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

NCT06367634 | Recruiting

• 1 other identifier: TEO-TSUL-2301
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nasolabial Folds

Keywords

Dermal Filler; Hyaluronic Acid

Outcome Measures

Primary Outcomes (1)

• WSRS grading

  Proportion of responders, defined by at least 1-point improvement from baseline 5-point WSRS, as measured by the blinded live evaluator at 24 weeks after the last treatment

  24 weeks after last treatment

Study Arms (2)

Ultra Deep

EXPERIMENTAL

Device: injection in NLF

Restylane

ACTIVE COMPARATOR

Device: injection in NLF

Interventions

injection in NLF DEVICE

TEOSYAL® PureSense ULTRA DEEP is a sterile, transparent, non-pyrogenic, viscoelastic gel made of HA of non-animal origin

Restylane; Ultra Deep

Eligibility Criteria

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

You may qualify if:

• Chinese male and female, 18 years of age or older.
• Subject desiring bilateral NLF treatment.
• 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.
• 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.
• Woman of childbearing potential must be using a highly effective method of birth control .
• Subject understands and is able to follow instructions and complete all scheduled visits.
• Subjects who voluntarily decided the participation of the investigation and signed the 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.
• History of connective tissue disease.
• Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.

Sponsors & Collaborators

• Teoxane SA: lead

Study Sites (1)

Guangdong Second Provincial General Hospital

Guangzhou, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Elise Gondard

CONTACT

+41 22 344 96 36; e.gondard@teoxane.com

Sophie Delhomme

CONTACT

+41798552342; s.delhomme@teoxane.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinded-Live evaluator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: January 19, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2026
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

CN (1)