A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in the United States
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 the United States
Merz North America, Inc.
300 participants
Aug 27, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- 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 Criteria7
- 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).
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Interventions
Clostridium Botulinum neurotoxin A (150 kiloDalton \[kD\], free of complexing proteins), powder for solution for injection.
NT 201 matching-placebo
Locations(28)
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NCT07122193