A Study to Evaluate AI-09 In Participants With Glabellar Lines

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.

Inclusion criteria

• 20 to 70 years of age
• moderate to severe glabellar lines (IGA 2 to 3) at maximum frown
• moderate to severe glabellar lines (SSA 2 to 3) at maximum frown
• willingness to refrain from the use of facial fillers, retinoids, Botox®, laser
• female participants of child-bearing potential must have a negative urine pregnancy test and be non-lactating at the Baseline (Day 0) visit and must utilize birth control throughout the study
• participants should be in good general health as determined by the investigator and free of any disease that may interfere with study evaluations or the Investigational Product

Exclusion criteria

• the inability to substantially lessen glabellar lines by physically spreading them apart
• eyelid ptosis, and/ or excessive weakness or atrophy in the target muscle(s)
• presence or history of "dry eye"
• history of periocular surgery, brow lift or related procedures, or deep dermal scarring
• concurrent or recent (within the last 6 months) use of any other botulinum toxin drug product anywhere in the body
• history of immunization or hypersensitivity to any botulinum toxin serotype
• history of non-response to any prior botulinum toxin treatments anticipated need for treatment with botulinum toxin of any serotype for any reason during the trial (other than the investigational treatment)
• any medical condition that may put the subject at increased risk with exposure to botulinum toxin including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
• pregnancy or lactation
• application of any topical prescription medication to the treatment area within 14 days prior to treatment
• participation in another investigational drug trial or receiving any investigational treatment(s) within 30 days of Baseline (Day 0)
• alcohol or drug abuse within the past 3 years
• refusal or inability with the subject's ability to give informed consent or comply with the requirements of the protocol for any reason