Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Forehead Lines (Frontalis)
NCT ID: NCT03786770
Last Updated: 2023-02-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
61 participants
INTERVENTIONAL
2019-01-24
2020-03-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase 2a Study of DaxibotulinumtoxinA-lanm for Injection in Dynamic Forehead Lines and Glabellar Lines
NCT06411002
Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Upper Facial Lines
NCT04259086
Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines
NCT03911102
Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines
NCT03014635
Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines
NCT03014622
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1: Dose A
DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)
DaxibotulinumtoxinA for injection
Intramuscular injection
Cohort 2: Dose B
DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)
DaxibotulinumtoxinA for injection
Intramuscular injection
Cohort 3: Dose C
DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)
DaxibotulinumtoxinA for injection
Intramuscular injection
Cohort 4: Dose D
DAXI for injection for the treatment of Forehead Lines (FHL) and Glabellar Lines (GL)
DaxibotulinumtoxinA for injection
Intramuscular injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DaxibotulinumtoxinA for injection
Intramuscular injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Revance Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Boca Raton site
Boca Raton, Florida, United States
Coral Gables site
Coral Gables, Florida, United States
Toronto, Ontario site
Toronto, Ontario, Canada
Woodbridge, Ontario site
Woodbridge, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1820202
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.