A Study To Assess the Safety of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence

Study Overview
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Brief Summary
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This is a Phase 3, open-label study to evaluate the safety of BOTOX Injection in Adult Participants with Platysma Prominence

Official Title
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Phase 3, Multicenter Open-label Extension Study to Evaluate the Safety of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Platysma Prominence

Conditions
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Platysma Prominence

Intervention / Treatment
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* Drug: BOTOX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Completion of all phases of the lead-in Phase 3 study (Screening Period, Treatment Period [randomization/treatment with 4-month follow-up visit] and Study Exit visit) Exclusion Criteria: Any medical condition that may put the participant at increased medical risk with exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function Participant has an anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention) Anticipated need for surgery or overnight hospitalization during the study Females who are pregnant or breastfeeding and are considering becoming pregnant or donating eggs during the study Known immunization or hypersensitivity to any botulinum toxin serotype History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months Lower facial and neck hair, scarring (e.g., acne), or other abnormal variations that may interfere with photography (such that photograph is not acceptable) Tattoos, jewelry, or clothing that cannot be removed, and that obscure the target area of interest

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BOTOX<br>BOTOX will be injected into the platysma muscle for up to 3 administrations. | Drug: BOTOX<br>* Intramuscular Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events | 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. 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 the study drug. | Day 1 to Day 240 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platysma Prominence, BOTOX, OnabotulinumtoxinA