RECRUITING

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

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 Platysma prominence

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2025-08-27

Study Completion:2028-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07122193

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).

Inclusion Criteria

Exclusion 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).

Contacts and Locations

Study Contact

Public Disclosure Manager Merz Aesthetics

CONTACT

+1 984-301-3095

Aesthetic.Trials@merz.com

Principal Investigator

Merz Medical Expert

STUDY_DIRECTOR

Merz North America, Inc.

Study Locations (Sites)

Merz Investigative Site

Cockeysville, Maryland, 21030

United States

Collaborators and Investigators

Sponsor: Merz North America, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-27

Study Completion Date2028-01

Study Record Updates

Study Start Date2025-08-27

Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

Platysma prominence

Additional Relevant MeSH Terms

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