A Study to Evaluate AI-09 In Participants With Glabellar Lines
NCT ID: NCT07321834
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
68 participants
INTERVENTIONAL
2025-12-03
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active Treatment
AI-09
AI-09 Ready Use Injectable Botulinum Toxin
AI-09 Ready Use Injectable Botulinum Toxin
Vehicle
Vehicle
Vehicle
Vehicle
Interventions
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AI-09 Ready Use Injectable Botulinum Toxin
AI-09 Ready Use Injectable Botulinum Toxin
Vehicle
Vehicle
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
70 Years
ALL
No
Sponsors
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Eirion Therapeutics Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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AI-09-GL-201
Identifier Type: -
Identifier Source: org_study_id
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