NCT02253147

TEOSYAL® RHA Ultra Deep and Perlane-L® for the Correction of Nasolabial Folds

A Controlled, Randomized, Double-Blinded, Within-Subject, Multicenter, Prospective Clinical Study of TEOSYAL® RHA (Resilient Hyaluronic Acid) Ultra Deep Versus Perlane-L® in the Treatment of Moderate to Severe Nasolabial Folds

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Teoxane SA · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effectiveness and safety of TEOSYAL® RHA Ultra Deep versus Perlane-L® in the treatment of moderate to severe nasolabial folds. This is a controlled, randomized, double-blinded, within subject (split-face), multicenter, prospective clinical study.

Conditions

• Nasolabial Folds, Wrinkles

Interventions

Type	Name	Description
DEVICE	TEOSYAL® RHA Ultra Deep	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 27Gauge ½" disposable sterile needles.

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-06-01
• Completion: 2016-05-01
• First posted: 2014-10-01
• Last updated: 2018-03-27
• Results posted: 2018-03-27

Locations

4 sites across 1 country: United States