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botulinum toxin Type A

Phase 3

Upper Facial Rhytides | Monoclonal antibody | Other |AbbVie Inc.|Last Updated: Feb 10, 2015

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment101
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01797094BOTOX® in the Treatment of Upper Facial Lines in JapanPHASE3 COMPLETED 101 — — Feb 1, 2013Jul 1, 2014Feb 10, 20151 Japan
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Study Endpoints
Primary Endpoints
Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)
Day 30

The Investigator assessed the severity of the participant's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.

Secondary Endpoints
Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow's Feet Lines (SGA-CFL)
Day 30
Percentage of Participants With a ≥2-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30
Baseline, Day 30
Percentage of Participants With a ≥2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30
Baseline, Day 30
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Botulinum toxin Type A (44U)EXPERIMENTAL44 units (U) botulinum toxin Type A (total dose) per treatment. 24 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
Botulinum toxin Type A (32U)EXPERIMENTAL32 units (U) botulinum toxin Type A (total dose) per treatment. 12 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
Interventions
NameTypeDescription
botulinum toxin Type A (44U)BIOLOGICAL44 units botulinum toxin Type A (total dose) per treatment. 24 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area.
botulinum toxin Type A (32U)BIOLOGICAL32 units botulinum toxin Type A (total dose) per treatment. 12 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area.
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Eligibility Criteria
Age Range20 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: -Moderate to severe Crow's Feet Lines and Frown Lines Exclusion Criteria: * Current or previous botulinum toxin treatment of any serotype * Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis * Facial laser or light treatment for cosmetic purp...

Countries:Japan
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