Frown Lines
Conditions
Keywords
Forehead Lines, Glabellar Lines, Frown Lines
Brief summary
This is a phase 2a, multicenter, open-label, dose-escalation study to evaluate treatment of moderate or severe dynamic forehead lines (FHL) (frontalis) in conjunction with treatment of the glabellar complex.
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 of age * Have a score of moderate (2) or severe (3) FHL during maximum contraction (eyebrow elevation) as assessed by the Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) * Have a score of moderate (2) or severe (3) FHL during maximum contraction (eyebrow elevation) as assessed by the Patient Forehead Wrinkle Severity (PFHWS) * Have a score of moderate (2) or severe (3) GL during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale * Have a score of moderate (2) or severe (3) on GL during maximum frown as assessed by the Patient Frown Wrinkle Severity (PFWS) * Be willing to refrain from receiving facial fillers, laser treatments, use of any product that affects skin remodeling, or a product that may cause an active dermal response in the treatment areas (e.g., above the inferior orbital rim) from screening through the end of the study * 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 * Plans to receive botulinum toxin type A anywhere in the face (other than study treatment) from screening through the end of the study * History of clinically significant bleeding disorders * Non-ablative laser or light treatments, microdermabrasion, or chemical peels (medium depth or deeper, for example trichloroacetic acid (TCA) or phenol) in the treatment areas within 3 months before enrollment through the end of the study * Clinically significant laboratory values at screening that may interfere with a subject's ability to complete the study as determined by the investigator * History of upper or lower lid blepharoplasty or brow lift * Prior periorbital or forehead surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation | Week 4 After FHL Treatment | Percentage of subjects achieving a score of 0 or 1 (none or mild) in FHL severity at maximum eyebrow elevation at 4 weeks after FHL treatment (Week 6) on the 4-point Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) scale where 0 indicates the lowest severity and 3 indicates the highest severity. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: DAXI 40 U GL / 12 U FHL DAXI for injection for the treatment of Forehead Lines (FHL) with 12 U and Glabellar Lines (GL) with 40 U | 14 |
| Cohort 2: DAXI 40 U GL / 18 U FHL DAXI for injection for the treatment of Forehead Lines (FHL) with 18 U and Glabellar Lines (GL) with 40 U | 15 |
| Cohort 3: DAXI 40 U GL / 24 U FHL DAXI for injection for the treatment of Forehead Lines (FHL) with 24 U and Glabellar Lines (GL) with 40 U | 16 |
| Cohort 4: DAXI 40 U GL / 30 U FHL DAXI for injection for the treatment of Forehead Lines (FHL) with 30 U and Glabellar Lines (GL) with 40 U | 16 |
| Total | 61 |
Baseline characteristics
| Characteristic | Cohort 1: DAXI 40 U GL / 12 U FHL | Cohort 2: DAXI 40 U GL / 18 U FHL | Cohort 3: DAXI 40 U GL / 24 U FHL | Cohort 4: DAXI 40 U GL / 30 U FHL | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 15 Participants | 16 Participants | 15 Participants | 60 Participants |
| Age, Continuous | 49 years | 48.1 years | 47.8 years | 45.6 years | 47.6 years |
| Race/Ethnicity, Customized Race Black/African American | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 14 Participants | 15 Participants | 15 Participants | 15 Participants | 59 Participants |
| Sex: Female, Male Female | 10 Participants | 14 Participants | 15 Participants | 15 Participants | 54 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 1 Participants | 1 Participants | 7 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 / 14 | 0 / 15 | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 5 / 14 | 5 / 15 | 5 / 16 | 5 / 16 |
| serious Total, serious adverse events | 0 / 14 | 0 / 15 | 0 / 16 | 0 / 16 |
Outcome results
Primary
Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation
Percentage of subjects achieving a score of 0 or 1 (none or mild) in FHL severity at maximum eyebrow elevation at 4 weeks after FHL treatment (Week 6) on the 4-point Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS) scale where 0 indicates the lowest severity and 3 indicates the highest severity.
Time frame: Week 4 After FHL Treatment
Population: The FHL-evaluable population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: DAXI 40 U GL / 12 U FHL | Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation | 85.7 percentage of subjects |
| Cohort 2: DAXI 40 U GL / 18 U FHL | Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation | 86.7 percentage of subjects |
| Cohort 3: DAXI 40 U GL / 24 U FHL | Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation | 93.8 percentage of subjects |
| Cohort 4: DAXI 40 U GL / 30 U FHL | Percentage of Participants With None or Mild in FHL Severity at Maximum Eyebrow Elevation | 100 percentage of subjects |