A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in the United States
NCT ID: NCT07122193
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2025-08-27
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Main Period: NT 201
Participants will receive NT 201 IM injection, once on Day 1 of the MP.
NT 201
Clostridium Botulinum neurotoxin A (150 kiloDalton \[kD\], free of complexing proteins), powder for solution for injection.
Main Period: NT 201 Matching Placebo
Participants will receive NT 201 matching placebo IM injection, once on Day 1 of the MP.
NT 201 Placebo
NT 201 matching-placebo
OLEX Period: NT 201
Participants will receive a reinjection of NT 201 IM injection, once on Day 1 of OLEX Cycle 1 and Cycle 2.
NT 201
Clostridium Botulinum neurotoxin A (150 kiloDalton \[kD\], free of complexing proteins), powder for solution for injection.
Interventions
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NT 201
Clostridium Botulinum neurotoxin A (150 kiloDalton \[kD\], free of complexing proteins), powder for solution for injection.
NT 201 Placebo
NT 201 matching-placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A score of Grade 3 ('moderate') or Grade 4 ('severe') on the MAPS-D at maximum contraction by the investigator and participant.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Merz North America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Merz Medical Expert
Role: STUDY_DIRECTOR
Merz North America, Inc.
Locations
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Merz Investigative Site
Scottsdale, Arizona, United States
Merz Investigative Site
Encino, California, United States
Merz Investigative Site
Los Angeles, California, United States
Merz Investigative Site
Redondo Beach, California, United States
Merz Investigative Site
Santa Monica, California, United States
Merz Investigative Site
Vista, California, United States
Merz Investigative Site
Greenwood Village, Colorado, United States
Merz Investigative Site
Westport, Connecticut, United States
Merz Investigative Site
Washington D.C., District of Columbia, United States
Merz Investigative Site
Aventura, Florida, United States
Merz Investigative Site
Boca Raton, Florida, United States
Merz Investigative Site
Bradenton, Florida, United States
Merz Investigative Site
Coral Gables, Florida, United States
Merz Investigative Site
Coral Gables, Florida, United States
Merz Investigative Site
West Palm Beach, Florida, United States
Merz Investigative Site
Alpharetta, Georgia, United States
Merz Investigative Site
Naperville, Illinois, United States
Merz Investigative Site
Hunt Valley, Maryland, United States
Merz Investigative Site
Mount Kisco, New York, United States
Merz Investigative Site
New York, New York, United States
Merz Investigative Site
New York, New York, United States
Merz Investigative Site
Chapel Hill, North Carolina, United States
Merz Investigative Site
Wilmington, North Carolina, United States
Merz Investigative Site
Ardmore, Pennsylvania, United States
Merz Investigative Site
Nashville, Tennessee, United States
Merz Investigative Site
Dallas, Texas, United States
Merz Investigative Site
Arlington, Virginia, United States
Merz Investigative Site
San Juan, , Puerto Rico
Countries
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Central Contacts
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Other Identifiers
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NT-PPR-US001
Identifier Type: -
Identifier Source: org_study_id
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