A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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.
Trial sites (26)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
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 Spain