NT 201 for Adults with Moderate to Severe Platysma Prominence
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
This study will see if NT 201 injections safely reduce moderate to severe platysma (neck band) prominence in adults compared with a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Merz North America, Inc. Industry-sponsored |
| Locations | 28 sites (Scottsdale, Arizona and 27 other locations) |
| Trial ID | NCT07122193 on ClinicalTrials.gov |
What this trial studies
Adults with four visible platysmal bands and a Grade 3 or 4 score on the MAPS-D will receive injections of NT 201 or matching placebo during a main study period, and those who complete it may enter an open-label extension to receive active treatment. The trial compares safety and efficacy outcomes between the NT 201 and placebo groups using investigator and participant assessments of platysma prominence. Key exclusions include prior botulinum toxin to the lower face/neck within seven months, relevant surgical or aesthetic procedures within the past year, hypersensitivity to botulinum toxins, and neuromuscular disorders. The study is conducted at Merz investigative sites in Arizona and California.
Who should consider this trial
Good fit: Adults who have four platysmal bands and a MAPS-D score of moderate or severe at maximum contraction, who have not had recent botulinum toxin in the lower face/neck and have no neuromuscular disorders or allergies to botulinum toxin, are the intended participants.
Not a fit: People with a history of hypersensitivity to botulinum toxins, recent lower-face/neck botulinum treatments, recent neck/face surgery or procedures, or neuromuscular conditions are unlikely to be eligible or to benefit from participation.
Why it matters
Potential benefit: If successful, NT 201 could offer a non-surgical injectable option to reduce visible platysma bands and improve neck appearance.
How similar studies have performed: Injectable botulinum toxin approaches for platysma bands have been used successfully in prior clinical work and clinical practice, so the overall approach is established though the specific product may be new.
Eligibility criteria
Show full inclusion / exclusion 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, 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 this trial is running
Scottsdale, Arizona and 27 other locations
- Merz Investigative Site — Scottsdale, Arizona, United States (Recruiting)
- Merz Investigative Site — Encino, California, United States (Recruiting)
- Merz Investigative Site — Los Angeles, California, United States (Recruiting)
- Merz Investigative Site — Redondo Beach, California, United States (Recruiting)
- Merz Investigative Site — Santa Monica, California, United States (Recruiting)
- Merz Investigative Site — Vista, California, United States (Recruiting)
- Merz Investigative Site — Greenwood Village, Colorado, United States (Recruiting)
- Merz Investigative Site — Westport, Connecticut, United States (Recruiting)
- Merz Investigative Site — Washington D.C., District of Columbia, United States (Recruiting)
- Merz Investigative Site — Aventura, Florida, United States (Recruiting)
- Merz Investigative Site — Boca Raton, Florida, United States (Recruiting)
- Merz Investigative Site — Bradenton, Florida, United States (Recruiting)
- Merz Investigative Site — Coral Gables, Florida, United States (Recruiting)
- Merz Investigative Site — Coral Gables, Florida, United States (Recruiting)
- Merz Investigative Site — West Palm Beach, Florida, United States (Recruiting)
- Merz Investigative Site — Alpharetta, Georgia, United States (Recruiting)
- Merz Investigative Site — Naperville, Illinois, United States (Recruiting)
- Merz Investigative Site — Hunt Valley, Maryland, United States (Recruiting)
- Merz Investigative Site — Mount Kisco, New York, United States (Recruiting)
- Merz Investigative Site — New York, New York, United States (Recruiting)
- Merz Investigative Site — New York, New York, United States (Recruiting)
- Merz Investigative Site — Chapel Hill, North Carolina, United States (Recruiting)
- Merz Investigative Site — Wilmington, North Carolina, United States (Recruiting)
- Merz Investigative Site — Ardmore, Pennsylvania, United States (Recruiting)
- Merz Investigative Site — Nashville, Tennessee, United States (Recruiting)
- Merz Investigative Site — Dallas, Texas, United States (Recruiting)
- Merz Investigative Site — Arlington, Virginia, United States (Recruiting)
- Merz Investigative Site — San Juan, Puerto Rico (Recruiting)
Study contacts
- Study coordinator: Public Disclosure Manager Merz Aesthetics
- Email: Aesthetic.Trials@merz.com
- Phone: +1 984-301-3095
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.