A Phase 3 interventional study of bimatoprost solution 0.03% and bimatoprost vehicle solution in Eyelash Hypotrichosis, sponsored by Allergan. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-07-08.
Sponsored by Allergan · Phase 3, Interventional, and Treatment
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes.
44 studies on the registry are indexed under Hypotrichosis; 5 are open to participants now.
This study's enrollment of 173 is above the median of 62 across 41 interventional studies indexed under Hypotrichosis.
Browse Hypotrichosis studies →Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
Drug: bimatoprost solution 0.03%
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
Drug: bimatoprost vehicle solution
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
Also known as: LATISSE®
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)
The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.
Time frame: Baseline, Month 4
Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)
Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).
Time frame: Baseline, Month 4
Change From Baseline in Eyelash Thickness as Measured by DIA
Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm\^2). A positive change from Baseline indicated fuller eyelashes (improvement).
Time frame: Baseline, Month 4
Change From Baseline in Eyelash Darkness as Measured by DIA
Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).
Time frame: Baseline, Month 4
| Milestone | Bimatoprost Solution 0.03% | Bimatoprost Vehicle Solution |
|---|---|---|
| Started | 88 | 85 |
| Completed | 84 | 83 |
| Not completed | 4 | 2 |
The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.
| Percentage of participants | Bimatoprost Solution 0.03% | Bimatoprost Vehicle Solution |
|---|---|---|
| Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA) | 77.3 | 17.6 |
Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).
| mm | Bimatoprost Solution 0.03% | Bimatoprost Vehicle Solution |
|---|---|---|
| Baseline | 6.92 ± 0.810 | 7.00 ± 0.825 |
| Change from Baseline at Month 4 | 1.62 ± 1.114 | -0.04 ± 0.362 |
Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm\^2). A positive change from Baseline indicated fuller eyelashes (improvement).
| mm^2 | Bimatoprost Solution 0.03% | Bimatoprost Vehicle Solution |
|---|---|---|
| Baseline | 0.98 ± 0.318 | 1.01 ± 0.327 |
| Change from Baseline at Month 4 | 0.35 ± 0.306 | -0.03 ± 0.195 |
Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).
| Units on a scale | Bimatoprost Solution 0.03% | Bimatoprost Vehicle Solution |
|---|---|---|
| Baseline | 147.57 ± 20.340 | 145.27 ± 18.069 |
| Change from Baseline at Month 4 | -12.02 ± 10.967 | 1.38 ± 10.854 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bimatoprost Solution 0.03% | — | 2/87 (2.3%) | 12/87 (13.8%) |
| Bimatoprost Vehicle Solution | — | 2/85 (2.4%) | 6/85 (7.1%) |
| Event | Bimatoprost Solution 0.03% | Bimatoprost Vehicle Solution |
|---|---|---|
| Breast cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/87 | 1/85 |
| Skin atrophySkin and subcutaneous tissue disorders | 0/87 | 1/85 |
| AppendicitisInfections and infestations | 1/87 | 0/85 |
| PyelonephritisInfections and infestations | 1/87 | 0/85 |
| Event | Bimatoprost Solution 0.03% | Bimatoprost Vehicle Solution |
|---|---|---|
| NasopharyngitisInfections and infestations | 12/87 | 6/85 |
| Age, Customized(Participants) | Bimatoprost Solution 0.03% | Bimatoprost Vehicle Solution | Total |
|---|---|---|---|
| < 45 Years | 58 | 48 | 106 |
| 45 to 65 Years | 29 | 37 | 66 |
| >65 Years | 1 | 0 | 1 |
| Sex: Female, Male(Participants) | Bimatoprost Solution 0.03% | Bimatoprost Vehicle Solution | Total |
|---|---|---|---|
| Female | 79 | 76 | 155 |
| Male | 9 | 9 | 18 |
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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