At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center Study to Evaluate the Perception of Facial Expressions Following Correction of Wrinkles and Folds in the Lower Face Using Emervel® Classic Lidocaine and Emervel® Deep Lidocaine
In Brief
A Phase 4 clinical trial evaluating Emervel Classic and/or Deep Treatment Group for Nasolabial Folds and 2 related conditions. Completed, enrolled 30 participants.
Detailed Summary
This study is designed to 1. evaluate the naturalness of facial expressions in motion (2D video images), by treating investigator assessment 2. evaluate naturalness of facial expressions (photographs), by treating investigator assessment 3. evaluate perceived attractiveness and age of subject (2D videos), by treating investigator assessment 4. evaluate aesthetic improvement, by subject and treating investigator assessments 5. evaluate subject satisfaction 6. evaluate nasolabial fold (NLF) severity, by treating investigator assessment 7. evaluate marionette lines (MLs) severity, by treating investigator assessment 8. evaluate dynamic facial strain in animation using 3D digital photogrammetric analysis 9. evaluate all adverse events reported during the study.
Study Details
Timeline
Interventions
Severity of Wrinkle Severity treated by product type: Emervel Classic: Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 2/2, 2/3 or 3/3; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 2/2, 2/3 or 3/3 Emervel Deep Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 3/3, 3/4 or 4/4; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 3/3, 3/4 or 4/4 Both products may be used in the same subject, but only in different anatomic locations. The same study product should be used within the same wrinkle or fold type (e.g., left and right NLFs treated with the same product)