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Botulinum Toxins, Type A

Phase 3

Glabellar Frown Lines | Monoclonal antibody | Dermatology |Revance Therapeutics, Inc.|Last Updated: Sep 18, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment3,300

FDA Designations

No designations recorded

Clinical trial landscape

Botulinum Toxins, Type A · 4 trials · 2 indications

Phase 3 3Phase 2 1
NCT03004248Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar LinesGlabellar Frown Lines
COMPLETED2,691 Analytics
NCT03014622Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar LinesGlabellar Frown Lines
COMPLETED303 Analytics
NCT03014635Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar LinesGlabellar Frown Lines
COMPLETED306 Analytics
PHASE3COMPLETED
Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar Lines
Glabellar Frown Lines
NCT030042482,691
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PHASE3COMPLETED
Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines
Glabellar Frown Lines
NCT03014622303
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PHASE3COMPLETED
Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines
Glabellar Frown Lines
NCT03014635306
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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

Change From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot
Week 8

The primary efficacy endpoint, as identified in the Statistical Analysis Plan (SAP) was the change from baseline in the visual analog scale (VAS) for pain for the affected foot at Week 8. The outcome was measured by means of a 100 mm VAS (0= no pain, 100= maximum pain) and higher reduction from baseline VAS pain scores means a better outcome.

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
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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
DAXI 240 UEXPERIMENTALDaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U

Interventions

NameTypeDescription
Botulinum Toxins, Type ABIOLOGICALIntramuscular Injection
PlacebosBIOLOGICALIntramuscular injection
PlaceboBIOLOGICALIntramuscular injection
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about Botulinum Toxins, Type A

What is Botulinum Toxins, Type A used for?

Botulinum Toxins, Type A, also known as DaxibotulinumtoxinA, is being studied for the treatment of glabellar frown lines and plantar fasciitis. It is an investigational product in clinical development, not yet approved by the FDA.

What does Botulinum Toxins, Type A target?

Botulinum Toxins, Type A is a botulinum toxin type A that works by blocking nerve signals to muscles, temporarily reducing muscle activity. This mechanism underlies its potential effects in treating glabellar frown lines and plantar fasciitis.

Who makes Botulinum Toxins, Type A?

Botulinum Toxins, Type A is being developed by Revance Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol RVNC.

What phase is Botulinum Toxins, Type A in?

Botulinum Toxins, Type A is in Phase 3 clinical development for glabellar frown lines and has completed Phase 2 trials for plantar fasciitis. It is an investigational drug and has not received FDA approval.

What clinical trials is Botulinum Toxins, Type A in?

Botulinum Toxins, Type A has completed three Phase 3 trials for glabellar frown lines: NCT03004248, NCT03014622, and NCT03014635. It also completed a Phase 2 trial for plantar fasciitis, NCT03137407. All trials are completed.

Is Botulinum Toxins, Type A the same as DaxibotulinumtoxinA?

Yes, Botulinum Toxins, Type A is also known as DaxibotulinumtoxinA. Clinical trials for this product use the name DaxibotulinumtoxinA for Injection.