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

Study Overview
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Brief Summary
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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)

Official Title
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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)

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

Intervention / Treatment
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* Drug: DaxibotulinumtoxinA for injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAXI 40 U GL / 32 U FHL / 48 U LCL<br>DaxibotulinumtoxinA for injection for the treatment of moderate to severe Glabellar Lines (GL), Forehead Lines (FHL), & Lateral Canthal Lines (LCL) | Drug: DaxibotulinumtoxinA for injection<br>* Intramuscular injection<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lateral Canthal Wrinkle, crow's feet lines, LCL, Forehead Lines, Glabellar Lines, Frown Lines, Upper facial lines