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

Phase 2

Completed

Conditions: Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines)

Brief Summary: 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)

Recruitment & Eligibility

Inclusion Criteria

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
Be outpatient, male or female subjects, in good general health, 18 years of age or older
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)
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)
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)
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

Active skin disease, infections, or inflammation at the injection sites
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 a 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

Arm && Interventions

Group	Intervention	Description
DAXI 40 U GL / 32 U FHL / 48 U LCL	DaxibotulinumtoxinA for injection	DaxibotulinumtoxinA for injection for the treatment of moderate to severe Glabellar Lines (GL), Forehead Lines (FHL), \& Lateral Canthal Lines (LCL)

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With None or Mild in GL Severity at Maximum Frown	Week 4	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
Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation	Week 4	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
Percentage of Participants With None or Mild in LCL Severity at Maximum Smile Effort	Week 4	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

Secondary Outcome Measures

Name	Time	Method

Locations (8): Site 7
🇺🇸
Santa Monica, California, United States
Site 4
🇨🇦
Vancouver, British Columbia, Canada
Site 1
🇺🇸
Manhattan Beach, California, United States
Site 3
🇺🇸
San Diego, California, United States
Site 5
🇺🇸
Coral Gables, Florida, United States
Site 6
🇺🇸
New York, New York, United States
Site 2
🇺🇸
Chestnut Hill, Massachusetts, United States
Site 8
🇨🇦
Toronto, Ontario, Canada