Moderate to Severe Platysma Prominence
Conditions
Brief summary
Composite 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 the MAPS-D at Visit 4 (V4; Main Period [MP] Week 2).
Detailed description
• Achievement of Grade 1 (‘none to minimal’) or Grade 2 (‘mild’) AND at least 2-grade improvement from baseline based on the investigator’s assessment using MAPS-D at V4., • 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 V4., • Achievement of at least a +1 (‘somewhat satisfied’) score using the participant’s satisfaction questionnaire at V4.
Interventions
DRUGPlacebo excipients (sucrose and human serum albumin) are reconstituted with sterile saline. Placebo vials will have identical appearance as the active product vials.
DRUGBocouture
Sponsors
Merz Aesthetics GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite 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 the MAPS-D at Visit 4 (V4; Main Period [MP] Week 2). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Achievement of Grade 1 (‘none to minimal’) or Grade 2 (‘mild’) AND at least 2-grade improvement from baseline based on the investigator’s assessment using MAPS-D at V4., • 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 V4., • Achievement of at least a +1 (‘somewhat satisfied’) score using the participant’s satisfaction questionnaire at V4. | — |
Countries
France, Germany, Poland, Spain
Outcome results
None listed