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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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