Clinical evaluation of the efficacy of Amalian SF intradermal implants with lidocaine: results of a multicenter study

Background: The increasing number of hyaluronic acid-based products available in the RF necessitates studies confirming the efficacy and safety of these new products. Aims: To evaluate the clinical efficacy and safety of the Amalian SF intradermal implant with lidocaine in a multicenter clinical trial. Materials and methods: The prospective study included 206 patients with aesthetic indications for hyaluronic acid products, with an average age of 49.6 years. The study was conducted in four centers in Russia and Germany from 2020-2025. The following scales were used to evaluate the safety and efficacy of the device: the MAS, the GAIS, and FPS. The study design did not include a control or comparison group. Results of the injection procedures were obtained before and immediately after treatment, as well as at follow-up visits: 2-3 weeks, 3, 6,12 months after treatment. Results: During the study, 236 procedures on 206 patients. During the entire prospective follow-up period, no patients were withdrawn from the study due to severe adverse reactions. The proportion of patients experiencing minor side effects and injection reactions did not exceed 5%. Across all groups, regardless of age subgroup, the analysis demonstrated statistically significant comparable clinical efficacy (p0.00012) for the Amalian SF intradermal implant with lidocaine. Conclusions: The study confirmed the clinical efficacy and safety of the Amalian SF intradermal implant with lidocaine, regardless of patient age and the severity of chrono- and/or photoaging of the skin. Keywords: intradermal implant, Amalian SF with lidocaine, skin aging.