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Completed

NCT Number: NCT03912805

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

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

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Key information

Conditions

Lateral Canthal Lines, LCL Crow's Feet

Age range

25 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Synexis, Inc., Pinellas Park, Florida, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin, Type A

Biological

topical liniment

Other names: ET-01 1610U

Vehicle

Biological

Vehicle Formulation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 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 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.

Sponsors and collaborators

Lead sponsor

Eirion Therapeutics Inc.

Industry

Registry information

Official study title

Clinical Trial to Evaluate ET-01 in Subjects With Lateral Canthal Lines

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2019
Registry last updated
Jul 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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