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

Teoxane

Status: Enrolling

Conditions: Nasolabial Folds

Treatments: Device: injection in NLF

Study type: Interventional

Funder types: Industry

Identifiers

NCT06367634

TEO-TSUL-2301

Details and patient eligibility

About

This is a prospective, multi-center, randomized, controlled, subject- and evaluator-blinded clinical investigation to demonstrate non-inferiority of TEOSYAL® PureSense ULTRA DEEP compared to Restylane® Lidocaine for the correction of moderate to severe NLF in Chinese adults.

Eligible subjects will be enrolled and randomized either to the treatment group or control group in a 1:1 ratio on Day 0. Each subject assigned to the treatment group will receive TEOSYAL® PureSense ULTRA DEEP in both NLFs, whereas subjects assigned to the control group will receive Restylane® Lidocaine.

The treating investigator will administer the corresponding product in both NLFs of the subject on Day 0.

All subjects will return to the site at 4, 12, 24, 36, and 52 weeks after the last treatment for effectiveness and safety assessment. All subjects will receive a safety phone call 7 days after the initial treatment at baseline, and after the touch-up treatment, if applicable.

Enrollment: 390 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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390 participants in 2 patient groups

Ultra Deep

Experimental group

Treatment:

Device: injection in NLF

Restylane

Active Comparator group

Treatment:

Device: injection in NLF