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

Active Not RecruitingPhase 3

Sponsor: Merz North America, Inc.

Conditions: Neuromuscular Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Acetylcholine Release Inhibitors, Membrane Transport Modulators

Interventions: NT 201, NT 201 Placebo

Countries: United States, Puerto Rico

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Presence of four (medial and lateral, left and right) platysmal bands assessed at screening and baseline.
* A score of Grade 3 ('moderate') or Grade 4 ('severe') on the MAPS-D at maximum contraction by the investigator and participant.

Exclusion Criteria:

* Hypersensitivity or a history of allergic reaction to botulinum toxin of any serotype or any of their formulation ingredients.
* 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, and aesthetic procedures in the past 12 months, and/or orthodontic procedures in the past 6 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).

Locations (28)

Scottsdale, Arizona, United States
Encino, California, United States
Los Angeles, California, United States
Redondo Beach, California, United States
Santa Monica, California, United States
Vista, California, United States
Greenwood Village, Colorado, United States
Westport, Connecticut, United States
Washington D.C., District of Columbia, United States
Aventura, Florida, United States
Boca Raton, Florida, United States
Bradenton, Florida, United States
Coral Gables, Florida, United States
Coral Gables, Florida, United States
West Palm Beach, Florida, United States
Alpharetta, Georgia, United States
Naperville, Illinois, United States
Hunt Valley, Maryland, United States
Mount Kisco, New York, United States
New York, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Wilmington, North Carolina, United States
Ardmore, Pennsylvania, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Arlington, Virginia, United States
San Juan, Puerto Rico