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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Clostridium Botulinum neurotoxin A (150 kiloDalton \[kD\], free of complexing proteins), powder for solution for injection.
NT 201 matching-placebo.
Merz Investigative Site
Munich, Bavaria, Germany
RECRUITINGMerz Investigative Site
Blankenfelde-Mahlow, Brandenburg, Germany
RECRUITINGMerz Investigative Site
Potsdam, Brandenburg, Germany
RECRUITINGMerz Investigative Site
Friedrichsdorf, Hesse, Germany
RECRUITINGMerz Investigative Site
Kassel, Hesse, Germany
RECRUITINGMerz Investigative Site
Bochum, North Rhine-Westphalia, Germany
RECRUITINGMerz Investigative Site
Düsseldorf, North Rhine-Westphalia, Germany
RECRUITINGMerz Investigative Site
Drensteinfurt, Germany
RECRUITINGMerz Investigative Site
Hamburg, Germany
RECRUITINGMerz Investigative Site
Hamburg, Germany
RECRUITING...and 16 more locations
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 (MAPS-D) At Week 2 of MP
MAPS-D 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 Investigator's Assessment Using MAPS-D at Week 2 of MP
MAPS-D 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 MAPS-D at Week 2 of MP
MAPS-D 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 MAPS-D at Week 1 and Week 4 up to Week 17 of MP
MAPS-D 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
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 MAPS-D at Week 1 and Week 4 up to Week 17 of MP
MAPS-D 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
Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) and at Least a 2-Grade Improvement From Baseline Based on Participant's Self-Assessment Using MAPS-D at Week 1 and Week 4 up to Week 17 of MP
MAPS-D 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
Achievement of at Least a +1 (Improved) Score on the Global Aesthetic Improvement Scale (GAIS)-Platysmal Bands Based on the Investigator's Assessment at Week 2 of MP
GAIS is a balanced seven-point Likert scale (range -3 \[very much worse\] to +3 \[very much improved\]) commonly used in aesthetic medicine to rate post-treatment improvement in appearance. A higher score indicates improvement.
Time frame: At Week 2 of MP
Achievement of at Least a +1 (Improved) Score on the GAIS-Platysmal Bands Based on the Participant's Self-Assessment at Week 2 of MP
GAIS is a balanced seven-point Likert scale (range -3 \[very much worse\] to +3 \[very much improved\]) commonly used in aesthetic medicine to rate post-treatment improvement in appearance. A higher score indicates improvement.
Time frame: At Week 2 of MP
Achievement of at Least a +1 (Improved) Score on the GAIS-Platysmal Bands at Rest Based on the Investigator's Assessment at Week 2 of MP
GAIS is a balanced seven-point Likert scale (range -3 \[very much worse\] to +3 \[very much improved\]) commonly used in aesthetic medicine to rate post-treatment improvement in appearance. A higher score indicates improvement.
Time frame: At Week 2 of MP
Achievement of at Least a +1 (Improved) Score on the GAIS-Platysmal Bands at Rest Based on the Participant's Self-Assessment at Week 2 of MP
GAIS is a balanced seven-point Likert scale (range -3 \[very much worse\] to +3 \[very much improved\]) commonly used in aesthetic medicine to rate post-treatment improvement in appearance. A higher score indicates improvement.
Time frame: At Week 2 of MP
Achievement of at Least a +1 (Improved) Score Using the GAIS-Lower Face Contour According to the Investigator's Assessment at Week 2 of MP
GAIS is a balanced seven-point Likert scale (range -3 \[very much worse\] to +3 \[very much improved\]) commonly used in aesthetic medicine to rate post-treatment improvement in appearance. A higher score indicates improvement.
Time frame: At Week 2 of MP
Achievement of at Least a +1 (Improved) Score Using the GAIS-Lower Face Contour According to the Participant's Self-Assessment at Week 2 of MP
GAIS is a balanced seven-point Likert scale (range -3 \[very much worse\] to +3 \[very much improved\]) commonly used in aesthetic medicine to rate post-treatment improvement in appearance. A higher score indicates improvement.
Time frame: At Week 2 of MP
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