Combined Fractional Radiofrequency Microneedling and High-Intensity Focused Ultrasound with Focus Dual for Facial Skin Rejuvenation: A 37-Patient Case Series

Background: Non-invasive energy-based technologies, including high-intensity focused ultrasound (HIFU) and fractional radiofrequency microneedling (RF-MN), are increasingly used for facial rejuvenation due to their ability to induce dermal remodeling and neocollagenesis, although evidence on combined protocols remains limited. Objective: To evaluate the clinical outcomes and safety of a combined treatment protocol using HIFU and RF-MN delivered via the Focus Dual® device for facial skin rejuvenation in patients with moderate-to-severe photo- and chrono-aging. Methods: This observational case series included 37 patients (52–85 years) treated with a combined regimen of HIFU and RF-MN over a 6-month period, consisting of two HIFU sessions and six RF-MN sessions; clinical outcomes were assessed using the Wrinkle Assessment Scale (WAS) across 11 facial anatomical regions and the Global Aesthetic Improvement Scale (GAIS), with evaluations performed on standardized photographs by two blinded independent assessors and safety monitored throughout. Statistical analysis was primarily descriptive and exploratory, including calculation of mean WAS scores, absolute and relative changes, inter-rater reliability assessment, and Pearson’s correlation analysis. Results: The combined treatment was associated with a measurable improvement in wrinkle severity, with median global WAS decreasing from 4.53 at baseline to 3.98 post-treatment, corresponding to a 12.1% overall improvement; the greatest improvements were observed in anatomically lax regions such as the cheeks (25.36%), periorbital lines (25.14%), nasolabial folds (23.92%), neck (23.77%), and marionette lines (21.36%) and corner of mouth lines (20.98%), while dynamic regions such as the glabellar and frontal areas showed a more limited response; a positive correlation between baseline severity and treatment response was observed (r = 0.73), with excellent inter-rater reliability (κ = 0.93–0.95) and no serious adverse events reported. Conclusions: The combined use of HIFU and RF-MN via the Focus Dual® device appears to be a safe and well-tolerated non-invasive approach for facial rejuvenation associated with clinical improvements in wrinkle severity with a region- and severity-dependent response profile; the interaction between deep structural tightening (HIFU) and superficial dermal remodeling (RF-MN) suggests a complementary mechanism of action, although further controlled studies are warranted to confirm these findings and evaluate long-term outcomes.