Status:
ACTIVE_NOT_RECRUITING
Safety and Effectiveness Evaluation of TEOSYAL® TPVM Versus COMPARATOR for the Remodeling of the Lower Face
Lead Sponsor:
Teoxane SA
Conditions:
Aging
Chin Retrusion
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT05986630
Start Date
April 6 2023
End Date
December 30 2026
Last Update
September 3 2025
Active Locations (1)
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1
Care- Geneva
Geneva, Switzerland