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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 Aging
NCT02580370450
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PHASE3COMPLETED
Efficacy and Safety Study of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines
Skin Aging
NCT01776606247
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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
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

CompanyTickerTrialsLead PhaseDrugs
Krystal Biotech, Inc.KRYS2PHASE1KB304, 0.9% Normal Saline
Century Therapeutics, Inc.IPSC1N/AUndisclosed
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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 developed for dermatology indications including lateral canthal lines, hyperhidrosis, skin aging, and glabellar frown lines. It is an investigational product studied for cosmetic and therapeutic uses, with clinical trials focusing on crow's feet lines and primary axillary hyperhidrosis.

Who makes Botulinum Toxin Type A?

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

What phase is Botulinum Toxin Type A in?

Botulinum Toxin Type A is in Phase 2 clinical development, with completed trials including Phase 2 and Phase 3 studies. It is an investigational product, not yet approved by regulatory authorities, and remains under clinical investigation for its proposed dermatology indications.

What clinical trials is Botulinum Toxin Type A in?

Botulinum Toxin Type A has completed three clinical trials: NCT01776606, a Phase 3 study of 247 participants for skin aging; NCT01940991, a Phase 2 study of 82 participants for skin aging; and NCT02565732, a Phase 2 study of 67 participants for hyperhidrosis. All trials were conducted in the United States.

Is Botulinum Toxin Type A the same as other botulinum toxin products?

Botulinum Toxin Type A is a specific formulation being developed by Revance Therapeutics. While it shares the active ingredient class with other botulinum toxin type A products, this particular product is distinct in its development and delivery method, as it is being studied as a topical gel for certain indications.