A Study To Assess the Adverse Effects and Change in Condition of OnabotulinumtoxinA X Injection in Adult Participants With Forehead Lines
- Registration Number
- NCT05152576
- Lead Sponsor
- Allergan
- Brief Summary
Facial lines that develop from repeated facial expression, such as forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. OnabotulinumtoxinA X is being investigated as another form of treatment to treat FHL by inhibiting the release of the neurotransmitter that causes the overactivity of the muscles responsible for the severity of these facial lines. The purpose of this study is to evaluate the safety and change in condition of 3 doses of OnabotulinumtoxinA X for the treatment of moderate to severe forehead lines.
Study doctors will determine if a subject is eligible for the study. If so, the subject will be randomized into 1 of the 4 groups, called treatment arms. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 120 adult participants with FHL will be enrolled in the study in approximately 10 sites in the United States.
Participants will receive either intramuscular injections of onabotulinumtoxinA X or placebo.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at the study site.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
- Participant has sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their facial lines
- Participant has moderate or severe Forehead Lines (FHL) at maximum eyebrow elevation
- 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.
- History of 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 OnabotulinumtoxinA X Dose A OnabotulinumtoxinA X OnabotulinumtoxinA X will be injected into the forehead on Day 1. OnabotulinumtoxinA X Dose B OnabotulinumtoxinA X OnabotulinumtoxinA X will be injected into the forehead on Day 1. Placebo Placebo Placebo will be injected into the forehead on Day 1. OnabotulinumtoxinA X Dose C OnabotulinumtoxinA X OnabotulinumtoxinA X will be injected into the forehead on Day 1.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Potentially Clinically Significant Vital Sign Parameters Day 1 to Day 180 Percentage of participants with potentially clinically significant vital sign measurements like systolic and diastolic blood pressure will be assessed.
Number of Participants with Adverse Events Day 1 to Day 180 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 casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the 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.
Percentage of Participants with Achievement of ≥ 1-grade improvement from baseline on the investigator-rated clinician forehead lines Scale at maximum contraction. Day 1 to Day 30 The Clinician Forehead Lines Scale is a four point scale used to assess the severity of forehead lines at maximum contraction ranging from 0 - None to 3 - Severe
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
The Center for Dermatology Cosmetics & Laser Surgery /ID# 239776
🇺🇸Mount Kisco, New York, United States
Dermatology Consulting Service /ID# 239779
🇺🇸High Point, North Carolina, United States
Steve Yoelin MD Medical Assoc. Inc /ID# 239771
🇺🇸Newport Beach, California, United States
The Eye Research Foundation /ID# 241512
🇺🇸Newport Beach, California, United States
Skin Search of Rochester Inc. /ID# 239773
🇺🇸Rochester, New York, United States
Wilmington Dermatology Center /ID# 239778
🇺🇸Wilmington, North Carolina, United States
Dallas Plastic Surgery Institute /ID# 239777
🇺🇸Dallas, Texas, United States
Austin Institute for Clinical Research /ID# 239783
🇺🇸Pflugerville, Texas, United States