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

Merz Pharmaceuticals

Status and phase: Enrolling; Phase 3

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

Treatments: Drug: NT 201; Drug: NT 201 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07210463

NT- PPR-EU002

Details and patient eligibility

About

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).

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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, 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups, including a placebo group

Main Period: NT 201

Experimental group

Description:

Participants will receive NT 201 IM injection, once on Day 1 of the MP.

Treatment:

Drug: NT 201

Main Period: NT 201 Matching Placebo

Placebo Comparator group

Description:

Participants will receive NT 201 matching placebo IM injection, once on Day 1 of the MP.

Treatment:

Drug: NT 201 Placebo

OLEX Period: NT 201

Experimental group

Description:

Participants will receive a reinjection of NT 201 IM injection, once on Day 1 of OLEX period.

Treatment:

Drug: NT 201