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
• Interventions: Biological: DaxibotulinumtoxinA for injection

• 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

Arm && Interventions

Group	Intervention	Description
Cohort 4: DAXI 48 U	DaxibotulinumtoxinA for injection	DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
Cohort 1: DAXI 12 U	DaxibotulinumtoxinA for injection	DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
Cohort 2: DAXI 24 U	DaxibotulinumtoxinA for injection	DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)
Cohort 3: DAXI 36 U	DaxibotulinumtoxinA for injection	DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)

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)

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

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

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

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