A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in the United States

Launched by MERZ NORTH AMERICA, INC. · Aug 7, 2025

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ClinConnect Summary

This clinical trial is studying a medicine called NT 201 to see if it is safe and effective for adults who have moderate to severe platysma prominence. Platysma prominence means having noticeable bands or cords in the neck muscles that can affect appearance. The study will compare NT 201 to a placebo (a treatment with no active medicine) to understand how well it works and how safe it is. The trial will include two parts: the main period where participants receive treatment, and an open-label extension where they may continue to get the medicine.

Adults aged 65 to 74 with visible neck muscle bands on both sides, rated as moderate or severe by both the doctor and themselves, might be eligible for this study. People who have allergies to botulinum toxins (the family of medicines NT 201 belongs to), have certain medical conditions that affect nerves or muscles, or have had recent surgeries or cosmetic treatments on their face or neck will not be able to join. Participants can expect to be closely monitored by the study team and will receive either NT 201 or a placebo during the trial. This study is not yet recruiting, so if you or a family member fit the criteria and are interested, you may want to watch for updates on how to join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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).