An IRB – approved 60 patient multi-center clinical studies evaluated the clinical effects of Sofwave’s ultrasound technology on facial wrinkles and necklines. Patients with mild to moderate facial wrinkles were enrolled.
Overall, 295 areas were treated. At 3 months, investigators rated 88% of the subjects to be improved to very much improved on the Global Aesthetic Improvement Scale (GAIS) and 86% of the subjects were improved by either -1 or -2 or -3 Fitzpatrick Elastosis Scores (ES). 72% of the subjects were satisfied with their results and rated them as improved to very much improved on the GAIS. The safety profile was excellent with no adverse events reported.