Long-term Performance and Safety of Princess VOLUME PLUS Lidocaine for Midface Augmentation: The PRIMAvera Clinical Study

Abstract

Background Hyaluronic acid-based dermal fillers are the most applied medical devices for midface augmentation. Objectives This post-market investigation evaluated Princess Volume Plus Lidocaine (now Saypha Volume Plus Lidocaine) (PVPL) long-term performance, safety and patient satisfaction for the correction of midface-volume-deficit (MVD). Methods This was an open-label, prospective, interventional, multicenter, non-comparative, post-approval study of 91 subjects with moderate or severe MVD [grade 2 or 3 on the five-point Midface Volume Deficit Severity Scale (MVDSS)]. At Day 0 (Visit 1), subjects were treated with PVPL; and, returned for follow-up assessments at week 2, 4, 12, 24, 36, 52; and long-term follow-up until 36 months. A touch-up treatment could be done at week 2. The performance was assessed using MVDSS, Global Aesthetic Improvement Scale (GAIS), and Subject Satisfaction Scale. Adverse events (AEs) were collected to assess safety throughout the study. Results 4-weeks after treatment, 100%-injected subjects improved by ≥1 grade on MVDSS compared to baseline, with improvements still visible in 77% of subjects 52-weeks after treatment. Based on GAIS and post-hoc survival analysis, the treatment effect was maintained for a median of 386 days; and, in severe cases the effect lasted longer, which seemed to be independent of the volume injected at baseline. No serious side effects were reported. Results were substantiated by high patient satisfaction. Conclusions Princess Volume Plus Lidocaine was perceived as safe and effective by subjects/investigators, with a long-term aesthetic improvement in moderate and severe cases.