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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Frown Lines

Intervention / Treatment
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* Biological: 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 (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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Dose A<br>DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) | Biological: DaxibotulinumtoxinA for injection<br>* Intramuscular injection<br>|
| Experimental: Cohort 2: Dose B<br>DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) | Biological: DaxibotulinumtoxinA for injection<br>* Intramuscular injection<br>|
| Experimental: Cohort 3: Dose C<br>DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) | Biological: DaxibotulinumtoxinA for injection<br>* Intramuscular injection<br>|
| Experimental: Cohort 4: Dose D<br>DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL) | Biological: 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Forehead Lines, Glabellar Lines, Frown Lines