Neuromuscular AgentsPhase 3PLATINUM EUNCT07210463
A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)
A Phase 3 study testing NT 201 in people with Neuromuscular Agents and Peripheral Nervous System Agents, run by Merz Aesthetics GmbH at 26 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuromuscular Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs
- What is being tested?
- NT 201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 26 sitesin 4 countries
- Study dates
- 1 Oct 2025to Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 MAPSD at maximum contraction by the investigator AND participant.
Who cannot join
- 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).
Trial locations and contacts
26 sites in 4 countries.
26 sites in 4 countries
Poland12 sites
Merz Investigative Site
Bialystok, Podlaskie Voivodeship, 15-453
Merz Investigative Site
Gdynia, Pomeranian Voivodeship, 81-537
Merz Investigative Site
Krakow, Lesser Poland Voivodeship, 30-002
Merz Investigative Site
Lodz, Łódź Voivodeship, 90-436
Merz Investigative Site
Lublin, Lublin Voivodeship, 20-607
Merz Investigative Site
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400
Merz Investigative Site
Oświęcim, Lesser Poland Voivodeship, 32-600
Merz Investigative Site
Warsaw, Masovian Voivodeship, 00-716
Merz Investigative Site
Warsaw, Masovian Voivodeship, 01-142
Merz Investigative Site
Warsaw, Masovian Voivodeship, 02-482
Merz Investigative Site
Warsaw, Masovian Voivodeship, 02-953
Merz Investigative Site
Warsaw, 02-962
Germany11 sites
Merz Investigative Site
Blankenfelde-Mahlow, Brandenburg, 15831
Merz Investigative Site
Bochum, North Rhine-Westphalia, 44793
Merz Investigative Site
Drensteinfurt, 48317
Merz Investigative Site
Düsseldorf, North Rhine-Westphalia, 40212
Merz Investigative Site
Friedrichsdorf, Hesse, 61381
Merz Investigative Site
Hamburg, 20146
Merz Investigative Site
Hamburg, 29354
Merz Investigative Site
Kassel, Hesse, 34117
Merz Investigative Site
Munich, Bavaria, 80539
Merz Investigative Site
Potsdam, Brandenburg, 14467
Merz Investigative Site
Wuppertal, 42287
Spain2 sites
Merz Investigative Site
Pamplona, Navarre, 31008
Merz Investigative Site
Valencia, 46010
About this study
Official title: 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 Europe
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
- Being tested
- NT 201, NT 201 Placebo
- Keywords
- Platysma prominence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT 201Drug
Also called IncobotulinumtoxinA, Xeomin/Bocouture, Xeomin Cosmetic, Xeomeen
Clostridium Botulinum neurotoxin A (150 kiloDalton [kD], free of complexing proteins), powder for solution for injection.
NT 201 PlaceboDrug
NT 201 matching-placebo.
| Study group | Role | What they receive |
|---|---|---|
| Main Period: NT 201 | Experimental | Participants will receive NT 201 IM injection, once on Day 1 of the MP. Receives: 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. Receives: 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. Receives: Drug: NT 201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (MAPSD) At Week 2 of MP
MAPSD 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.
Measured: 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 MAPSD at Week 2 of MP
MAPSD 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.
Measured: 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 MAPSD at Week 2 of MP
MAPSD 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.
Measured: 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
Participants satisfaction questionnaire responses will be rated on a scale ranging from +3 (very satisfied) to -3 (very dissatisfied). A higher score indicates satisfaction.
Measured: 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 MAPSD at Week 1 and Week 4 up to Week 17 of MP
MAPSD 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.
Measured: 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 MAPSD at Week 1 and Week 4 up to Week 17 of MP
MAPSD 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.
Measured: 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 Participant's Self-Assessment Using MAPSD at Week 1 and Week 4 up to Week 17 of MP
MAPSD 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.
Measured: At Week 1 and Week 4 up to Week 17 of MP
Achievement of at Least a +1 (Improved) Score on the Global Aesthetic Improvement Scale (GAIS)-Platysmal Bands at maximum contraction Based on the Investigator's Assessment at Week 2 of MP
GAIS is a balanced seven-point Likert scale (range -3 [very much worse] to +3 [very much improved]) commonly used in aesthetic medicine to rate post-treatment improvement in appearance. A higher score indicates improvement.
Measured: At Week 2 of MP
Achievement of at Least a +1 (Improved) Score on the GAIS-Platysmal Bands at maximum contraction Based on the Participant's Self-Assessment at Week 2 of MP
GAIS is a balanced seven-point Likert scale (range -3 [very much worse] to +3 [very much improved]) commonly used in aesthetic medicine to rate post-treatment improvement in appearance. A higher score indicates improvement.
Measured: At Week 2 of MP
Achievement of at Least a +1 (Improved) Score on the GAIS-Platysmal Bands at Rest Based on the Investigator's Assessment at Week 2 of MP
GAIS is a balanced seven-point Likert scale (range -3 [very much worse] to +3 [very much improved]) commonly used in aesthetic medicine to rate post-treatment improvement in appearance. A higher score indicates improvement.
