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BOTOX purified neurotoxin complex

Phase 2

Platysma Prominence | Small molecule | Other |AbbVie Inc.|Last Updated: May 3, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment171
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03915067BOTOX® for the Treatment of Platysma ProminencePHASE2 COMPLETED 171 — — Apr 23, 2019Apr 16, 2020May 3, 202312 United States, Canada
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Study Endpoints
Primary Endpoints
Percentage of Participants With at Least 1-Grade Improvement at Day 14 as Rated by Investigator Using the Clinician Allergan Platysma Prominence Scale (C-APPS)
Day 14

The investigator evaluated the participant's platysma prominence severity using a 5-grade scale C-APPS at maximum contraction where 1= minimal, and 5= extreme. Higher values indicate worsening condition. Data is reported for participants who achieved at least a 1-grade improvement rated on the C-APPS. Percentages are rounded off to whole number at the nearest decimal. Cochran-Mantel-Haenszel (CMH) chi-squared test was used for analysis.

Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE)
From the first dose of study drug up to end of study (up to Day 120)

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. Treatment-emergent adverse events are defined as any event that began or worsened in severity on or after the first dose of study drug or any AE that was present before the first dose of study intervention, but increased in severity or became serious after the first dose of study intervention.

Pulse Rate at Baseline
Baseline (Day 1)

Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.

Change From Baseline in Pulse Rate at Day 7
Baseline; Day 7

Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.

Change From Baseline in Pulse Rate at Day 14
Baseline; Day 14

Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.

Change From Baseline in Pulse Rate at Day 30
Baseline; Day 30

Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.

Change From Baseline in Pulse Rate at Day 60
Baseline; Day 60

Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.

Change From Baseline in Pulse Rate at Day 90
Baseline; Day 90

Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.

Change From Baseline in Pulse Rate at Day 120
Baseline; Day 120

Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.

Systolic and Diastolic Blood Pressure (BP) at Baseline
Baseline (Day 1)

Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.

Change From Baseline in Systolic and Diastolic BP at Day 7
Baseline; Day 7

Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.

Change From Baseline in Systolic and Diastolic BP at Day 14
Baseline; Day 14

Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.

Change From Baseline in Systolic and Diastolic BP at Day 30
Baseline; Day 30

Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.

Change From Baseline in Systolic and Diastolic BP at Day 60
Baseline; Day 60

Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.

Change From Baseline in Systolic and Diastolic BP at Day 90
Baseline; Day 90

Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.

Change From Baseline in Systolic and Diastolic BP at Day 120
Baseline; Day 120

Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.

Respiratory Rate at Baseline
Baseline (Day 1)

Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.

Change From Baseline in Respiratory Rate at Day 7
Baseline; Day 7

Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.

Change From Baseline in Respiratory Rate at Day 14
Baseline; Day 14

Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.

Change From Baseline in Respiratory Rate at Day 30
Baseline; Day 30

Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.

Change From Baseline in Respiratory Rate at Day 60
Baseline; Day 60

Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.

Change From Baseline in Respiratory Rate at Day 90
Baseline; Day 90

Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.

Change From Baseline in Respiratory Rate at Day 120
Baseline; Day 120

Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.

Secondary Endpoints
Percentage of Participants With at Least a 1-Grade Improvement at Day 14 as Rated by Participant Using the Participant Allergan Platysma Prominence Scale (P-APPS)
Day 14
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORParticipants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
BOTOX® Low DoseEXPERIMENTALParticipants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
BOTOX® High DoseACTIVE_COMPARATORParticipants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
Interventions
NameTypeDescription
BOTOX® purified neurotoxin complexDRUGBOTOX® superficial intramuscular injections.
PlaceboDRUGPlacebo injections.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period * A female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization), not breas...

Countries:United StatesCanada
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