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

Last updated: November 3, 2025
Sponsor: Merz North America, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

NT 201 Placebo

NT 201

Clinical Study ID

NCT07122193
NT-PPR-US001
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Presence of four (medial and lateral, left and right) platysmal bands assessed atscreening and baseline.

  • A score of Grade 3 ('moderate') or Grade 4 ('severe') on the MAPS-D at maximumcontraction by the investigator and participant.

Exclusion

Exclusion Criteria:

  • Hypersensitivity or a history of allergic reaction to botulinum toxin of anyserotype or any of their formulation ingredients.

  • Any medical condition that may put the participant at increased risk with exposureto botulinum toxin of any serotype, or any disorders that might interfere withneuromuscular function.

  • Any serious disease or disorder that could interfere with the safe completion oftreatment or with study outcome assessments, or compromise participant safety.

  • Botulinum toxin treatment in the face (below the lower orbital rim), jawline, orneck within the last seven months.

  • History of lower face surgery, neck or chest surgery, aesthetic procedures, andorthodontic procedures in the past 12 months.

  • Planned surgery or aesthetic procedures to the lower face, neck, or chest during thestudy period.

  • Anticipated need for treatment with botulinum toxin of any serotype for anyindication during the study (other than study products).

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: NT 201 Placebo
Phase: 3
Study Start date:
August 27, 2025
Estimated Completion Date:
January 31, 2028

Connect with a study center

  • Merz Investigative Site

    San Juan 4568127, 00917
    Puerto Rico

    Active - Recruiting

  • Merz Investigative Site

    Scottsdale 5313457, Arizona 5551752 85260
    United States

    Active - Recruiting

  • Merz Investigative Site

    Encino 5346649, California 5332921 91436
    United States

    Active - Recruiting

  • Merz Investigative Site

    Los Angeles 5368361, California 5332921 90069
    United States

    Active - Recruiting

  • Merz Investigative Site

    Redondo Beach 5386785, California 5332921 90277
    United States

    Active - Recruiting

  • Merz Investigative Site

    Santa Monica 5393212, California 5332921 90404
    United States

    Active - Recruiting

  • Merz Investigative Site

    Vista 5406602, California 5332921 92803
    United States

    Active - Recruiting

  • Merz Investigative Site

    Greenwood Village 5423908, Colorado 5417618 80111
    United States

    Active - Recruiting

  • Merz Investigative Site

    Westport 4845585, Connecticut 4831725 06880
    United States

    Active - Recruiting

  • Merz Investigative Site

    Washington D.C. 4140963, District of Columbia 4138106 20037
    United States

    Active - Recruiting

  • Merz Investigative Site

    Aventura 4146429, Florida 4155751 33180
    United States

    Active - Recruiting

  • Merz Investigative Site

    Boca Raton 4148411, Florida 4155751 33431
    United States

    Active - Recruiting

  • Merz Investigative Site

    Bradenton 4148708, Florida 4155751 34209
    United States

    Active - Recruiting

  • Merz Investigative Site

    Coral Gables 4151871, Florida 4155751 33146
    United States

    Active - Recruiting

  • Merz Investigative Site

    West Palm Beach 4177887, Florida 4155751 33404
    United States

    Active - Recruiting

  • Merz Investigative Site

    Alpharetta 4179574, Georgia 4197000 30005
    United States

    Active - Recruiting

  • Merz Investigative Site

    Naperville 4903279, Illinois 4896861 60563
    United States

    Active - Recruiting

  • Merz Investigative Site

    Cockeysville 4351887, Maryland 4361885 21030
    United States

    Site Not Available

  • Merz Investigative Site

    Hunt Valley 4358701, Maryland 4361885 21030
    United States

    Active - Recruiting

  • Merz Investigative Site

    Mount Kisco 5127744, New York 5128638 10549
    United States

    Active - Recruiting

  • Merz Investigative Site

    New York 5128581, New York 5128638 10021
    United States

    Active - Recruiting

  • Merz Investigative Site

    Chapel Hill 4460162, North Carolina 4482348 27517
    United States

    Active - Recruiting

  • Merz Investigative Site

    Wilmington 4499379, North Carolina 4482348 28405
    United States

    Active - Recruiting

  • Merz Investigative Site

    Ardmore 5178481, Pennsylvania 6254927 19003
    United States

    Active - Recruiting

  • Merz Investigative Site

    Nashville 4644585, Tennessee 4662168 37215
    United States

    Active - Recruiting

  • Merz Investigative Site

    Dallas 4684888, Texas 4736286 75225
    United States

    Active - Recruiting

  • Merz Investigative Site

    Arlington 4744709, Virginia 6254928 22209
    United States

    Active - Recruiting

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