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

Last updated: December 6, 2024
Sponsor: Eirion Therapeutics Inc.
Overall Status: Completed

Phase

2

Condition

N/A

Treatment

botulinum toxin, Type A

Vehicle

Clinical Study ID

NCT04985916
ET-01-LCL-210
  • Ages 25-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 amirror (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 anactive dermal response during the course of the study

  • female subjects of childbearing potential must have a negative urine pregnancy testand be non-lactating at the Baseline visit

  • female subjects of childbearing potential must utilize one of the following methodsof birth control throughout the study: intra-uterine device (IUD), diaphragm, acondom, a spermicidal gel or foam, oral contraceptives (provided subject has beenutilizing this method for at least 3 months prior to Baseline and has not changedthe brand within this period), or patch, injectable, implantable, or vaginal ringcontraceptives. 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 freeof any disease that may interfere with study evaluations or the InvestigationalProduct.

Exclusion

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 inthe past

  • history of periocular surgery, brow lift or related procedures

  • soft tissue augmentation or any procedures affecting the lateral canthal region inthe 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 14days prior to treatment

  • subjects on clinically significant, concomitant drug therapy (See Section 5.3below).).

  • present or history of neuromuscular disease, eyelid ptosis, muscle weakness orparalysis

  • present or history of "dry eye"

  • hemophilia, hemorrhagic disorder, hemostatic dysfunction or other blood clottingdisorders

  • use of systemic aminoglycosides in the week prior to treatment application

  • participation in another investigational drug trial or receiving any investigationaltreatment(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 Design

Total Participants: 280
Treatment Group(s): 2
Primary Treatment: botulinum toxin, Type A
Phase: 2
Study Start date:
July 19, 2021
Estimated Completion Date:
February 08, 2024

Study Description

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

Connect with a study center

  • Eirion Research Site

    Scottsdale, Arizona 85255
    United States

    Site Not Available

  • Eirion Research Site

    San Diego, California 92121
    United States

    Site Not Available

  • Center for Clinical and Cosmetic Research

    Aventura, Florida 33180
    United States

    Site Not Available

  • Eirion Research Site

    Aventura, Florida 33180
    United States

    Site Not Available

  • Eirion Research Site

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Skin Care Research, LLc

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Baumann Cosmetic & Research Institute

    Miami, Florida 33137
    United States

    Site Not Available

  • Eirion Research Site

    Miami, Florida 33137
    United States

    Site Not Available

  • Eirion Research Site

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Research Institute of the Southeast, LLC

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Eirion Research Site

    Chicago, Illinois 60654
    United States

    Site Not Available

  • DS Research

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Eirion Research Site

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Eirion Research Site

    New Orleans, Louisiana 70124
    United States

    Site Not Available

  • Lupo Center for Aesthetic & General Dermatology

    New Orleans, Louisiana 70124
    United States

    Site Not Available

  • Eirion Research Site

    Glenn Dale, Maryland 20769
    United States

    Site Not Available

  • Eirion Research Site

    Clinton Township, Michigan 48038
    United States

    Site Not Available

  • Eirion Research Site

    New Brighton, Minnesota 55112
    United States

    Site Not Available

  • Eirion Research Site

    New York, New York 10075
    United States

    Site Not Available

  • Eirion Research Site

    Exton, Pennsylvania 19341
    United States

    Site Not Available

  • The Pennsylvania Centre for Dermatology, LLC

    Exton, Pennsylvania 19341
    United States

    Site Not Available

  • Eirion Research Site

    Newtown Square, Pennsylvania 19073
    United States

    Site Not Available

  • KGL Skin Study Center

    Newtown Square, Pennsylvania 19073
    United States

    Site Not Available

  • Eirion Research Site

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Eirion Research Site

    Houston, Texas 77056
    United States

    Site Not Available

  • Eirion Research Site

    Plano, Texas 75093
    United States

    Site Not Available

  • Eirion Research Site

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia 23502
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.