Safety of Microfocused Ultrasound With Visualization in Patients With Fitzpatrick Skin Phototypes III to VI

Area of Science:

• Aesthetic dermatology
• Medical aesthetics
• Ultrasound technology

Background:

• Microfocused ultrasound (MFU) systems offer a non-invasive approach to skin tightening and lifting.
• Assessing the safety of MFU treatments is crucial, particularly for individuals with darker skin tones (Fitzpatrick skin types III to VI).

Purpose of the Study:

• To evaluate the safety and efficacy of microfocused ultrasound for improving facial and neck skin laxity.
• To assess MFU treatment outcomes in adults with Fitzpatrick skin types III to VI.

Main Methods:

• An open-label, nonrandomized trial involving 52 adult participants with Fitzpatrick skin types III to VI.
• Pre-treatment skin assessment and ultrasound imaging were conducted to ensure proper acoustic coupling.
• Treatments were administered between March 23, 2011, and July 20, 2011.

Main Results:

• Three temporary adverse events were reported: two instances of mild edema (welts) and one case of prolonged erythema with mild scabbing.
• All reported adverse events resolved completely within 90 days without any lasting side effects.
• The study demonstrated a favorable safety profile for MFU in the target population.

Conclusions:

• Microfocused ultrasound (MFU) treatments are safe for individuals with Fitzpatrick skin types III to VI when performed by trained physicians.
• The observed adverse events were transient and linked to treatment technique, not inherent to the MFU system.
• MFU is a viable and safe option for addressing skin laxity in diverse skin types.