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Botulinum Toxin Type A

Phase 3

Skin Aging | Small molecule | Dermatology |Revance Therapeutics, Inc.|Last Updated: Aug 28, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment779

FDA Designations

No designations recorded

Clinical trial landscape

Botulinum Toxin Type A · 8 trials · 6 indications

Phase 3 2Phase 2 6
NCT02580370Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Lateral Canthal LinesSkin Aging
COMPLETED450 Analytics
NCT01776606Efficacy and Safety Study of Botulinum Toxin Type A for Moderate to Severe Crow's Feet LinesSkin Aging
COMPLETED247 Analytics
PHASE3COMPLETED
Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Lateral Canthal Lines
Skin AgingUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety Study of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines
Skin AgingUnlock trial analytics

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
Hyperhidrosis Disease Severity Scale (HDSS)
Week 4

Improvement at follow-up in the experimental groups compared to the placebo group

Gravimetry
Week 4

The amount of sweat measured gravimetrically

Proportion of subjects assessed as responders by investigator assessment of severity of glabellar lines at maximum frown
Week 24
Duration of response assessed by investigator assessment of severity of glabellar lines at maximum frown from the date of injection to when subject reverts to baseline severity
Up to Week 36
Composite endpoint
Week 4

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

The number of subjects who show improvement based on the investigator global and patient assessments.
Week 4
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment of Lateral Canthal Line-Rest Severity Scale of the LCA at Baseline compared to Week 8; incidence of treatment emergent AEs
Week 8
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment of Lateral Canthal Line Severity at Rest from Baseline (Day 0) to Week 4; incidence of treatment emergent AEs
Week 4

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
Dose CPLACEBO_COMPARATORPlacebo comparator
Dose DACTIVE_COMPARATORDose D: Botulinum Toxin Type A
Dose EPLACEBO_COMPARATORDose E: Placebo

Interventions

NameTypeDescription
Botulinum toxin type ABIOLOGICALTopical botulinum toxin type A
Placebo comparatorBIOLOGICALTopical placebo comparator
PlaceboDRUGPlacebo, Dose B; dose applied to the lateral canthal lines
Active Comparator botulinum toxinBIOLOGICALIM injection
Placebo (Dose B)DRUGPlacebo (Dose B), applied topically at Baseline (Day 0) to the lateral canthal lines
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Eligibility Criteria

Age Range18 Years to 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 StatesCanada
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Competitive Landscape -Skin Aging 3 trials

Top 1 of 2 competitors

CompanyTickerTrialsLead PhaseDrugs
Krystal Biotech, Inc.KRYS2PHASE1KB304, KB301
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Frequently asked questions about Botulinum Toxin Type A

What is Botulinum Toxin Type A used for?

Botulinum Toxin Type A is being studied for use in dermatology, specifically for lateral canthal lines, also known as crow's feet, and for primary axillary hyperhidrosis, which is excessive underarm sweating. It is an investigational product being developed by Revance Therapeutics, Inc. and is currently in Phase 2 clinical trials.

What does Botulinum Toxin Type A target?

Botulinum Toxin Type A is a monoclonal antibody that targets the molecular mechanisms underlying facial wrinkles and hyperhidrosis. It is being investigated for its ability to treat lateral canthal lines and primary axillary hyperhidrosis by affecting the neuromuscular signaling that contributes to these conditions.

Who makes Botulinum Toxin Type A?

Botulinum Toxin Type A is being developed by Revance Therapeutics, Inc., a biopharmaceutical company traded under the ticker symbol RVNC. The company is conducting clinical trials to evaluate the safety and efficacy of this product for dermatological indications.

What phase is Botulinum Toxin Type A in?

Botulinum Toxin Type A is in Phase 2 clinical development. It is an investigational product and has not been approved by the FDA. Revance Therapeutics, Inc. has completed Phase 2 trials for lateral canthal lines and primary axillary hyperhidrosis, with all three completed trials being randomized, double-blind, and placebo-controlled.

What clinical trials is Botulinum Toxin Type A in?

Botulinum Toxin Type A has been studied in three completed Phase 2 clinical trials. These include NCT00968825, NCT00968942, and NCT01064518, which evaluated the treatment of moderate to severe lateral canthal lines, and NCT02565732, which assessed a topical gel formulation for primary axillary hyperhidrosis. All trials were conducted in the United States.

Is Botulinum Toxin Type A the same as RT001?

Botulinum Toxin Type A is also known as RT001 in clinical trials. The studies NCT00968825, NCT00968942, and NCT01064518 refer to RT001 when evaluating its safety and efficacy for treating lateral canthal lines, also known as crow's feet, in adult patients.