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Botulinum Toxin Type A

Phase 3

Skin Aging | Small molecule | Dermatology |Revance Therapeutics, Inc.|Last Updated: Sep 9, 2016

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 Trials3
Total Enrollment779
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02580370Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Lateral Canthal LinesPHASE3 COMPLETED 450 — — Sep 1, 2015Aug 1, 2016Sep 9, 20161 United States
NCT01776606Efficacy and Safety Study of Botulinum Toxin Type A for Moderate to Severe Crow's Feet LinesPHASE3 COMPLETED 247 — — Dec 1, 2012May 1, 2013May 7, 20141 United States
NCT01940991Efficacy and Safety of Botulinum Toxin Type A for Moderate to Severe Crow's Feet LinesPHASE2 COMPLETED 82 — — Aug 1, 2013Nov 1, 2013Jan 31, 20141 United States
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Study Endpoints
Primary Endpoints
Composite endpoint based upon the investigator global assessment (IGA-LCL) and patient assessment of severity (PSA) of lateral canthal lines
Week 4
Composite endpoint based upon the investigator global assessment and patient assessment of severity of lateral canthal lines
Week 4
Composite endpoint
Week 4

Composite endpoint based upon the investigator global assessment and patient assessment of severity of lateral canthal lines

Secondary Endpoints
Investigator Global Assessment with 2 points or greater improvement from baseline
Week 4
Investigator Global Assessment with 1 point or greater improvement from baseline
Week 4
Patient Severity Assessment with 2 points or greater improvement from baseline
Week 4
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose AEXPERIMENTALBotulinum toxin type A
Dose BPLACEBO_COMPARATORPlacebo comparator
Interventions
NameTypeDescription
Botulinum toxin type ABIOLOGICALTopical botulinum toxin type A
Placebo comparatorBIOLOGICALTopical placebo comparator
PlaceboDRUGPlacebo, Dose B; dose applied to the lateral canthal lines
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * In good general health * Moderate to severe lateral canthal lines when evaluated at rest based on the investigator's global assessment * Moderate to severe lateral canthal lines when evaluated at rest based on the patient assessment of severity Exclusion Criteria: * Any neur...

Countries:United States
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Competitive Landscape -Skin Aging 3 trials
CompanyTickerTrialsLead PhaseDrugs
Krystal Biotech, Inc.KRYS2PHASE1KB304, 0.9% Normal Saline, KB301
Century Therapeutics, Inc.IPSC1NAUndisclosed
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