Masseter Muscle Prominence
Conditions
Brief summary
Achievement of MMPS ≥ 2-grade improvement from baseline at Day 90, per investigator assessment of MMP, Achievement of MMPS-P ≥ 2-grade improvement from baseline at Day 90, per subject assessment of MMP
Detailed description
Response on the LFSQ-TXSAT follow-up version at Day 90, Response of on the BIA-MMP at Day 90, Change from baseline in lower facial volume (cm3) at Day 90, calculated from standardized images, Change from baseline in lower facial width (mm) at Day 90, calculated from standardized images, Change from baseline in Lower Facial Shape Questionnaire - Impact Assessment (LFSQ-IA) summary score at Day 90, Response of on the LFSQ-TXSAT follow-up version, Response on the BIA-MMP, Change from baseline in LFSQ-IA summary score
Interventions
DRUGPlacebo for Botox - Solution for Injection
Sponsors
Abbvie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of MMPS ≥ 2-grade improvement from baseline at Day 90, per investigator assessment of MMP, Achievement of MMPS-P ≥ 2-grade improvement from baseline at Day 90, per subject assessment of MMP | — |
Secondary
| Measure | Time frame |
|---|---|
| Response on the LFSQ-TXSAT follow-up version at Day 90, Response of on the BIA-MMP at Day 90, Change from baseline in lower facial volume (cm3) at Day 90, calculated from standardized images, Change from baseline in lower facial width (mm) at Day 90, calculated from standardized images, Change from baseline in Lower Facial Shape Questionnaire - Impact Assessment (LFSQ-IA) summary score at Day 90, Response of on the LFSQ-TXSAT follow-up version, Response on the BIA-MMP, Change from baseline in LFSQ-IA summary score | — |
Countries
Belgium, Bulgaria, France, Germany, Italy, Netherlands, Spain
Outcome results
None listed