standard Deviation 6.985 |
| Vehicle to Bimatoprost Solution BID | Change From Baseline in Eyebrow Darkness as Measured Using DMSIA | Change from Baseline at Month 7 | 0.11 intensity units | Standard Deviation 1.837 |
Secondary
Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA)
Photographs were taken of the eyebrows. Eyebrow fullness was measured by DMSIA for both eyes and averaged. Eyebrow fullness was reported in millimeters squared (mm\^2). A positive change from Baseline indicated fuller eyebrows (improvement).
Time frame: Baseline, Month 7
Population: Participants from the Intent-to-treat population, all randomized participants, with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost Solution BID | Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA) | Baseline | 101.08 mm^2 | Standard Deviation 47.252 |
| Bimatoprost Solution BID | Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA) | Change from Baseline at Month 7 | 34.51 mm^2 | Standard Deviation 35.94 |
| Bimatoprost Solution QD | Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA) | Baseline | 97.80 mm^2 | Standard Deviation 41.525 |
| Bimatoprost Solution QD | Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA) | Change from Baseline at Month 7 | 30.96 mm^2 | Standard Deviation 33.638 |
| Vehicle to Bimatoprost Solution BID | Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA) | Baseline | 98.17 mm^2 | Standard Deviation 49.657 |
| Vehicle to Bimatoprost Solution BID | Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA) | Change from Baseline at Month 7 | 6.42 mm^2 | Standard Deviation 26.87 |
Secondary
Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6
ESS Item #6 measured the participant's satisfaction with eyebrow treatment: Overall, how satisfied are you with the way the eyebrow treatment makes your eyebrows look right now? using a 5-point scale where: 1=very satisfied, 2=mostly satisfied, 3=neither dissatisfied nor satisfied, 4=mostly dissatisfied and 5=very dissatisfied. The percentage of participants 'very satisfied' or 'mostly satisfied' is reported.
Time frame: Month 7
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimatoprost Solution BID | Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6 | 70.3 percentage of participants |
| Bimatoprost Solution QD | Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6 | 52.5 percentage of participants |
| Vehicle to Bimatoprost Solution BID | Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6 | 36.4 percentage of participants |