Phase 2
Completed N=63
Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines
Lateral Canthal Lines
Source: ClinicalTrials.gov NCT03911102 ↗
Enrolled (actual)
63
Serious AEs
1.6%
Results posted
Jun 2023
Primary outcomePrimary: Percentage of Participants With None or Mild in LCL Severity at Maximum Smile — 9; 10; 8; 14 Participants
Summary
A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Treatment of Moderate or Severe Lateral Canthal Lines (LCL).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With None or Mild in LCL Severity at Maximum Smile |
9; 10; 8; 14 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT03911102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.