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 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

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

Study Overview

• Status: Completed
• Conditions: Lateral Canthal Lines
• Intervention / Treatment: Biological: DaxibotulinumtoxinA for injection

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • Sacramento, CA Site
  • Florida
    • Sarasota, Florida, United States, 34239
      • Sarasota, FL Site
  • Illinois
    • Itasca, Illinois, United States, 60143
      • Itasca, IL Site
  • Virginia
    • Arlington, Virginia, United States, 22209
      • Arlington, VA Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: DAXI 12 U; DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)	Biological: DaxibotulinumtoxinA for injection; Intramuscular injection
Experimental: Cohort 2: DAXI 24 U; DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)	Biological: DaxibotulinumtoxinA for injection; Intramuscular injection
Experimental: Cohort 3: DAXI 36 U; DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)	Biological: DaxibotulinumtoxinA for injection; Intramuscular injection
Experimental: Cohort 4: DAXI 48 U; DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL)	Biological: DaxibotulinumtoxinA for injection; Intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With None or Mild in LCL Severity at Maximum Smile	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	Week 4 After LCL Treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The responder rate of DAXI for injection in the treatment of Lateral Canthal Lines (LCL)	The responder rate is determined by the proportion of subjects achieving a score of 0 or 1 (none or mild) in Lateral Canthal Lines (LCL) severity at maximum smile on the Patient Lateral Canthal Wrinkle Severity (PLCWS) scale at 4 weeks after Lateral Canthal Lines (LCL) treatment	Baseline-Week 36
The responder rate of DAXI for injection in the treatment of Lateral Canthal Lines (LCL)	The responder rate is determined by the proportion of subjects achieving an improvement of at least 1 point from baseline in LCL severity at maximum smile on the IGA-LCWS at Week 4 after LCL treatment	Baseline-Week 36

Collaborators and Investigators

• Sponsor: Revance Therapeutics, Inc.
• Investigators: Study Director: Dom Vitarella, Revance Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2019
• Primary Completion (Actual): April 23, 2020
• Study Completion (Actual): April 23, 2020

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: April 9, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: LCL; Lateral canthal wrinkle; Crow's feet lines
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 1820205

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No