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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COMPLETED
PHASE1/PHASE2
72 participants
INTERVENTIONAL
2022-09-03
2024-06-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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AI-09 Dose 1
Dose 1 of botulinum toxin, Type A, intramuscular injection, administered once at baseline
AI-09
Botulinum toxin, Type A, intramuscular injection, administered once at baseline
Vehicle Dose 1
Vehicle, intramuscular injection, administered once at baseline
Vehicle
Vehicle Formulation
AI-09 Dose 2
Dose 2 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline
AI-09
Botulinum toxin, Type A, intramuscular injection, administered once at baseline
Vehicle Dose 2
Vehicle, intramuscular injection, administered once at baseline
Vehicle
Vehicle Formulation
AI-09 Dose 3
Dose 3 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline
AI-09
Botulinum toxin, Type A, intramuscular injection, administered once at baseline
Vehicle Dose 3
Vehicle, intramuscular injection, administered once at baseline
Vehicle
Vehicle Formulation
AI-09 Dose 4
Dose 4 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline
AI-09
Botulinum toxin, Type A, intramuscular injection, administered once at baseline
Vehicle Dose 4
Vehicle, intramuscular injection, administered once at baseline
Vehicle
Vehicle Formulation
AI-09 Dose 5
Dose 5 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline
AI-09
Botulinum toxin, Type A, intramuscular injection, administered once at baseline
Vehicle Dose 5
Vehicle, intramuscular injection, administered once at baseline
Vehicle
Vehicle Formulation
AI-09 Dose 6
Dose 6 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline
AI-09
Botulinum toxin, Type A, intramuscular injection, administered once at baseline
Vehicle Dose 6
Vehicle, intramuscular injection, administered once at baseline
Vehicle
Vehicle Formulation
AI-09 Dose 7
Dose 7 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline
AI-09
Botulinum toxin, Type A, intramuscular injection, administered once at baseline
Vehicle Dose 7
Vehicle, intramuscular injection, administered once at baseline
Vehicle
Vehicle Formulation
Interventions
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AI-09
Botulinum toxin, Type A, intramuscular injection, administered once at baseline
Vehicle
Vehicle Formulation
Eligibility Criteria
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Inclusion Criteria
* willingness to have their pictures taken
* 20 - 70 years of age
* moderate to severe glabellar lines (IGA 2-3) on contraction
* moderate to severe glabellar lines (SSA 2-3) on contraction
* none to mild glabellar lines wrinkles (IGA 0-1) at rest
* willingness to refrain from the use of facial fillers, retinoids, Botox, laser treatments, or any product affecting skin remodeling or that might cause an active dermal response during the course of the study
* female subjects of child-bearing potential must have a negative urine pregnancy test and be non-lactating at the Baseline visit
* female subjects of child-bearing potential must utilize one of the following methods of birth control throughout the study: IUD, diaphragm, a condom, a spermicidal gel or foam, oral contraceptives (provided subject has been utilizing this method for at least 4 months prior to Baseline and has not changed the brand within this period), or patch, injectable, implantable, or vaginal ring contraceptives. Subjects may also participate if they are surgically sterilized (tubal sterilization or hysterectomy)
* subjects 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
* excessive weakness or atrophy in the target muscle(s)
* eyelid ptosis
* 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 a 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
* subjects on clinically significant, concomitant drug therapy
* participation in another investigational drug trial or receiving any investigational treatment(s) within 30 days of Baseline
* alcohol or drug abuse within the past 3 years
* psychiatric disease interfering with the subject's ability to give informed consent
* refusal or inability to comply with the requirements of the protocol for any reason
20 Years
70 Years
ALL
Yes
Sponsors
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Eirion Therapeutics Inc.
INDUSTRY
Responsible Party
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Locations
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Eirion Research Site
Boca Raton, Florida, United States
Eirion Research Site
Miami, Florida, United States
Countries
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Other Identifiers
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AI-09-GL-101
Identifier Type: -
Identifier Source: org_study_id
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