Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines
Completed · Phase 2
Conditions studied: Lateral Canthal Lines
In brief
A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Treatment of Moderate or Severe Lateral Canthal Lines (LCL).
Key facts
- Study ID
- NCT03911102
- Run by
- Revance Therapeutics, Inc.
- People needed
- 63
- Starts
- 2019-03-11
- Expected to finish
- 2020-04-23
- Last updated by the study team
- 2023-06-27
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
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 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.
You may not qualify if…
- 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
Where it is running
- Sacramento, CA Site — Sacramento, California, United States
- Sarasota, FL Site — Sarasota, Florida, United States
- Itasca, IL Site — Itasca, Illinois, United States
- Arlington, VA Site — Arlington, Virginia, United States
Full record on ClinicalTrials.gov
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