CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Revanesse Ultra+ (with lidocaine) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02991040
NCT02991040N/ACompleted
CompareCT.gov

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)

Prollenium Medical Technologies Inc.·interventional·Posted Dec 13, 2016·Updated Apr 11, 2019

In Brief

A clinical study evaluating Revanesse Ultra+ (with lidocaine) and Revanesse Ultra for Nasolabial Fold Correction. Completed, enrolled 100 participants across 1 site.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasolabial Fold Correction
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedDec 13, 2016
Enrollment StartAug 1, 2016
Primary CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 9.6 years ago

Interventions

Revanesse Ultra+ (with lidocaine)device

Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)

Revanesse Ultradevice

Comparator without lidocaine