RECRUITING

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

Description

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 AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsAcetylcholine Release InhibitorsMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionCholinergic AgentsNeurotransmitter AgentsincobotulinumtoxinABotulinum Toxins, Type A
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Related Conditions:

Neuromuscular AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsAcetylcholine Release InhibitorsMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionCholinergic AgentsNeurotransmitter AgentsincobotulinumtoxinABotulinum Toxins, Type A

Study Overview

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Study Details

Study overview

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).

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

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

Condition
Neuromuscular Agents
Intervention / Treatment

-

Contacts and Locations

Cockeysville

Merz Investigative Site, Cockeysville, Maryland, United States, 21030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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, aesthetic procedures, and orthodontic procedures in the past 12 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).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merz North America, Inc.,

Merz Medical Expert, STUDY_DIRECTOR, Merz North America, Inc.

Study Record Dates

2028-01