Safety and Efficacy of LATISSE® in the Augmentation of Eyelashes of Korean Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01229423|
Recruitment Status : Completed
First Posted : October 27, 2010
Results First Posted : January 23, 2012
Last Update Posted : January 29, 2019
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Eyelash Hypotrichosis||Drug: bimatoprost 0.03%||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||October 2010|
bimatoprost 0.03% (LATISSE®)
Drug: bimatoprost 0.03%
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 Name: LATISSE®
- 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.
- 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.
- 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.
- 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.
- 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.
- 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."
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Eyelash prominence assessment of minimal or moderate
- Of Korean ethnicity
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229423
|Korea, Republic of|
|Seoul, Korea, Republic of|
|Study Director:||Medical Director||Allergan|
|Other Study ID Numbers:||
|First Posted:||October 27, 2010 Key Record Dates|
|Results First Posted:||January 23, 2012|
|Last Update Posted:||January 29, 2019|
|Last Verified:||January 2019|