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

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

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

Study Overview

• Status: Recruiting
• Conditions: Aging; Chin Retrusion
• Intervention / Treatment: Device: TEOSYAL® TPVM; Device: COMPARATOR

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.

• Study Type: Interventional
• Enrollment (Estimated): 155
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Louis Chapu; Phone Number: +41223449636; Email: clinical@teoxane.com

Study Locations

• Switzerland
  • Geneva, Switzerland
    • Recruiting
    • Canton - Geneva
    • Contact: Site 001 Geneva; Phone Number: +41223475757

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEOSYAL® TPVM; n=116 subjects	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.
Active Comparator: COMPARATOR; n= 39 subjects	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Teoxane SA

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2023
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: August 3, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Dermal filler; Hyaluronic acid (HA); Chin
• Other Study ID Numbers: TEO-TPVM-2101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No