What side effects are associated with this type of intervention?

Common side effects of Botulinum Toxin Type A treatments for Crow's Feet include localized pain, bruising, swelling, and redness at the injection site. Patients may also experience headaches, flu-like symptoms, or temporary eyelid drooping. Rare but serious side effects can include muscle weakness in areas distant from the injection site and allergic reactions.

What prior FDA approvals exist?

Botulinum Toxin Type A, commonly known under brand names such as Botox, Dysport, and Xeomin, has been FDA-approved for the treatment of Crow's Feet. These treatments work by inhibiting acetylcholine release, causing temporary muscle paralysis and reducing the appearance of wrinkles. Botox was the first to receive FDA approval for this indication, followed by other formulations like Dysport and Xeomin, which offer similar mechanisms of action and efficacy.

What other types of research exist?

Promising novel alternatives to ET-01 for treating Crow's Feet include: 1) MT10107 (Coretox), a new formulation of botulinum toxin A, which has shown efficacy in treating spasticity and may offer similar benefits for aesthetic applications. 2) Non-invasive neuromodulation techniques, such as focused ultrasound or radiofrequency treatments, which can reduce wrinkles by stimulating collagen production and tightening the skin. 3) Peptide-based topical treatments that target neuromuscular junctions to reduce muscle contractions and smooth wrinkles. These alternatives are currently being explored in clinical trials and may become viable options in 2024.

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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

Must not have

History of non-response to any prior botulinum toxin treatments

History of periocular surgery, brow lift or related procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 2, 4, 8,12, and 18

Summary

This trial tests a topical cream or gel with botulinum toxin to reduce Crow's Feet by relaxing the muscles under the skin. Botulinum toxin has been used in various treatments, including for excessive sweating and muscle relaxation.

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.

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.

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 below

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I am using a specified birth control method during the study.

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I agree not to use facial fillers, retinoids, or similar treatments during the study.

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I am between 25 and 65 years old.

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I am not pregnant or breastfeeding and have a negative pregnancy test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not responded to previous botulinum toxin treatments.

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I have had surgery around my eyes or a brow lift.

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I have or have had dry eye.

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I have a bleeding or blood clotting disorder.

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I haven't had dermabrasion or laser treatment near my eyes in the last 6 months.

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I have or had a muscle-related disease or weakness.

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I am unable to follow the study's requirements.

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I have not taken any aminoglycoside antibiotics in the last week.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2, 4, 8,12, and 18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

IGA (Investigators Global Assessment)

Secondary study objectives

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

2021

Completed Phase 2

~520

0 / 12Eligibility criteria met

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

Botulinum Toxin Type A, commonly used to treat Crow's Feet, works by inhibiting the release of acetylcholine, a neurotransmitter that triggers muscle contractions. This inhibition results in temporary muscle paralysis, which smooths out the wrinkles and fine lines around the eyes. This mechanism is crucial for Crow's Feet patients as it directly addresses the muscle activity causing these wrinkles, offering a non-surgical method to achieve a more youthful appearance.

Increased quantal size in transmission at slow but not fast neuromuscular synapses of apolipoprotein E deficient mice.