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Clinical Trials in Germany / NCT07210463
Active, not recruiting Phase 3

A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)

NCT07210463 · tracked via the Priya Life Science Germany tracker
Sponsor
Merz Aesthetics GmbH
Phase
Phase 3
Started
2025-10-01
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
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)

Trial sites (26)

FacilityCityRegionStatus
Merz Investigative Site Lyon France
Merz Investigative Site Munich Bavaria
Merz Investigative Site Blankenfelde-Mahlow Brandenburg
Merz Investigative Site Potsdam Brandenburg
Merz Investigative Site Friedrichsdorf Hesse
Merz Investigative Site Kassel Hesse
Merz Investigative Site Bochum North Rhine-Westphalia
Merz Investigative Site Düsseldorf North Rhine-Westphalia
Merz Investigative Site Drensteinfurt Germany
Merz Investigative Site Hamburg Germany
Merz Investigative Site Hamburg Germany
Merz Investigative Site Wuppertal Germany
Merz Investigative Site Krakow Lesser Poland Voivodeship
Merz Investigative Site Oświęcim Lesser Poland Voivodeship
Merz Investigative Site Lublin Lublin Voivodeship
Merz Investigative Site Warsaw Masovian Voivodeship
Merz Investigative Site Warsaw Masovian Voivodeship
Merz Investigative Site Warsaw Masovian Voivodeship
Merz Investigative Site Warsaw Masovian Voivodeship
Merz Investigative Site Bialystok Podlaskie Voivodeship
Merz Investigative Site Gdynia Pomeranian Voivodeship
Merz Investigative Site Warsaw Poland
Merz Investigative Site Lodz Łódź Voivodeship
Merz Investigative Site Ostrowiec Świętokrzyski Świętokrzyskie Voivodeship
Merz Investigative Site Pamplona Navarre
Merz Investigative Site Valencia Spain

Other trials for the same condition

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 NCT07210463 on ClinicalTrials.gov ↗ ← All trials in Germany