Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection)… (NCT03911102) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines
United States63 participantsStarted 2019-03-11
Plain-language summary
A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Treatment of Moderate or Severe Lateral Canthal Lines (LCL).
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
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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 old
* Have a score of moderate (2) or severe (3) LCL at maximum smile effort as assessed by the IGA-LCWS
* 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
* History of clinically significant bleeding disorders
* Clinically significant laboratory values at screening that may interfere with a subject's ability to complete the study, as determined by the investigator
* 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 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 through the end of the study
What they're measuring
1
Percentage of Participants With None or Mild in LCL Severity at Maximum Smile