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OpenTrials
Completed

NCT Number: NCT03911102

Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines

A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Treatment of Moderate or Severe Lateral Canthal Lines (LCL).

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Key information

Conditions

Lateral Canthal Lines

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sacramento, CA Site, Sacramento, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provide written informed consent consistent with International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP) guidelines and local laws, including authorization to release health information, signed prior to any study procedures being performed
  • Be outpatient, male or female subjects, in good general health, 18-65 years old
  • Have a score of moderate (2) or severe (3) LCL at maximum smile effort as assessed by the IGA-LCWS
  • Able to understand the requirements of the study and be willing and able to follow all study procedures, attend all scheduled visits, and successfully complete the study.

Exclusion criteria

  • Active skin disease, infections, or inflammation at the injection sites
  • History of clinically significant bleeding disorders
  • Clinically significant laboratory values at screening that may interfere with a subject's ability to complete the study, as determined by the investigator
  • Planned or anticipated need for surgery or hospitalization through the end of the study
  • Pregnant, nursing, or planning a pregnancy during the study; or is Women of Child Bearing Potential (WOCBP) but is not willing to use an effective method of contraception
  • Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to screening through the end of the study

Treatment and study plan

DaxibotulinumtoxinA for injection

Biological

Intramuscular injection

Primary outcomes

  1. Percentage of Participants With None or Mild in LCL Severity at Maximum Smile

    Time frame: Week 4 After LCL Treatment

    Percentage of subjects achieving a score or 0 or 1 (none or mild) in LCL severity at maximum smile at Week 4 after LCL treatment on the Investigator Global Assessment Lateral Canthal Wrinkle Severity (IGA-LCWS) scale

Sponsors and collaborators

Lead sponsor

Revance Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Efficacy, Safety, and Duration of Benefit of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 10, 2019
Registry last updated
Jun 27, 2023

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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