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NT 201 treatment for adults with moderate to severe platysma prominence in Europe

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 Europe

Phase 3 Interventional Merz North America, Inc. · NCT07210463

This trial will test whether NT 201 reduces moderate to severe platysma bands in adults compared with placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorMerz North America, Inc. Industry-sponsored
Locations26 sites (Munich, Bavaria and 25 other locations)
Trial IDNCT07210463 on ClinicalTrials.gov

What this trial studies

Adults with moderate to severe platysma prominence who have four visible platysmal bands and a MAPS-D score of 3 or 4 at maximum contraction will enter a main period receiving either NT 201 or placebo, followed by an open-label extension where eligible participants can receive NT 201. The trial compares outcomes between the NT 201 and placebo groups and monitors safety throughout the study. Efficacy will be measured by changes in platysma prominence using clinician and participant ratings (MAPS-D) and other outcome measures, while adverse events and tolerability will be recorded. Participants with recent botulinum toxin treatments, relevant surgeries, hypersensitivity to botulinum toxins, or neuromuscular disorders are excluded.

Who should consider this trial

Good fit: Ideal candidates are adults with four platysmal bands and investigator- and participant-rated MAPS-D scores of Grade 3 or 4 who meet health criteria and can attend study visits at the German sites.

Not a fit: Patients who recently received botulinum toxin in the lower face/neck, have hypersensitivity to botulinum toxins, neuromuscular disorders, or recent relevant surgeries are unlikely to be eligible or benefit from participation.

Why it matters

Potential benefit: If successful, NT 201 could reduce visible platysma band prominence and improve neck appearance for adults with moderate to severe platysma prominence.

How similar studies have performed: Similar approaches using botulinum toxin injections to soften platysma bands and improve neck appearance have shown positive cosmetic results in prior studies, so the treatment concept is not entirely novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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, 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).

Where this trial is running

Munich, Bavaria and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Neuromuscular AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsAcetylcholine Release InhibitorsMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionCholinergic AgentsNeurotransmitter Agents
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.