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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 ;


Study Design


Related Conditions & MeSH terms


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

See also
  Status Clinical Trial Phase
Completed NCT04971876 - Evaluation of the Safety and Performance of an Injectable Hyaluronic Acid Filler N/A
Completed NCT02984878 - Multicenter Study to Evaluate the Safety and Efficacy of Revanesse® Ultra Retreatment N/A
Completed NCT02987205 - Multicenter Double-Blind Randomized Split-Face Study to Evaluate Revanesse® Ultra vs Restylane® for Correction of NLF N/A