A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in the United States

NCT07122193 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: NT-PPR-US001
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 28

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

Neurotransmitter Agents; incobotulinumtoxinA; Botulinum Toxins, Type A; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neuromuscular Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Acetylcholine Release Inhibitors; Membrane Transport Modulators

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 (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

  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 Cycle 1 and Cycle 2.

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+
• 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, 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).

Sponsors & Collaborators

• Merz North America, Inc.: lead

Study Sites (28)

Merz Investigative Site

Scottsdale, Arizona, 85260, United States

RECRUITING

Merz Investigative Site

Encino, California, 91436, United States

RECRUITING

Merz Investigative Site

Los Angeles, California, 90069, United States

RECRUITING

Merz Investigative Site

Redondo Beach, California, 90277, United States

RECRUITING

Merz Investigative Site

Santa Monica, California, 90404, United States

RECRUITING

Merz Investigative Site

Vista, California, 92803, United States

RECRUITING

Merz Investigative Site

Greenwood Village, Colorado, 80111, United States

RECRUITING

Merz Investigative Site

Westport, Connecticut, 06880, United States

RECRUITING

Merz Investigative Site

Washington D.C., District of Columbia, 20037, United States

RECRUITING

Merz Investigative Site

Aventura, Florida, 33180, United States

RECRUITING

Merz Investigative Site

Boca Raton, Florida, 33431, United States

RECRUITING

Merz Investigative Site

Bradenton, Florida, 34209, United States

RECRUITING

Merz Investigative Site

Coral Gables, Florida, 33143, United States

RECRUITING

Merz Investigative Site

Coral Gables, Florida, 33146, United States

RECRUITING

Merz Investigative Site

West Palm Beach, Florida, 33404, United States

RECRUITING

Merz Investigative Site

Alpharetta, Georgia, 30005, United States

RECRUITING

Merz Investigative Site

Naperville, Illinois, 60563, United States

RECRUITING

Merz Investigative Site

Hunt Valley, Maryland, 21030, United States

RECRUITING

Merz Investigative Site

Mount Kisco, New York, 10549, United States

RECRUITING

Merz Investigative Site

New York, New York, 10021, United States

RECRUITING

Merz Investigative Site

New York, New York, 10028, United States

RECRUITING

Merz Investigative Site

Chapel Hill, North Carolina, 27517, United States

RECRUITING

Merz Investigative Site

Wilmington, North Carolina, 28405, United States

RECRUITING

Merz Investigative Site

Ardmore, Pennsylvania, 19003, United States

RECRUITING

Merz Investigative Site

Nashville, Tennessee, 37215, United States

RECRUITING

Merz Investigative Site

Dallas, Texas, 75225, United States

RECRUITING

Merz Investigative Site

Arlington, Virginia, 22209, United States

RECRUITING

Merz Investigative Site

San Juan, 00917, Puerto Rico

RECRUITING

MeSH Terms

Interventions

incobotulinumtoxinA

Study Officials

• Merz Medical Expert

  Merz North America, Inc.

  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: August 7, 2025
• First Posted: August 14, 2025
• Study Start: August 27, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (27); PR (1)