Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines

Study Overview
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Brief Summary
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A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Treatment of Moderate or Severe Lateral Canthal Lines (LCL).

Official Title
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A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Efficacy, Safety, and Duration of Benefit of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines

Conditions
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Lateral Canthal Lines

Intervention / Treatment
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* Biological: DaxibotulinumtoxinA for injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: DAXI 12 U<br>DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) | Biological: DaxibotulinumtoxinA for injection<br>* Intramuscular injection<br>|
| Experimental: Cohort 2: DAXI 24 U<br>DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) | Biological: DaxibotulinumtoxinA for injection<br>* Intramuscular injection<br>|
| Experimental: Cohort 3: DAXI 36 U<br>DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) | Biological: DaxibotulinumtoxinA for injection<br>* Intramuscular injection<br>|
| Experimental: Cohort 4: DAXI 48 U<br>DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) | Biological: DaxibotulinumtoxinA for injection<br>* Intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With None or Mild in LCL Severity at Maximum Smile | Percentage of subjects achieving a score or 0 or 1 (none or mild) in LCL severity at maximum smile at Week 4 after LCL treatment on the Investigator Global Assessment Lateral Canthal Wrinkle Severity (IGA-LCWS) scale | Week 4 After LCL Treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lateral canthal wrinkle, Crow's feet lines, LCL