Microfocused ultrasound for facial and neck rejuvenation: A pilot prospective observational study on efficacy and safety in patients with skin laxity.

Facial and neck skin laxity reflects age‑related changes in collagen fibers and deeper support structures. Growing patient demand for effective, non‑invasive tightening has driven interest in microfocused ultrasound (MFU) as a treatment modality. This study aims to evaluate the clinical efficacy and safety of MFU in improving facial and neck skin laxity and wrinkles in young and middle-aged adults. A pilot study was conducted on 21 patients with facial laxity who underwent a single MFU treatment using the MFUS One device. Efficacy was assessed using the Wrinkle Severity Rating Scale and Global Aesthetic Improvement Scale at baseline, immediately posttreatment, 1 month, and 3 months posttreatment. Safety was evaluated via adverse events, pain scores (Visual Analog Scale), and patient satisfaction. The cohort included 21 patients (1 male, 20 female; mean age 39.62 ± 7.24 years). Wrinkle Severity Rating Scale scores decreased significantly immediately posttreatment (1.90 ± 0.30 vs baseline 3.33 ± 0.58, P < .01), with a 42.9% reduction, and remained improved at 1 month (2.10 ± 0.44, P < .01) and 3 months (2.19 ± 0.40, P < .01). Global Aesthetic Improvement Scale scores showed significant immediate improvement (2.95 ± 0.74) and sustained efficacy at 1 month (2.43 ± 0.60) and 3 months (2.38 ± 0.50). Adverse events were mild and transient: edema (3.95 ± 1.28 days) and erythema (1.05 ± 0.59 days), with 1 case of mild hyperpigmentation resolving within 1 month. Mean Visual Analog Scale pain score was 2.86 ± 0.79 (mild), and patient satisfaction was high (3.67 ± 0.58). In this small, uncontrolled pilot study, MFU showed preliminary evidence of improvements in skin tightness and wrinkle reduction, together with high patient acceptance and acceptable short-term safety during the 3-month follow-up period.