Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Upper Facial Lines
Condition: Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines)
MeSH terms: Facies
Intervention: DaxibotulinumtoxinA for injection
Intervention description: Intramuscular injection
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lateral Canthal Wrinkle; crow's feet lines; LCL; Forehead Lines; Glabellar Lines; Frown Lines; Upper facial lines

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)
    

Eligibility criteria:

        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