A Study to Evaluate AI-09 In Participants With Glabellar Lines (NCT07321834) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Evaluate AI-09 In Participants With Glabellar Lines
United States68 participantsStarted 2025-12-03
Plain-language summary
Phase 2 clinical study to evaluate the efficacy, safety, and tolerability of AI-09, a Ready-to-Use Liquid Injectable Botulinum Toxin.
Who can participate
Age range20 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-…
What they're measuring
1
IGA-C
Timeframe: From enrollment (baseline) to the Week 04 Visit