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

Aging Clinical Trial

— LIFTUP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05986630
• Other study ID #: TEO-TPVM-2101
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: August 2023
• Source: Teoxane SA
• Contact: Louis Chapu
• Phone: +41223449636
• Email: clinical[@]teoxane.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 155
• Est. completion date: April 30, 2025
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Chin Retrusion

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Canton - Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Teoxane SA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in TCRS score between Baseline and 8 weeks after last treatment as assessed by the Blinded Evaluator	Non-inferiority of TCRS score change from Baseline for subjects treated with TEOSYAL TPVM compared to subjects treated with a COMPARATOR at 8 weeks after last treatment as assessed by the BE.; TCRS (Teoxane Chin Retrusion Scale) is a validated 4-point scale assessing chin retrusion severity with 0 being "None/minimal" and 3 being "Severe"	8 weeks