Neuromuscular AgentsPhase 3PLATINUM USNCT07122193
A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in the United States
A Phase 3 study testing NT 201 in people with Neuromuscular Agents and Peripheral Nervous System Agents, run by Merz North America, Inc. at 28 sites in 2 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 years and older
- 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
- 28 sitesin 2 countries
- Study dates
- 27 Aug 2025to Sep 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 years and older
- 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 MAPS-D 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
28 sites in 2 countries.
28 sites in 2 countries
United States27 sites
Merz Investigative Site
Alpharetta, Georgia, 30005
Merz Investigative Site
Ardmore, Pennsylvania, 19003
Merz Investigative Site
Arlington, Virginia, 22209
Merz Investigative Site
Aventura, Florida, 33180
Merz Investigative Site
Boca Raton, Florida, 33431
Merz Investigative Site
Bradenton, Florida, 34209
Merz Investigative Site
Chapel Hill, North Carolina, 27517
Merz Investigative Site
Coral Gables, Florida, 33143
Merz Investigative Site
Coral Gables, Florida, 33146
Merz Investigative Site
Dallas, Texas, 75225
Merz Investigative Site
Encino, California, 91436
Merz Investigative Site
Greenwood Village, Colorado, 80111
Merz Investigative Site
Hunt Valley, Maryland, 21030
Merz Investigative Site
Los Angeles, California, 90069
Merz Investigative Site
Mount Kisco, New York, 10549
Merz Investigative Site
Naperville, Illinois, 60563
Merz Investigative Site
Nashville, Tennessee, 37215
Merz Investigative Site
New York, New York, 10021
Merz Investigative Site
New York, New York, 10028
Merz Investigative Site
Redondo Beach, California, 90277
Merz Investigative Site
Santa Monica, California, 90404
Merz Investigative Site
Scottsdale, Arizona, 85260
Merz Investigative Site
Vista, California, 92803
Merz Investigative Site
Washington D.C., District of Columbia, 20037
Merz Investigative Site
West Palm Beach, Florida, 33404
Merz Investigative Site
Westport, Connecticut, 06880
Merz Investigative Site
Wilmington, North Carolina, 28405
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 the United States
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 Cycle 1 and Cycle 2. 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 (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.
Measured: At Week 2 of MP
Secondary outcomes (10)
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
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.
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 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.
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 MAPS-D at Week 1 and Week 4 up to Week 17 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.
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 MAPS-D at Week 1 and Week 4 up to Week 17 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.
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 MAPS-D at Week 1 and Week 4 up to Week 17 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.
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 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 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 posted14 Aug 2025
- Study start27 Aug 2025
- Primary completion5 Jun 2026
- Study completionSep 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 North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122193
- Sponsor's protocol ID
- NT-PPR-US001
- Acronym
- PLATINUM US
- Status last verified
- Sep 2026
- First submitted
- 7 Aug 2025
- Last updated
- 10 Sep 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 10 Sep 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 the United States
- ClinicalTrials.gov ID
- NCT07122193
- Acronym / sponsor ID
- PLATINUM US / NT-PPR-US001
- 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 North America, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- Sep 2027 (estimated)
- First posted
- 14 Aug 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 Cycle 1 and Cycle 2. |
Who may qualify
- Ages
- 18 years and older
- 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 MAPS-D 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 (MAPS-D) At Week 2 of MP
Time frame: 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.
10 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 MAPS-D 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 MAPS-D 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 MAPS-D 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 MAPS-D 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 MAPS-D 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 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 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 10 Sep 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 North America, Inc.
28 sites in 2 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 North America, Inc. at 28 sites in 2 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Puerto Rico. 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 (MAPS-D) 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 10 Sep 2026.