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

Frown Lines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03786770
• Other study ID #: 1820202
• Status: Completed
• Phase: Phase 2
• Start date: January 24, 2019
• Est. completion date: March 9, 2020

Study information

• Verified date: January 2023
• Source: Revance Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 9, 2020
• Est. primary completion date: March 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Frown Lines

Intervention

Biological:
• DaxibotulinumtoxinA for injection
Intramuscular injection

Locations

Country	Name	City	State
Canada	Toronto, Ontario site	Toronto	Ontario
Canada	Woodbridge, Ontario site	Woodbridge	Ontario
United States	Boca Raton site	Boca Raton	Florida
United States	Coral Gables site	Coral Gables	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Revance Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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