Clinical Trial on Polycaprolactone Microsphere Fillers for Nasolabial Fold Correction

This clinical trial is a prospective, multi-center, evaluator-blinded, randomized, parallel-controlled study designed to evaluate the safety and efficacy of polycaprolactone (PCL) microsphere fillers for correcting moderate to severe nasolabial folds. The study compares the PCL filler (Lafullen) against a hyaluronate gel (HA) filler, aiming to demonstrate superior wrinkle correction. The trial will enroll an estimated 208 participants aged 18 and above, with WSRS scores of 3 or 4 for bilateral nasolabial folds.

Key Objectives: The primary outcome measure is the WSRS responder rate at week 48, assessing the percentage of participants achieving at least a 1-point improvement from baseline. Secondary measures include safety assessments and patient satisfaction.

Intervention Details: Participants will receive either the PCL filler (maximum 1.0 mL per side) or the HA filler (maximum 1.5 mL per side), with optional touch-ups at 4 weeks. The study excludes individuals with allergies to PCL or HA, recent cosmetic procedures, or uncontrolled medical conditions.

Eligibility Criteria: Inclusion requires willingness to undergo treatment and follow-up, while exclusion criteria cover allergies, recent cosmetic procedures, certain medical conditions, and pregnancy. The trial is sponsored by Samyang Biopharmaceuticals Corporation in collaboration with Hangzhou Inshow Biotechnology Co., Ltd.

Study Design: The trial employs a double-blinded, randomized, parallel-controlled design to ensure unbiased results. Participants will be monitored for safety and efficacy over 48 weeks, with standardized photographic assessments by blinded evaluators.

Significance: This study aims to provide robust evidence on the efficacy and safety of PCL microsphere fillers, offering a potential alternative to HA fillers for long-lasting nasolabial fold correction. Results could impact future cosmetic dermatology practices and patient outcomes.