Phase 2 clinical study to evaluate the efficacy, safety, and tolerability of AI-09, a Ready-to-Use Liquid Injectable Botulinum Toxin.
This is a Phase 2, multicenter, out-patient, prospectively randomized, double-blind, vehicle-controlled, multi-center clinical study to evaluate the efficacy, safety, and tolerability of AI-09, a Ready-to-Use Liquid Injectable Botulinum Toxin, administered to participants with glabellar lines. The study is designed as a single dose study evaluating AI-09 at a dose of versus Vehicle.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
68
AI-09 Ready Use Injectable Botulinum Toxin
Vehicle
Center for Clinical and Cosmetic Research
Aventura, Florida, United States
Research Institute of the Southeast, Inc.
West Palm Beach, Florida, United States
Delricht Research
New Orleans, Louisiana, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
IGA-C
Change from Baseline (CfB) in IGA-C (Investigator Global Assessment on Contraction) as assessed using the 4-point Glabellar Line Severity Scale (GLS), with score "3" being Severe and score "0" being None.
Time frame: From enrollment (baseline) to the Week 04 Visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Your Health
Plano, Texas, United States