Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Forehead Lines (Frontalis)

A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for the Treatment of Dynamic Forehead Lines (Frontalis) Following Glabellar Line Injections

This is a phase 2a, multicenter, open-label, dose-escalation study to evaluate treatment of moderate or severe dynamic forehead lines (FHL) (frontalis) in conjunction with treatment of the glabellar complex.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5R3N8
      • Toronto, Ontario site
    • Woodbridge, Ontario, Canada, L4L8E2
      • Woodbridge, Ontario Site
• United States
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Boca Raton site
    • Coral Gables, Florida, United States, 33146
      • Coral Gables site

Participation Criteria

Eligibility Criteria

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

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 of age
• Have a score of moderate (2) or severe (3) FHL during maximum contraction (eyebrow elevation) as assessed by the Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS)
• Have a score of moderate (2) or severe (3) FHL during maximum contraction (eyebrow elevation) as assessed by the Patient Forehead Wrinkle Severity (PFHWS)
• Have a score of moderate (2) or severe (3) GL during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale
• Have a score of moderate (2) or severe (3) on GL during maximum frown as assessed by the Patient Frown Wrinkle Severity (PFWS)
• Be willing to refrain from receiving facial fillers, laser treatments, use of any product that affects skin remodeling, or a product that may cause an active dermal response in the treatment areas (e.g., above the inferior orbital rim) from screening through the end of the study
• 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
• Plans to receive botulinum toxin type A anywhere in the face (other than study treatment) from screening through the end of the study
• History of clinically significant bleeding disorders
• Non-ablative laser or light treatments, microdermabrasion, or chemical peels (medium depth or deeper, for example trichloroacetic acid (TCA) or phenol) in the treatment areas within 3 months before enrollment through the end of the study
• Clinically significant laboratory values at screening that may interfere with a subject's ability to complete the study as determined by the investigator
• History of upper or lower lid blepharoplasty or brow lift
• Prior periorbital or forehead surgery

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: Dose A; DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)	Biological: DaxibotulinumtoxinA for injection; Intramuscular injection
Experimental: Cohort 2: Dose B; DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)	Biological: DaxibotulinumtoxinA for injection; Intramuscular injection
Experimental: Cohort 3: Dose C; DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)	Biological: DaxibotulinumtoxinA for injection; Intramuscular injection
Experimental: Cohort 4: Dose D; DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)	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 FHL Severity at Maximum Eyebrow Elevation	Percentage of subjects achieving a score of 0 or 1 (none or mild) in FHL severity at maximum eyebrow elevation at 4 weeks after FHL treatment (Week 6) on the 4-point Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) scale where 0 indicates the lowest severity and 3 indicates the highest severity.	Week 4 After FHL Treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the responder rate of DAXI for injection in the treatment of Forehead Lines in conjunction with treatment for Glabellar Lines.	Proportion of subjects achieving an improvement of at least 1 point from baseline on the IGA FHWS.	Baseline-Week 36

Collaborators and Investigators

• Sponsor: Revance Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2019
• Primary Completion (Actual): March 9, 2020
• Study Completion (Actual): March 9, 2020

Study Registration Dates

• First Submitted: December 21, 2018
• First Submitted That Met QC Criteria: December 21, 2018
• First Posted (Actual): December 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Glabellar Lines; Frown Lines; Forehead 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: 1820202

Drug and device information, study documents

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