Actively Recruiting
A Phase 3, Randomized, Double-blind Study Comparing NT 201 and Placebo in Adults With Moderate to Severe Platysma Prominence in Europe
Led by Merz Aesthetics GmbH · Updated on 2026-04-01
300
Participants Needed
26
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of NT 201, a type of botulinum toxin A, compared with a placebo in adults who have moderate to severe platysma prominence, which refers to noticeable bands in the neck area. This Phase 3 study aims to understand how well NT 201 works and how safe it is for these participants. The study is sponsored by Merz Aesthetics GmbH and will be conducted in Europe. Participants will be randomly assigned to receive either a single injection of NT 201 or a matching placebo injection in the main study period (MP) on Day 1. After this period, those who received NT 201 can enter an open-label extension period (OLEX) where they will receive another injection of NT 201 on Day 1 of that phase. The study involves a double-blind design, meaning neither the participants nor the researchers know who receives the active drug or placebo during the main period. During the study, participants will be assessed using the Merz Aesthetics Platysma Scale - Dynamic (MAPS-D) to measure improvement in platysma prominence at various time points, including Week 2 and up to Week 17 in the main period. Both investigator and participant assessments will be used to evaluate the degree of improvement. Satisfaction questionnaires and global aesthetic improvement scales will also be used to measure participant satisfaction and aesthetic changes. Safety and efficacy will be closely monitored throughout the study, which lasts through the main and extension periods.
CONDITIONS
Brief Title
A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 Merz Aesthetics Platysma Scale - Dynamic (MAPS-D) at maximum contraction by the investigator and participant.
- Age between 18 and 65 years.
You will not qualify if you...
- 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, or any disorders that might interfere with neuromuscular function.
- Any serious disease or disorder that could interfere with safe treatment or study assessments, or compromise 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 botulinum toxin treatment for any indication during the study (other than study products).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 17 weeks
Participants receive an intramuscular injection of NT 201 or placebo on Day 1 of the main period.
Visits at Week 1, Week 2, Week 4, and up to Week 17 for assessments
Duration - Duration not specified
Participants in the open-label extension period receive a reinjection of NT 201 on Day 1 of the extension period.
1 visit for reinjection
Trial Site Locations
Total: 26 locations
1
Merz Investigative Site
Munich, Bavaria, Germany, 80539
Actively Recruiting
2
Merz Investigative Site
Blankenfelde-Mahlow, Brandenburg, Germany, 15831
Actively Recruiting
3
Merz Investigative Site
Potsdam, Brandenburg, Germany, 14467
Actively Recruiting
4
Merz Investigative Site
Friedrichsdorf, Hesse, Germany, 61381
Actively Recruiting
5
Merz Investigative Site
Kassel, Hesse, Germany, 34117
Actively Recruiting
6
Merz Investigative Site
Bochum, North Rhine-Westphalia, Germany, 44793
Actively Recruiting
7
Merz Investigative Site
Düsseldorf, North Rhine-Westphalia, Germany, 40212
Actively Recruiting
8
Merz Investigative Site
Drensteinfurt, Germany, 48317
Actively Recruiting
9
Merz Investigative Site
Hamburg, Germany, 20146
Actively Recruiting
10
Merz Investigative Site
Hamburg, Germany, 29354
Actively Recruiting
11
Merz Investigative Site
Wuppertal, Germany, 42287
Actively Recruiting
12
Merz Investigative Site
Krakow, Lesser Poland Voivodeship, Poland, 30-002
Actively Recruiting
13
Merz Investigative Site
Oświęcim, Lesser Poland Voivodeship, Poland, 32-600
Actively Recruiting
14
Merz Investigative Site
Lublin, Lublin Voivodeship, Poland, 20-607
Actively Recruiting
15
Merz Investigative Site
Warsaw, Masovian Voivodeship, Poland, 00-716
Actively Recruiting
16
Merz Investigative Site
Warsaw, Masovian Voivodeship, Poland, 01-142
Actively Recruiting
17
Merz Investigative Site
Warsaw, Masovian Voivodeship, Poland, 02-482
Actively Recruiting
18
Merz Investigative Site
Warsaw, Masovian Voivodeship, Poland, 02-953
Actively Recruiting
19
Merz Investigative Site
Bialystok, Podlaskie Voivodeship, Poland, 15-453
Actively Recruiting
20
Merz Investigative Site
Gdynia, Pomeranian Voivodeship, Poland, 81-537
Actively Recruiting
21
Merz Investigative Site
Warsaw, Poland, 02-962
Actively Recruiting
22
Merz Investigative Site
Lodz, Łódź Voivodeship, Poland, 90-436
Actively Recruiting
23
Merz Investigative Site
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland, 27-400
Actively Recruiting
24
Merz Investigative Site
Pamplona, Navarre, Spain, 31008
Actively Recruiting
25
Merz Investigative Site
Madrid, Spain, 28001
Not Yet Recruiting
26
Merz Investigative Site
Valencia, Spain, 46010
Actively Recruiting
Research Team
P
Public Disclosure Manager Merz Aesthetics
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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