Topical Botulinum Toxin for Crow's Feet
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new topical treatment for crow's feet, the wrinkles around the eyes. Researchers are testing a special formulation of botulinum toxin Type A (commonly known as Botox), applied directly to the skin. The study includes different groups, with one receiving a placebo and others trying various doses of the treatment. Ideal participants have noticeable crow's feet when smiling or squinting and have not had recent cosmetic treatments around the eyes. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop taking my current medications for the trial?
The trial requires you to stop using any topical prescription medications on the treatment area within 14 days before treatment. It also mentions that participants should not be on clinically significant, concomitant drug therapy, but it doesn't specify which medications. It's best to discuss your current medications with the trial team to see if they are allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that botulinum toxin Type A is generally safe and well-tolerated for treating facial lines, such as crow's feet. Research on similar treatments, like BOTOX Cosmetic, indicates that most side effects are mild and temporary, with common issues including slight redness or swelling at the application site. This study uses a cream form of the treatment, potentially resulting in even fewer side effects since it avoids needles. Although exact data for this cream is not yet available, existing evidence is promising. The treatment's approval for other uses suggests its safety.12345
Why are researchers excited about this trial's treatments?
Unlike the standard treatments for crow's feet, which often involve injections of botulinum toxin, this new approach uses a topical application of Botulinum Toxin Type A. Researchers are excited about this because it offers a non-invasive alternative, potentially reducing discomfort and side effects associated with injections. The treatment uses a unique delivery method with microneedles that help the toxin penetrate the skin effectively, offering a promising new way to smooth out those pesky wrinkles around the eyes.
What evidence suggests that this treatment might be an effective treatment for Crow's Feet?
Research has shown that botulinum toxin type A effectively treats facial lines, such as crow's feet. It blocks nerve signals to muscles, reducing muscle activity and smoothing out wrinkles. Previous studies found that this treatment significantly lessens the appearance of crow's feet, making it a popular choice for reducing facial wrinkles. In this trial, ET-01, a cream form of botulinum toxin, is under study specifically for crow's feet. Early results suggest it might offer similar benefits to injectable forms, potentially providing a non-invasive way to reduce wrinkles.36789
Who Is on the Research Team?
Klaus PJ Theobald, MD, PhD
Principal Investigator
Eirion Therapeutics
Klaus Theobald, MD, PhD
Principal Investigator
Eirion Therapeutics
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single topical application of ET-01 or placebo at baseline
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Botulinum Toxin Type A
Trial Overview
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.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Dose 2 of botulinum toxin, Type A, topical liniment, administered once at baseline. 250µm microneedle length
Dose 1 of botulinum toxin, Type A, topical liniment, administered once at baseline. 250µm microneedle length
Vehicle, topical liniment, administered once at baseline
Botulinum Toxin Type A is already approved in United States, European Union, Canada for the following indications:
- Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
- Temporary improvement in the appearance of moderate to severe facial wrinkles and folds
- Axillary hyperhidrosis
- Blepharospasm
- Strabismus
- Cervical dystonia
- Chronic migraine
- Overactive bladder
- Detrusor overactivity associated with a neurologic condition
- Glabellar lines
- Facial wrinkles and folds
- Axillary hyperhidrosis
- Blepharospasm
- Strabismus
- Cervical dystonia
- Chronic migraine
- Overactive bladder
- Detrusor overactivity associated with a neurologic condition
- Spasticity of the upper limb
- Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
- Temporary improvement in the appearance of moderate to severe facial wrinkles and folds
- Axillary hyperhidrosis
- Blepharospasm
- Strabismus
- Cervical dystonia
- Chronic migraine
- Overactive bladder
- Detrusor overactivity associated with a neurologic condition
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eirion Therapeutics Inc.
Lead Sponsor
Citations
Treatment of crow's feet lines and forehead lines with Botox ...
OnabotulinumtoxinA is a highly effective treatment for facial lines that inhibits acetylcholine release at the neuromuscular junction.
Efficacy of Botulinum Toxin Type A in Reducing Facial ...
Methods: This review examines clinical outcomes across various facial areas, including glabellar lines, crow's feet, and forehead lines, ...
A Single-Center Retrospective Clinical Study in Vietnam
The objective of this study was to compare the efficacy of different botulinum toxin type A injection patterns for the treatment of crow's feet.
ET-01 in Subjects With Lateral Canthal Lines, LCL-208
This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL). Detailed Description. This ...
Botulinum toxin type A for facial wrinkles - Camargo, CPires
Botulinum toxin type A (BontA) is the most frequent treatment for facial wrinkles, but its effectiveness and safety have not previously been ...
Safety and tolerability of onabotulinumtoxinA in ...
Meta-analysis examining the safety of onabotulinumtoxinA for treatment of glabellar lines (GL), crow's feet lines (CFL), and forehead lines (FHL). Methods.
3803291 This label may not be the latest approved by FDA ...
Postmarketing safety data from BOTOX Cosmetic and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond ...
Safety and Efficacy Study of Botulinum Toxin Type A for the ...
This study will evaluate the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of Crow's Feet Lines and Frown Lines ...
BOTOX® (onabotulinumtoxinA) and BOTOX® Cosmetic
... BOTOX Cosmetic has been used at the recommended dose to treat frown lines, crow's feet lines, forehead lines, or platysma bands. INDICATIONS. BOTOX is a ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.