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Trial record 18 of 724 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.

Tracking Information
First Submitted Date  ICMJE August 30, 2018
First Posted Date  ICMJE August 31, 2018
Last Update Posted Date July 3, 2019
Actual Study Start Date  ICMJE August 16, 2018
Actual Primary Completion Date November 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03655691 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2019)
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
  • IGA [ Time Frame: Week 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).
  • Subject's Self-Assessment (SSA) [ Time Frame: Week 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ET-01 in Subjects With Lateral Canthal Lines, LCL-207
Official Title  ICMJE Clinical Trial to Evaluate ET-01 in Subjects With Lateral Canthal Lines
Brief Summary This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).
Detailed Description This product is being tested for its ability to reduce lateral canthal lines, also known as Crow's Feet.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Lateral Canthal Lines
  • Crow's Feet
Intervention  ICMJE
  • Biological: Vehicle
    Vehicle Formulation
    Other Name: ET-01
  • Biological: Dose 1
    botulinum toxin, Type A
    Other Name: ET-01
  • Biological: Dose 2
    botulinum toxin, Type A
    Other Name: ET-01
Study Arms  ICMJE
  • Placebo Comparator: Vehicle
    Vehicle / Placebo formulation
    Intervention: Biological: Vehicle
  • Experimental: Dose 1
    lower dose of ET-01
    Intervention: Biological: Dose 1
  • Experimental: Dose 2
    higher dose of ET-01
    Intervention: Biological: Dose 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2019)
79
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2018)
75
Actual Study Completion Date  ICMJE April 10, 2019
Actual Primary Completion Date November 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03655691
Other Study ID Numbers  ICMJE ET-01-LCL-207
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eirion Therapeutics Inc.
Study Sponsor  ICMJE Eirion Therapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Klaus Theobald, MD, PhD Eirion Therapeutics
PRS Account Eirion Therapeutics Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP