The Safety and Efficacy of Macrofocused Ultrasound without Visualization on Enlarged Facial Pores among Thai Patients: A Pilot Study

Abstract

Introduction. Visibly enlarged facial pores are familiar dermatologic concerns. Macrofocused ultrasound energy without visualization (MaFU-WV) showed efficacy in facial tightening and an improvement in skin textural irregularities which opened the potential of the positive effects in reducing the appearance of facial pores. This study aims to assess the safety and efficacy of MaFU-WV in tightening facial pores. Methods. This was a prospective, single-blinded pilot study. Thirty-four Thai subjects with enlarged pores received a single treatment of MaFU-WV using a 2.0 mm transducer on bilateral malar areas of the face. Primary outcome measures included the pore count, pore volume, and pore index measurements using an instrument with a camera for image acquisition and software for analysis of skin. Secondary outcome measures incorporated two blinded dermatologists’ evaluation of clinical photographs and the subjects’ perception of improvement in their facial pores using a 6-point scale. Measurements were taken at baseline, 1 week, 1 month, 3 month, and 6 month after treatment. Results. The pore count significantly decreased from baseline to 6 month after treatment ( $p<0.001$ ). Pore volume was significantly lowered from baseline to 1 week and 1, 3, and 6 months after treatment ( $p<0.05$ ). The pore index was likewise significantly reduced from baseline in every visit ( $p<0.05$ ). The majority of photographic evaluations by blinded dermatologists were scored as a 1–25% pore minimizing effect across nearly all follow-up visits. On the other hand, patient satisfaction kept improving until the end of the study at 6 months. No adverse events occurred throughout the conduct of the study. Conclusion. Macrofocused ultrasound energy using a 2 mm transducer is a safe and effective treatment for facial pore tightening. The trial is registered with registration number: TCTR20220719001.