Acetylcholine Release Inhibitors, Botulinum Toxins, Type A, Cholinergic Agents, incobotulinumtoxinA, Membrane Transport Modulators, Molecular Mechanisms of Pharmacological Action, Neuromuscular Agents, Neurotransmitter Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs
Conditions
Keywords
Platysma prominence
Brief summary
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).
Interventions
DRUGNT 201
Clostridium Botulinum neurotoxin A (150 kiloDalton \[kD\], free of complexing proteins), powder for solution for injection.
DRUGNT 201 Placebo
NT 201 matching-placebo.
Sponsors
Merz Aesthetics GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * History of lower face surgery, neck or chest surgery, and aesthetic procedures in the past 12 months and/or orthodontic procedures in the past 6 months. * Planned surgery or aesthetic procedures to the lower face, neck, or chest during the study period. * Anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study products).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
| Achievement of at Least a +1 (Somewhat Satisfied) Score Using the Participant's Satisfaction Questionnaire at Week 2 of MP | 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. |
| 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 | 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. |
| 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 1 and Week 4 up to Week 17 of MP | 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. |
| 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 MAPSD at Week 1 and Week 4 up to Week 17 of MP | 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. |
| Achievement of at Least a +1 (Improved) Score on the Global Aesthetic Improvement Scale (GAIS)-Platysmal Bands at maximum contraction Based on the Investigator's Assessment at Week 2 of MP | 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. |
| Achievement of at Least a +1 (Improved) Score on the GAIS-Platysmal Bands at maximum contraction Based on the Participant's Self-Assessment at Week 2 of MP | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
Countries
France, Germany, Poland, Spain
Contacts
STUDY_DIRECTORMerz Medical Expert
Merz Aesthetics GmbH
Outcome results
None listed