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

Sponsor
Eirion Therapeutics Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04985916
Collaborator
(none)
120
Enrollment
9
Locations
3
Arms
17.4
Anticipated Duration (Months)
13.3
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Vehicle
  • Biological: botulinum toxin, Type A
 Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
vehicle controlled, parallel groupvehicle controlled, parallel group
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Trial to Evaluate ET-01 in Subjects With Lateral Canthal Lines
Actual Study Start Date :
Jul 19, 2021
Actual Primary Completion Date :
Sep 30, 2021
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

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

    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

    Biological: botulinum toxin, Type A
    ET-01 topical liniment
    Other Names:
  • ET-01

    		•

    Outcome Measures

    Primary Outcome Measures

    1. IGA (Investigators Global Assessment) [Week 4]

      Investigators Global Assessment. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe).

    Secondary Outcome Measures

    1. IGA (Investigators Global Assessment) [Week 2, 4, 8,12, and 18]

      Investigators Global Assessment. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe).

    2. SSA (Subject Self-Assessment) [Week 2, 4, 8,12, and 18]

      Subject Self-Assessment. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • adults 25 - 65 years of age

    • mild or less Crow's Feet wrinkles (IGA 0-2) "at rest"

    • moderate to severe Crow's Feet (IGA 3-4) "on contraction"

    • adequate vision to assess facial wrinkles in a mirror

    • willingness to refrain from products affecting skin remodeling

    • female subjects must be not pregnant and non-lactating

    • subjects should be in good general health

    Exclusion Criteria:

    • history of adverse reactions to any prior botulinum toxin treatments

    • history of vaccination or non-response to any prior botulinum toxin treatments

    • botulinum toxin treatment in the prior 6 months

    • present or history of neuromuscular disease, eyelid ptosis, muscle weakness, paralysis, or "dry eye"

    • history of peri-ocular surgery, brow lift or related procedures

    • procedures affecting the lateral canthal region in the prior 12 months

    • application of topical prescription medication to the treatment area

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center for Clinical and Cosmetic Research Aventura Florida United States 33180
    2 Skin Care Research, LLc Boca Raton Florida United States 33486
    3 Baumann Cosmetic & Research Institute Miami Florida United States 33137
    4 Research Institute of the Southeast, LLC West Palm Beach Florida United States 33401
    5 DS Research Louisville Kentucky United States 40241
    6 Lupo Center for Aesthetic & General Dermatology New Orleans Louisiana United States 70124
    7 The Pennsylvania Centre for Dermatology, LLC Exton Pennsylvania United States 19341
    8 KGL Skin Study Center Newtown Square Pennsylvania United States 19073
    9 Virginia Clinical Research, Inc. Norfolk Virginia United States 23502

    Sponsors and Collaborators

    • Eirion Therapeutics Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eirion Therapeutics Inc.
    ClinicalTrials.gov Identifier:
    NCT04985916
    Other Study ID Numbers:
    • ET-01-LCL-210
    First Posted:
    Aug 2, 2021
    Last Update Posted:
    May 9, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Botulinum Toxins
    Botulinum Toxins, Type A
    abobotulinumtoxinA

    Study Results

    No Results Posted as of May 9, 2022