Efficacy and safety profile of multi-depth microfocused ultrasound and microneedle radiofrequency for facial tightening: a prospective split-face randomized trial

Microfocused ultrasound (MFUS) and microneedle radiofrequency (MRF) are widely used for nonsurgical facial tightening, yet single-session outcomes remain variable. This evaluator-blinded, prospective, split-face randomized trial assessed volumetric, ultrasound-derived, skin-quality, and safety outcomes after single-session MFUS, MRF, or combined MFUS + MRF treatment. Thirty participants received one randomized hemiface intervention, with standardized photography, three-dimensional volumetric imaging, high-frequency ultrasound, VISIA skin analysis, and adverse-event monitoring during follow-up. MFUS + MRF produced earlier and greater mandibular volume reduction at 1 month (mean change, − 2.34 mL; 95% CI − 3.63 to − 1.04) than MFUS (− 0.39 mL; 95% CI − 1.34 to 0.55) or MRF (0.05 mL; 95% CI − 0.47 to 0.56; both adjusted P < 0.05). At 3 and 6 months, reductions remained numerically greater after MFUS + MRF (− 2.48 and − 2.66 mL) than after MRF (− 1.44 and − 1.23 mL) and were similar to MFUS (− 2.46 and − 2.28 mL). In this early-phase study, MFUS combined with MRF resulted in more rapid and greater lower-face contour changes than either modality alone; however, MFUS-containing treatments were associated with higher rates of transient paresthesia and rare transient motor weakness, underscoring the need for cautious parameter optimization. Adequately powered studies with longer follow-up are needed to confirm durability and define the optimal efficacy–safety balance. Clinical trial registration : This study was registered with the Chinese Clinical Trial Registry (ChiCTR) under the registration number ChiCTR2400087490 ( https://www.chictr.org.cn/showproj.html?proj=227608 ), and was first posted on 29/07/2024.