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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)
Awards & highlights
Study Summary
This trial found that the use of botulinum toxin type A significantly improved the appearance of glabellar lines.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Investigators Global Assessment (IGA)
Secondary outcome measures
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 1Placebo Group1 Intervention
Vehicle, intramuscular injection, administered once at baseline
Group X: Vehicle Dose 2Placebo Group1 Intervention
Vehicle, intramuscular injection, administered once at baseline
Group XI: Vehicle Dose 4Placebo 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
Find a Location
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: AI-09 Dose 7
- Group 3: Vehicle Dose 1
- Group 4: Vehicle Dose 2
- Group 5: AI-09 Dose 3
- Group 6: Vehicle Dose 4
- Group 7: Vehicle 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study recruiting elderly participants?
"The specified age range for eligible participants is 20 to 70 years old, as outlined in the study's inclusion criteria."
Answered by AI
What is the current enrollment limit for this medical experiment?
"Yes, the research available on clinicaltrials.gov implies that this medical study is presently looking for participants. This trial was initiated on October 3rd 2022 and has been updated most recently on October 11th 2022. A total of 72 patients are needed from a single location to complete recruitment goals."
Answered by AI
Are there any opportunities for volunteers to join this clinical trial?
"Affirmative. According to clinicaltrials.gov, this research endeavour has been recruiting since October 3rd 2022 and is still searching for participants - 72 patients from a single medical centre."
Answered by AI
To whom is enrollment in this trial open?
"The current clinical trial is seeking 72 participants of 20 to 70 years old with existing arterial lines. In order for a patient to be eligible, they must demonstrate the capability to grant informed consent and agree to have their photograph taken throughout the study. Additionally, those involved may not use facial fillers, retinoids, Botox or any product that could affect skin remodeling as well as need satisfy one form of birth control method if female and child-bearing potential. Furthermore, all individuals should be in good health with no underlying diseases which might impede assessment results during treatment before being accepted into the investigation. Finally, women must also pass a"
Answered by AI
Who else is applying?
What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Eirion Research Site
Baumann Cosmetic & Research Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have lines that i would like treated. Looking for no charge Botox or similar product.
PatientReceived 1 prior treatment
I was planning on Botox treatment for my frown lines but I rather go through a clinical trial and have my frown lines treated for free.
PatientReceived 1 prior treatment
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