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A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)
Sponsor: Merz Aesthetics GmbH
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).
Official 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 Europe
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2025-10-01
Completion Date
2027-11
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (26)
Merz Investigative Site
Munich, Bavaria, Germany
Merz Investigative Site
Blankenfelde-Mahlow, Brandenburg, Germany
Merz Investigative Site
Potsdam, Brandenburg, Germany
Merz Investigative Site
Friedrichsdorf, Hesse, Germany
Merz Investigative Site
Kassel, Hesse, Germany
Merz Investigative Site
Bochum, North Rhine-Westphalia, Germany
Merz Investigative Site
Düsseldorf, North Rhine-Westphalia, Germany
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, Poland
Merz Investigative Site
Oświęcim, Lesser Poland Voivodeship, Poland
Merz Investigative Site
Lublin, Lublin Voivodeship, Poland
Merz Investigative Site
Warsaw, Masovian Voivodeship, Poland
Merz Investigative Site
Warsaw, Masovian Voivodeship, Poland
Merz Investigative Site
Warsaw, Masovian Voivodeship, Poland
Merz Investigative Site
Warsaw, Masovian Voivodeship, Poland
Merz Investigative Site
Bialystok, Podlaskie Voivodeship, Poland
Merz Investigative Site
Gdynia, Pomeranian Voivodeship, Poland
Merz Investigative Site
Warsaw, Poland
Merz Investigative Site
Lodz, Łódź Voivodeship, Poland
Merz Investigative Site
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland
Merz Investigative Site
Pamplona, Navarre, Spain
Merz Investigative Site
Madrid, Spain
Merz Investigative Site
Valencia, Spain