A Phase 3 interventional study of NT 201 and NT 201 Placebo in Neuromuscular Agents, Peripheral Nervous System Agents and Physiological Effects of Drugs, sponsored by Merz North America, Inc.. Active, not recruiting at 28 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Merz North America, Inc. (part of Merz Pharma) · Phase 3, Interventional, and Treatment
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).
Merz North America, Inc. is the lead sponsor of 53 studies on the registry; 2 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 19 (95%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive NT 201 IM injection, once on Day 1 of the MP.
Drug: NT 201
Participants will receive NT 201 matching placebo IM injection, once on Day 1 of the MP.
Drug: NT 201 Placebo
Participants will receive a reinjection of NT 201 IM injection, once on Day 1 of OLEX Cycle 1 and Cycle 2.
Drug: NT 201
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
NT 201 matching-placebo
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.
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 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.
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
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.
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
Participants satisfaction questionnaire responses will be rated on a scale ranging from +3 (very satisfied) to -3 (very dissatisfied). A higher score indicates satisfaction.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Time frame: At Week 2 of MP
Plan to share: No
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This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: incobotulinumtoxinA