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

Eirion Therapeutics

Status and phase

Active, not recruiting

Phase 2

Conditions

Glabellar Lines

Treatments

Biological: AI-09 Ready Use Injectable Botulinum Toxin

Biological: Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT07321834

AI-09-GL-201

Details and patient eligibility

About

Phase 2 clinical study to evaluate the efficacy, safety, and tolerability of AI-09, a Ready-to-Use Liquid Injectable Botulinum Toxin.

Full description

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.

Enrollment

68 patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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