Back to resultsBimatoprost for the Treatment of Eyebrow Hypotrichosis
Primary Purpose
Eyebrow Hypotrichosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
bimatoprost solution
Vehicle to bimatoprost solution
Sponsored by
About this trial
This is an interventional treatment trial for Eyebrow Hypotrichosis
Eligibility Criteria
Inclusion Criteria:
-Adult participants with eyebrow hypotrichosis (inadequate eyebrow growth).
Exclusion Criteria:
- Patients with disease, infection, or abnormality of the eyebrow area
- Patients with permanent eyebrow loss due to over-grooming
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Bimatoprost Solution BID
Bimatoprost Solution QD
Vehicle to Bimatoprost Solution BID
Arm Description
Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
Outcomes
Primary Outcome Measures
Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale
The physician evaluated eyebrow fullness using the 4-point GEBA Scale where: 1=very sparse, 2=sparse, 3=full and 4=very full. The percentage of participants with at least a 1-grade increase from Baseline is reported.
Secondary Outcome Measures
Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA)
Photographs were taken of the eyebrows. Eyebrow fullness was measured by DMSIA for both eyes and averaged. Eyebrow fullness was reported in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyebrows (improvement).
Change From Baseline in Eyebrow Darkness as Measured Using DMSIA
Photographs were taken of the eyebrows. Eyebrow darkness (intensity) was measured by DMSIA for both eyes and averaged. Eyebrow darkness was reported in intensity units. A negative change from Baseline indicated darker eyebrows (improvement).
Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6
ESS Item #6 measured the participant's satisfaction with eyebrow treatment: "Overall, how satisfied are you with the way the eyebrow treatment makes your eyebrows look right now?" using a 5-point scale where: 1=very satisfied, 2=mostly satisfied, 3=neither dissatisfied nor satisfied, 4=mostly dissatisfied and 5=very dissatisfied. The percentage of participants 'very satisfied' or 'mostly satisfied' is reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01765764
Brief Title
Bimatoprost for the Treatment of Eyebrow Hypotrichosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 13, 2013 (Actual)
Primary Completion Date
January 31, 2014 (Actual)
Study Completion Date
February 11, 2014 (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 compared with vehicle in the treatment of eyebrow hypotrichosis (inadequate eyebrows).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyebrow Hypotrichosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
357 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bimatoprost Solution BID
Arm Type
Experimental
Arm Description
Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
Arm Title
Bimatoprost Solution QD
Arm Type
Experimental
Arm Description
Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
Arm Title
Vehicle to Bimatoprost Solution BID
Arm Type
Placebo Comparator
Arm Description
Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
Intervention Type
Drug
Intervention Name(s)
bimatoprost solution
Intervention Description
Bimatoprost solution once a day or twice a day applied to each eyebrow for 7 months.
Intervention Type
Drug
Intervention Name(s)
Vehicle to bimatoprost solution
Intervention Description
Vehicle to bimatoprost solution once or twice a day applied to each eyebrow for 7 months.
Primary Outcome Measure Information:
Title
Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale
Description
The physician evaluated eyebrow fullness using the 4-point GEBA Scale where: 1=very sparse, 2=sparse, 3=full and 4=very full. The percentage of participants with at least a 1-grade increase from Baseline is reported.
Time Frame
Baseline, Month 7
Secondary Outcome Measure Information:
Title
Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA)
Description
Photographs were taken of the eyebrows. Eyebrow fullness was measured by DMSIA for both eyes and averaged. Eyebrow fullness was reported in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyebrows (improvement).
Time Frame
Baseline, Month 7
Title
Change From Baseline in Eyebrow Darkness as Measured Using DMSIA
Description
Photographs were taken of the eyebrows. Eyebrow darkness (intensity) was measured by DMSIA for both eyes and averaged. Eyebrow darkness was reported in intensity units. A negative change from Baseline indicated darker eyebrows (improvement).
Time Frame
Baseline, Month 7
Title
Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6
Description
ESS Item #6 measured the participant's satisfaction with eyebrow treatment: "Overall, how satisfied are you with the way the eyebrow treatment makes your eyebrows look right now?" using a 5-point scale where: 1=very satisfied, 2=mostly satisfied, 3=neither dissatisfied nor satisfied, 4=mostly dissatisfied and 5=very dissatisfied. The percentage of participants 'very satisfied' or 'mostly satisfied' is reported.
Time Frame
Month 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-Adult participants with eyebrow hypotrichosis (inadequate eyebrow growth).
Exclusion Criteria:
Patients with disease, infection, or abnormality of the eyebrow area
Patients with permanent eyebrow loss due to over-grooming
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Houston
State/Province
Texas
Country
United States
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
27124878
Citation
Carruthers J, Beer K, Carruthers A, Coleman WP 3rd, Draelos ZD, Jones D, Goldman MP, Pucci ML, VanDenburgh A, Weng E, Whitcup SM. Bimatoprost 0.03% for the Treatment of Eyebrow Hypotrichosis. Dermatol Surg. 2016 May;42(5):608-17. doi: 10.1097/DSS.0000000000000755.
Results Reference
background
Learn more about this trial
Bimatoprost for the Treatment of Eyebrow Hypotrichosis
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