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

Revance Therapeutics

Status and phase: Completed; Phase 2

Conditions: Frown Lines

Treatments: Biological: DaxibotulinumtoxinA for injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT03786770

1820202

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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61 participants in 4 patient groups

Cohort 1: Dose A

Experimental group

Description:

DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)

Treatment:

Biological: DaxibotulinumtoxinA for injection

Cohort 2: Dose B

Experimental group

Description:

DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)

Treatment:

Biological: DaxibotulinumtoxinA for injection

Cohort 3: Dose C

Experimental group

Description:

DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)

Treatment:

Biological: DaxibotulinumtoxinA for injection

Cohort 4: Dose D

Experimental group

Description:

DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)

Treatment:

Biological: DaxibotulinumtoxinA for injection