Safety and efficacy of superficial micro-focused ultrasound with visualization for melasma in Asians: An uncontrolled pilot study

Abstract

Background: The pathophysiology of melasma is multifactorial, resulting in treatment resistance and a high recurrence rate. Recent research suggests that focused ultrasound might treat melasma effectively.

Objectives: To investigate the efficacy and safety of superficial micro-focused ultrasound with visualization (MFU-V) for melasma in Asians.

Methods: Patients (n = 20) with mixed melasma on both cheeks received 2 MFU-V treatments spaced 1 month apart. At monthly visits over 5 months, treatment efficacy and safety were evaluated. Standardized photographs were clinically assessed using the modified Melasma Area and Severity Index (mMASI), and 6-point grading scales for melasma lightening and area of involvement. Patients provided pain, global aesthetic improvement scale (GAIS), and satisfaction assessments.

Results: In 40 cheeks, the mean mMASI score was significantly reduced from 13.2 at baseline to 2.4 at month 4, and 2.8 at month 5. Twenty-nine cheeks (72.5%) showed lightening of melasma at month 4 that persisted until month 5, with improvements up to 75% compared to baseline. Melasma area decreased overall, with sites containing >30% melasma involvement decreasing from 55% to 20% by month 5, and none with 70%-89% involvement. Melasma lightening and area improved visibly in 40% and 20% of cheeks, respectively, as early as 1 month after index MFU-V treatment. Improvements continued after the second treatment and persisted until study closure, correlating with patient GAIS and satisfaction scores. Procedure was well tolerated with only mild-to-moderate pain reported in 92.5% of treatments.

Conclusion: Superficial MFU-V is a safe and effective treatment for melasma.

Keywords: melasma; micro-focused ultrasound with visualization; photoaging pigmentation; pigmentary conditions; superficial high intensity focused ultrasound.