NCT02718040

Emervel for the Correction of Lower Face Wrinkles & Folds

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Nasolabial Folds
• Marionette Lines
• Wrinkles

Interventions

Type	Name	Description
DEVICE	Emervel Classic and/or Deep Treatment Group	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)

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-07-01
• Completion: 2016-08-01
• First posted: 2016-03-24
• Last updated: 2022-08-01
• Results posted: 2018-09-25