NCT06961448

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: Samyang Biopharmaceuticals Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Nasolabial Fold Correction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-05-01
• Completion: 2026-11-01
• First posted: 2025-05-08
• Last updated: 2025-05-08