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NCT Number: NCT07122193

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Neuromuscular Agents Acetylcholine Release Inhibitors Botulinum Toxins, Type A Cholinergic Agents Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Physiological Effects of Drugs incobotulinumtoxinA

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Merz Investigative Site, San Juan, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

NT 201

Drug

Clostridium Botulinum neurotoxin A (150 kiloDalton [kD], free of complexing proteins), powder for solution for injection.

Other names: IncobotulinumtoxinA, Xeomin/Bocouture, Xeomin Cosmetic, Xeomeen

NT 201 Placebo

Drug

NT 201 matching-placebo

Primary outcomes

  1. 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

    Time frame: 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 outcomes

  1. 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

    Time frame: 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.

  2. 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

    Time frame: 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.

  3. Achievement of at Least a +1 (Somewhat Satisfied) Score Using the Participant's Satisfaction Questionnaire at Week 2 of MP

    Time frame: 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.

  4. 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

    Time frame: 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.

  5. 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

    Time frame: 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.

  6. 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

    Time frame: 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.

  7. 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

    Time frame: 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.

  8. 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

    Time frame: 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.

  9. 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

    Time frame: 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.

  10. 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merz North America, Inc.

Industry

Registry information

Official study title

A Phase 3, Randomized, Parallel-Group, Double-Blind, Multicenter Study Investigating the Safety and Efficacy of NT 201 Compared With Placebo in Adult Participants With Moderate to Severe Platysma Prominence in the United States

Acronym: PLATINUM US

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Aug 14, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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