CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 148 enrolled
Drug / intervention
TEOSYAL® RHA Global Action +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/NCT02195427
NCT02195427N/ACompleted

A Controlled, Randomized, Double-Blinded, Within-Subject, Multicenter, Prospective Clinical Study of TEOSYAL® RHA Global Action and TEOSYAL® RHA Deep Lines Versus Juvéderm® Ultra XC in the Treatment of Moderate to Severe Nasolabial Folds

Teoxane SA·interventional·Posted Jul 21, 2014·Updated Apr 25, 2018

In Brief

A clinical study evaluating TEOSYAL® RHA Global Action and TEOSYAL® RHA Deep Lines for Nasolabial Folds, Wrinkles. Completed, enrolled 148 participants across 5 sites.

Detailed Summary

The purpose of this study is 1) to compare the effectiveness and safety of TEOSYAL® RHA Global Action versus Juvéderm® Ultra XC, and 2) to compare the effectiveness and safety of TEOSYAL® RHA Deep Lines versus Juvéderm® Ultra XC, in the treatment of moderate to severe nasolabial folds.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 21, 2014
Enrollment StartJun 1, 2014
Primary CompletionMar 1, 2015
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.9 years ago

Interventions

TEOSYAL® RHA Global Actiondevice

A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 30G1/2" disposable sterile needles.

TEOSYAL® RHA Deep Linesdevice

A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 27G1/2" disposable sterile needles.