A Study to Evaluate AI-09 In Participants With Glabellar Lines
Running, not enrolling · Phase 2
Conditions studied: Glabellar Lines
In brief
Phase 2 clinical study to evaluate the efficacy, safety, and tolerability of AI-09, a Ready-to-Use Liquid Injectable Botulinum Toxin.
Key facts
- Study ID
- NCT07321834
- Run by
- Eirion Therapeutics Inc.
- People needed
- 68
- Starts
- 2025-12-03
- Expected to finish
- 2026-02-01
- Last updated by the study team
- 2026-01-07
Who can join
Age: 20 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
- Research Your Health — Plano, Texas, United States
Full record on ClinicalTrials.gov
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