Glabellar Frown Lines
Conditions
Keywords
glabellar lines, frown lines
Brief summary
This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to severe frown lines.
Interventions
BIOLOGICALBotulinum Toxins, Type A
Intramuscular injection
BIOLOGICALPlacebos
Intramuscular injection
Sponsors
Revance Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Provide written informed consent including authorization to release health information * Moderate (2) or severe (3) glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale * Moderate (2) or severe (3) glabellar lines during maximum frown based on the Patient Frown Wrinkle Severity (PFWS) scale * Willing and able to follow all trial procedures, attend all scheduled visits, and successfully complete the trial
Exclusion criteria
* Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis * Active skin disease, infections or inflammation at the injection sites * Plan to receive botulinum toxin type A anywhere in the face through the duration of the study * History of allergy or sensitivity to any botulinum toxin preparations or to any component of the test article * Current enrollment in an investigational drug or device trial or participation in such a trial within the last 30 days prior to screening through end of trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales | Week 4 | Percentage of subjects who achieve at least a 2-point improvement from baseline and a score of 0 or 1 (i.e., none or mild wrinkles in severity) on both Investigator and Subject Frown Wrinkle Severity (FWS) assessments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | 0-36 weeks | The duration of response will be evaluated by analyzing the number of days to return to moderate or severe on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group. |
| The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | 0-36 weeks | The duration of response will be evaluated by analyzing the number of days to return to, or worse than, baseline on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group. |
Countries
Canada, United States
Participant flow
Pre-assignment details
Outpatient, male or non-pregnant, non-nursing females, 18-75 years of age, and in good general health with moderate (2) or severe (3) glabellar lines during maximum frown based on the IGA-FWS and PFWS
Participants by arm
| Arm | Count |
|---|---|
| DaxibotulinumtoxinA 40 Units Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection
Botulinum Toxins, Type A: Intramuscular injection | 204 |
| Placebo Biological/Vaccine: Placebo Intramuscular injection
Placebo: Intramuscular injection | 102 |
| Total | 306 |
Baseline characteristics
| Characteristic | DaxibotulinumtoxinA 40 Units | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 8 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 189 Participants | 94 Participants | 283 Participants |
| Age, Continuous | 49.6 years | 50.5 years | 49.9 years |
| Race/Ethnicity, Customized Race Asian | 11 Participants | 5 Participants | 16 Participants |
| Race/Ethnicity, Customized Race Black or African American | 9 Participants | 3 Participants | 12 Participants |
| Race/Ethnicity, Customized Race More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Unknown or not reported | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Race White | 180 Participants | 92 Participants | 272 Participants |
| Region of Enrollment North America | 204 participants | 102 participants | 306 participants |
| Sex: Female, Male Female | 183 Participants | 87 Participants | 270 Participants |
| Sex: Female, Male Male | 21 Participants | 15 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 205 | 0 / 101 |
| other Total, other adverse events | 30 / 205 | 5 / 101 |
| serious Total, serious adverse events | 2 / 205 | 1 / 101 |
Outcome results
Primary
Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales
Percentage of subjects who achieve at least a 2-point improvement from baseline and a score of 0 or 1 (i.e., none or mild wrinkles in severity) on both Investigator and Subject Frown Wrinkle Severity (FWS) assessments
Time frame: Week 4
Population: Intent to treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DaxibotulinumtoxinA 40 Units | Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales | 74.0 percentage of responders |
| Placebo | Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales | 1.0 percentage of responders |
Secondary
The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group
The duration of response will be evaluated by analyzing the number of days to return to moderate or severe on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.
Time frame: 0-36 weeks
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DaxibotulinumtoxinA 40 Units | The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | 167 days |
Secondary
The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group
The duration of response will be evaluated by analyzing the number of days to return to, or worse than, baseline on both IGA-FWS and PFWS scales for DaxibotulinumtoxinA for Injection group.
Time frame: 0-36 weeks
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DaxibotulinumtoxinA 40 Units | The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | 182 days |