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

NCT07122193 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-22

No results posted yet for this study

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

Interventions

DRUG

NT 201

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

DRUG

NT 201 Placebo

NT 201 matching-placebo

Sponsors & Collaborators

  • Merz North America, Inc.

    lead INDUSTRY

Principal Investigators

  • Merz Medical Expert · Merz North America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-27
Primary Completion
2026-10-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07122193 on ClinicalTrials.gov