Glabellar Frown Lines
Conditions
Keywords
glabellar lines, frown lines
Brief summary
This is a long term safety study of DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar lines following single and repeat administration.
Interventions
BIOLOGICALBotulinum Toxins, Type A
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
* 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 |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAE) | 0-36 weeks | Incidence rates based on the number and percentage of subjects treated within each cycle who report Adverse Events (AEs) at anytime following study treatment. Note that subjects could receive up to 3 consecutive treatments during the 36-week follow up period. |
Secondary
| 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 |
| The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | 0-36 weeks per cycles 1 and 2 | The time to return to moderate to severe on both scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed for this cycle. |
| The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | 0-36 weeks per Cycle 1 and 2 | The time to return to or worse than baseline on both FWS scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed in this cycle. |
Countries
Canada, United States
Participant flow
Pre-assignment details
Outpatient, male or non-pregnant, non-nursing females, 18 years of age or older, 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 | 2,691 |
| Total | 2,691 |
Baseline characteristics
| Characteristic | DaxibotulinumtoxinA 40 Units |
|---|---|
| Age, Continuous | 50.0 years |
| Race/Ethnicity, Customized Race Asian | 73 Participants |
| Race/Ethnicity, Customized Race Black of African American | 129 Participants |
| Race/Ethnicity, Customized Race Others | 82 Participants |
| Race/Ethnicity, Customized Race White | 2407 Participants |
| Region of Enrollment North America | 2691 participants |
| Sex: Female, Male Female | 2383 Participants |
| Sex: Female, Male Male | 308 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 2,691 |
| other Total, other adverse events | 158 / 2,691 |
| serious Total, serious adverse events | 29 / 2,691 |
Outcome results
Primary
Incidence of Treatment Emergent Adverse Events (TEAE)
Incidence rates based on the number and percentage of subjects treated within each cycle who report Adverse Events (AEs) at anytime following study treatment. Note that subjects could receive up to 3 consecutive treatments during the 36-week follow up period.
Time frame: 0-36 weeks
Population: Safety Evaluable Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Cycle 1 | Incidence of Treatment Emergent Adverse Events (TEAE) | 831 Participants |
| Treatment Cycle 2 | Incidence of Treatment Emergent Adverse Events (TEAE) | 267 Participants |
| Treatment Cycle 3 | Incidence of Treatment Emergent Adverse Events (TEAE) | 118 Participants |
Secondary
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: Safety Evaluable Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Cycle 1 | Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales | 73.2 percentage of responders |
| Treatment Cycle 2 | Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales | 76.8 percentage of responders |
| Treatment Cycle 3 | Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales | 76.6 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 time to return to moderate to severe on both scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed for this cycle.
Time frame: 0-36 weeks per cycles 1 and 2
Population: Safety Evaluable Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Cycle 1 | The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | 168.0 days |
| Treatment Cycle 2 | The Time to Return to Moderate to Severe on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | 169.0 days |
Secondary
The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group
The time to return to or worse than baseline on both FWS scales was measured following treatment cycles 1 and 2. Because subjects were only followed for 12 weeks following treatment cycle 3, time to return was not analyzed in this cycle.
Time frame: 0-36 weeks per Cycle 1 and 2
Population: Safety Evaluable Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Cycle 1 | The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | 196 days |
| Treatment Cycle 2 | The Time to Return to, or Worse Than, Baseline on Both IGA-FWS and PFWS Scales for DaxibotulinumtoxinA for Injection Group | 197 days |