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

IMPORTANCE: A microfocused ultrasound (MFU) system is a safe and effective aesthetic treatment for tightening and lifting skin in the facial and neck areas. This open-label, nonrandomized trial was performed to further demonstrate the safety of MFU for improving laxity of the skin of the face and neck in 52 adults with Fitzpatrick skin types III to VI. OBSERVATIONS: Before treatment with MFU, the skin tissue of each participant was assessed and ultrasound imaging was performed on the treatment area to ensure appropriate acoustic transducer coupling. Treatment was performed from March 23, 2011, to July 20, 2011. Following treatment, there were 3 reported adverse events described as raised areas of mild edema or welts (2 events) and moderately severe prolonged erythema with mild scabbing (1 event). All events resolved after 90 days without sequelae. Analysis was conducted from Janaury 18, 2012, to March 13, 2013. CONCLUSIONS AND RELEVANCE: The adverse events that occurred in this trial were temporary and associated with treatment technique. When performed by trained physicians, MFU is safe in patients with Fitzpatrick skin types III to VI. LEVEL OF EVIDENCE: 4. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01368965.