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Active, not recruiting Phase 3

A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in the United States

NCT07122193 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2025-08-27
Last updated
2026-09-10

Condition(s) studied

Neuromuscular AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsAcetylcholine Release InhibitorsMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionCholinergic AgentsNeurotransmitter AgentsincobotulinumtoxinABotulinum Toxins, Type A

Investigational drug(s) / intervention(s)

NT 201 →NT 201 Placebo

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
—
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 MAPS-D 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 (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.

Trial sites (28)

FacilityCityRegionStatus
Merz Investigative Site Scottsdale Arizona
Merz Investigative Site Encino California
Merz Investigative Site Los Angeles California
Merz Investigative Site Redondo Beach California
Merz Investigative Site Santa Monica California
Merz Investigative Site Vista California
Merz Investigative Site Greenwood Village Colorado
Merz Investigative Site Westport Connecticut
Merz Investigative Site Washington D.C. District of Columbia
Merz Investigative Site Aventura Florida
Merz Investigative Site Boca Raton Florida
Merz Investigative Site Bradenton Florida
Merz Investigative Site Coral Gables Florida
Merz Investigative Site Coral Gables Florida
Merz Investigative Site West Palm Beach Florida
Merz Investigative Site Alpharetta Georgia
Merz Investigative Site Naperville Illinois
Merz Investigative Site Hunt Valley Maryland
Merz Investigative Site Mount Kisco New York
Merz Investigative Site New York New York
Merz Investigative Site New York New York
Merz Investigative Site Chapel Hill North Carolina
Merz Investigative Site Wilmington North Carolina
Merz Investigative Site Ardmore Pennsylvania
Merz Investigative Site Nashville Tennessee
Merz Investigative Site Dallas Texas
Merz Investigative Site Arlington Virginia
Merz Investigative Site San Juan Puerto Rico
Official registry record

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.

View NCT07122193 on ClinicalTrials.gov ↗ ← All trials in the USA