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Completed

NCT Number: NCT01229423

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

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

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Key information

Conditions

Eyelash Hypotrichosis

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: LATISSE®

Primary outcomes

  1. Change From Baseline in Eyelash Length at Week 20

    Time frame: 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 outcomes

  1. Percentage of Subjects With an Improvement of at Least 1-Point in Global Eyelash Assessment (GEA) Score at Week 20

    Time frame: 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.

  2. Change From Baseline in Eyelash Thickness at Week 20

    Time frame: 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.

  3. Change From Baseline in Eyelash Intensity (Darkness) at Week 20

    Time frame: 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.

  4. Percentage of Subjects With an Improvement in Satisfaction With Overall Eyelash Prominence at Week 20

    Time frame: 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.

  5. Percentage of Subjects Satisfied With Treatment at Week 20

    Time frame: 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."

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 27, 2010
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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