A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)
NCT ID: NCT07210463
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2025-10-01
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Main Period: NT 201
Participants will receive NT 201 IM injection, once on Day 1 of the MP.
NT 201
Clostridium Botulinum neurotoxin A (150 kiloDalton \[kD\], free of complexing proteins), powder for solution for injection.
Main Period: NT 201 Matching Placebo
Participants will receive NT 201 matching placebo IM injection, once on Day 1 of the MP.
NT 201 Placebo
NT 201 matching-placebo.
OLEX Period: NT 201
Participants will receive a reinjection of NT 201 IM injection, once on Day 1 of OLEX period.
NT 201
Clostridium Botulinum neurotoxin A (150 kiloDalton \[kD\], free of complexing proteins), powder for solution for injection.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A score of Grade 3 ('moderate') or Grade 4 ('severe') on the MAPS-D at maximum contraction by the investigator and participant.
Exclusion Criteria
* 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).
18 Years
65 Years
ALL
No
Sponsors
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Merz Aesthetics GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Merz Medical Expert
Role: STUDY_DIRECTOR
Merz Aesthetics GmbH
Locations
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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
Warsaw, Masovian Voivodeship, Poland
Merz Investigative Site
Bialystok, Podlaskie Voivodeship, Poland
Merz Investigative Site
Gdynia, Pomeranian Voivodeship, 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
Countries
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Central Contacts
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Public Disclosure Manager Merz Aesthetics
Role: CONTACT
Phone: +1 984-301-3095
Email: [email protected]
Other Identifiers
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NT- PPR-EU002
Identifier Type: -
Identifier Source: org_study_id