Clinical trial NCT03786770: Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Forehead Lines (Frontalis)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Frown Lines
Keywords: Forehead Lines
Glabellar Lines
Frown Lines
Lead sponsor: Revance Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-26
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation
timeFrame: Week 4 After FHL Treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Boca Raton site
state: Florida
city: Coral Gables
country: United States
facility: Coral Gables site
state: Florida
city: Toronto
country: Canada
facility: Toronto, Ontario site
state: Ontario
city: Woodbridge
country: Canada
facility: Woodbridge, Ontario site
state: Ontario
Study officials:
References: