Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines)
Conditions
Keywords
Lateral Canthal Wrinkle, crow's feet lines, LCL, Forehead Lines, Glabellar Lines, Frown Lines, Upper facial lines
Brief summary
This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of DaxibotulinumtoxinA for injection (DAXI for injection) in the treatment of Glabellar Lines (GL), Dynamic Forehead Lines (FHL), and Lateral Canthal Lines(LCL)
Interventions
Intramuscular injection
Sponsors
Revance Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provide written informed consent consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines and local laws, including authorization to release health information, signed prior to any study procedures being performed 2. Be outpatient, male or female subjects, in good general health, 18 years of age or older 3. Have a score of moderate (2) or severe (3) Glabellar Lines during maximum contraction as assessed by the Investigator Global Assessment-Frown Wrinkle Severity (IGA-FWS) and Patient Frown Wrinkle Severity (PFWS) 4. Have a score of moderate (2) or severe (3) Forehead Lines during maximum contraction as assessed by the Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) and Patient Forehead Wrinkle Severity (PFHWS) 5. Have a score of moderate (2) or severe (3) Lateral Canthal Lines at maximum contraction as assessed by the Investigator Global Assessment of Lateral Canthal Wrinkle Severity (IGA-LCWS) and Patient Lateral Canthal Wrinkle Severity (PLCWS) (scores must be consistent bilaterally for each scale considered separately) 6. Able to understand the requirements of the study and be willing and able to follow all study procedures, attend all scheduled visits, comprehend and complete the questionnaires without outside assistance and successfully complete the study
Exclusion criteria
1. Active skin disease, infections, or inflammation at the injection sites 2. Planned or anticipated need for surgery or hospitalization through the end of the study 3. Pregnant, nursing, or planning a pregnancy during the study; or is a Women of Child Bearing Potential (WOCBP) but is not willing to use an effective method of contraception 4. Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With None or Mild in GL Severity at Maximum Frown | Week 4 | The percentage of subjects achieving a score of 0 (none) or 1 (mild) in GL severity at maximum contraction (maximum frown) at Week 4 as assessed by the IGA-FWS |
| Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation | Week 4 | The percentage of subjects achieving a score of 0 (none) or 1 (mild) in FHL severity at maximum contraction (maximum eyebrow elevation) at Week 4 as assessed by the IGA-FHWS |
| Percentage of Participants With None or Mild in LCL Severity at Maximum Smile Effort | Week 4 | The percentage of subjects achieving a score of 0 (none) or 1 (mild) in LCL severity at maximum contraction (maximum smile effort) at Week 4 as assessed by the IGA-LCWS |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DAXI 40 U GL / 32 U FHL / 48 U LCL DaxibotulinumtoxinA for injection for the treatment of moderate to severe Glabellar Lines (GL), Forehead Lines (FHL), & Lateral Canthal Lines (LCL)
DaxibotulinumtoxinA for injection: Intramuscular injection | 48 |
| Total | 48 |
Baseline characteristics
| Characteristic | DAXI 40 U GL / 32 U FHL / 48 U LCL |
|---|---|
| Age, Continuous | 48.9 years |
| Race/Ethnicity, Customized Race Black/African American | 3 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants |
| Race/Ethnicity, Customized Race White | 44 Participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 48 |
| other Total, other adverse events | 3 / 48 |
| serious Total, serious adverse events | 1 / 48 |
Outcome results
Primary
Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation
The percentage of subjects achieving a score of 0 (none) or 1 (mild) in FHL severity at maximum contraction (maximum eyebrow elevation) at Week 4 as assessed by the IGA-FHWS
Time frame: Week 4
Population: Evaluable population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DAXI 40 U GL / 32 U FHL / 48 U LCL | Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation | 46 Participants |
Primary
Percentage of Participants With None or Mild in GL Severity at Maximum Frown
The percentage of subjects achieving a score of 0 (none) or 1 (mild) in GL severity at maximum contraction (maximum frown) at Week 4 as assessed by the IGA-FWS
Time frame: Week 4
Population: Evaluable population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DAXI 40 U GL / 32 U FHL / 48 U LCL | Percentage of Participants With None or Mild in GL Severity at Maximum Frown | 46 Participants |
Primary
Percentage of Participants With None or Mild in LCL Severity at Maximum Smile Effort
The percentage of subjects achieving a score of 0 (none) or 1 (mild) in LCL severity at maximum contraction (maximum smile effort) at Week 4 as assessed by the IGA-LCWS
Time frame: Week 4
Population: Evaluable population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DAXI 40 U GL / 32 U FHL / 48 U LCL | Percentage of Participants With None or Mild in LCL Severity at Maximum Smile Effort | 44 Participants |