TEOSYAL® PureSense ULTRA DEEP Versus Restylane® Lidocaine for the Correction of Moderate to Severe Nasolabial Folds in Chinese Adults

Launched by TEOXANE SA · Apr 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two different treatments for reducing the appearance of moderate to severe nasolabial folds, which are the lines that run from the sides of the nose to the corners of the mouth. The treatments being tested are TEOSYAL® PureSense ULTRA DEEP and Restylane® Lidocaine. The goal is to see if TEOSYAL® is just as effective as Restylane® for improving these facial lines in Chinese adults.

To be eligible for the study, participants must be at least 18 years old, have noticeable nasolabial folds that are either moderate or severe, and be willing to avoid other cosmetic procedures during the trial. Those who join will receive one of the treatments and will have follow-up visits for a year to check on how well the treatment is working and if there are any side effects. This trial is currently looking for participants, and all who take part will be informed and provide their consent before starting.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Chinese male and female, 18 years of age or older.
• • 2. Subject desiring bilateral NLF treatment.
• • 3. Has symmetrical NLFs, with the same WSRS score of 3 (moderate) or 4 (severe) for both right and left NLFs, as determined on live assessment by the blinded evaluator.
• • 4. Subject willing to abstain from all other facial aesthetic procedures/therapies that could interfere with effectiveness evaluations (e.g., dermal fillers outside of this investigation, toxin treatments, facial ablative or fractional laser, intense pulsed light \[IPL\], microdermabrasion, chemical peels, skin bleaching agents, non-ablative laser, or energy-based device for skin-tightening, surgical procedures, etc.) during participation in the investigation.
• • 5. Woman of childbearing potential must be using a highly effective method of birth control .
• • 6. Subject understands and is able to follow instructions and complete all scheduled visits.
• • 7. Subjects who voluntarily decided the participation of the investigation and signed the informed consent.
• Exclusion Criteria:
• • 1. Known hypersensitivity or previous allergic reaction to any component of the study devices
• • 2. Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
• • 3. History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
• • 4. History of connective tissue disease.
• • 5. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
• • 6. Subjects who participated in other clinical investigation within 30 days, or in an exclusion period from a previous study.