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ET-01 in Subjects With Lateral Canthal Lines, LCL-210

Clinical Trial to Evaluate ET-01 in Subjects With Lateral Canthal Lines

NCT04985916•Eirion Therapeutics Inc.

Summary

This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).

Detailed Description

This product is being tested for its ability to reduce lateral canthal lines (LCL), also known as Crow's Feet.

Eligibility

Age

25 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•able to understand and give written informed consent
•25 - 65 years of age
•willing to have facial pictures/videos taken per protocol
•mild or less Crow's Feet wrinkles (IGA 0-2) "at rest"
•moderate to severe Crow's Feet (IGA 3-4) "on contraction"
•ability to correctly grade a series of Crow's Feet pictures
•moderate to severe Crow's Feet (SSA 3-4) "on contraction"
•have adequate vision without the use of eyeglasses to assess facial wrinkles in a mirror (contact lenses are OK)
•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
•female subjects of childbearing potential must have a negative urine pregnancy test and be non-lactating at the Baseline visit
+2 more criteria

Exclusion Criteria

•history of adverse reactions to any prior botulinum toxin treatments
•history of vaccination with botulinum toxin
•history of non-response to any prior botulinum toxin treatments
•any botulinum toxin treatment anywhere in the prior 6 months
•history of participation in ET-01-LCL-210 in previous Cohorts 1 or 2 at any time in the past
•history of periocular surgery, brow lift or related procedures
•soft tissue augmentation or any procedures affecting the lateral canthal region in the prior 12 months
•dermabrasion or laser treatment in the periocular region in the last 6 months
•topical prescription-strength retinoids in the prior 3 months to the treatment area
•application of any topical prescription medication to the treatment area within 14 days prior to treatment
+9 more criteria

Locations (19)

Eirion Research Site

Scottsdale, Arizona, United States

Eirion Research Site

San Diego, California, United States

Eirion Research Site

Aventura, Florida, United States

Eirion Research Site

Boca Raton, Florida, United States

Eirion Research Site

Miami, Florida, United States

Eirion Research Site

West Palm Beach, Florida, United States

Eirion Research Site

Chicago, Illinois, United States

Eirion Research Site

Louisville, Kentucky, United States

Eirion Research Site

New Orleans, Louisiana, United States

Eirion Research Site

Glenn Dale, Maryland, United States

Key Dates

Start Date

July 19, 2021

Primary Completion Date

February 8, 2024

Completion Date

February 8, 2024

Last Updated

December 9, 2024

Enrollment

280

ACTUAL participants

Conditions

Lateral Canthal Lines, LCLCrow's Feet

Interventions

Vehicle

BIOLOGICAL

botulinum toxin, Type A

BIOLOGICAL

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A Study Comparing DMSB01 and Rejuran® for Temporary Crow's Feet Lines Improvement

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ET-01 in Subjects With Lateral Canthal Lines, LCL-210

Inclusion Criteria

Exclusion Criteria

A Study on the Anti-Wrinkle Efficacy Assessment and Safety Evaluation of the Cluster of Autologous Dermal Fibroblast on Bilateral Crow's Feet

A Study Comparing DMSB01 and Rejuran® for Temporary Crow's Feet Lines Improvement

Efficacy and Safety of DKB-119 in Patients in Crow's Feet

Evaluate the Safety and Efficacy of Botulax® as Compared to Botox® in Subject With Moderate to Severe Crow's Feet Lines

BOTOX® in the Treatment of Crow's Feet Lines in Japan

Patient Satisfaction Study of Combined Facial Treatment With BOTOX® Cosmetic, JUVÉDERM® and LATISSE® (HARMONY Study)