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

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

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

Study Overview

• Status: Completed
• Conditions: Crow's Feet; Lateral Canthal Lines, LCL
• Intervention / Treatment: Biological: Vehicle; Biological: botulinum toxin, Type A

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Eirion Research Site
  • California
    • San Diego, California, United States, 92121
      • Eirion Research Site
  • Florida
    • Aventura, Florida, United States, 33180
      • Eirion Research Site
    • Boca Raton, Florida, United States, 33486
      • Eirion Research Site
    • Miami, Florida, United States, 33137
      • Eirion Research Site
    • West Palm Beach, Florida, United States, 33401
      • Eirion Research Site
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Eirion Research Site
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Eirion Research Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70124
      • Eirion Research Site
  • Maryland
    • Glenn Dale, Maryland, United States, 20769
      • Eirion Research Site
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Eirion Research Site
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Eirion Research Site
  • New York
    • New York, New York, United States, 10075
      • Eirion Research Site
  • Pennsylvania
    • Exton, Pennsylvania, United States, 19341
      • Eirion Research Site
    • Newtown Square, Pennsylvania, United States, 19073
      • Eirion Research Site
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Eirion Research Site
  • Texas
    • Houston, Texas, United States, 77056
      • Eirion Research Site
    • Plano, Texas, United States, 75093
      • Eirion Research Site
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Eirion Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
• female subjects of childbearing potential must utilize one of the following methods of birth control throughout the study: intra-uterine device (IUD), diaphragm, a condom, a spermicidal gel or foam, oral contraceptives (provided subject has been utilizing this method for at least 3 months prior to Baseline and has not changed the brand within this period), or patch, injectable, implantable, or vaginal ring contraceptives. Subjects may also participate if they are surgically sterilized (tubal sterilization or hysterectomy) or are in menopause.
• subjects should be in good general health as determined by the Investigator and free of any disease that may interfere with study evaluations or the Investigational Product.

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
• subjects on clinically significant, concomitant drug therapy (See Section 5.3 below).).
• present or history of neuromuscular disease, eyelid ptosis, muscle weakness or paralysis
• present or history of "dry eye"
• hemophilia, hemorrhagic disorder, hemostatic dysfunction or other blood clotting disorders
• use of systemic aminoglycosides in the week prior to treatment application
• participation in another investigational drug trial or receiving any investigational treatment(s) within 30 days of Baseline
• alcohol or drug abuse within the past 3 years
• psychiatric disease interfering with the subject's ability to give informed consent
• refusal or inability to comply with the requirements of the protocol for any reason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle; Vehicle, topical liniment, administered once at baseline	Biological: Vehicle; topical liniment without investigational product; Other Names: ET-01 Vehicle
Experimental: ET-01, Dose 1; Dose 1 of botulinum toxin, Type A, topical liniment, administered once at baseline. 250µm microneedle length	Biological: botulinum toxin, Type A; ET-01 topical liniment; Other Names: ET-01
Experimental: ET-01, Dose 2; Dose 2 of botulinum toxin, Type A, topical liniment, administered once at baseline. 250µm microneedle length	Biological: botulinum toxin, Type A; ET-01 topical liniment; Other Names: ET-01

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IGA (Investigators Global Assessment)	Investigators Global Assessment. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe).	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IGA (Investigators Global Assessment)	Investigators Global Assessment. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe).	Week 2, 4, 8,12, and 18
SSA (Subject Self-Assessment)	Subject Self-Assessment. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe).	Week 2, 4, 8,12, and 18

Collaborators and Investigators

• Sponsor: Eirion Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2021
• Primary Completion (Actual): February 8, 2024
• Study Completion (Actual): February 8, 2024

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Neurotransmitter Agents; Membrane Transport Modulators; Cholinergic Agents; Neuromuscular Agents; Acetylcholine Release Inhibitors; Botulinum Toxins, Type A; abobotulinumtoxinA; Botulinum Toxins
• Other Study ID Numbers: ET-01-LCL-210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No