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Completed

NCT Number: NCT03326856

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).

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Key information

Conditions

Lateral Canthal Lines Crow's Feet

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cary Skin Care

Cary, North Carolina, 27519, United States

About this study

This product is being tested for its ability to reduce lateral canthal lines, 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

  • 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

Treatment and study plan

Botulinum Toxin, Type A

Biological

topical liniment

Other names: ET-01

Vehicle

Biological

Vehicle Formulation

Primary outcomes

  1. Number of Participants With a Response Defined as IGA-C (Investigators Global Assessment) Score ≤ 2 and a SSA-C (Subject Self-Assessment) Score ≤ 2

    Time frame: Week 4

    Composite of Investigators Global Assessment & Subject Self-Assessment on contraction.

    Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). The same scale is used for the Investigator's Assessment as well as the Subject's Self Assessment. To count, both assessments (on contraction) have to be "responders" defined as Score ≤ 2.

Secondary outcomes

  1. Total Number of Observations With a Response Defined as IGA-C Score ≤ 2

    Time frame: Week 2, 4, 8,12,18

    Total number of observations with a Score of ≤ 2 on the Investigators Global Assessment on Contraction, IGA-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 Score ≤ 2. The observation period ranges from the earliest expected onset of action at Week 2 to the likely offset of action by Week 18.

  2. Total Number of Observations With a Response Defined as SSA-C Score ≤ 2

    Time frame: Week 2, 4, 8,12,18

    Total number of observations with a Score of ≤ 2 on 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 Score ≤ 2. The observation period ranges from the earliest expected onset of action at Week 2 to the likely offset of action by Week 18.

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
2017
Primary completion
2018
Study completion
2018
First posted
Oct 31, 2017
Registry last updated
Apr 21, 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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