Lateral Canthal Lines
Conditions
Keywords
Lateral canthal wrinkle, Crow's feet lines, LCL
Brief summary
A Phase 2a, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Treatment of Moderate or Severe Lateral Canthal Lines (LCL).
Interventions
BIOLOGICALDaxibotulinumtoxinA for injection
Intramuscular injection
Sponsors
Revance Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With None or Mild in LCL Severity at Maximum Smile | Week 4 After LCL Treatment | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: DAXI 12 U DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) | 15 |
| Cohort 2: DAXI 24 U DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) | 17 |
| Cohort 3: DAXI 36 U DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) | 15 |
| Cohort 4: DAXI 48 U DAXI for injection for the treatment of moderate to severe Lateral Canthal Lines (LCL) | 16 |
| Total | 63 |
Baseline characteristics
| Characteristic | Cohort 1: DAXI 12 U | Cohort 2: DAXI 24 U | Cohort 3: DAXI 36 U | Cohort 4: DAXI 48 U | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 17 Participants | 14 Participants | 15 Participants | 61 Participants |
| Age, Continuous | 49.9 years | 51.8 years | 52.8 years | 45.5 years | 50 years |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Black/African American | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race White | 15 Participants | 16 Participants | 13 Participants | 14 Participants | 58 Participants |
| Sex: Female, Male Female | 14 Participants | 14 Participants | 13 Participants | 14 Participants | 55 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 2 Participants | 2 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 17 | 0 / 15 | 0 / 16 |
| other Total, other adverse events | 6 / 15 | 7 / 17 | 7 / 15 | 6 / 16 |
| serious Total, serious adverse events | 0 / 15 | 1 / 17 | 0 / 15 | 0 / 16 |
Outcome results
Primary
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
Time frame: Week 4 After LCL Treatment
Population: LCL Evaluable
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: DAXI 12 U | Percentage of Participants With None or Mild in LCL Severity at Maximum Smile | 9 Participants |
| Cohort 2: DAXI 24 U | Percentage of Participants With None or Mild in LCL Severity at Maximum Smile | 10 Participants |
| Cohort 3: DAXI 36 U | Percentage of Participants With None or Mild in LCL Severity at Maximum Smile | 8 Participants |
| Cohort 4: DAXI 48 U | Percentage of Participants With None or Mild in LCL Severity at Maximum Smile | 14 Participants |