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RT001

Phase 2

Lateral Canthal Lines | Small molecule | Other |Revance Therapeutics, Inc.|Last Updated: Aug 28, 2020

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 Trials4
Total Enrollment202
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01124565Safety Study of Two Repeat Doses of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in AdultsPHASE2 COMPLETED 40 — — May 1, 2010Jul 1, 2010Jan 17, 20143 United States
NCT00907387Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal LinesPHASE2 COMPLETED 72 — — Apr 1, 2009Oct 1, 2009Jan 17, 20149 United States
NCT00884234Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal LinesPHASE2 COMPLETED 30 — — Feb 1, 2009Jun 1, 2009Aug 28, 20201 United States
NCT00888914Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal LinesPHASE2 COMPLETED 60 — — Nov 1, 2008Feb 1, 2009Nov 19, 20134 United States
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Study Endpoints
Primary Endpoints
Assessment of treatment-emergent adverse events based on safety assessments.
4 weeks and 8 weeks
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Rest from Baseline (Day 0) to Day 28
Day 28
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment from Baseline (Day 0) to End of Study (Week 6).
Baseline (Day 0) and Week 6
Incidence of treatment emergent AEs.
Baseline (Day 0) and Week 6
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Smile from Baseline (Day 0) to End of Study (Day 28)
Day 28
Secondary Endpoints
Incidence of treatment-emergent adverse events
Day 28
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Rest from Baseline (Day 0) to End of Study (Day 28)
Day 28
Incidence of treatment-emergent AEs
Day 28
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RT001EXPERIMENTALRT001 (Botulinum Toxin Type A) Topical Gel
Dose AACTIVE_COMPARATORDose A RT001
Dose BACTIVE_COMPARATORDose B RT001
Dose CPLACEBO_COMPARATORDose C Placebo
1EXPERIMENTALRT001 (Botulinum Toxin Type A Topical Gel)
2PLACEBO_COMPARATORVehicle Control
Dose DACTIVE_COMPARATORRT001 Dose D; Active Comparator
Dose EPLACEBO_COMPARATORRT001 Dose E; Vehicle Comparator
Interventions
NameTypeDescription
RT001DRUGRT001 (Botulinum Toxin Type A Topical Gel, Dose A) at Baseline (Day 0) and Week 4 to the lateral canthal areas
PlaceboOTHERDose C Placebo
Vehicle ControlOTHERTwo sequential doses of Vehicle Control at Baseline (Day 0) and Week 2
RT001 (Botulinum Toxin Type A Topical Gel)DRUGTwo sequential doses of RT001 at Baseline (Day 0) and Week 2
Vehicle ComparatorOTHERVehicle Comparator
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites3

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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