This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to severe frown lines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
303
Intramuscular injection
Intramuscular injection
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Beverly Hills, California, United States
Unnamed facility
Newport Beach, California, United States
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
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
San Francisco, California, United States
Unnamed facility
Santa Monica, California, United States
Unnamed facility
Greenwood, Colorado, United States
Unnamed facility
Boca Raton, Florida, United States
Unnamed facility
Coral Gables, Florida, United States
Unnamed facility
Chestnut Hill, Massachusetts, United States
Unnamed facility
Birmingham, Michigan, United States
...and 5 more locations