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

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).

NCT Number	NCT06961448
Lead Sponsor	Samyang Biopharmaceuticals Corporation Collaborators: Hangzhou Inshow Biotechnology Co.,Ltd.
Conditions	Nasolabial Fold Correction
Enrollment	208 participants
Start Date	2025-05-01
Primary Completion	2026-05-01 (estimated)
Study Completion	2026-11-01 (estimated)
Updated on ClinicalTrials.gov	2025-05-08