Measured: At Week 2 of MP
Achievement of at Least a +1 (Improved) Score on the GAIS-Platysmal Bands at Rest Based on the Participant's Self-Assessment at Week 2 of MP
GAIS is a balanced seven-point Likert scale (range -3 [very much worse] to +3 [very much improved]) commonly used in aesthetic medicine to rate post-treatment improvement in appearance. A higher score indicates improvement.
Measured: At Week 2 of MP
Achievement of at Least a +1 (Improved) Score Using the GAIS-Lower Face Contour According to the Investigator's Assessment at Week 2 of MP
GAIS is a balanced seven-point Likert scale (range -3 [very much worse] to +3 [very much improved]) commonly used in aesthetic medicine to rate post-treatment improvement in appearance. A higher score indicates improvement.
Measured: At Week 2 of MP
Achievement of at Least a +1 (Improved) Score Using the GAIS-Lower Face Contour According to the Participant's Self-Assessment at Week 2 of MP
GAIS is a balanced seven-point Likert scale (range -3 [very much worse] to +3 [very much improved]) commonly used in aesthetic medicine to rate post-treatment improvement in appearance. A higher score indicates improvement.
Measured: At Week 2 of MP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Oct 2025
- Primary completion5 Aug 2026
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular AgentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Aesthetics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz Aesthetics GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210463
- Sponsor's protocol ID
- NT- PPR-EU002
- Acronym
- PLATINUM EU
- Status last verified
- Nov 2026
- First submitted
- 29 Sep 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 Europe
- ClinicalTrials.gov ID
- NCT07210463
- Acronym / sponsor ID
- PLATINUM EU / NT- PPR-EU002
- Conditions
- Neuromuscular Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Acetylcholine Release Inhibitors, Membrane Transport Modulators, Molecular Mechanisms of Pharmacological Action
- Keywords
- Platysma prominence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Merz Aesthetics GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 5 Aug 2026 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Main Period: NT 201 | Experimental | Drug: NT 201Participants will receive NT 201 IM injection, once on Day 1 of the MP. |
| Main Period: NT 201 Matching Placebo | Placebo comparator | Drug: NT 201 PlaceboParticipants will receive NT 201 matching placebo IM injection, once on Day 1 of the MP. |
| OLEX Period: NT 201 | Experimental | Drug: NT 201Participants will receive a reinjection of NT 201 IM injection, once on Day 1 of OLEX period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 MAPSD at maximum contraction by the investigator AND participant.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NT 201Also: IncobotulinumtoxinA, Xeomin/Bocouture, Xeomin Cosmetic, XeomeenClostridium Botulinum neurotoxin A (150 kiloDalton [kD], free of complexing proteins), powder for solution for injection. | Drug | Main Period: NT 201, OLEX Period: NT 201 |
| NT 201 PlaceboNT 201 matching-placebo. | Drug | Main Period: NT 201 Matching Placebo |
Primary outcome
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 (MAPSD) At Week 2 of MP
Time frame: At Week 2 of MP
MAPSD 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.
12 secondary outcomes
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 MAPSD at Week 2 of MP
Time frame: 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 MAPSD at Week 2 of MP
Time frame: 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
Time frame: 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 MAPSD at Week 1 and Week 4 up to Week 17 of MP
Time frame: 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 MAPSD at Week 1 and Week 4 up to Week 17 of MP
Time frame: 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 Participant's Self-Assessment Using MAPSD at Week 1 and Week 4 up to Week 17 of MP
Time frame: At Week 1 and Week 4 up to Week 17 of MP
Achievement of at Least a +1 (Improved) Score on the Global Aesthetic Improvement Scale (GAIS)-Platysmal Bands at maximum contraction Based on the Investigator's Assessment at Week 2 of MP
Time frame: At Week 2 of MP
Achievement of at Least a +1 (Improved) Score on the GAIS-Platysmal Bands at maximum contraction Based on the Participant's Self-Assessment at Week 2 of MP
Time frame: At Week 2 of MP
Achievement of at Least a +1 (Improved) Score on the GAIS-Platysmal Bands at Rest Based on the Investigator's Assessment at Week 2 of MP
Time frame: At Week 2 of MP
Achievement of at Least a +1 (Improved) Score on the GAIS-Platysmal Bands at Rest Based on the Participant's Self-Assessment at Week 2 of MP
Time frame: At Week 2 of MP
Achievement of at Least a +1 (Improved) Score Using the GAIS-Lower Face Contour According to the Investigator's Assessment at Week 2 of MP
Time frame: At Week 2 of MP
Achievement of at Least a +1 (Improved) Score Using the GAIS-Lower Face Contour According to the Participant's Self-Assessment at Week 2 of MP
Time frame: At Week 2 of MP
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merz Medical Expert study director
Merz Aesthetics GmbH
26 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NT 201 in people with Neuromuscular Agents and Peripheral Nervous System Agents, run by Merz Aesthetics GmbH at 26 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Poland, Germany, Spain, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (MAPSD) At Week 2 of MP (time frame: At Week 2 of MP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.