Neuromuscular AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsAcetylcholine Release InhibitorsMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionCholinergic AgentsNeurotransmitter AgentsincobotulinumtoxinABotulinum Toxins, Type A
NT 201: Clostridium Botulinum neurotoxin A (150 kiloDalton \[kD\], free of complexing proteins), powder for solution for injection.
NT 201 Placebo: NT 201 matching-placebo.
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 MAPSD at maximum contraction by the investigator AND participant.
Exclusion Criteria:
* 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, and aesthetic procedures in the past 12 months and/or orthodontic procedures in the past 6 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).
Primary outcome measure(s)
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 (MAPSD) At Week 2 of MP — At Week 2 of MP MAPSD 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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