Trial Outcomes & Findings for Bimatoprost for the Treatment of Eyebrow Hypotrichosis (NCT NCT01765764)
NCT ID: NCT01765764
Last Updated: 2019-04-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
357 participants
Primary outcome timeframe
Baseline, Month 7
Results posted on
2019-04-23
Participant Flow
Participant milestones
| Measure |
Bimatoprost Solution BID
Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
|
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.
|
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.
|
|---|---|---|---|
|
Treatment Period
STARTED
|
118
|
118
|
121
|
|
Treatment Period
COMPLETED
|
115
|
109
|
115
|
|
Treatment Period
NOT COMPLETED
|
3
|
9
|
6
|
|
Post-treatment Period
STARTED
|
114
|
107
|
112
|
|
Post-treatment Period
COMPLETED
|
114
|
107
|
112
|
|
Post-treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Bimatoprost Solution BID
Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
|
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.
|
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.
|
|---|---|---|---|
|
Treatment Period
Adverse Event
|
1
|
2
|
1
|
|
Treatment Period
Lost to Follow-up
|
0
|
3
|
2
|
|
Treatment Period
Personal Reasons
|
1
|
2
|
1
|
|
Treatment Period
Other Miscellaneous Reasons
|
1
|
2
|
2
|
Baseline Characteristics
Bimatoprost for the Treatment of Eyebrow Hypotrichosis
Baseline characteristics by cohort
| Measure |
Bimatoprost Solution BID
n=118 Participants
Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
|
Bimatoprost Solution QD
n=118 Participants
Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
|
Vehicle to Bimatoprost Solution BID
n=121 Participants
Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
|
Total
n=357 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18 to <45 years
|
18 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
59 Participants
n=31 Participants
|
|
Age, Customized
≥45 years
|
100 Participants
n=39 Participants
|
99 Participants
n=41 Participants
|
99 Participants
n=35 Participants
|
298 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=39 Participants
|
112 Participants
n=41 Participants
|
112 Participants
n=35 Participants
|
338 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
19 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 7Population: Intent-to-treat population included all randomized participants.
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.
Outcome measures
| Measure |
Bimatoprost Solution BID
n=118 Participants
Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
|
Bimatoprost Solution QD
n=118 Participants
Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
|
Vehicle to Bimatoprost Solution BID
n=121 Participants
Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
|
|---|---|---|---|
|
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
|
77.1 percentage of participants
|
43.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 7Population: Participants from the Intent-to-treat population, all randomized participants, with data available for analysis.
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).
Outcome measures
| Measure |
Bimatoprost Solution BID
n=117 Participants
Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
|
Bimatoprost Solution QD
n=117 Participants
Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
|
Vehicle to Bimatoprost Solution BID
n=118 Participants
Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
|
|---|---|---|---|
|
Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA)
Baseline
|
101.08 mm^2
Standard Deviation 47.252
|
97.80 mm^2
Standard Deviation 41.525
|
98.17 mm^2
Standard Deviation 49.657
|
|
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 35.940
|
30.96 mm^2
Standard Deviation 33.638
|
6.42 mm^2
Standard Deviation 26.870
|
SECONDARY outcome
Timeframe: Baseline, Month 7Population: Participants from the Intent-to-treat population, all randomized participants, with data available for analysis.
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).
Outcome measures
| Measure |
Bimatoprost Solution BID
n=116 Participants
Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
|
Bimatoprost Solution QD
n=116 Participants
Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
|
Vehicle to Bimatoprost Solution BID
n=117 Participants
Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
|
|---|---|---|---|
|
Change From Baseline in Eyebrow Darkness as Measured Using DMSIA
Baseline
|
53.90 intensity units
Standard Deviation 6.314
|
53.59 intensity units
Standard Deviation 7.688
|
52.87 intensity units
Standard Deviation 6.985
|
|
Change From Baseline in Eyebrow Darkness as Measured Using DMSIA
Change from Baseline at Month 7
|
-4.53 intensity units
Standard Deviation 3.294
|
-3.76 intensity units
Standard Deviation 3.212
|
0.11 intensity units
Standard Deviation 1.837
|
SECONDARY outcome
Timeframe: Month 7Population: Intent-to-treat population included all randomized participants.
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.
Outcome measures
| Measure |
Bimatoprost Solution BID
n=118 Participants
Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
|
Bimatoprost Solution QD
n=118 Participants
Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
|
Vehicle to Bimatoprost Solution BID
n=121 Participants
Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
|
|---|---|---|---|
|
Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6
|
70.3 percentage of participants
|
52.5 percentage of participants
|
36.4 percentage of participants
|
Adverse Events
Bimatoprost Solution BID
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Bimatoprost Solution QD
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Vehicle to Bimatoprost Solution BID
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bimatoprost Solution BID
n=118 participants at risk
Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
|
Bimatoprost Solution QD
n=118 participants at risk
Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
|
Vehicle to Bimatoprost Solution BID
n=121 participants at risk
Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.85%
1/118
|
0.00%
0/118
|
1.7%
2/121
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.85%
1/118
|
0.00%
0/118
|
0.00%
0/121
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/118
|
0.00%
0/118
|
0.83%
1/121
|
|
Infections and infestations
Localised infection
|
0.00%
0/118
|
0.00%
0/118
|
0.83%
1/121
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/118
|
0.00%
0/118
|
0.83%
1/121
|
Other adverse events
| Measure |
Bimatoprost Solution BID
n=118 participants at risk
Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
|
Bimatoprost Solution QD
n=118 participants at risk
Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
|
Vehicle to Bimatoprost Solution BID
n=121 participants at risk
Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
5.1%
6/118
|
4.2%
5/118
|
5.8%
7/121
|
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