Safety and Efficacy of LATISSE® in the Augmentation of Eyelashes of Korean Subjects

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of LATISSE® (bimatoprost 0.03%) in the augmentation of eyelashes in Korean women.

Conditions
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Eyelash Hypotrichosis

Intervention / Treatment
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* Drug: bimatoprost 0.03%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LATISSE®<br>bimatoprost 0.03% (LATISSE®) | Drug: bimatoprost 0.03%<br>* 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.<br>* Other names: LATISSE®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Week 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 20 | 
| 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. | Baseline, Week 20 | 
| 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. | Baseline, Week 20 | 
| 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. | Week 20 | 
| 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. | Week 20 |