A Multicenter Randomized, Evaluator-Blinded, Active Controlled Design Study to Evaluate the Safety and Effectiveness of Neuramis® Deep Lidocaine Compared to YVOIRE® Volume Plus for Correction of Nasolabial Folds

Medy-Tox1 site in 1 country370 target enrollmentApril 2, 2018

ConditionsNasolabial Folds

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Nasolabial Folds
Sponsor: Medy-Tox
Enrollment: 370
Locations: 1
Primary Endpoint: WSRS improvement rate at Week 24
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This clinical investigation is a randomized, evaluator-blind, active controlled, noninferiority study to evaluate the effectiveness and safety of Neuramis® Deep Lidocaine when compared with YVOIRE® Volume Plus.

Detailed Description

Males or females between 18 and 75 years of age, who want to correct both NLFs with 3 or 4 points in the WSRS and who provided written informed consent are to be included in the investigation.

Registry

clinicaltrials.gov

Start Date

April 2, 2018

End Date

October 16, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medy-Tox

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female, 18 to 75 years of age.
•Subjects who desire correction of bilateral NLFs that are rated as 3 or 4 points on the WSRS.

Exclusion Criteria

•Subjects who have received anticoagulation, antiplatelet, or thrombolytic medications, anti inflammatory medications.
•Subjects who had soft tissue augmentation, medium or deep peeling, or dermal photorejuvenation on the lower inferior orbital rim for wrinkle correction.