Single-Plane Versus Dual-Plane Microfocused Ultrasound With Visualization in the Treatment of Upper Arm Skin Laxity: A Randomized, Single-Blinded, Controlled Trial.

Abstract

Non-invasive skin tightening devices have become a safe and non-invasive treatment for patients with skin laxity of the upper arm. The efficacy of microfocused ultrasound with visualization (MFU-V) in skin tightening had been demonstrated in several studies. This study aimed to evaluate the efficacy and safety of MFU-V in treating skin laxity of the upper arm using different treatment protocols. Thirty patients with upper arm laxity were enrolled. Patients were randomly assigned to receive single-plane MFU-V treatment (4 MHz/4.5 mm transducer) on one arm and dual-plane treatment (4 MHz/4.5 mm and 7 MHz/3.0 mm transducer) on the contralateral arm, totaling 200 lines in each arm. Investigator Assessment Skin Laxity Scoring System (IASLSS) and improvement scores were evaluated at 1, 3, and 6 months after the treatment. Adverse events were recorded. A modest reduction of mean arm circumference was observed on both sides. Mean physician-rated improvement scores, single-plane treatment received 2.22 (±1.05), 2.70 (±1.32), and 1.61 (±0.79), respectively. Dual-plane treatment received 2.00 (±1.00), 2.56 (±1.05), and 1.39 (±0.54), respectively. Single-plane treatment was superior from physician's ratings (P < 0.05). IASLSS followed the same trend as the improvement scores. Mean patient-rated improvement scores in single-plane treatment were 3.63 (±2.63), 3.69 (±2.83), 1.90(±2.51) for 1, 3, and 6 months, respectively. Dual-plane treatment received 3.5 (±2.57), 3.22 (±2.59), 1.78 (±2.48), respectively. The median pain scores were 2.6 (0-8) for single-plane treatment and 1.9 (0-8) for dual-plane treatment (P = 0.136). No other significant side effects were observed. Both single-plane and dual-plane treatment provide a modest skin tightening effect in the upper arm for at least 3 months. Physicians should assess skin thickness in every patient using the visualization screen to select the appropriate transducer for each individual patient. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.