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

NCT05986630 | Active Not Recruiting DMC

• 1 other identifier: TEO-TPVM-2101
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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

Conditions

Aging; Chin Retrusion

Keywords

Dermal filler; Hyaluronic acid (HA); Chin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

TEOSYAL® TPVM

EXPERIMENTAL

n=116 subjects

Device: TEOSYAL® TPVM

COMPARATOR

ACTIVE COMPARATOR

n= 39 subjects

Device: COMPARATOR

Interventions

TEOSYAL® TPVM DEVICE

Injection of TEOSYAL® TPVM at Baseline Optional Touch-up treatment at 4 weeks if needed to achieve optimal correction as judged by the PI.

TEOSYAL® TPVM

COMPARATOR DEVICE

Injection of a COMPARATOR at Baseline Optional Touch-up treatment at 4 weeks if needed to achieve optimal correction as judged by the PI.

COMPARATOR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teoxane SA: lead

Study Sites (1)

Care- Geneva

Geneva, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: April 6, 2023
• Primary Completion: July 21, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-09

Locations

CH (1)