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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03786770
Recruitment Status : Completed
First Posted : December 26, 2018
Results First Posted : February 16, 2023
Last Update Posted : February 16, 2023
Sponsor:
Information provided by (Responsible Party):
Revance Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Frown Lines Biological: DaxibotulinumtoxinA for injection Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 24, 2019
Actual Primary Completion Date : March 9, 2020
Actual Study Completion Date : March 9, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1: Dose A
DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)
 Biological: DaxibotulinumtoxinA for injection
Intramuscular injection
Experimental: Cohort 2: Dose B
DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)
 Biological: DaxibotulinumtoxinA for injection
Intramuscular injection
Experimental: Cohort 3: Dose C
DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)
 Biological: DaxibotulinumtoxinA for injection
Intramuscular injection
Experimental: Cohort 4: Dose D
DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)
 Biological: DaxibotulinumtoxinA for injection
Intramuscular injection


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786770


Locations
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United States, Florida
Boca Raton site
Boca Raton, Florida, United States, 33431
Coral Gables site
Coral Gables, Florida, United States, 33146
Canada, Ontario
Toronto, Ontario site
Toronto, Ontario, Canada, M5R3N8
Woodbridge, Ontario site
Woodbridge, Ontario, Canada, L4L8E2
Sponsors and Collaborators
Revance Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Revance Therapeutics, Inc.:
Study Protocol  [PDF] March 4, 2019
Statistical Analysis Plan  [PDF] April 6, 2020

More Information
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Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03786770    
Other Study ID Numbers: 1820202
First Posted: December 26, 2018    Key Record Dates
Results First Posted: February 16, 2023
Last Update Posted: February 16, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Revance Therapeutics, Inc.:
Forehead Lines
Glabellar Lines
Frown Lines
Additional relevant MeSH terms:
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Botulinum Toxins, Type A
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents