HYALURONIC ACID BEYOND SKIN REJUVENATION: THE INTERSECTION BETWEEN BEAUTY AND SAFETY IN COMPLIANCE WITH THE NEW EU MEDICAL DEVICES REGULATION

Hyaluronic acid-based mesotherapy has become a highly popular and valuable option for facial rejuvenation, with a renowned efficacy and safety profile.The new European Regulation (EU) 2017/745 on medical devices remarks the need for post-market clinical follow-up to guarantee safety and efficacy during the entire life cycle of medical devices. In line with the new regulation, we aimed to further evaluate the clinical performance and safety of hyaluronic acid-based mesotherapy within routine practice in a period of 9 weeks. The present work is anobservational, prospective, open and non-controlled study in a cohort of patients treated with hyaluronic acid-based mesotherapy for facial aging. Patients between 30 and 75 years old, treated with hyaluronic acid 1% injections for facial rejuvenation, were included. Point-by-point and epidermal administration techniques were usedin three visits (initial, 3 weeks and 6 weeks). The outcomes were measured using GAIS for efficacy and VAS for patient satisfaction. A total of 25 patients underwent hyaluronic acid mesotherapy in the face or neck, and were followed up for 9 weeks. Throughout the study, a significant improvement (p < 0.05) in skin appearance and hydration was observed in both groups between first and last visit. No significant differences were observed between the two groups. All participants showed increased skin hydration and/or reduced fine lines. In conclusion, hyaluronic acid-based mesotherapy is effective for facial and neck skin boosting, with an excellent safety profile, highlighting the potential of linear hyaluronic acid as a non-surgical solution for skin rejuvenation.