Lips Enhancement and Perioral Area Correction With New Hyaluronic Acid Dermal Fillers: A Prospective Safety Study

Background Injectable hyaluronic acid (HA) is the gold standard for the aesthetic treatment of facial volume and wrinkles. Objectives This study aims to evaluate the safety and performance of two new HA fillers for the treatment of the lips and perioral area. Methods This multicenter prospective study enrolled 72 subjects. All subjects received lip enhancement with ESTYME® LIPS (ESTLP, SYMATESE, Chaponost, France), and 61 of them also had correction for lip fine lines and nasolabial folds (NLFs) with ESTYME® SMOOTH (ESTSM). Assessments were conducted by injector-investigators, the subjects, and an independent evaluator. The primary endpoint was the proportion of subjects with at least one Injection Site Reaction (ISR) lasting beyond 14 days. Secondary endpoints included adverse events, aesthetic improvements, lip functionality and participant satisfaction, assessed over 12 months. Results After 30 days, at least one ISR was observed in 35% of the participants on the lips, 2% on the fine lines, and 2% on the NLF. At 12 months, an improvement of at least one point was still observed in 66% of participants on the lips, 74% on the fine lines, and 54% on the NLFs. Throughout the study, lip functionality was not affected by their treatment and both assessors and subjects rated overall aesthetic improvement and good satisfaction. Conclusions In this limited cohort, ESTLP and ESTSM proved to be safe and effective options for lip enhancement as well as correction of NLFs and lip fine lines, demonstrating sustained results in the majority of patients for up to 12 months.