Efficacy and Safety of Polycaprolactone in Treating Nasolabial Folds: A Prospective, Multicenter, and Randomized Controlled Trial
October 2022
in “
Facial Plastic Surgery
”
Studysummary This study found that polycaprolactone gel injections were significantly more effective than sodium hyaluronate gel in improving nasolabial fold severity for Chinese patients over 12 months, with similar rates of mild injection-related adverse events between the groups. Our plain-language summary of this paper — not a Tressless recommendation.
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.
