Topical Botulinum Toxin for Crow's Feet

Recruiting at 27 trial locations

Overseen By PATRICK MURPHY

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eirion Therapeutics Inc.

Must not be taking: Aminoglycosides, Retinoids

Disqualifiers: Neuromuscular disease, Hemophilia, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 1 day

280 Participants Needed

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.

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.

What data supports the effectiveness of the drug Botulinum Toxin Type A for treating crow's feet?

Research shows that Botulinum Toxin Type A is effective in treating crow's feet, as several studies have demonstrated its ability to reduce these wrinkles. The studies highlight its effectiveness compared to a placebo, although the optimal dose is still being determined. ^{1 2 3 4 5}

How is the drug Botulinum Toxin Type A unique for treating crow's feet?

Botulinum Toxin Type A is unique for treating crow's feet because it is applied topically (on the skin) and works by temporarily relaxing the muscles that cause wrinkles, unlike other treatments that may involve injections or different mechanisms. ^{1 2 3 4 6}

Research Team

Klaus PJ Theobald, MD, PhD

Principal Investigator

Eirion Therapeutics

Klaus Theobald, MD, PhD

Principal Investigator

Eirion Therapeutics

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single topical application of ET-01 or placebo at baseline

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 weeks

5 visits (in-person) at weeks 2, 4, 8, 12, and 18

Treatment Details

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.

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

Who Is Running the Clinical Trial?

Eirion Therapeutics Inc.

Lead Sponsor

Trials

6

Recruited

590+

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of botulinum toxin type A in the treatment of lateral crow's feet: double-blind, placebo-controlled, dose-ranging study. [2010]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of two botulinum toxin type A preparations for treating crow's feet: a split-face, double-blind, proof-of-concept study. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

Double-blind, randomized, placebo-controlled, dose-response study of the safety and efficacy of botulinum toxin type A in subjects with crow's feet. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Bilateral, double-blind, randomized comparison of 3 doses of botulinum toxin type A and placebo in patients with crow's feet. [2010]

5. United States pubmed.ncbi.nlm.nih.gov

A double-blinded, randomized, placebo-controlled pilot study of the safety and efficacy of Myobloc (botulinum toxin type B)-purified neurotoxin complex for the treatment of crow's feet: a double-blinded, placebo-controlled trial. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

A Comparative In Vivo Study on Three Treatment Approaches to Applying Topical Botulinum Toxin A for Crow's Feet. [2022]