This is a Phase 2, dose ranging study to evaluate the safety of OnabotulinumtoxinA X and to compare the efficacy of OnabotulinumtoxinA X and placebo for the treatment of Glabellar Lines in adult participants with moderate to severe GL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
328
Injection
Injection
Advanced Research Associates - Glendale /ID# 230418
Glendale, Arizona, United States
Percentage of Participants With Achievement of ≥ 1-grade Improvement From Baseline as Rated by Investigator Using the Clinician Glabellar Lines Scale.
The Clinician Glabellar Lines Scale is a four point scale used to assess the severity of Glabellar Lines at maximum contraction ranging from 0 - None to 3 - Severe
Time frame: Day 1 to Day 30
Percentage of Participants With Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Time frame: Day 1 to Day 270
Percentage of Participants With Achievement of None or Mild as Rated by Investigator Using the Clinician Glabellar Lines Scale.
The Clinician Glabellar Lines Scale is a four point scale used to assess the severity of Glabellar Lines at maximum contraction ranging from 0 - None to 3 - Severe
Time frame: Day 1 to Day 30
Percentage of Participants With Achievement of Improvement Per the Facial Lines Satisfaction Questionnaire Impact Domain, Among Subjects With Baseline Scores of 14 Points or Greater.
The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective. Domain scores are calculated as the mean of transformed item scores on a 0 (low impact) to 100 (highest negative impact) scale.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Westside Aesthetics /ID# 230305
Los Angeles, California, United States
The Eye Research Foundation /ID# 232544
Newport Beach, California, United States
The Research Center at The Maas Clinic /ID# 230685
San Francisco, California, United States
Center for Dermatology and Dermatologic Surgery /ID# 230684
Washington D.C., District of Columbia, United States
Steven Fagien MD Aesthetic Eyelid Plastic Surgery /ID# 232542
Boca Raton, Florida, United States
Baumann Cosmetic and Research Institute /ID# 232545
Miami, Florida, United States
Research Institute of the Southeast, LLC /ID# 230436
West Palm Beach, Florida, United States
Coleman Center For Cosmetic Dermatologic Surgery /ID# 230693
Metairie, Louisiana, United States
Etre Cosmetic Dermatology and Laser Center /ID# 230437
New Orleans, Louisiana, United States
...and 8 more locations
Time frame: Day 1 to Day 30
Percentage of Participants With Achievement of Satisfaction With Treatment Per the Facial Line Satisfaction Questionnaire Item 5.
The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective. A score of 100 represents the best score (very satisfied) and a score of 0 represent the worst score (very dissatisfied) on the satisfaction domain or satisfaction single items.
Time frame: Day 1 to Day 60