NCT05986630

Safety and Effectiveness Evaluation of TEOSYAL® TPVM Versus COMPARATOR for the Remodeling of the Lower Face

A Prospective, Randomized, Blinded Evaluator, Multicenter, Clinical Study to Evaluate Safety and Effectiveness of TEOSYAL® TPVM Versus COMPARATOR for the Remodeling of the Lower Face

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 155 (estimated)
• Sponsor: Teoxane SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The clinical study is designed to prospectively evaluate the safety and effectiveness of TEOSYAL® TPVM when compared to COMPARATOR for the remodeling of the lower face

Detailed description

This is a prospective, randomized, blinded evaluator, multicenter, clinical study to evaluate safety and effectiveness of TEOSYAL® TPVM versus COMPARATOR for the remodeling of the lower face. Subject will be enrolled in the study based on evaluation of their chin retrusion severity. For the purpose of this study, all injections will be done by principal investigators (PIs) with several years of experience in aesthetic treatment. An external aesthetic and cosmetic surgeon will act as a BE to assess the performance of the treatment and the product based on photographs.

Conditions

• Aging
• Chin Retrusion

Interventions

Type	Name	Description
DEVICE	TEOSYAL® TPVM	Injection of TEOSYAL® TPVM at Baseline Optional Touch-up treatment at 4 weeks if needed to achieve optimal correction as judged by the PI.
DEVICE	COMPARATOR	Injection of a COMPARATOR at Baseline Optional Touch-up treatment at 4 weeks if needed to achieve optimal correction as judged by the PI.

Timeline

• Start date: 2023-04-06
• Primary completion: 2025-07-21
• Completion: 2026-12-30
• First posted: 2023-08-14
• Last updated: 2025-09-03

Locations

1 site across 1 country: Switzerland