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Trial record 18 of 720 for:    Botulinum Toxins, Type A

ET-01 in Subjects With Lateral Canthal Lines, LCL-207

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: NCT03655691
Recruitment Status : Completed
First Posted : August 31, 2018
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 Crow's Feet Biological: Vehicle Biological: Dose 1 Biological: Dose 2 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: parallel dose groups
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: different doses are packaged in identical containers
Primary Purpose: Treatment
Official Title: Clinical Trial to Evaluate ET-01 in Subjects With Lateral Canthal Lines
Actual Study Start Date : August 16, 2018
Actual Primary Completion Date : November 9, 2018
Actual Study Completion Date : April 10, 2019

Arm Intervention/treatment
Placebo Comparator: Vehicle
Vehicle / Placebo formulation
Biological: Vehicle
Vehicle Formulation
Other Name: ET-01

Experimental: Dose 1
lower dose of ET-01
Biological: Dose 1
botulinum toxin, Type A
Other Name: ET-01

Experimental: Dose 2
higher dose of ET-01
Biological: Dose 2
botulinum toxin, Type A
Other Name: ET-01




Primary Outcome Measures :
  1. Investigators Global Assessment (IGA) [ 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 to ordinals.


Secondary Outcome Measures :
  1. IGA [ 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. Subject's Self-Assessment (SSA) [ Time Frame: Week 1, 2, 4, 8,12,18, and 26 ]
    Subject's 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

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 25 - 65 years of age
  • minimal to moderate Crow's Feet wrinkles at rest
  • moderate to severe Crow's Feet wrinkles on contraction
  • willingness to refrain from any product affecting skin remodeling
  • female subjects must be not pregnant and non-lactating

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): NCT03655691


Locations
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United States, Florida
Baumann Cosmetic & Research Institute
Miami, Florida, United States, 33137
Radiant Research, Inc.
Pinellas Park, Florida, United States, 33781
Research Institute of the Southeast, LLC
West Palm Beach, Florida, United States, 33401
United States, Louisiana
Dermatology NOLA Inc.
Metairie, Louisiana, United States, 70006
United States, Texas
Westlake Dermatology Clinical Research Center
Austin, Texas, United States, 78746
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Eirion Therapeutics Inc.
Investigators
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Study Director: Klaus Theobald, MD, PhD Eirion Therapeutics

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Responsible Party: Eirion Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03655691     History of Changes
Other Study ID Numbers: ET-01-LCL-207
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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