Topical Botulinum Toxin for Crow's Feet

Recruiting in Palo Alto (17 mi)

+27 other locations

Overseen by Klaus Theobald, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Eirion Therapeutics Inc.

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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

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.

Willing to have facial pictures/videos taken per protocol

Exclusion Criteria

History of adverse reactions to any prior botulinum toxin treatments

History of vaccination with botulinum toxin

I have not responded to previous botulinum toxin treatments.

Treatment Details

Interventions

• Botulinum Toxin Type A (Neurotoxin)

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.

Participant Groups

Group I: ET-01, Dose 2 Experimental Treatment 1 Intervention

Dose 2 of botulinum toxin, Type A, topical liniment, administered once at baseline. 250µm microneedle length

Group II: ET-01, Dose 1 Experimental Treatment 1 Intervention

Dose 1 of botulinum toxin, Type A, topical liniment, administered once at baseline. 250µm microneedle length

Group III: Vehicle Placebo Group 1 Intervention

Vehicle, topical liniment, administered once at baseline

Botulinum Toxin Type A is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Botox for:

• 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

🇪🇺 Approved in European Union as Botox for:

• 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

🇨🇦 Approved in Canada as Botox for:

• 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

Research Locations Nearby Select from list below to view details:

Eirion Research Site Exton, PA

Eirion Research Site Aventura, FL

Eirion Research Site New Orleans, LA

Eirion Research Site Plano, TX

More Trial Locations

Who Is Running the Clinical Trial?

Eirion Therapeutics Inc. Lead Sponsor

References