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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Teoxane SA
- Enrollment
- 155
- Locations
- 1
- Primary Endpoint
- Change in TCRS score between Baseline and 8 weeks after last treatment as assessed by the Blinded Evaluator
Study Overview
Brief 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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
TEOSYAL® TPVM
n=116 subjects
Intervention: TEOSYAL® TPVM (Device)
COMPARATOR
n= 39 subjects
Intervention: COMPARATOR (Device)
Outcomes
Primary Outcomes
Change in TCRS score between Baseline and 8 weeks after last treatment as assessed by the Blinded Evaluator
Time Frame: 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"
Secondary Outcomes
No secondary outcomes reported