Reduced pain with injection of hyaluronic acid with pre-incorporated lidocaine for nasolabial fold correction: A multicenter, double-blind, randomized, active-controlled, split-face designed, clinical study.

Abstract

Injection of hyaluronic acid (HA) filler for nasolabial fold (NLF) correction is a popular aesthetic procedure. In relation to HA filler injections, effective pain control for patient comfort is an important concern. We compared the pain relief achieved by HA filler with 0.3% lidocaine (HAF-Lidocaine) with that achieved by HA filler without lidocaine (HAF) for NLF correction. A total of 62 subjects with visible NLFs were enrolled in this double-blind study at two university hospitals and injected with HAF-Lidocaine and HAF, randomly assigned to the each NLFs. Subjects assessed pain using the visual analog scale (VAS). Blinded independent dermatologists assessed the Wrinkle Severity Rating Scale (WSRS) and subjects assessed the Global Aesthetic Improvement Scale (GAIS) for the evaluation of effectiveness. All adverse events during the follow-up period were recorded. Immediately after treatment, 95.2% of subjects who were treated with HAF-Lidocaine reported reduced pain when compared with those who were treated with HAF and the mean VAS score difference was 38.6mm. At 15, 30, 45, and 60minutes after treatment, respectively, 67.7%, 41.9%, 32.3%, and 21.0% of subjects experienced reduced pain. Based on the mean WSRS and GAIS scores and the incidence of local injection site reactions, the clinical effectiveness and safety profile of HAF-Lidocaine were comparable to those of HAF. We conclude that HA filler containing pre-incorporated lidocaine could reduce pain in Korean patients for NLF correction, and the addition of lidocaine does not affect the effectiveness and safety of HA filler.