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Botulinum Toxin Type A

Phase 3

Glabellar Lines | Small molecule | Other |GSK plc|Last Updated: May 31, 2017

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 Enrollment256
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00408785A Study Of BOTOX For The Treatment Of Glabellar LinesPHASE3 COMPLETED 256 — — Nov 1, 2006May 9, 2007May 31, 20174 China
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Study Endpoints
Primary Endpoints
The investigator's rating of Glabellar line severity at maximum frown
Day 30 after injection
Secondary Endpoints
Investigator's rating of Glabellar line severity at rest, subject's global assessment of change in appearance of glabellar lines, the subject's perception of age and safety evaluations.
Day 7, 30, 60, 90, 120 after injection
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTALInjection
BPLACEBO_COMPARATORInjection
Interventions
NameTypeDescription
Botulinum Toxin Type ADRUGbotulinum toxin type A 100 units, human serum albumin 0.5 mg, sodium chloride 0.9 mg
sodium chlorideDRUGsodium chloride 0.9 mg
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion criteria: * Male and female adult with Glabellar lines of at least moderate severity at maximum frown by investigator's assessment. Exclusion criteria: * Patients with systemic nerve conduction junction disorder or patients with infection or other skin disease/surgery at injection sites...

Countries:China
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