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

Phase 2

Completed

• Conditions: Lateral Canthal Lines

• Registration Number: NCT03911102
• Lead Sponsor: Revance Therapeutics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-11
• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-04-09
• Study First Posted: 2019-04-10
• Primary Completion: 2020-04-23
• Study Completion: 2020-04-23
• Disposition First Submitted: 2021-02-11
• Disposition First Submitted QC: 2021-02-11
• Disposition First Posted: 2021-02-12
• Status Verified: 2023-06
• Results First Submitted: 2023-06-02
• Results First Submitted QC: 2023-06-02
• Last Update Submitted: 2023-06-02
• Results First Posted: 2023-06-27
• Last Update Posted: 2023-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With None or Mild in LCL Severity at Maximum Smile	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

Trial Locations

Locations (4)

Sacramento, CA Site; 🇺🇸 Sacramento, California, United States

Sarasota, FL Site; 🇺🇸 Sarasota, Florida, United States

Itasca, IL Site; 🇺🇸 Itasca, Illinois, United States

Arlington, VA Site; 🇺🇸 Arlington, Virginia, United States