Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

ET-01 in Subjects With Lateral Canthal Lines, LCL-209

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03912805
Recruitment Status : Active, not recruiting
First Posted : April 11, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Eirion Therapeutics Inc.

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
Lateral Canthal Lines, LCL Crow's Feet Biological: botulinum toxin, Type A Biological: Vehicle Phase 2

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: vehicle 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 : February 28, 2019
Actual Primary Completion Date : May 2, 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Placebo Comparator: Vehicle
Vehicle, topical liniment, administered once at baseline
Biological: Vehicle
Vehicle Formulation

Experimental: ET-01
botulinum toxin, Type A, topical liniment, administered once at baseline
Biological: botulinum toxin, Type A
topical liniment
Other Name: ET-01




Primary Outcome Measures :
  1. IGA (Investigators Global Assessment) [ Time Frame: 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) [ Time Frame: Week 1, 2, 4, 8,12,18, and 26 ]
    Investigators Global Assessment. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe).

  2. SSA (Subject Self-Assessment) [ Time Frame: Week 1, 2, 4, 8,12,18, and 26 ]
    Subject Self-Assessment. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912805


Locations
Layout table for location information
United States, Florida
Synexis, Inc.
Pinellas Park, Florida, United States, 33781
United States, Pennsylvania
Yardley Dermatology Associates
Yardley, Pennsylvania, United States, 19067
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Eirion Therapeutics Inc.
Investigators
Layout table for investigator information
Study Director: Klaus Theobald, MD, PhD Eirion Therapeutics

Layout table for additonal information
Responsible Party: Eirion Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03912805     History of Changes
Other Study ID Numbers: ET-01-LCL-209
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents