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

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.