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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 uses including hyperhidrosis, glabellar frown lines, skin aging, and lateral canthal lines, commonly called crow's feet. It is an investigational product being studied for these cosmetic and medical skin conditions.

Who makes Botulinum Toxin Type A?

Revance Therapeutics, Inc. (NASDAQ: RVNC) is developing Botulinum Toxin Type A. The company is conducting clinical trials of this investigational product for facial wrinkle treatments, including lateral canthal lines and glabellar frown lines.

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. All completed trials for this product are Phase 2 studies, with no active trials currently listed.

What clinical trials is Botulinum Toxin Type A in?

Botulinum Toxin Type A has completed three Phase 2 trials: NCT00968825, NCT00968942, and NCT01064518, all studying treatment of moderate to severe lateral canthal lines. A fourth trial, NCT02303002, studied glabellar frown lines. All trials were completed in the United States and Canada.

Is Botulinum Toxin Type A the same as RT001?

Yes, Botulinum Toxin Type A is the same as RT001. Clinical trials NCT00968825 and NCT00968942 refer to RT001 in their titles, studying the same product for lateral canthal lines, also known as crow's feet or facial wrinkles.