NCT06367634

TEOSYAL® PureSense ULTRA DEEP Versus Restylane® Lidocaine for the Correction of Moderate to Severe Nasolabial Folds in Chinese Adults

A Prospective, Multi-Center, Randomized, Controlled, Subject- and Evaluator-Blinded, Non-Inferior Clinical Investigation of the Safety and Effectiveness of TEOSYAL® PureSense ULTRA DEEP Versus Restylane® Lidocaine for the Correction of Moderate to Severe Nasolabial Folds in Chinese Adults

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: Teoxane SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, multi-center, randomized, controlled, subject- and evaluator-blinded clinical investigation to demonstrate non-inferiority of TEOSYAL® PureSense ULTRA DEEP compared to Restylane® Lidocaine for the correction of moderate to severe NLF in Chinese adults. Eligible subjects will be enrolled and randomized either to the treatment group or control group in a 1:1 ratio on Day 0. Each subject assigned to the treatment group will receive TEOSYAL® PureSense ULTRA DEEP in both NLFs, whereas subjects assigned to the control group will receive Restylane® Lidocaine. The treating investigator will administer the corresponding product in both NLFs of the subject on Day 0. All subjects will return to the site at 4, 12, 24, 36, and 52 weeks after the last treatment for effectiveness and safety assessment. All subjects will receive a safety phone call 7 days after the initial treatment at baseline, and after the touch-up treatment, if applicable.

Conditions

• Nasolabial Folds

Interventions

Type	Name	Description
DEVICE	injection in NLF	TEOSYAL® PureSense ULTRA DEEP is a sterile, transparent, non-pyrogenic, viscoelastic gel made of HA of non-animal origin

Timeline

• Start date: 2024-01-19
• Primary completion: 2025-01-01
• Completion: 2026-02-01
• First posted: 2024-04-16
• Last updated: 2024-04-16

Locations

1 site across 1 country: China