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.
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Change in TCRS score between Baseline and 8 weeks after last treatment as assessed by the Blinded Evaluator — 8 weeks 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"
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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