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

Background. An increasing number of hyaluronic acid-based products are available in the Russian Federation, which necessitates studies to confirm the efficacy and safety of these new products.

Aim. To evaluate the clinical efficacy and safety of the Amalian SF intradermal implant with lidocaine in a multicenter clinical trial.

Methods. A prospective study included 206 patients with an average age of 49.6 years with aesthetic indications for hyaluronic acid products. The study was conducted at four sites in Russia (Ryazan Region) and Germany (Berlin/Brandenburg Metropolitan Region) from 2020 to 2025. This observational, non-comparative clinical trial of the Amalian SF intradermal implant with lidocaine assessed short-term adverse events and injection reactions, long-term safety, product efficacy, and the duration of the effect as stated by the manufacturer. The safety and efficacy of the product were evaluated using the following scales: Merz Aesthetics Scales™, the GAIS, and the four-point scale for assessing injection reactions. The study design did not include a control or comparison group. The results of the injection procedures were obtained before and immediately after the treatment as well as at follow-up visits: 2–3 weeks, 3 months, 6, and 12 months after the treatment.
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Results. During the study, 236 procedures were performed in 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 During the entire prospective follow-up period, no patients were withdrawn from the study due to severe adverse reactions.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%. The efficacy of the intradermal implant was analyzed in four groups of patients with different baseline Skin Aging Index scores. Across all groups, regardless of age subgroup, the analysis demonstrated statistically significant and comparable clinical efficacy (p < 0.00012) for the Amalian SF intradermal implant with lidocaine.

Conclusion. The study confirmed the clinical efficacy and safety of the Amalian SF intradermal implant with lidocaine, regardless of patient age and the severity of skin chrono- and/or photoaging.