Prospective Study on Clinical Efficacy and Safety of a Single Session of Microfocused Ultrasound With Visualization for Collagen Regeneration.

BACKGROUND: Recent studies have shown that transcutaneous microfocused ultrasound with visualization is beneficial for noninvasive skin tightening, collagen regeneration, and lower face contour improvement. OBJECTIVES: The primary study endpoint was the improvement of the laxity and ptosis face skin; the secondary endpoint was the improvement of wrinkles, texture, and hemoglobin content; and the third endpoint was the patient's responses to a patient satisfaction questionnaire. METHODS: Patients with soft to moderate skin laxity and ptosis of the face and neck were enrolled and their sex, ethnicity, age, Fitzpatrick skin type, and smoking habit recorded. Patient assessment was made by digital macro-photographs, Vectra H2, and Antera 3D, and strict exclusion criteria were set up. RESULTS: From November 2017 to November 2018, 47 women and 3 men with a mean age of 52.8 +/- 7.43 years and Araco's Ptosis Scale System 2.7 +/- 0.46, which fit the inclusion criteria, were enrolled in the study. All patients signed a consent form and received 1200 spot-lines (400 lines from each transducer) of microfocused ultrasound with visualization. No major side effects were reported during the study and all patients completed the follow-up after 6 months. Wrinkles, texture, Surgeon Assessment Scoring System scores, and patient satisfaction questionnaire scores improved significantly. Patients found the treatment tolerable according to the patient pain scale rate. No statistically significative differences were found among homogenous groups of smokers and nonsmokers. CONCLUSIONS: The study proves that microfocused ultrasound with visualization in a single session of treatment in monotherapy is safe and effective for the treatment of face laxity and ptosis when a proper number of energy spot-lines is delivered in the correct tissue layer. LEVEL OF EVIDENCE: 4: