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bimatoprost

Phase 3

Eyebrow Hypotrichosis | Small molecule | Other |AbbVie Inc.|Last Updated: Apr 23, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment357
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01765764Bimatoprost for the Treatment of Eyebrow HypotrichosisPHASE3 COMPLETED 357Mar 13, 2013Feb 11, 2014Apr 23, 20192 United States, Canada
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Study Endpoints
Primary Endpoints
Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale
Baseline, Month 7

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 Endpoints
Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA)
Baseline, Month 7
Change From Baseline in Eyebrow Darkness as Measured Using DMSIA
Baseline, Month 7
Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6
Month 7
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Bimatoprost Solution BIDEXPERIMENTALBimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
Bimatoprost Solution QDEXPERIMENTALVehicle 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 Solution BIDPLACEBO_COMPARATORVehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
Interventions
NameTypeDescription
bimatoprost solutionDRUGBimatoprost solution once a day or twice a day applied to each eyebrow for 7 months.
Vehicle to bimatoprost solutionDRUGVehicle to bimatoprost solution once or twice a day applied to each eyebrow for 7 months.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

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

Countries:United StatesCanada
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