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

Phase 4

Completed

• Conditions: Eyelash Hypotrichosis
• Interventions: Drug: bimatoprost 0.03%

• Registration Number: NCT01229423
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2010-06
• Study Completion: 2010-10
• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-10-26
• Study First Posted: 2010-10-27
• Results First Submitted: 2011-12-16
• Results First Submitted QC: 2011-12-16
• Results First Posted: 2012-01-23
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LATISSE®	bimatoprost 0.03%	bimatoprost 0.03% (LATISSE®)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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."
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.