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

Teoxane

Status: Enrolling

Conditions: Aging; Chin Retrusion

Treatments: Device: TEOSYAL® TPVM; Device: COMPARATOR

Study type: Interventional

Funder types: Industry

Identifiers

NCT05986630

TEO-TPVM-2101

Details and patient eligibility

About

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

Full 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.

Enrollment: 155 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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155 participants in 2 patient groups

TEOSYAL® TPVM

Experimental group

Description:

n=116 subjects

Treatment:

Device: TEOSYAL® TPVM

COMPARATOR

Active Comparator group

Description:

n= 39 subjects

Treatment:

Device: COMPARATOR