The purpose of this study is to assess the safety and efficacy of NT 201 in adults with moderate to severe platysma prominence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
73
Clostridium botulinum neurotoxin type A (150 kiloDalton \[kD\], free of complexing proteins) powder for solution for injection.
NT 201 Matching-placebo.
Merz Investigation Site #0010170
Washington D.C., District of Columbia, United States
Merz Investigational Site #0010453
Aventura, Florida, United States
Merz Investigation Site #0010470
Coral Gables, Florida, United States
Merz Investigation Site #0010105
Metairie, Louisiana, United States
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
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Merz Investigation Site #0010471
Verona, New Jersey, United States
Merz Investigation Site #0010469
New York, New York, United States
Merz Investigation Site #0010405
New York, New York, United States