Eyelash Hypotrichosis
Conditions
Brief summary
This study will evaluate the safety and efficacy of LATISSE® (bimatoprost 0.03%) in the augmentation of eyelashes in Korean women.
Interventions
One drop of bimatoprost 0.03% (LATISSE®) applied evenly to each upper eyelid in the evening. Treatment is once daily for up to 40 weeks.
Sponsors
Allergan
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eyelash prominence assessment of minimal or moderate * Of Korean ethnicity
Exclusion criteria
* Any eye disease or abnormality * Any ocular surgery or use of any eyelash extension or eyelash growth products within 3 months * Any permanent eyeliner within 5 years * Eyelash implants of any kind * Eyelash tint or dye application within 2 months * Use of any treatment that may affect hair growth within 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Eyelash Length at Week 20 | Baseline, Week 20 | Change from baseline in eyelash length at Week 20. Measurements made were based on the mean length of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash length, and a negative change from baseline indicates a decrease in eyelash length. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With an Improvement of at Least 1-Point in Global Eyelash Assessment (GEA) Score at Week 20 | Week 20 | Percentage of subjects with an improvement of at least 1-point in GEA score at Week 20 from baseline. The GEA scale is an investigator-graded 4-point scale of overall eyelash prominence where 1=minimal, 2=moderate, 3=marked, and 4=very marked prominence. |
| Change From Baseline in Eyelash Thickness at Week 20 | Baseline, Week 20 | Change from baseline in eyelash thickness at Week 20. Assessments made were based on the mean thickness of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash thickness, and a negative change from baseline indicates a decrease in eyelash thickness. |
| Change From Baseline in Eyelash Intensity (Darkness) at Week 20 | Baseline, Week 20 | Change from baseline in eyelash intensity (darkness) at Week 20. Assessments made were based on the mean eyelash intensity of the upper left and right eyelashes. Intensity was measured on a scale ranging from 0 (black) to 255 (white). A negative change from baseline indicates eyelash darkening in color, and a positive change from baseline indicates eyelash lightening in color. |
| Percentage of Subjects With an Improvement in Satisfaction With Overall Eyelash Prominence at Week 20 | Week 20 | Percentage of subjects with an improvement in satisfaction with overall eyelash prominence at Week 20. Subject satisfaction with overall eyelash prominence was assessed by response to the question Overall how satisfied are you with your eyelashes? Responses were based on a 5-point scale (very unsatisfied, unsatisfied, neutral, satisfied, very satisfied). Improvement in subject satisfaction is defined as a 1-point increase from baseline. |
| Percentage of Subjects Satisfied With Treatment at Week 20 | Week 20 | Percentage of subjects satisfied with treatment at week 20 was assessed using the Treatment Satisfaction Scale response to the question Which best describes your satisfaction with LATISSE®? Responses were very satisfied, satisfied, neutral, unsatisfied, and very unsatisfied. Satisfied is defined as responses of very satisfied and satisfied. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LATISSE® bimatoprost 0.03% (LATISSE®) | 62 |
| Total | 62 |
Baseline characteristics
| Characteristic | LATISSE® |
|---|---|
| Age, Continuous | 37.3 years STANDARD_DEVIATION 6.69 |
| Sex: Female, Male Female | 62 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / 62 |
| serious Total, serious adverse events | 0 / 62 |
Outcome results
Primary
Change From Baseline in Eyelash Length at Week 20
Change from baseline in eyelash length at Week 20. Measurements made were based on the mean length of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash length, and a negative change from baseline indicates a decrease in eyelash length.
Time frame: Baseline, Week 20
Population: Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LATISSE® | Change From Baseline in Eyelash Length at Week 20 | Baseline | 5.92 Millimeter (mm) | Standard Deviation 0.72 |
| LATISSE® | Change From Baseline in Eyelash Length at Week 20 | Change from Baseline at Week 20 | 1.10 Millimeter (mm) | Standard Deviation 0.8 |
Secondary
Change From Baseline in Eyelash Intensity (Darkness) at Week 20
Change from baseline in eyelash intensity (darkness) at Week 20. Assessments made were based on the mean eyelash intensity of the upper left and right eyelashes. Intensity was measured on a scale ranging from 0 (black) to 255 (white). A negative change from baseline indicates eyelash darkening in color, and a positive change from baseline indicates eyelash lightening in color.
Time frame: Baseline, Week 20
Population: Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LATISSE® | Change From Baseline in Eyelash Intensity (Darkness) at Week 20 | Baseline | 140.02 Units on a Scale | Standard Deviation 15.788 |
| LATISSE® | Change From Baseline in Eyelash Intensity (Darkness) at Week 20 | Change from Baseline at Week 20 | -12.97 Units on a Scale | Standard Deviation 13.115 |
Secondary
Change From Baseline in Eyelash Thickness at Week 20
Change from baseline in eyelash thickness at Week 20. Assessments made were based on the mean thickness of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash thickness, and a negative change from baseline indicates a decrease in eyelash thickness.
Time frame: Baseline, Week 20
Population: Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LATISSE® | Change From Baseline in Eyelash Thickness at Week 20 | Baseline | 1.39 Millimeters Squared (mm^2) | Standard Deviation 0.395 |
| LATISSE® | Change From Baseline in Eyelash Thickness at Week 20 | Change from Baseline at Week 20 | 0.25 Millimeters Squared (mm^2) | Standard Deviation 0.269 |
Secondary
Percentage of Subjects Satisfied With Treatment at Week 20
Percentage of subjects satisfied with treatment at week 20 was assessed using the Treatment Satisfaction Scale response to the question Which best describes your satisfaction with LATISSE®? Responses were very satisfied, satisfied, neutral, unsatisfied, and very unsatisfied. Satisfied is defined as responses of very satisfied and satisfied.
Time frame: Week 20
Population: Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LATISSE® | Percentage of Subjects Satisfied With Treatment at Week 20 | 83.1 Percentage of Subjects |
Secondary
Percentage of Subjects With an Improvement in Satisfaction With Overall Eyelash Prominence at Week 20
Percentage of subjects with an improvement in satisfaction with overall eyelash prominence at Week 20. Subject satisfaction with overall eyelash prominence was assessed by response to the question Overall how satisfied are you with your eyelashes? Responses were based on a 5-point scale (very unsatisfied, unsatisfied, neutral, satisfied, very satisfied). Improvement in subject satisfaction is defined as a 1-point increase from baseline.
Time frame: Week 20
Population: Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LATISSE® | Percentage of Subjects With an Improvement in Satisfaction With Overall Eyelash Prominence at Week 20 | 83.05 Percentage of Subjects |
Secondary
Percentage of Subjects With an Improvement of at Least 1-Point in Global Eyelash Assessment (GEA) Score at Week 20
Percentage of subjects with an improvement of at least 1-point in GEA score at Week 20 from baseline. The GEA scale is an investigator-graded 4-point scale of overall eyelash prominence where 1=minimal, 2=moderate, 3=marked, and 4=very marked prominence.
Time frame: Week 20
Population: Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LATISSE® | Percentage of Subjects With an Improvement of at Least 1-Point in Global Eyelash Assessment (GEA) Score at Week 20 | 81.4 Percentage of Subjects |