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 (PLATINUM EU)

NCT07210463 Phase 3 RECRUITING

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).

Details

Lead sponsor	Merz Aesthetics GmbH
Phase	Phase 3
Status	RECRUITING
Enrolment	300
Start date	2025-10-01
Completion	2027-11

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

• NT 201
• NT 201 Placebo

Primary outcomes

• 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 — 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.

Countries

Germany, Poland, Spain