Back to resultsSafety and Efficacy Study of Bimatoprost in Japanese Patients With Eyelash Hypotrichosis
Primary Purpose
Eyelash Hypotrichosis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
bimatoprost solution 0.03%
bimatoprost vehicle solution
Sponsored by
About this trial
This is an interventional treatment trial for Eyelash Hypotrichosis
Eligibility Criteria
Inclusion Criteria:
- Have inadequate eyelashes
Exclusion Criteria:
- Any disease/infection/abnormality of the eye or area around the eye
- Any ocular surgery within 3 months or anticipated need for ocular surgery during the study
- Any permanent eyeliner or implants of any kind or anticipated use of false eyelashes
- Any semi-permanent eyelash tint, dye, curl or eyelash extension application within 3 months
- Use of any over-the-counter eyelash growth product within 6 months or any use of prescription eyelash growth products
- Use of treatments which may affect hair growth (eg, minoxidil, chemotherapy) within 6 months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
bimatoprost solution 0.03%
bimatoprost vehicle solution
Arm Description
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
Outcomes
Primary Outcome Measures
Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)
The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.
Secondary Outcome Measures
Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)
Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).
Change From Baseline in Eyelash Thickness as Measured by DIA
Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement).
Change From Baseline in Eyelash Darkness as Measured by DIA
Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01391273
Brief Title
Safety and Efficacy Study of Bimatoprost in Japanese Patients With Eyelash Hypotrichosis
Official Title
A Multicenter, Double-masked, Randomized, Parallel-group Study Assessing the Safety and Efficacy of Once-Daily Application of Bimatoprost Solution 0.03% Compared to Vehicle in Increasing Overall Eyelash Prominence in Japanese Subjects With Hypotrichosis of the Eyelashes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2011 (Actual)
Primary Completion Date
May 19, 2012 (Actual)
Study Completion Date
May 19, 2012 (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 bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes.
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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
173 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bimatoprost solution 0.03%
Arm Type
Experimental
Arm Description
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
Arm Title
bimatoprost vehicle solution
Arm Type
Placebo Comparator
Arm Description
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
Intervention Type
Drug
Intervention Name(s)
bimatoprost solution 0.03%
Other Intervention Name(s)
LATISSE®
Intervention Description
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
Intervention Type
Drug
Intervention Name(s)
bimatoprost vehicle solution
Intervention Description
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
Primary Outcome Measure Information:
Title
Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)
Description
The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.
Time Frame
Baseline, Month 4
Secondary Outcome Measure Information:
Title
Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)
Description
Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).
Time Frame
Baseline, Month 4
Title
Change From Baseline in Eyelash Thickness as Measured by DIA
Description
Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement).
Time Frame
Baseline, Month 4
Title
Change From Baseline in Eyelash Darkness as Measured by DIA
Description
Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).
Time Frame
Baseline, Month 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have inadequate eyelashes
Exclusion Criteria:
Any disease/infection/abnormality of the eye or area around the eye
Any ocular surgery within 3 months or anticipated need for ocular surgery during the study
Any permanent eyeliner or implants of any kind or anticipated use of false eyelashes
Any semi-permanent eyelash tint, dye, curl or eyelash extension application within 3 months
Use of any over-the-counter eyelash growth product within 6 months or any use of prescription eyelash growth products
Use of treatments which may affect hair growth (eg, minoxidil, chemotherapy) 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
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
24643895
Citation
Harii K, Arase S, Tsuboi R, Weng E, Daniels S, VanDenburgh A. Bimatoprost for eyelash growth in Japanese subjects: two multicenter controlled studies. Aesthetic Plast Surg. 2014 Apr;38(2):451-60. doi: 10.1007/s00266-014-0293-7. Epub 2014 Mar 19. Erratum In: Aesthetic Plast Surg. 2014 Oct;38(5):1071-2.
Results Reference
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Safety and Efficacy Study of Bimatoprost in Japanese Patients With Eyelash Hypotrichosis
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