Clinical Investigation of the Medical Device "Alexa Volume" for Correction of Midface Volume Loss

This is a post-marketing, open-label, non-comparative, multi-center clinical investigation to evaluate the effectiveness and safety of the medical device "Alexa Volume" (DIACO BIOFARMACEUTICI S.r.l., Italy), based on cross-linked hyaluronic acid, for the correction of midface volume loss. The study involved 68 female subjects across Poland and Ukraine who received Alexa Volume injections in the midface area. Effectiveness was assessed using the Global Aesthetic Improvement Scale (GAIS), Wrinkle Severity Rating Scale (WSRS), and Medicis Midface Volume Scale (MMVS). The study demonstrated statistically significant improvements in aesthetic outcomes and confirmed a favorable safety profile with minimal adverse events