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Non-comparative Evaluation of Facial Expressions Following Lower Face Correction Using Emervel Classic and Emervel Deep

Wrinkles Clinical Trial

Official title:
A Single-Center, Non-Comparative Study to Evaluate Subject Recovery Following Correction of Bilateral Nasolabial Folds Using Emervel® Classic Lidocaine and Emervel® Deep Lidocaine

Clinical Trial Summary

Study is designed to characterize subject and treating investigator reported outcomes in the early post-treatment period, following bilateral correction of nasolabial folds using Emervel Classic and Emervel Deep. 1. to evaluate subject-reported return to social engagement, after the initial treatment (Baseline/Day 1 visit). 2. to evaluate change in Global Aesthetic Improvement Scale (GAIS) at day 30- subject/investigator reported 3. to evaluate subject satisfaction with treatment outcome at baseline, day 14 and day 30. 4. to evaluate change in Wrinkle Severity Rating Scale (WSRS) from baseline to post-treatment follow-up time points at day 14 and Day 30 - investigator reported 5. to evaluate all adverse events during the course of the study

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02672644
Study type Interventional
Source Galderma R&D
Contact
Status Completed
Phase Phase 4
Start date March 2016
Completion date May 2016
View Details
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