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NOT YET RECRUITING
NCT06961448
NA

A Study in Adults Evaluating Polycaprolactone Microsphere Filler for Treatment of Moderate to Severe Nasolabial Folds

Sponsor: Samyang Biopharmaceuticals Corporation

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of polycaprolactone microsphere filler (Lafullen) for the correction of moderate to severe nasolabial folds in adults aged 18 and above, regardless of gender. The main questions it aims to answer are: * Does Lafullen improve wrinkle severity in the nasolabial fold area at 48 weeks post-injection (WSRS responder rate)? * Is Lafullen superior to the control product (Restylane, a hyaluronic acid filler) in terms of long-term wrinkle correction and safety? Researchers will compare Lafullen (polycaprolactone filler) with Restylane (modified sodium hyaluronate gel) to see if Lafullen provides superior wrinkle correction at 12 months post-injection. Participants will: * Receive either Lafullen or Restylane via injection in the nasolabial fold area. * Optionally receive a touch-up injection at 4 weeks after the first treatment if needed. * Undergo regular follow-up visits at 4, 12, 24, 36, and 48 weeks post-treatment. * Subjects in the Lafullen group will continue follow-up up to 72 weeks to assess long-term efficacy and safety. * Be assessed through clinical photography, pain scale (VAS), satisfaction questionnaires, and safety evaluations (e.g., AEs, vital signs, lab tests).

Official title: A Prospective, Multi-center, Evaluator-blinded, Randomized, Parallel-controlled, Superiority Clinical Trial to Evaluate the Safety and Efficacy of Polycaprolactone Microsphere Fillers for Correction of Moderate to Severe Nasolabial Folds

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

208

Start Date

2025-05-01

Completion Date

2026-11-01

Last Updated

2025-05-08

Healthy Volunteers

No

Interventions

DEVICE

Hyaluronate Gel for Injection

Apply a maximum of 1.5 mL per side of the nasolabial fold using the test device (Lafullen) or the control device, with an optional touch-up of up to 0.5 mL per side at 4 weeks based on investigator assessment.

DEVICE

Polycaprolactone microsphere filler

Apply a maximum of 1.0 mL per side of the nasolabial fold using the test device (Lafullen) or the control device, with an optional touch-up of up to 0.5 mL per side at 4 weeks based on investigator assessment.