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

NCT05773053 | Completed Phase 2 FDA Drug

• 1 other identifier: M602011078
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Platysma Prominence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Baseline (Screening Visit), Week 2 (V4)

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

  Baseline up to Week 17/End of Study

Study Arms (4)

NT 201 Dose 1

EXPERIMENTAL

Subjects will receive Dose 1.

Drug: NT 201

NT 201 Dose 2

EXPERIMENTAL

Subjects will receive Dose 2.

Drug: NT 201

NT 201 Dose 3

EXPERIMENTAL

Subjects will receive Dose 3.

Drug: NT 201

Placebo

PLACEBO COMPARATOR

Subjects will receive matching placebo.

Drug: NT 201 Placebo

Interventions

NT 201 DRUG

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

Also known as: IncobotulinumtoxinA, Xeomin/Bocouture, Xeomin Cosmetic, Xeomeen

NT 201 Dose 1; NT 201 Dose 2; NT 201 Dose 3

NT 201 Placebo DRUG

NT 201 Matching-placebo.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merz Aesthetics GmbH: lead

Study Sites (7)

Merz Investigation Site #0010170

Washington D.C., District of Columbia, 20037, United States

Location

Merz Investigational Site #0010453

Aventura, Florida, 33180, United States

Location

Merz Investigation Site #0010470

Coral Gables, Florida, 33143, United States

Location

Merz Investigation Site #0010105

Metairie, Louisiana, 70006, United States

Location

Merz Investigation Site #0010471

Verona, New Jersey, 07044, United States

Location

Merz Investigation Site #0010469

New York, New York, 10022, United States

Location

Merz Investigation Site #0010405

New York, New York, 10028, United States

Location

MeSH Terms

Interventions

incobotulinumtoxinA

Study Officials

• Merz Medical Expert

  Merz North America, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 17, 2023
• Study Start: March 22, 2023
• Primary Completion: October 19, 2023
• Study Completion: January 24, 2024
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)