Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Upper Facial Lines

A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection (DAXI for Injection) for the Combined Treatment of Upper Facial Lines (Glabellar Lines, Dynamic Forehead Lines and Lateral Canthal Lines)

This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of DaxibotulinumtoxinA for injection (DAXI for injection) in the treatment of Glabellar Lines (GL), Dynamic Forehead Lines (FHL), and Lateral Canthal Lines(LCL)

Study Overview

• Status: Completed
• Conditions: Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines)
• Intervention / Treatment: Drug: DaxibotulinumtoxinA for injection

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E1
      • Site 4
  • Ontario
    • Toronto, Ontario, Canada, M5R3N8
      • Site 8
• United States
  • California
    • Manhattan Beach, California, United States, 90266
      • Site 1
    • San Diego, California, United States, 92121
      • Site 3
    • Santa Monica, California, United States, 90404
      • Site 7
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Site 5
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Site 2
  • New York
    • New York, New York, United States, 10028
      • Site 6

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Provide written informed consent consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines and local laws, including authorization to release health information, signed prior to any study procedures being performed
2. Be outpatient, male or female subjects, in good general health, 18 years of age or older
3. Have a score of moderate (2) or severe (3) Glabellar Lines during maximum contraction as assessed by the Investigator Global Assessment-Frown Wrinkle Severity (IGA-FWS) and Patient Frown Wrinkle Severity (PFWS)
4. Have a score of moderate (2) or severe (3) Forehead Lines during maximum contraction as assessed by the Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) and Patient Forehead Wrinkle Severity (PFHWS)
5. Have a score of moderate (2) or severe (3) Lateral Canthal Lines at maximum contraction as assessed by the Investigator Global Assessment of Lateral Canthal Wrinkle Severity (IGA-LCWS) and Patient Lateral Canthal Wrinkle Severity (PLCWS) (scores must be consistent bilaterally for each scale considered separately)
6. Able to understand the requirements of the study and be willing and able to follow all study procedures, attend all scheduled visits, comprehend and complete the questionnaires without outside assistance and successfully complete the study

Exclusion Criteria:

1. Active skin disease, infections, or inflammation at the injection sites
2. Planned or anticipated need for surgery or hospitalization through the end of the study
3. Pregnant, nursing, or planning a pregnancy during the study; or is a Women of Child Bearing Potential (WOCBP) but is not willing to use an effective method of contraception
4. Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DAXI 40 U GL / 32 U FHL / 48 U LCL; DaxibotulinumtoxinA for injection for the treatment of moderate to severe Glabellar Lines (GL), Forehead Lines (FHL), & Lateral Canthal Lines (LCL)	Drug: 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 GL Severity at Maximum Frown	The percentage of subjects achieving a score of 0 (none) or 1 (mild) in GL severity at maximum contraction (maximum frown) at Week 4 as assessed by the IGA-FWS	Week 4
Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation	The percentage of subjects achieving a score of 0 (none) or 1 (mild) in FHL severity at maximum contraction (maximum eyebrow elevation) at Week 4 as assessed by the IGA-FHWS	Week 4
Percentage of Participants With None or Mild in LCL Severity at Maximum Smile Effort	The percentage of subjects achieving a score of 0 (none) or 1 (mild) in LCL severity at maximum contraction (maximum smile effort) at Week 4 as assessed by the IGA-LCWS	Week 4

Other Outcome Measures

Outcome Measure	Time Frame
Incidence, severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the overall study duration. [ Time Frame: Screening - Week 36 ]	Screening - 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): December 6, 2019
• Primary Completion (Actual): November 2, 2020
• Study Completion (Actual): November 2, 2020

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 6, 2020

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: Glabellar Lines; Frown Lines; Forehead Lines; LCL; Lateral Canthal Wrinkle; crow's feet lines; Upper facial lines
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies; 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: 1920201

Drug and device information, study documents

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