Eyelash Hypotrichosis
Conditions
Brief summary
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes following chemotherapy treatment.
Interventions
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have inadequate eyelashes due to chemotherapy treatment * Treated for solid tumors such as breast or colorectal cancer in early stages where the cancer has not spread outside the primary organ (eg, stage 1, 2 or 3a for breast cancer) * Have completed chemotherapy treatment for at least 4 weeks but not more than 24 weeks and all side effects related to chemotherapy are recovered, improved or maintained, with the exception of hair loss
Exclusion criteria
* Any disease/infection/abnormality of the eye or area around the eye * Any ocular surgery within 3 months or anticipated need for ocular surgery during the study * Any permanent eyeliner or implants of any kind or anticipated use of false eyelashes * Any semi-permanent eyelash tint, dye, curl or eyelash extension application within 3 months * Use of any over-the-counter eyelash growth product within 6 months or any use of prescription eyelash growth products * Use of treatments which may affect hair growth (eg, minoxidil) within 6 months except for prior chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA) | Baseline, Month 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA) | Baseline, Month 4 | 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). |
| Change From Baseline in Eyelash Thickness as Measured by DIA | Baseline, Month 4 | 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). |
| Change From Baseline in Eyelash Darkness as Measured by DIA | Baseline, Month 4 | 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). |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost Solution 0.03% One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months. | 18 |
| Bimatoprost Vehicle Solution One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months. | 18 |
| Total | 36 |
Baseline characteristics
| Characteristic | Bimatoprost Solution 0.03% | Bimatoprost Vehicle Solution | Total |
|---|---|---|---|
| Age, Customized 45 to 65 Years | 10 Participants | 12 Participants | 22 Participants |
| Age, Customized < 45 Years | 8 Participants | 3 Participants | 11 Participants |
| Age, Customized > 65 Years | 0 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Female | 18 Participants | 18 Participants | 36 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 18 | 13 / 18 |
| serious Total, serious adverse events | 0 / 18 | 2 / 18 |
Outcome results
Primary
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
Population: Intent to treat population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimatoprost Solution 0.03% | Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA) | 88.9 Percentage of participants |
| Bimatoprost Vehicle Solution | Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA) | 27.8 Percentage of participants |
Secondary
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
Population: Participants from the Intent to treat population with data available for analysis.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost Solution 0.03% | Change From Baseline in Eyelash Darkness as Measured by DIA | Baseline | 140.15 Units on a scale | Full Range 21.855 |
| Bimatoprost Solution 0.03% | Change From Baseline in Eyelash Darkness as Measured by DIA | Change from Baseline at Month 4 | -19.40 Units on a scale | Full Range 12.666 |
| Bimatoprost Vehicle Solution | Change From Baseline in Eyelash Darkness as Measured by DIA | Baseline | 144.98 Units on a scale | Full Range 18.561 |
| Bimatoprost Vehicle Solution | Change From Baseline in Eyelash Darkness as Measured by DIA | Change from Baseline at Month 4 | -10.03 Units on a scale | Full Range 18.248 |
Secondary
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
Population: Participants from the Intent to treat population with data available for analysis.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost Solution 0.03% | Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA) | Baseline | 5.70 mm | Full Range 1.397 |
| Bimatoprost Solution 0.03% | Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA) | Change from Baseline at Month 4 | 2.70 mm | Full Range 1.574 |
| Bimatoprost Vehicle Solution | Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA) | Change from Baseline at Month 4 | 0.6 mm | Full Range 1.317 |
| Bimatoprost Vehicle Solution | Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA) | Baseline | 5.00 mm | Full Range 1.543 |
Secondary
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
Population: Participants from the Intent to treat population with data available for analysis.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost Solution 0.03% | Change From Baseline in Eyelash Thickness as Measured by DIA | Baseline | 0.60 mm^2 | Full Range 0.456 |
| Bimatoprost Solution 0.03% | Change From Baseline in Eyelash Thickness as Measured by DIA | Change from Baseline at Month 4 | 0.80 mm^2 | Full Range 0.46 |
| Bimatoprost Vehicle Solution | Change From Baseline in Eyelash Thickness as Measured by DIA | Baseline | 0.45 mm^2 | Full Range 0.294 |
| Bimatoprost Vehicle Solution | Change From Baseline in Eyelash Thickness as Measured by DIA | Change from Baseline at Month 4 | 0.25 mm^2 | Full Range 0.393 |