Comparison of two dermal fillers for treating nasolabial folds in Chinese adults

A Prospective, Multi-Center, Randomized, Controlled, Subject- and Evaluator-Blinded, Non-Inferior Clinical Investigation of the Safety and Effectiveness of TEOSYAL® PureSense ULTRA DEEP Versus Restylane® Lidocaine for the Correction of Moderate to Severe Nasolabial Folds in Chinese Adults

This study is testing which of two dermal fillers works better for smoothing out deep smile lines in Chinese adults.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 390 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Teoxane SA (Industry-sponsored)
• Locations: 1 site (Guangzhou)
• Trial ID: NCT06367634 on ClinicalTrials.gov

What this trial studies

This clinical investigation aims to compare the effectiveness of TEOSYAL® PureSense ULTRA DEEP and Restylane® Lidocaine in correcting moderate to severe nasolabial folds in Chinese adults. Participants will be randomly assigned to receive one of the two treatments in a 1:1 ratio. The study will assess the safety and effectiveness of the treatments over a period of 52 weeks, with follow-up visits at various intervals to monitor outcomes. Both subjects and evaluators will be blinded to the treatment assignments to ensure unbiased results.

Who should consider this trial

Good fit: Ideal candidates are Chinese adults aged 18 and older with moderate to severe nasolabial folds.

Not a fit: Patients with asymmetrical nasolabial folds or those undergoing other facial aesthetic procedures during the study may not benefit.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for individuals seeking to improve the appearance of nasolabial folds.

How similar studies have performed: Previous studies have shown promising results with similar dermal filler comparisons, indicating potential for success in this approach.

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.

Where this trial is running

Guangzhou

• Guangdong Second Provincial General Hospital — Guangzhou, China (Recruiting)

Study contacts

• Study coordinator: Elise Gondard

Conditions Nasolabial Folds; Dermal Filler; Hyaluronic Acid