Back to resultsSafety and Efficacy of LATISSE® in the Augmentation of Eyelashes of Korean Subjects
Primary Purpose
Eyelash Hypotrichosis
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
bimatoprost 0.03%
Sponsored by
About this trial
This is an interventional treatment trial for Eyelash Hypotrichosis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LATISSE®
Arm Description
bimatoprost 0.03% (LATISSE®)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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."
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01229423
Brief Title
Safety and Efficacy of LATISSE® in the Augmentation of Eyelashes of Korean Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the safety and efficacy of LATISSE® (bimatoprost 0.03%) in the augmentation of eyelashes in Korean women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyelash Hypotrichosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LATISSE®
Arm Type
Experimental
Arm Description
bimatoprost 0.03% (LATISSE®)
Intervention Type
Drug
Intervention Name(s)
bimatoprost 0.03%
Other Intervention Name(s)
LATISSE®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Eyelash Length at Week 20
Description
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 Outcome Measure Information:
Title
Percentage of Subjects With an Improvement of at Least 1-Point in Global Eyelash Assessment (GEA) Score at Week 20
Description
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
Title
Change From Baseline in Eyelash Thickness at Week 20
Description
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
Title
Change From Baseline in Eyelash Intensity (Darkness) at Week 20
Description
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
Title
Percentage of Subjects With an Improvement in Satisfaction With Overall Eyelash Prominence at Week 20
Description
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.
Time Frame
Week 20
Title
Percentage of Subjects Satisfied With Treatment at Week 20
Description
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."
Time Frame
Week 20
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
25228046
Citation
Kwon O, Kim JY, Paik SH, Jeon HC, Jung YJ, Lee Y, Baek JH, Chun JH, Lee WS, Lee JY, Rogers JD, Halstead M, Eun HC. Long-term utility and durability of the therapeutic effects of bimatoprost 0.03% for eyelash augmentation in healthy Asian subjects. Dermatology. 2014;229(3):222-9. doi: 10.1159/000363379. Epub 2014 Sep 6.
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Safety and Efficacy of LATISSE® in the Augmentation of Eyelashes of Korean Subjects
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