BOTOX® for the Treatment of Platysma Prominence

Study Overview
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Brief Summary
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To assess the efficacy and safety of BOTOX® in adults with moderate to severe platysma prominence.

Official Title
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A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging 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: BOTOX® purified neurotoxin complex
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period A female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization), not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the studies contraceptive guidance during the treatment and follow-up period through study exit. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this study's protocol 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 Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study Females who are pregnant, nursing, or planning a pregnancy during the study Known immunization or hypersensitivity to any botulinum toxin serotype History of alcohol or drug abuse within 12 months of the study Participant has tattoos, jewelry, or clothing that cannot be removed, and that obscure the neck

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1. | Drug: Placebo<br>* Placebo injections.<br>|
| Experimental: BOTOX® Low Dose<br>Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1. | Drug: BOTOX® purified neurotoxin complex<br>* BOTOX® superficial intramuscular injections.<br>* Other names: Botulinum toxin type A purified neurotoxin complex;|
| Active Comparator: BOTOX® High Dose<br>Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1. | Drug: BOTOX® purified neurotoxin complex<br>* BOTOX® superficial intramuscular injections.<br>* Other names: Botulinum toxin type A purified neurotoxin complex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least 1-Grade Improvement at Day 14 as Rated by Investigator Using the Clinician Allergan Platysma Prominence Scale (C-APPS) | The investigator evaluated the participant's platysma prominence severity using a 5-grade scale C-APPS at maximum contraction where 1= minimal, and 5= extreme. Higher values indicate worsening condition. Data is reported for participants who achieved at least a 1-grade improvement rated on the C-APPS. Percentages are rounded off to whole number at the nearest decimal. Cochran-Mantel-Haenszel (CMH) chi-squared test was used for analysis. | Day 14 | 
| Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE) | 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 drug. Treatment-emergent adverse events are defined as any event that began or worsened in severity on or after the first dose of study drug or any AE that was present before the first dose of study intervention, but increased in severity or became serious after the first dose of study intervention. | From the first dose of study drug up to end of study (up to Day 120) | 
| Pulse Rate at Baseline | Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded. | Baseline (Day 1) | 
| Change From Baseline in Pulse Rate at Day 7 | Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded. | Baseline; Day 7 | 
| Change From Baseline in Pulse Rate at Day 14 | Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded. | Baseline; Day 14 | 
| Change From Baseline in Pulse Rate at Day 30 | Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded. | Baseline; Day 30 | 
| Change From Baseline in Pulse Rate at Day 60 | Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded. | Baseline; Day 60 | 
| Change From Baseline in Pulse Rate at Day 90 | Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded. | Baseline; Day 90 | 
| Change From Baseline in Pulse Rate at Day 120 | Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded. | Baseline; Day 120 | 
| Systolic and Diastolic Blood Pressure (BP) at Baseline | Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured. | Baseline (Day 1) | 
| Change From Baseline in Systolic and Diastolic BP at Day 7 | Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured. | Baseline; Day 7 | 
| Change From Baseline in Systolic and Diastolic BP at Day 14 | Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured. | Baseline; Day 14 | 
| Change From Baseline in Systolic and Diastolic BP at Day 30 | Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured. | Baseline; Day 30 | 
| Change From Baseline in Systolic and Diastolic BP at Day 60 | Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured. | Baseline; Day 60 | 
| Change From Baseline in Systolic and Diastolic BP at Day 90 | Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured. | Baseline; Day 90 | 
| Change From Baseline in Systolic and Diastolic BP at Day 120 | Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured. | Baseline; Day 120 | 
| Respiratory Rate at Baseline | Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2. | Baseline (Day 1) | 
| Change From Baseline in Respiratory Rate at Day 7 | Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2. | Baseline; Day 7 | 
| Change From Baseline in Respiratory Rate at Day 14 | Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2. | Baseline; Day 14 | 
| Change From Baseline in Respiratory Rate at Day 30 | Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2. | Baseline; Day 30 | 
| Change From Baseline in Respiratory Rate at Day 60 | Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2. | Baseline; Day 60 | 
| Change From Baseline in Respiratory Rate at Day 90 | Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2. | Baseline; Day 90 | 
| Change From Baseline in Respiratory Rate at Day 120 | Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2. | Baseline; Day 120 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least a 1-Grade Improvement at Day 14 as Rated by Participant Using the Participant Allergan Platysma Prominence Scale (P-APPS) | The participants evaluated their own Platysma Prominence severity using a 5-grade scale where 1= minimal, and 5= extreme. Higher values indicate worsening conditions. Data is reported for participants who achieved at least a 1-grade improvement rated on the P-APPS. Percentages are rounded off to whole number at the nearest decimal. CMH chi-squared test was used for analysis. | Day 14 |