Study to Evaluate Safety and Efficacy of Revanesse® Ultra + vs Revanesse® Ultra for Correction of NLF

Nasolabial Fold Correction Clinical Trial

Official title: A Multicenter, Double-Blind, Randomized, Split-Face Study to Evaluate the Safety and Efficacy of Revanesse® Ultra + (With Lidocaine) Versus Revanesse® Ultra for the Correction of Nasolabial Folds (NLF)

Status Completed

Clinical Trial Summary

A Multicenter, Double-Blind, Randomized, Split-Face Study to Evaluate the Safety and Efficacy of Revanesse® Ultra + (with Lidocaine) versus Revanesse® Ultra for the Correction of Nasolabial Folds to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine, hereafter referred to as Revanesse Ultra +) to Revanesse Ultra for subjects undergoing correction of nasolabial folds (NLFs)

Clinical Trial Description

This is a randomized, multicenter, double-blind, split-face study in subjects seeking nasolabial fold correction. Subjects will be treated with Revanesse Ultra + in the NLF on one side of the face and Revanesse Ultra in the NLF on the other side of the face. The side of the face for each study product will be randomly assigned. The investigator and the subject will be blinded to the treatment; injections of the study product will be performed by an unblinded injecting investigator.

At each visit, investigator and subject evaluations of the treated areas will be performed and recorded ;

Related Conditions & MeSH terms

• Nasolabial Fold Correction

• NCT number: NCT02991040
• Study type: Interventional
• Source: Prollenium Medical Technologies Inc.
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Completion date: August 2017