Skip to main content
OpenTrials
Completed

NCT Number: NCT05773053

A Study of NT 201 Doses in the Treatment of Platysma Prominence

The purpose of this study is to assess the safety and efficacy of NT 201 in adults with moderate to severe platysma prominence.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Merz Investigation Site #0010170, Washington D.C., District of Columbia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of four (medial and lateral, left and right) prominent platysmal bands
  • Moderate to severe platysmal bands as assessed by the investigator and subject on the MAPS-D at maximum contraction

Exclusion criteria

  • Any serious disease or disorder (medical or psychiatric) that could interfere with the safe completion of treatment or compromise subject safety
  • Botulinum toxin treatment in the face (below the lower orbital rim), neck, or chest within the last 12 months prior to study treatment
  • History of lower face surgery, neck or chest surgery, aesthetic procedures (e.g., ablative skin resurfacing, laser, chemical peel, micro-focused ultrasound, deoxycholic acid injections, micro-needling, non-surgical fat reduction procedure), and orthodontic procedures (e.g., braces) in the 12 months prior to study treatment
  • Previous use of any permanent (non-biodegradable) or semi-permanent (e.g., calcium hydroxylapatite, poly-L-lactic acid, polymethyl methacrylate, etc.) facial tissue augmentation therapy, lifting sutures, permanent implants or autologous fat to the lower face (i.e., below the level of the bottom of the nose), neck, or chest within 24 months prior to study treatment
  • Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy to the lower face (i.e., below the level of the bottom of the nose), neck, or chest within 12 months prior to study treatment
  • Any medical condition that may put the subject at increased risk with exposure to botulinum toxin of any serotype, including myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function
  • Female of childbearing potential not using a highly effective method of birth control, planning to get pregnant, or pregnant or lactating

Treatment and study plan

NT 201

Drug

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

Other names: IncobotulinumtoxinA, Xeomin/Bocouture, Xeomin Cosmetic, Xeomeen

NT 201 Placebo

Drug

NT 201 Matching-placebo.

Primary outcomes

  1. Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Investigator at Visit 4 (V4)

    Time frame: Baseline (Screening Visit), Week 2 (V4)

    The platysma area will be assessed live by the investigator at maximum contraction and graded according to the validated five-point Merz Aesthetic Platysma Scale-Dynamic (MAPS-D). Scores range from Grade 1 (none to minimal) to Grade 5 (very severe).

Secondary outcomes

  1. Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Subject at V4

    Time frame: Baseline (Screening Visit), Week 2 (V4)

    The platysma area will be assessed by the subjects at maximum contraction and graded according to the validated five-point MAPS-D. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe).

  2. Number of Subjects With Related Treatment Emergent Adverse Events (Related TEAEs)

    Time frame: Baseline up to Week 17/End of Study

    TEAEs are defined as adverse events (AEs) with onset or worsening on or after date and time of first dose of study treatment. An AE is considered to be related if a causal relationship between NT 201 and the AE is at least reasonably possible.

Sponsors and collaborators

Lead sponsor

Merz Aesthetics GmbH

Industry

Registry information

Official study title

A Prospective, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of NT 201 Doses in the Treatment of Platysma Prominence

Acronym: PAOLA

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 17, 2023
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.