A Study to the Assess the Change in Condition and Adverse Events of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines
- Registration Number
- NCT05100199
- Lead Sponsor
- Allergan
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 328
- Participant has sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their facial lines, in the opinion of the investigator.
- Participant has moderate or severe GL at maximum frown.
- History of known immunization to any botulinum toxin serotype.
- History of known hypersensitivity to any botulinum toxin serotype, or any other constituents of the study drug or its excipients, and/or other products in the same class.
- Presence or history of any medical condition that may place the participant at increased risk following exposure to OnabotulinumtoxinA X or interfere with the study evaluation, including:
- Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.
- Facial nerve palsy.
- Infection or dermatological condition at the site of study drug injection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo will be injected into the Glabellar Complex on Day 1. OnabotulinumtoxinA X Dose A OnabotulinumtoxinA X OnabotulinumtoxinA X Dose A will be injected into the Glabellar Complex on Day 1. OnabotulinumtoxinA X Dose B OnabotulinumtoxinA X OnabotulinumtoxinA X Dose B will be injected into the Glabellar Complex on Day 1. OnabotulinumtoxinA X Dose C OnabotulinumtoxinA X OnabotulinumtoxinA X Dose C will be injected into the Glabellar Complex on Day 1.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Achievement of ≥ 1-grade improvement from baseline as rated by investigator using the Clinician Glabellar Lines Scale. Day 1 to Day 30 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
Percentage of Participants With Adverse Events (AEs) Day 1 to Day 270 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Achievement of None or Mild as rated by investigator using the Clinician Glabellar Lines Scale. Day 1 to Day 30 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
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. Day 1 to Day 30 The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective.
Percentage of Participants with Achievement of satisfaction with treatment per the Facial Line Satisfaction Questionnaire Item 5. Day 1 to Day 60 The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective.
Trial Locations
- Locations (18)
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
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
Westside Aesthetics /ID# 230305
🇺🇸Los Angeles, California, United States
Advanced Research Associates - Glendale /ID# 230418
🇺🇸Glendale, Arizona, 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
Aesthetic Solutions /ID# 230716
🇺🇸Chapel Hill, North Carolina, United States
Laser & Skin Surgery Center of New York /ID# 230683
🇺🇸New York, New York, United States
SLUCare Cosmetic Dermatology /ID# 230333
🇺🇸Saint Louis, Missouri, United States
Skin Search of Rochester Inc. /ID# 242540
🇺🇸Rochester, New York, United States
Wilmington Dermatology Center /ID# 242544
🇺🇸Wilmington, North Carolina, United States
Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 232543
🇺🇸Austin, Texas, United States
Aventiv Research Dublin /ID# 232546
🇺🇸Dublin, Ohio, United States
Premier Clinical Research /ID# 230682
🇺🇸Spokane, Washington, United States
Center for Dermatology and Dermatologic Surgery /ID# 230684
🇺🇸Washington, District of Columbia, United States
Research Institute of the Southeast, LLC /ID# 230436
🇺🇸West Palm Beach, Florida, United States