A Phase 2 interventional study of NT 201 and NT 201 Placebo in Platysma Prominence, sponsored by Merz Aesthetics GmbH. Completed at 7 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-21.
Sponsored by Merz Aesthetics GmbH (part of Merz Pharma) · Phase 2, Interventional, and Treatment
The purpose of this study is to assess the safety and efficacy of NT 201 in adults with moderate to severe platysma prominence.
Merz Aesthetics GmbH is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Subjects will receive Dose 1.
Drug: NT 201
Subjects will receive Dose 2.
Drug: NT 201
Subjects will receive Dose 3.
Drug: NT 201
Subjects will receive matching placebo.
Drug: NT 201 Placebo
Clostridium botulinum neurotoxin type A (150 kiloDalton \[kD\], free of complexing proteins) powder for solution for injection.
Also known as: IncobotulinumtoxinA, Xeomin/Bocouture, Xeomin Cosmetic, Xeomeen
NT 201 Matching-placebo.
Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Investigator at Visit 4 (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)
Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Subject at 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 (Screening Visit), Week 2 (V4)
Number of Subjects With Related Treatment Emergent Adverse Events (Related TEAEs)
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.
Time frame: Baseline up to Week 17/End of Study
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2023 to primary completion in Oct 2023, 6 months.
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: incobotulinumtoxinA