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

Launched by TEOXANE SA · Aug 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a treatment called TEOSYAL® TPVM for reshaping the lower face, specifically for individuals experiencing signs of aging or chin retrusion. The goal is to see how well this treatment works compared to another option. The trial is currently looking for healthy adults aged 18 and older who want to improve their lower facial appearance and have been rated with a grade 2 or 3 on a specific facial assessment scale.

To participate, women of childbearing age must have a negative pregnancy test and use reliable contraception during the study. Participants should be willing to avoid any facial procedures that might affect the results and must be able to follow the study's guidelines. However, certain individuals, such as those with known allergies to the treatment ingredients or local anesthetics, or those with significant health issues, may not qualify. If you decide to join, you can expect to attend several visits where you’ll receive the treatment and help the researchers gather important information about its effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy adult subjects over 18 years old seeking correction of their lower face
• • Subject scored grade 2 or 3 on the TCRS
• • Female subjects of childbearing potential must have a negative UPT and practice a reliable method of contraception throughout the study.
• • Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations
• • Able to follow study instructions and complete all required visits.
• • Having given its signed informed consent
• Exclusion Criteria:
• • Known hypersensitivity or previous allergic reaction to any component of the study devices
• • Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
• • History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
• • Subject exhibits any physical attribute that may prevent assessment or treatment of the lower face as judged by the PI
• • Clinically significant alcohol or drug abuse.
• • Subject has received any investigational product within 90 days prior to Visit 1 or planning to participate in another investigation during the course of the study.