A Phase 2, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of OnabotulinumtoxinA X for Forehead Lines
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 124
- Locations
- 8
- Primary Endpoint
- Number of Participants With Adverse Events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Placebo
Placebo will be injected into the forehead on Day 1.
Intervention: Placebo (Drug)
OnabotulinumtoxinA X Dose A
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
Intervention: OnabotulinumtoxinA X (Drug)
OnabotulinumtoxinA X Dose B
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
Intervention: OnabotulinumtoxinA X (Drug)
OnabotulinumtoxinA X Dose C
OnabotulinumtoxinA X will be injected into the forehead on Day 1.
Intervention: OnabotulinumtoxinA X (Drug)
Outcomes
Primary Outcomes
Number of Participants With Adverse Events
Time Frame: 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 Potentially Clinically Significant Vital Sign Parameters
Time Frame: Day 1 to Day 180
Percentage of participants with potentially clinically significant vital sign measurements like systolic and diastolic blood pressure will be assessed.
Percentage of Participants With Achievement of ≥ 1-grade Improvement From Baseline on the Investigator-rated Clinician Forehead Lines Scale at Maximum Contraction.
Time Frame: Day 1 to Day 30
Facial Wrinkle Scale - Forehead Lines (FWS-FHL) at maximum contraction (also known as eyebrow elevation) 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 Outcomes
No secondary outcomes reported