Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Upper Facial Lines (NCT04259086) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Upper Facial Lines
United States, Canada48 participantsStarted 2019-12-06
Plain-language summary
This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of DaxibotulinumtoxinA for injection (DAXI for injection) in the treatment of Glabellar Lines (GL), Dynamic Forehead Lines (FHL), and Lateral Canthal Lines(LCL)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provide written informed consent consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-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 years of age or older
. Have a score of moderate (2) or severe (3) Glabellar Lines during maximum contraction as assessed by the Investigator Global Assessment-Frown Wrinkle Severity (IGA-FWS) and Patient Frown Wrinkle Severity (PFWS)
. Have a score of moderate (2) or severe (3) Forehead Lines during maximum contraction as assessed by the Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) and Patient Forehead Wrinkle Severity (PFHWS)
. Have a score of moderate (2) or severe (3) Lateral Canthal Lines at maximum contraction as assessed by the Investigator Global Assessment of Lateral Canthal Wrinkle Severity (IGA-LCWS) and Patient Lateral Canthal Wrinkle Severity (PLCWS) (scores must be consistent bilaterally for each scale considered separately)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With None or Mild in GL Severity at Maximum Frown
Timeframe: Week 4
2
Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation
Timeframe: Week 4
3
Percentage of Participants With None or Mild in LCL Severity at Maximum Smile Effort
. Able to understand the requirements of the study and be willing and able to follow all study procedures, attend all scheduled visits, comprehend and complete the questionnaires without outside assistance and successfully complete the study
Exclusion criteria
. Active skin disease, infections, or inflammation at the injection sites
. Planned or anticipated need for surgery or hospitalization through the end of the study
. Pregnant, nursing, or planning a pregnancy during the study; or is a Women of Child Bearing Potential (WOCBP) but is not willing to use an effective method of contraception
. Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to screening