A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in the United States
- Conditions
- Neuromuscular AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsAcetylcholine Release InhibitorsMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionCholinergic AgentsNeurotransmitter AgentsincobotulinumtoxinABotulinum Toxins, Type A
- Interventions
- Drug: NT 201 Placebo
- Registration Number
- NCT07122193
- Lead Sponsor
- Merz North America, Inc.
- Brief Summary
The purpose of this study is to assess the safety and efficacy of NT 201 compared with placebo in participants with moderate to severe platysma prominence. The study will be conducted in two periods: Main Period (MP) and Open label Extension Period (OLEX).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Presence of four (medial and lateral, left and right) platysmal bands assessed at screening and baseline.
- A score of Grade 3 ('moderate') or Grade 4 ('severe') on the MAPS-D at maximum contraction by the investigator and participant.
- Hypersensitivity or a history of allergic reaction to botulinum toxin of any serotype or any of their formulation ingredients.
- Any medical condition that may put the participant at increased risk with exposure to botulinum toxin of any serotype, or any disorders that might interfere with neuromuscular function.
- Any serious disease or disorder that could interfere with the safe completion of treatment or with study outcome assessments, or compromise participant safety.
- Botulinum toxin treatment in the face (below the lower orbital rim), jawline, or neck within the last seven months.
- History of lower face surgery, neck or chest surgery, aesthetic procedures, and orthodontic procedures in the past 12 months.
- Planned surgery or aesthetic procedures to the lower face, neck, or chest during the study period.
- Anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study products).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Main Period: NT 201 NT 201 Participants will receive NT 201 IM injection, once on Day 1 of the MP. Main Period: NT 201 Matching Placebo NT 201 Placebo Participants will receive NT 201 matching placebo IM injection, once on Day 1 of the MP. OLEX Period: NT 201 NT 201 Participants will receive a reinjection of NT 201 IM injection, once on Day 1 of OLEX Cycle 1 and Cycle 2.
- Primary Outcome Measures
Name Time Method Composite Achievement of Grade 1 or Grade 2 and at Least a 2-Grade Improvement From Baseline Based on Both the Investigator's Assessment and Participant's Self-Assessment Using the Merz Aesthetics Platysma Scale - Dynamic (MAPS-D) At Week 2 of MP At Week 2 of MP MAPS-D is a validated five-point scale that will be used to grade the platysma prominence. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). A lower score indicates improvement.
- Secondary Outcome Measures
Name Time Method Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) And at Least a 2-Grade Improvement From Baseline Based on the Investigator's Assessment Using MAPS-D at Week 1 and Week 4 up to Week 17 of MP At Week 1 and Week 4 up to Week 17 of MP MAPS-D is a validated five-point scale that will be used to grade the platysma prominence. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). A lower score indicates improvement.
Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) And at Least a 2-Grade Improvement From Baseline Based on Participant's Self-Assessment Using MAPS-D at Week 1 and Week 4 up to Week 17 of MP At Week 1 and Week 4 up to Week 17 of MP MAPS-D is a validated five-point scale that will be used to grade the platysma prominence. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). A lower score indicates improvement.
Achievement of at Least a +1 (Improved) Score on the Global Aesthetic Improvement Scale (GAIS)-Platysmal Bands Based on the Investigator's Assessment at Week 2 of MP At Week 2 of MP GAIS is a balanced seven-point Likert scale (range -3 \[very much worse\] to +3 \[very much improved\]) commonly used in aesthetic medicine to rate post-treatment improvement in appearance. A higher score indicates improvement.
Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) And at Least a 2-Grade Improvement From Baseline Based on the Investigator's Assessment Using MAPS-D at Week 2 of MP At Week 2 of MP MAPS-D is a validated five-point scale that will be used to grade the platysma prominence. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). A lower score indicates improvement.
Achievement of at Least a +1 (Improved) Score on the GAIS-Platysmal Bands Based on the Participant's Self-Assessment at Week 2 of MP At Week 2 of MP GAIS is a balanced seven-point Likert scale (range -3 \[very much worse\] to +3 \[very much improved\]) commonly used in aesthetic medicine to rate post-treatment improvement in appearance. A higher score indicates improvement.
Achievement of at Least a +1 (Improved) Score Using the GAIS-Lower Face Contour According to the Participant's Self-Assessment at Week 2 of MP At Week 2 of MP GAIS is a balanced seven-point Likert scale (range -3 \[very much worse\] to +3 \[very much improved\]) commonly used in aesthetic medicine to rate post-treatment improvement in appearance. A higher score indicates improvement.
Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) And at Least a 2-Grade Improvement From Baseline Based on the Participant's Self-Assessment Using MAPS-D at Week 2 of MP At Week 2 of MP MAPS-D is a validated five-point scale that will be used to grade the platysma prominence. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). A lower score indicates improvement.
Achievement of at Least a +1 (Improved) Score Using the GAIS-Lower Face Contour According to the Investigator's Assessment at Week 2 of MP At Week 2 of MP GAIS is a balanced seven-point Likert scale (range -3 \[very much worse\] to +3 \[very much improved\]) commonly used in aesthetic medicine to rate post-treatment improvement in appearance. A higher score indicates improvement.
Achievement of at Least a +1 (Somewhat Satisfied) Score Using the Participant's Satisfaction Questionnaire at Week 2 of MP At Week 2 of MP Participants satisfaction questionnaire responses will be rated on a scale ranging from +3 (very satisfied) to -3 (very dissatisfied). A higher score indicates satisfaction.
Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) And at Least a 2-Grade Improvement From Baseline Based on Both the Investigator's Assessment and Participant's Self-Assessment Using MAPS-D at Week 1 and Week 4 up to Week 17 of MP At Week 1 and Week 4 up to Week 17 of MP MAPS-D is a validated five-point scale that will be used to grade the platysma prominence. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). A lower score indicates improvement.