Status:
RECRUITING
A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)
Lead Sponsor:
Merz Aesthetics GmbH
Conditions:
Neuromuscular Agents
Peripheral Nervous System Agents
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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: ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07210463
Start Date
October 1 2025
End Date
November 1 2027
Last Update
December 17 2025
Active Locations (26)
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1
Merz Investigative Site
Munich, Bavaria, Germany, 80539
2
Merz Investigative Site
Blankenfelde-Mahlow, Brandenburg, Germany, 15831
3
Merz Investigative Site
Potsdam, Brandenburg, Germany, 14467
4
Merz Investigative Site
Friedrichsdorf, Hesse, Germany, 61381