Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Forehead Lines (Frontalis)
Condition: Frown Lines
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
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Forehead Lines; Glabellar Lines; Frown Lines

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.
    

Eligibility criteria:

        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