NCT02195427

TEOSYAL® RHA Global Action, TEOSYAL® RHA Deep Lines, and Juvéderm® Ultra XC for the Correction of Nasolabial Folds

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Teoxane SA · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nasolabial Folds, Wrinkles

Interventions

Type	Name	Description
DEVICE	TEOSYAL® RHA Global Action	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.
DEVICE	TEOSYAL® RHA Deep Lines	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.

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-03-01
• Completion: 2016-03-01
• First posted: 2014-07-21
• Last updated: 2018-04-25
• Results posted: 2018-03-26

Locations

5 sites across 1 country: United States