ET-01 in Subjects With Lateral Canthal Lines, LCL-208

July 27, 2022 updated by: Eirion Therapeutics Inc.

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

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Miami, Florida, United States, 33137
        • Baumann Cosmetic & Research Institute
      • Pinellas Park, Florida, United States, 33781
        • Synexus, Inc.
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Forefront Dermatology
    • Texas
      • Austin, Texas, United States, 78746
        • Westlake Dermatology Clinical Research Center
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Clinical Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • females 25 - 65 years of age
  • minimal to moderate Crow's Feet wrinkles at rest
  • moderate to severe Crow's Feet 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
  • female subjects who are pregnant or are nursing a child

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle
Vehicle Formulation
Experimental: ET-01 345U
botulinum toxin, Type A, Dose 1, 345 U
topical liniment
Other Names:
  • ET-01
Experimental: ET-01 1100U
botulinum toxin, Type A, Dose 2, 1100 U
topical liniment
Other Names:
  • ET-01

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With a Response Defined as Change in IGA-C (Investigators Global Assessment) Score by at Least 2 Ordinals From Baseline to Week 4
Time Frame: Week 4
Investigators Global Assessment of the Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). Response is defined as change by at least two ordinals from Baseline to Week 4.
Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Number of Observations With a Response Defined as Change ≥2 in IGA-C and SSA-C Score at Any Post Baseline Visit
Time Frame: Week 1, 2, 4, 8,12,18, and 26
Total number of observations with a change in the Investigators Global Assessment on Contraction, IGA-C, and the Subject Self-Assessment on Contraction, SSA-C, using the Crow's Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as a change by at least two ordinals in both assessments. The observation period includes all post-baseline visits from Week 1 to Week 26.
Week 1, 2, 4, 8,12,18, and 26
Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Time Between Week 4 and Week 12
Time Frame: Week 4, 8,and 12
Total number of observations with a change by at least two ordinals in the Subjects Self-Assessment on Contraction, SSA-C, using the Crow's Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as an improvement ≥ 2 score points. The observation period covers the time time of expected peak efficacy from Week 4 to Week 12.
Week 4, 8,and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2018

Primary Completion (Actual)

April 18, 2019

Study Completion (Actual)

September 19, 2019

Study Registration Dates

First Submitted

February 8, 2019

First Submitted That Met QC Criteria

February 11, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

August 23, 2022

Last Update Submitted That Met QC Criteria

July 27, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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