Eyelash Hypotrichosis, Alopecia Areata
Conditions
Brief summary
This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily application to the upper eyelid margins compared with vehicle in treating eyelash loss or hypotrichosis (inadequate or not enough eyelashes) in children.
Interventions
One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Children who have inadequate eyelashes or have lost their eyelashes as a result of chemotherapy treatment, who completed their chemotherapy (intensive treatment) at least 4 weeks before starting the study, are considered to be at low risk for relapse of their cancer, and are well enough to complete the study * Children who have minimal to moderate inadequate eyelashes due to alopecia areata * Adolescents between the ages of 15-17 years who have minimal to marked inadequate eyelashes
Exclusion criteria
* Any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants. * Semi-permanent eyelash tint, dye or eyelash extension application within 3 months * Use of over the counter eyelash growth products within 6 months. * Use of prescription eyelash growth products (eg, Latisse®) * Any eye condition that would prevent required ophthalmology exams
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events | 5 Months | An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. |
| Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score | Baseline, Month 4 | The physician evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Upper 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 Upper 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 Upper Eyelash Darkness as Measured by DIA | Baseline, Month 4 | Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) 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
Brazil, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost Ophthalmic Solution 0.03% One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months. | 48 |
| Vehicle Sterile Solution One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months. | 23 |
| Total | 71 |
Baseline characteristics
| Characteristic | Bimatoprost Ophthalmic Solution 0.03% | Vehicle Sterile Solution | Total |
|---|---|---|---|
| Age, Customized 12-17 years | 42 participants | 20 participants | 62 participants |
| Age, Customized 5-11 years | 6 participants | 3 participants | 9 participants |
| Sex: Female, Male Female | 37 Participants | 16 Participants | 53 Participants |
| Sex: Female, Male Male | 11 Participants | 7 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 1 / 23 |
| serious Total, serious adverse events | 0 / 48 | 0 / 23 |
Outcome results
Primary
Percentage of Participants With Adverse Events
An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Time frame: 5 Months
Population: Safety population included all randomized participants who received treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimatoprost Ophthalmic Solution 0.03% | Percentage of Participants With Adverse Events | 35.4 Percentage of participants |
| Vehicle Sterile Solution | Percentage of Participants With Adverse Events | 43.5 Percentage of participants |
Primary
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score
The physician evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement 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 Ophthalmic Solution 0.03% | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score | 70.8 Percentage of participants |
| Vehicle Sterile Solution | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score | 26.1 Percentage of participants |
Secondary
Change From Baseline in Upper Eyelash Darkness as Measured by DIA
Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) 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, that included all randomized participants, with data available at Baseline and Month 4.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost Ophthalmic Solution 0.03% | Change From Baseline in Upper Eyelash Darkness as Measured by DIA | Baseline | 143.78 Intensity units | Standard Deviation 20.446 |
| Bimatoprost Ophthalmic Solution 0.03% | Change From Baseline in Upper Eyelash Darkness as Measured by DIA | Change from Baseline at Month 4 | -15.34 Intensity units | Standard Deviation 15.724 |
| Vehicle Sterile Solution | Change From Baseline in Upper Eyelash Darkness as Measured by DIA | Baseline | 143.44 Intensity units | Standard Deviation 25.844 |
| Vehicle Sterile Solution | Change From Baseline in Upper Eyelash Darkness as Measured by DIA | Change from Baseline at Month 4 | -5.47 Intensity units | Standard Deviation 12.289 |
Secondary
Change From Baseline in Upper 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, that included all randomized participants, with data available at Baseline and Month 4.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost Ophthalmic Solution 0.03% | Change From Baseline in Upper Eyelash Thickness as Measured by DIA | Baseline | 1.20 mm^2 | Standard Deviation 0.738 |
| Bimatoprost Ophthalmic Solution 0.03% | Change From Baseline in Upper Eyelash Thickness as Measured by DIA | Change from Baseline at Month 4 | 0.41 mm^2 | Standard Deviation 0.535 |
| Vehicle Sterile Solution | Change From Baseline in Upper Eyelash Thickness as Measured by DIA | Baseline | 1.18 mm^2 | Standard Deviation 0.862 |
| Vehicle Sterile Solution | Change From Baseline in Upper Eyelash Thickness as Measured by DIA | Change from Baseline at Month 4 | 0.05 mm^2 | Standard Deviation 0.449 |
Secondary
Change From Baseline Upper 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: Intent-to-treat population included all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost Ophthalmic Solution 0.03% | Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA) | Baseline | 6.83 mm | Standard Deviation 2.568 |
| Bimatoprost Ophthalmic Solution 0.03% | Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA) | Change from Baseline at Month 4 | 1.12 mm | Standard Deviation 1.626 |
| Vehicle Sterile Solution | Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA) | Change from Baseline at Month 4 | 0.67 mm | Standard Deviation 1.846 |
| Vehicle Sterile Solution | Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA) | Baseline | 6.04 mm | Standard Deviation 2.915 |