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A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)

Active Not RecruitingPhase 3

Sponsor: Merz Aesthetics GmbH

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

Interventions: NT 201, NT 201 Placebo

Countries: France, Germany, Poland, Spain

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 65 Years

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 MAPSD 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 (26)

Lyon, France
Munich, Bavaria, Germany
Blankenfelde-Mahlow, Brandenburg, Germany
Potsdam, Brandenburg, Germany
Friedrichsdorf, Hesse, Germany
Kassel, Hesse, Germany
Bochum, North Rhine-Westphalia, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Drensteinfurt, Germany
Hamburg, Germany
Hamburg, Germany
Wuppertal, Germany
Krakow, Lesser Poland Voivodeship, Poland
Oświęcim, Lesser Poland Voivodeship, Poland
Lublin, Lublin Voivodeship, Poland
Warsaw, Masovian Voivodeship, Poland
Warsaw, Masovian Voivodeship, Poland
Warsaw, Masovian Voivodeship, Poland
Warsaw, Masovian Voivodeship, Poland
Bialystok, Podlaskie Voivodeship, Poland
Gdynia, Pomeranian Voivodeship, Poland
Warsaw, Poland
Lodz, Łódź Voivodeship, Poland
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland
Pamplona, Navarre, Spain
Valencia, Spain