NT 201
DrugClostridium botulinum neurotoxin type A (150 kiloDalton [kD], free of complexing proteins) powder for solution for injection.
Other names: IncobotulinumtoxinA, Xeomin/Bocouture, Xeomin Cosmetic, Xeomeen
NCT Number: NCT05773053
The purpose of this study is to assess the safety and efficacy of NT 201 in adults with moderate to severe platysma prominence.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2
Merz Investigation Site #0010170, Washington D.C., District of Columbia, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Clostridium botulinum neurotoxin type A (150 kiloDalton [kD], free of complexing proteins) powder for solution for injection.
Other names: IncobotulinumtoxinA, Xeomin/Bocouture, Xeomin Cosmetic, Xeomeen
NT 201 Matching-placebo.
Time frame: Baseline (Screening Visit), Week 2 (V4)
The platysma area will be assessed live by the investigator at maximum contraction and graded according to the validated five-point Merz Aesthetic Platysma Scale-Dynamic (MAPS-D). Scores range from Grade 1 (none to minimal) to Grade 5 (very severe).
Time frame: Baseline (Screening Visit), Week 2 (V4)
The platysma area will be assessed by the subjects at maximum contraction and graded according to the validated five-point MAPS-D. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe).
Time frame: Baseline up to Week 17/End of Study
TEAEs are defined as adverse events (AEs) with onset or worsening on or after date and time of first dose of study treatment. An AE is considered to be related if a causal relationship between NT 201 and the AE is at least reasonably possible.
Merz Aesthetics GmbH
Industry
A Prospective, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of NT 201 Doses in the Treatment of Platysma Prominence
Acronym: PAOLA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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