A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)

NCT07210463 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: NT- PPR-EU002
• Study Type: interventional
• Target: 300
• Locations: 3 countries
• Sites: 26

Brief 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).

Conditions

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

Keywords

Platysma prominence

Outcome Measures

Primary Outcomes (1)

• Composite Achievement of Grade 1 or Grade 2 and at Least a 2-Grade Improvement From Baseline Based on Both the Investigator's Assessment and Participant's Self-Assessment Using the Merz Aesthetics Platysma Scale - Dynamic (MAPS-D) At Week 2 of MP

  MAPS-D is a validated five-point scale that will be used to grade the platysma prominence. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). A lower score indicates improvement.

  At Week 2 of MP

Secondary Outcomes (12)

• Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) and at Least a 2-Grade Improvement From Baseline Based on the Investigator's Assessment Using MAPS-D at Week 2 of MP

  At Week 2 of MP

• Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) and at Least a 2-Grade Improvement From Baseline Based on the Participant's Self-Assessment Using MAPS-D at Week 2 of MP

  At Week 2 of MP

• Achievement of at Least a +1 (Somewhat Satisfied) Score Using the Participant's Satisfaction Questionnaire at Week 2 of MP

  At Week 2 of MP

• Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) and at Least a 2-Grade Improvement From Baseline Based on Both the Investigator's Assessment and Participant's Self-Assessment Using MAPS-D at Week 1 and Week 4 up to Week 17 of MP

  At Week 1 and Week 4 up to Week 17 of MP

• Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) and at Least a 2-Grade Improvement From Baseline Based on the Investigator's Assessment Using MAPS-D at Week 1 and Week 4 up to Week 17 of MP

  At Week 1 and Week 4 up to Week 17 of MP

Study Arms (3)

Main Period: NT 201

EXPERIMENTAL

Participants will receive NT 201 IM injection, once on Day 1 of the MP.

Drug: NT 201

Main Period: NT 201 Matching Placebo

PLACEBO COMPARATOR

Participants will receive NT 201 matching placebo IM injection, once on Day 1 of the MP.

Drug: NT 201 Placebo

OLEX Period: NT 201

EXPERIMENTAL

Participants will receive a reinjection of NT 201 IM injection, once on Day 1 of OLEX period.

Drug: NT 201

Interventions

NT 201 DRUG

Clostridium Botulinum neurotoxin A (150 kiloDalton \[kD\], free of complexing proteins), powder for solution for injection.

Also known as: IncobotulinumtoxinA, Xeomin/Bocouture, Xeomin Cosmetic, Xeomeen

Main Period: NT 201; OLEX Period: NT 201

NT 201 Placebo DRUG

NT 201 matching-placebo.

Main Period: NT 201 Matching Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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, 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).

Sponsors & Collaborators

• Merz Aesthetics GmbH: lead

Study Sites (26)

Merz Investigative Site

Munich, Bavaria, 80539, Germany

RECRUITING

Merz Investigative Site

Blankenfelde-Mahlow, Brandenburg, 15831, Germany

RECRUITING

Merz Investigative Site

Potsdam, Brandenburg, 14467, Germany

RECRUITING

Merz Investigative Site

Friedrichsdorf, Hesse, 61381, Germany

RECRUITING

Merz Investigative Site

Kassel, Hesse, 34117, Germany

RECRUITING

Merz Investigative Site

Bochum, North Rhine-Westphalia, 44793, Germany

RECRUITING

Merz Investigative Site

Düsseldorf, North Rhine-Westphalia, 40212, Germany

RECRUITING

Merz Investigative Site

Drensteinfurt, 48317, Germany

RECRUITING

Merz Investigative Site

Hamburg, 20146, Germany

RECRUITING

Merz Investigative Site

Hamburg, 29354, Germany

RECRUITING

Merz Investigative Site

Wuppertal, 42287, Germany

RECRUITING

Merz Investigative Site

Krakow, Lesser Poland Voivodeship, 30-002, Poland

RECRUITING

Merz Investigative Site

Oświęcim, Lesser Poland Voivodeship, 32-600, Poland

RECRUITING

Merz Investigative Site

Lublin, Lublin Voivodeship, 20-607, Poland

RECRUITING

Merz Investigative Site

Warsaw, Masovian Voivodeship, 00-716, Poland

RECRUITING

Merz Investigative Site

Warsaw, Masovian Voivodeship, 01-142, Poland

RECRUITING

Merz Investigative Site

Warsaw, Masovian Voivodeship, 02-482, Poland

RECRUITING

Merz Investigative Site

Warsaw, Masovian Voivodeship, 02-953, Poland

RECRUITING

Merz Investigative Site

Bialystok, Podlaskie Voivodeship, 15-453, Poland

RECRUITING

Merz Investigative Site

Gdynia, Pomeranian Voivodeship, 81-537, Poland

RECRUITING

Merz Investigative Site

Warsaw, 02-962, Poland

RECRUITING

Merz Investigative Site

Lodz, Łódź Voivodeship, 90-436, Poland

RECRUITING

Merz Investigative Site

Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland

RECRUITING

Merz Investigative Site

Pamplona, Navarre, 31008, Spain

RECRUITING

Merz Investigative Site

Madrid, 28001, Spain

NOT YET RECRUITING

Merz Investigative Site

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Interventions

incobotulinumtoxinA

Study Officials

• Merz Medical Expert

  Merz Aesthetics GmbH

  STUDY DIRECTOR

Central Study Contacts

Public Disclosure Manager Merz Aesthetics

CONTACT

+1 984-301-3095; Aesthetic.Trials@merz.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); PL (12); DE (11)