Trials / Recruiting
RecruitingNCT07122193
A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in the United States
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Merz North America, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2025-08-27
- Primary completion
- 2026-10-01
- Completion
- 2028-01-01
- First posted
- 2025-08-14
- Last updated
- 2026-04-08
Locations
28 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07122193. Inclusion in this directory is not an endorsement.