Glabellar Lines
Conditions
Keywords
Botulinum Toxin, Ready to use, Glabellar Lines, AI-09-GL-201
Brief summary
Phase 2 clinical study to evaluate the efficacy, safety, and tolerability of AI-09, a Ready-to-Use Liquid Injectable Botulinum Toxin.
Detailed 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.
Interventions
BIOLOGICALAI-09 Ready Use Injectable Botulinum Toxin
AI-09 Ready Use Injectable Botulinum Toxin
BIOLOGICALVehicle
Vehicle
Sponsors
Eirion Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double Blind
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IGA-C | From enrollment (baseline) to the Week 04 Visit | 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. |
Countries
United States
Outcome results
None listed