A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in the United States
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Neuromuscular Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Acetylcholine Release Inhibitors, Membrane Transport Modulators, Molecular Mechanisms of Pharmacological Action, Cholinergic Agents, Neurotransmitter Agents, incobotulinumtoxinA, Botulinum Toxins, Type A
In brief
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).
Key facts
- Study ID
- NCT07122193
- Run by
- Merz North America, Inc.
- People needed
- 300
- Starts
- 2025-08-27
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2026-05-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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, and aesthetic procedures in the past 12 months, and/or orthodontic procedures in the past 6 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).
Where it is running
- Merz Investigative Site — Scottsdale, Arizona, United States
- Merz Investigative Site — Encino, California, United States
- Merz Investigative Site — Los Angeles, California, United States
- Merz Investigative Site — Redondo Beach, California, United States
- Merz Investigative Site — Santa Monica, California, United States
- Merz Investigative Site — Vista, California, United States
- Merz Investigative Site — Greenwood Village, Colorado, United States
- Merz Investigative Site — Westport, Connecticut, United States
- Merz Investigative Site — Washington D.C., District of Columbia, United States
- Merz Investigative Site — Aventura, Florida, United States
- Merz Investigative Site — Boca Raton, Florida, United States
- Merz Investigative Site — Bradenton, Florida, United States
- Merz Investigative Site — Coral Gables, Florida, United States
- Merz Investigative Site — Coral Gables, Florida, United States
- Merz Investigative Site — West Palm Beach, Florida, United States
- Merz Investigative Site — Alpharetta, Georgia, United States
- Merz Investigative Site — Naperville, Illinois, United States
- Merz Investigative Site — Hunt Valley, Maryland, United States
- Merz Investigative Site — Mount Kisco, New York, United States
- Merz Investigative Site — New York, New York, United States
- Merz Investigative Site — New York, New York, United States
- Merz Investigative Site — Chapel Hill, North Carolina, United States
- Merz Investigative Site — Wilmington, North Carolina, United States
- Merz Investigative Site — Ardmore, Pennsylvania, United States
- Merz Investigative Site — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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