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

Phase 2

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Cohort 2: Dose B	DaxibotulinumtoxinA for injection	DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)
Cohort 3: Dose C	DaxibotulinumtoxinA for injection	DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)
Cohort 1: Dose A	DaxibotulinumtoxinA for injection	DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)
Cohort 4: Dose D	DaxibotulinumtoxinA for injection	DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation	Week 4 After FHL Treatment	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.

Secondary Outcome Measures

Name	Time	Method

Locations (4): Boca Raton site
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Boca Raton, Florida, United States
Toronto, Ontario site
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Toronto, Ontario, Canada
Coral Gables site
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Coral Gables, Florida, United States
Woodbridge, Ontario site
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Woodbridge, Ontario, Canada