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Neurotoxin
Topical Botulinum Toxin for Crow's Feet
Phase 2
Waitlist Available
Led By Klaus Theobald, MD, PhD
Research Sponsored by Eirion Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female subjects of childbearing potential must utilize one of the specified methods of birth control throughout the study
Willingness to refrain from the use of facial fillers, retinoids, botulinum toxins, laser treatments, or any product affecting skin remodeling or that might cause an active dermal response during the course of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2, 4, 8,12, and 18
Awards & highlights
Study Summary
This trial is testing the effectiveness of botulinum toxin type A as a topical cream for treating wrinkles near the corners of the eyes.
Who is the study for?
This trial is for adults aged 25-65 with moderate to severe Crow's Feet wrinkles when they squint but mild or no wrinkles at rest. Participants must be able to assess their own wrinkles, avoid certain skin treatments, and use approved birth control if applicable. They should be in good health without conditions that could affect the study.Check my eligibility
What is being tested?
The study examines ET-01, a topical form of botulinum toxin Type A, for treating lateral canthal lines (Crow's Feet). It compares the effects of this new formulation against a placebo (vehicle) applied directly to the affected area.See study design
What are the potential side effects?
While specific side effects are not listed here, typical reactions to botulinum toxins may include temporary muscle weakness near where it's applied, eyelid drooping, dry eye symptoms, and local reactions like redness or swelling.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am using a specified birth control method during the study.
Select...
I agree not to use facial fillers, retinoids, or similar treatments during the study.
Select...
I am between 25 and 65 years old.
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I am not pregnant or breastfeeding and have a negative pregnancy test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 2, 4, 8,12, and 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 2, 4, 8,12, and 18
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
IGA (Investigators Global Assessment)
SSA (Subject Self-Assessment)
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: ET-01, Dose 2Experimental Treatment1 Intervention
Dose 2 of botulinum toxin, Type A, topical liniment, administered once at baseline. 250µm microneedle length
Group II: ET-01, Dose 1Experimental Treatment1 Intervention
Dose 1 of botulinum toxin, Type A, topical liniment, administered once at baseline. 250µm microneedle length
Group III: VehiclePlacebo Group1 Intervention
Vehicle, topical liniment, administered once at baseline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
botulinum toxin, Type A
2018
Completed Phase 2
~240
Find a Location
Who is running the clinical trial?
Eirion Therapeutics Inc.Lead Sponsor
5 Previous Clinical Trials
312 Total Patients Enrolled
Klaus PJ Theobald, MD, PhDStudy DirectorEirion Therapeutics
Klaus Theobald, MD, PhDPrincipal InvestigatorEirion Therapeutics
4 Previous Clinical Trials
240 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My Crow's Feet wrinkles are mild or not noticeable without facial expressions.You can see well enough to check your own wrinkles in a mirror.I have moderate to severe wrinkles around my eyes when I smile or squint.I have moderate to severe wrinkles around my eyes when I smile or squint.You agree not to use any products that change the structure of your skin.I have moderate to severe wrinkles around my eyes when I smile or squint.I have not responded to previous botulinum toxin treatments.I have had surgery around my eyes or a brow lift.I have used prescription-strength retinoids on the treatment area in the last 3 months.I have or have had dry eye.I have not had any botulinum toxin treatments in the last 6 months.I am using a specified birth control method during the study.I agree not to use facial fillers, retinoids, or similar treatments during the study.I have a bleeding or blood clotting disorder.I am between 25 and 65 years old.I haven't had dermabrasion or laser treatment near my eyes in the last 6 months.I am currently taking medication that has a major impact on my health.I have or had a muscle-related disease or weakness.I am unable to follow the study's requirements.I haven't used prescription skin treatments in the last 14 days.I have not taken any aminoglycoside antibiotics in the last week.I haven't had any cosmetic procedures near the corner of my eye in the last year.I am not pregnant or breastfeeding and have a negative pregnancy test.I have moderate to severe wrinkles around my eyes when I smile or squint.I have moderate to severe wrinkles around my eyes when I smile.You have only a few, mild wrinkles around your eyes when your face is not making any expressions.
Research Study Groups:
This trial has the following groups:- Group 1: Vehicle
- Group 2: ET-01, Dose 1
- Group 3: ET-01, Dose 2
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.
Crow's Feet Patient Testimony for trial: Trial Name: NCT04985916 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who are the ideal candidates for participating in this trial?
"This trial is recruiting up to 280 participants aged 25-65 years with mild to severe lateral canthal lines (lcl). Furthermore, all applicants must possess satisfactory visual acuity for facial wrinkle assessment in a mirror, be abstinent from skin remodelling agents, and not pregnant or lactating. Finally, it's essential that the subject has no pre-existing health conditions which could affect their candidacy."
Answered by AI
Are recruitment opportunities still available for this research project?
"According to the most recent clinicaltrials.gov data, this medical trial is not presently recruiting participants. It was initially posted on July 19th 2021 and its last update occurred in October 24th 2022. Despite that, there are 3 additional studies actively seeking candidates at present."
Answered by AI
Are elderly individuals being incorporated into this research project?
"This clinical study has an upper and lower age limit of 65 years and 25 years respectively."
Answered by AI
What is the geographic distribution of this experiment?
"At present, 9 medical centres are active for this trial. Locations include West Palm Beach, New Orleans and Aventura along with 6 other sites. To reduce the need to travel extensively, it is advised that participants select a nearby location when enrolling in the study."
Answered by AI
What risks do individuals face when exposed to botulinum toxin, Type A?
"Botulinum Toxin, Type A was given a rating of 2 out of 3 on our safety scale as this is a Phase 2 clinical trial. There are some data suggesting its safety but none that demonstrate efficacy."
Answered by AI
Who else is applying?
What state do they live in?
Louisiana
Florida
What site did they apply to?
Research Institute of the Southeast, LLC
Eirion Research Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
3+
Why did patients apply to this trial?
I’ve tried varies products and nothing seems to be helping. I'm very concerned about aging and I have crossfits that are coming in.
PatientReceived no prior treatments
I've been a trial subject in the past and enjoy contributing to science and development.
PatientReceived 2+ prior treatments
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