Efficacy and Safety of Polycaprolactone in Treating Nasolabial Folds: A Prospective, Multicenter, and Randomized Controlled Trial

This study evaluated the efficacy and safety of polycaprolactone gel for treating moderate-to-severe nasolabial folds (NLFs) in Chinese patients. Conducted across three centers from July 2017 to September 2019, the trial involved 80 patients in both the polycaprolactone and control groups, with a 1:1 randomization ratio. The primary endpoint was the effectiveness rate of the Wrinkle Severity Rating Score (WSRS) at 12 months post-injection. Results showed an 88.8% effectiveness rate in the polycaprolactone group compared to 23.8% in the control group (P < 0.001). The polycaprolactone group maintained WSRS improvements for 12 months, while the control group's improvements diminished after 3 months. The global aesthetic improvement scale (GAIS) indicated sustained improvements in the polycaprolactone group, whereas the control group saw an increase in "no change" assessments after 6 months. Injection-related adverse events were 8.8% in the polycaprolactone group versus 11.3% in the control group, with no severe adverse events in the polycaprolactone group. The study concluded that polycaprolactone gel is an effective and safe treatment for moderate-to-severe NLFs in this patient population.