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RT001 Botulinum toxin type A

Phase 2

Lateral Canthal Lines | Small molecule | Other |Revance Therapeutics, Inc.|Last Updated: Jan 30, 2014

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment180
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01124552A 4-Arm Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in AdultsPHASE2 COMPLETED 180Apr 1, 2010Jul 1, 2010Jan 30, 20141 United States
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Study Endpoints
Primary Endpoints
Subject improvement based in investigator assessment
Week 4

The number of subjects who show improvement based on the investigator global assessment

Secondary Endpoints
Subject Improvement Based on investigator and patient assessments
Week 4
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RT001 Botulinum toxin Type A (Dose A)EXPERIMENTALRT001 (Botulinum toxin Type A)
RT001 Botulinum toxin type A (Dose B)EXPERIMENTALRT001 (Botulinum Toxin Type A)
Dose COTHERVehicle Control
Dose DPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
RT001 Botulinum toxin type A (Dose A)DRUGRT001 Botulinum Toxin Type A (Dose A)
RT001 Botulinum Toxin Type A (Dose B)DRUGRT001 Botulinum Toxin Type A (Dose B)
VehicleOTHERVehicle Control
PlaceboDRUGPlacebo Comparator
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Written informed consent including authorization to release health information * Female or male, 18 to 65 years of age and in good general health * Willing and able to follow study instructions and likely to complete all study requirements * Moderate to severe lateral canthal ...

Countries:United States
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