NCT02672644

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 35 Years – 60 Years
• Healthy volunteers: Accepted

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

Conditions

• Nasolabial Folds
• Wrinkles

Interventions

Type	Name	Description
DEVICE	Emervel Classic	Subjects requiring bilateral correction of NLFs and meeting eligibility criteria will be enrolled and treated with Emervel Classic (moderate NLFs; WSRS = 3/3)
DEVICE	Emervel Deep	Subjects requiring bilateral correction of NLFs and meeting eligibility criteria will be enrolled and treated with Emervel Deep (severe NLFs; WSRS = 4/4).

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2016-02-03
• Last updated: 2022-07-29

Locations

1 site across 1 country: Canada