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

Allergan62 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eyelash Hypotrichosis

Interventions

bimatoprost 0.03%DRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Seoul, South Korea

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

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

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.

Data from ClinicalTrials.gov

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