Evaluation of TEOSYAL® TPVM for Lower Face Remodeling
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
This study is testing a new injection treatment for adults with chin retrusion to see if it can safely improve the appearance of their lower face compared to a standard option.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 155 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Teoxane SA Industry-sponsored |
| Locations | 1 site (Geneva) |
| Trial ID | NCT05986630 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the safety and effectiveness of TEOSYAL® TPVM compared to a standard comparator for remodeling the lower face, specifically targeting chin retrusion. It is a prospective, randomized, and blinded evaluator study conducted across multiple centers. Participants will receive injections administered by experienced principal investigators, and their treatment outcomes will be assessed by an external aesthetic surgeon using photographs. The study focuses on healthy adults over 18 years old who meet specific criteria related to chin retrusion severity.
Who should consider this trial
Good fit: Ideal candidates are healthy adults over 18 years old with a chin retrusion severity score of grade 2 or 3.
Not a fit: Patients with known hypersensitivity to any study components or those with chronic debilitating systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for individuals seeking to improve the appearance of their lower face.
How similar studies have performed: Other studies evaluating similar dermal fillers have shown promising results, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Geneva
- Care- Geneva — Geneva, Switzerland (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.