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Neurotoxin
Botulinum Toxin Type A for Frown Lines
Phase 1 & 2
Waitlist Available
Research Sponsored by Eirion Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1, 2, 4, 8, 12, 18 (week 26 assessments for cohorts 4, 5 & 6)
Summary
This trial is testing a new treatment called AI-09 to see if it can safely and effectively reduce frown lines between the eyebrows. It focuses on people who have these lines and want to lessen their appearance.
Who is the study for?
This trial is for adults aged 20-70 with moderate to severe frown lines when contracting their forehead muscles, but none to mild at rest. Participants must not use facial treatments that affect skin during the study and women of childbearing age need a negative pregnancy test and birth control. People can't join if they have muscle weakness in the area, dry eye, recent botulinum toxin use, or conditions affecting neuromuscular function.
What is being tested?
The GL-101 trial tests AI-09 against a placebo (vehicle) in reducing glabellar (frown) lines. Participants will be randomly assigned to receive either AI-09 or a placebo treatment and will be photographed to assess changes in their frown lines over time.
What are the potential side effects?
Potential side effects may include localized reactions like pain at the injection site, headache, eyelid drooping (ptosis), dry eye symptoms due to muscle relaxation near the eyes after receiving AI-09 which is similar to other botulinum toxin products.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1, 2, 4, 8, 12, 18 (week 26 assessments for cohorts 4, 5 & 6)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1, 2, 4, 8, 12, 18 (week 26 assessments for cohorts 4, 5 & 6)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Investigators Global Assessment (IGA)
Secondary study objectives
Total Number of Observations With a Response Defined as Change ≥2 in IGA-C and SSA-C Score
Trial Design
14Treatment groups
Experimental Treatment
Placebo Group
Group I: AI-09 Dose 7Experimental Treatment1 Intervention
Dose 7 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline
Group II: AI-09 Dose 6Experimental Treatment1 Intervention
Dose 6 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline
Group III: AI-09 Dose 5Experimental Treatment1 Intervention
Dose 5 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline
Group IV: AI-09 Dose 4Experimental Treatment1 Intervention
Dose 4 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline
Group V: AI-09 Dose 3Experimental Treatment1 Intervention
Dose 3 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline
Group VI: AI-09 Dose 2Experimental Treatment1 Intervention
Dose 2 of botulinum toxin, Type A, intra-muscular injection, administered once at baseline
Group VII: AI-09 Dose 1Experimental Treatment1 Intervention
Dose 1 of botulinum toxin, Type A, intramuscular injection, administered once at baseline
Group VIII: Vehicle Dose 7Placebo Group1 Intervention
Vehicle, intramuscular injection, administered once at baseline
Group IX: Vehicle Dose 4Placebo Group1 Intervention
Vehicle, intramuscular injection, administered once at baseline
Group X: Vehicle Dose 1Placebo Group1 Intervention
Vehicle, intramuscular injection, administered once at baseline
Group XI: Vehicle Dose 2Placebo Group1 Intervention
Vehicle, intramuscular injection, administered once at baseline
Group XII: Vehicle Dose 3Placebo Group1 Intervention
Vehicle, intramuscular injection, administered once at baseline
Group XIII: Vehicle Dose 5Placebo Group1 Intervention
Vehicle, intramuscular injection, administered once at baseline
Group XIV: Vehicle Dose 6Placebo Group1 Intervention
Vehicle, intramuscular injection, administered once at baseline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AI-09
2022
Completed Phase 2
~80
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatment for frown lines involves the use of neuromodulators like botulinum toxin type A. These agents work by blocking the release of acetylcholine, a neurotransmitter responsible for muscle contraction.
By inhibiting acetylcholine release, these neuromodulators reduce muscle activity in the treated area, leading to a temporary relaxation of the facial muscles that cause wrinkles. This mechanism is crucial for patients with frown lines as it directly addresses the underlying cause of the wrinkles, providing a smoother and more youthful appearance.
Muscarinic modulation of neurotransmission: the effects of some agonists and antagonists.Novel Antimuscarinic Antidepressant-like Compounds with Reduced Effects on Cognition.Facial blanching due to neurotoxins: proposed mechanisms.
Muscarinic modulation of neurotransmission: the effects of some agonists and antagonists.Novel Antimuscarinic Antidepressant-like Compounds with Reduced Effects on Cognition.Facial blanching due to neurotoxins: proposed mechanisms.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Eirion Therapeutics Inc.Lead Sponsor
5 Previous Clinical Trials
520 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My eyelid droops.I have or had dry eye condition.My targeted muscles are very weak or have shrunk significantly.I am currently taking medication that has a major impact on my health.I haven't used prescription skin treatments on the area for 2 weeks.I am between 20 and 70 years old.I am willing to have my pictures taken for the study.I have moderate to severe frown lines between my eyebrows.I am using reliable birth control or am surgically sterilized.I have mild to moderate forehead wrinkles even when my face is relaxed.I agree not to use facial fillers, Botox, or similar treatments during the study.I do not have conditions like myasthenia gravis that affect muscle control.I have no or mild forehead wrinkles when my face is relaxed.I am unable or unwilling to follow the study's requirements.I have not responded to previous botulinum toxin treatments.I have had eye area surgery, brow lift, or have deep scars.I expect to need botulinum toxin treatment for a condition during the trial.I have used a botulinum toxin product in the last 6 months.I am not pregnant or breastfeeding.I have moderate to severe frown lines between my eyebrows.I have moderate to severe frown lines between my eyebrows.I have moderate to severe frown lines between my eyebrows.I am willing to have my pictures taken.I am between 20 and 70 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Vehicle Dose 7
- Group 2: Vehicle Dose 4
- Group 3: AI-09 Dose 7
- Group 4: Vehicle Dose 1
- Group 5: Vehicle Dose 2
- Group 6: Vehicle Dose 3
- Group 7: AI-09 Dose 3
- Group 8: Vehicle Dose 5
- Group 9: AI-09 Dose 2
- Group 10: AI-09 Dose 4
- Group 11: AI-09 Dose 6
- Group 12: AI-09 Dose 1
- Group 13: AI-09 Dose 5
- Group 14: Vehicle Dose 6
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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