A Study of NT 201 Doses in the Treatment of Platysma Prominence

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and efficacy of NT 201 in adults with moderate to severe platysma prominence.

Official Title
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A Prospective, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of NT 201 Doses in the Treatment of Platysma Prominence

Conditions
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Platysma Prominence

Intervention / Treatment
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* Drug: NT 201
* Drug: NT 201 Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of four (medial and lateral, left and right) prominent platysmal bands Moderate to severe platysmal bands as assessed by the investigator and subject on the MAPS-D at maximum contraction Exclusion Criteria: Any serious disease or disorder (medical or psychiatric) that could interfere with the safe completion of treatment or compromise subject safety Botulinum toxin treatment in the face (below the lower orbital rim), neck, or chest within the last 12 months prior to study treatment History of lower face surgery, neck or chest surgery, aesthetic procedures (e.g., ablative skin resurfacing, laser, chemical peel, micro-focused ultrasound, deoxycholic acid injections, micro-needling, non-surgical fat reduction procedure), and orthodontic procedures (e.g., braces) in the 12 months prior to study treatment Previous use of any permanent (non-biodegradable) or semi-permanent (e.g., calcium hydroxylapatite, poly-L-lactic acid, polymethyl methacrylate, etc.) facial tissue augmentation therapy, lifting sutures, permanent implants or autologous fat to the lower face (i.e., below the level of the bottom of the nose), neck, or chest within 24 months prior to study treatment Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy to the lower face (i.e., below the level of the bottom of the nose), neck, or chest within 12 months prior to study treatment Any medical condition that may put the subject at increased risk with exposure to botulinum toxin of any serotype, including myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function Female of childbearing potential not using a highly effective method of birth control, planning to get pregnant, or pregnant or lactating

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NT 201 Dose 1<br>Subjects will receive Dose 1. | Drug: NT 201<br>* Clostridium botulinum neurotoxin type A (150 kiloDalton [kD], free of complexing proteins) powder for solution for injection.<br>* Other names: Xeomeen;|
| Experimental: NT 201 Dose 2<br>Subjects will receive Dose 2. | Drug: NT 201<br>* Clostridium botulinum neurotoxin type A (150 kiloDalton [kD], free of complexing proteins) powder for solution for injection.<br>* Other names: Xeomeen;|
| Experimental: NT 201 Dose 3<br>Subjects will receive Dose 3. | Drug: NT 201<br>* Clostridium botulinum neurotoxin type A (150 kiloDalton [kD], free of complexing proteins) powder for solution for injection.<br>* Other names: Xeomeen;|
| Placebo Comparator: Placebo<br>Subjects will receive matching placebo. | Drug: NT 201 Placebo<br>* NT 201 Matching-placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Investigator at Visit 4 (V4) | The platysma area will be assessed live by the investigator at maximum contraction and graded according to the validated five-point Merz Aesthetic Platysma Scale-Dynamic (MAPS-D). Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). | Baseline (Screening Visit), Week 2 (V4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Subject at V4 | The platysma area will be assessed by the subjects at maximum contraction and graded according to the validated five-point MAPS-D. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). | Baseline (Screening Visit), Week 2 (V4) | 
| Number of Subjects With Related Treatment Emergent Adverse Events (Related TEAEs) | TEAEs are defined as adverse events (AEs) with onset or worsening on or after date and time of first dose of study treatment. An AE is considered to be related if a causal relationship between NT 201 and the AE is at least reasonably possible. | Baseline up to Week 17/End of Study |