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

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the safety and effects of onabotulinumtoxinA (BOTOX) for the temporary improvement in the appearance of platysma prominence. Study doctors will randomize participants into 1 of the 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 400 participants will be enrolled in the study across approximately 35 sites in USA, Belgium, Canada, Germany and the UK. Participants will receive a single treatment of intramuscular injection of onabotulinumtoxinA (BOTOX) or placebo on Day 1 during this 4 month long study. Participants will attend regular monthly visits during the study at the study site.

Official Title
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A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy 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: OnabotulinumtoxinA
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study specific procedures Are willing and able to comply with procedures required in the protocol Adult male or female, at least 18 years old at the time of signing the informed consent Good health as determined by medical history, physical examination, vital signs, and investigator's judgment 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BOTOX<br>BOTOX will be injected into the platysma muscle on Day 1 | Drug: OnabotulinumtoxinA<br>* Injection<br>* Other names: BOTOX;|
| Placebo Comparator: Placebo<br>Placebo will be injected into the platysma muscle on Day 1 | Drug: Placebo<br>* 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 -14 to Day 120 | 
| Composite Achievement of Grade 1 or 2 (Minimal or Mild) and at Least a 2-Grade Improvement from Baseline Based on Both Investigator's Assessment using C-APPS and Participant's Self-Assessment using P-APPS | The Clinician Allergan Platysma Prominence Scale (C-APPS) evaluates platysma prominence and is a static measurement encompassing visual examination of the platysma muscle ranging from 1 - Minimal to 5- Extreme. The Participant Allergan Platysma Prominence Scale (P-APPS) evaluates platysma prominence and is a single-item measure that is accompanied by a 5-grade photonumeric scale ranging from 1 - Minimal to 5 - Extreme. | Day 1 to Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants who Achieved Grade 1 or 2 (Minimal or Mild) according to Investigator's Assessment using C-APPS | The Clinician Allergan Platysma Prominence Scale (C-APPS) evaluates platysma prominence and is a static measurement encompassing visual examination of the platysma muscle ranging from 1 - Minimal to 5- Extreme. | Day 1 to Day 120 | 
| Percentage of Participants who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Assessment using P-APPS | The P-APPS evaluates platysma prominence and is a single-item measure that is accompanied by a 5-grade photonumeric scale ranging from 1 - Minimal to 5 - Extreme. | Day 1 to Day 120 | 
| Percentage of Participants with Responses of Satisfied or Very Satisfied on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction (Follow-up) Item 5 (effect of treatment) | The ANLFQ is a 11-item measure that assesses how satisfied the participants are with the treatment they received for the appearance of their neck and lower face. | Day 14 | 
| Percentage of Participants with Responses of 'Not at all bothered' or 'A little bothered' on the Bother Assessment Scale - Platysma Prominence (BAS-PP) Scale Item 2 (Jawline) | The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered). | Day 14 | 
| Percentage of Participants with Responses of 'Not at all Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands) | The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered). | Day 14 | 
| Change from baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts summary score | The Appearance of Neck and Lower Face Questionnaire: Impacts is a 7-item measure that assesses the psychosocial impact of the appearance of the neck and lower face. | Day 1 to Day 14 | 
| Percentage of Participants who Achieved at Least 1-Grade Improvement from Baseline Based on Investigator's Assessment Using C-APPS | The C-APPS evaluates platysma prominence and is a static measurement encompassing visual examination of the platysma muscle ranging from 1 - Minimal to 5- Extreme. | Day 1 to Day 120 | 
| Percentage of Participants who Achieved at Least 1-Grade Improvement from Baseline Based on Participant's Assessment using P-APPS | The P-APPS evaluates platysma prominence and is a single-item measure that is accompanied by a 5-grade photonumeric scale ranging from 1 - Minimal to 5 - Extreme. | Day 1 to Day 120 | 

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