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

ConditionsNeuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents incobotulinumtoxinA Botulinum Toxins, Type A

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-65

SponsorMerz Aesthetics GmbH

About this trial

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

Qualifiers

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.

Disqualifiers

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.