Recent Updates
Recently added Catalysts

Botulinum Toxins, Type A

Phase 3

Glabellar Frown Lines | Monoclonal antibody | Other |Revance Therapeutics, Inc.|Last Updated: Jul 21, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment3,300
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03004248Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar LinesPHASE3 COMPLETED 2,691 — — Dec 9, 2016Oct 17, 2018Jul 13, 202261 United States, Canada
NCT03014622Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar LinesPHASE3 COMPLETED 303 — — Dec 8, 2016Nov 14, 2017Jul 21, 202215 United States
NCT03014635Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar LinesPHASE3 COMPLETED 306 — — Dec 5, 2016Nov 3, 2017Jul 21, 202214 United States, Canada
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Incidence of Treatment Emergent Adverse Events (TEAE)
0-36 weeks

Incidence rates based on the number and percentage of subjects treated within each cycle who report Adverse Events (AEs) at anytime following study treatment. Note that subjects could receive up to 3 consecutive treatments during the 36-week follow up period.

Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales
Week 4

Percentage of subjects who achieve at least a 2-point improvement from baseline and a score of 0 or 1 (i.e., none or mild wrinkles in severity) on both Investigator and Subject Frown Wrinkle Severity (FWS) assessments

Secondary Endpoints
Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales
Week 4
The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group
0-36 weeks per cycles 1 and 2
The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group
0-36 weeks per Cycle 1 and 2
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DaxibotulinumtoxinA 40 unitsEXPERIMENTALBiological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
PlaceboPLACEBO_COMPARATORBiological/Vaccine: Placebos Intramuscular injection
Interventions
NameTypeDescription
Botulinum Toxins, Type ABIOLOGICALIntramuscular Injection
PlacebosBIOLOGICALIntramuscular injection
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites61

Inclusion Criteria: * Provide written informed consent including authorization to release health information * Moderate (2) or severe (3) glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale * Moderate (2) or severe (3) glabellar li...

Countries:United StatesCanada
Unlock Eligibility Criteria