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

NCT03786770 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 1820202
• Study Type: interventional
• Target: 61
• Locations: 2 countries
• Sites: 4

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.

Conditions

Frown Lines

Keywords

Forehead Lines; Glabellar Lines; Frown Lines

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Cohort 1: Dose A

EXPERIMENTAL

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

Biological: DaxibotulinumtoxinA for injection

Cohort 2: Dose B

EXPERIMENTAL

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

Biological: DaxibotulinumtoxinA for injection

Cohort 3: Dose C

EXPERIMENTAL

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

Biological: DaxibotulinumtoxinA for injection

Cohort 4: Dose D

EXPERIMENTAL

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

Biological: DaxibotulinumtoxinA for injection

Interventions

DaxibotulinumtoxinA for injection BIOLOGICAL

Intramuscular injection

Cohort 1: Dose A; Cohort 2: Dose B; Cohort 3: Dose C; Cohort 4: Dose D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Revance Therapeutics, Inc.: lead

Study Sites (4)

Boca Raton site

Boca Raton, Florida, 33431, United States

Location

Coral Gables site

Coral Gables, Florida, 33146, United States

Location

Toronto, Ontario site

Toronto, Ontario, M5R3N8, Canada

Location

Woodbridge, Ontario site

Woodbridge, Ontario, L4L8E2, Canada

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A; Injections

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Domenico Vitarella, Sr. Director, Clinical Development
• Organization: Revance Therapeutics, Inc.

dvitarella@revance.com

510-742-3400

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: December 26, 2018
• Study Start: January 24, 2019
• Primary Completion: March 9, 2020
• Study Completion: March 9, 2020
• Last Updated: February 16, 2023
• Results First Posted: February 16, 2023

Record last verified: 2023-01

Locations

CA (2); US (2)