A Study of NT 201 Doses in the Treatment of Platysma Prominence (PAOLA)

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

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

Study Overview

• Status: Completed
• Conditions: Platysma Prominence
• Intervention / Treatment: Drug: NT 201; Drug: NT 201 Placebo

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Public Disclosure Manager Merz Aesthetics; Phone Number: +1 984-301-3095; Email: Aesthetic.Trials@merz.com

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Merz Investigation Site #0010170
  • Florida
    • Aventura, Florida, United States, 33180
      • Merz Investigational Site #0010453
    • Coral Gables, Florida, United States, 33143
      • Merz Investigation Site #0010470
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Merz Investigation Site #0010105
  • New Jersey
    • Verona, New Jersey, United States, 07044
      • Merz Investigation Site #0010471
  • New York
    • New York, New York, United States, 10022
      • Merz Investigation Site #0010469
    • New York, New York, United States, 10028
      • Merz Investigation Site #0010405

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NT 201 Dose 1; Subjects will receive Dose 1.	Drug: NT 201; 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
Experimental: NT 201 Dose 2; Subjects will receive Dose 2.	Drug: NT 201; 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
Experimental: NT 201 Dose 3; Subjects will receive Dose 3.	Drug: NT 201; 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
Placebo Comparator: Placebo; Subjects will receive matching placebo.	Drug: NT 201 Placebo; NT 201 Matching-placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Investigator at Visit 4 (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).	Baseline (Screening Visit), Week 2 (V4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Related Treatment Emergent Adverse Events (Related TEAEs)	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.	Baseline up to Week 17/End of Study
Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Subject at 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).	Baseline (Screening Visit), Week 2 (V4)

Collaborators and Investigators

• Sponsor: Merz Aesthetics GmbH
• Investigators: Study Director: Merz Medical Expert, Merz North America, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Actual): October 19, 2023
• Study Completion (Actual): January 24, 2024

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; incobotulinumtoxinA
• Other Study ID Numbers: M602011078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No