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

This trial does not accept healthy volunteers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

NT 201
Drug
Clostridium Botulinum neurotoxin A (150 kiloDalton \[kD\], free of complexing proteins), powder for solution for injection.
NT 201 Placebo
Drug
NT 201 matching-placebo.

Treatment groups

300 Participants

are divided into 3 treatment groups

Group A: Main Period: NT 201Experimental treatment 1 intervention

Group B: Main Period: NT 201 Matching PlaceboPlacebo comparator 1 intervention

Group C: OLEX Period: NT 201Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Composite Achievement of Grade 1 or Grade 2 and at Least a 2-Grade Improvement From Baseline Based on Both the Investigator's Assessment and Participant's Self-Assessment Using the Merz Aesthetics Platysma Scale Dynamic (MAPSD) At Week 2 of MP

MAPSD is a validated five-point scale that will be used to grade the platysma prominence. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). A lower score indicates improvement.

Time frame

At Week 2 of MP

Secondary outcomes

Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) and at Least a 2-Grade Improvement From Baseline Based on the Investigator's Assessment Using MAPSD at Week 2 of MP

MAPSD is a validated five-point scale that will be used to grade the platysma prominence. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). A lower score indicates improvement.

Time frame

At Week 2 of MP

Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) and at Least a 2-Grade Improvement From Baseline Based on the Participant's Self-Assessment Using MAPSD at Week 2 of MP

MAPSD is a validated five-point scale that will be used to grade the platysma prominence. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). A lower score indicates improvement.

Time frame

At Week 2 of MP

Achievement of at Least a +1 (Somewhat Satisfied) Score Using the Participant's Satisfaction Questionnaire at Week 2 of MP

Participants satisfaction questionnaire responses will be rated on a scale ranging from +3 (very satisfied) to -3 (very dissatisfied). A higher score indicates satisfaction.

Time frame

At Week 2 of MP

Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) and at Least a 2-Grade Improvement From Baseline Based on Both the Investigator's Assessment and Participant's Self-Assessment Using MAPSD at Week 1 and Week 4 up to Week 17 of MP

MAPSD is a validated five-point scale that will be used to grade the platysma prominence. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). A lower score indicates improvement.

Time frame

At Week 1 and Week 4 up to Week 17 of MP