A Prospective, Multicenter, Single-Arm Clinical Study of 51 subjects who are seeking a procedure to reduce the appearance of the periorbital wrinkles, and meet study eligibility criteria, and have provided informed consent will be enrolled in the study. Up to 5 investigational centers in Israel and the United States will participate in the recruitment. Each study subject will receive 4 treatments with Tixel in a monthly interval. Follow-up will occur at 1 month and 3 months following the last treatment.~The clinic visits will be as follow:~Baseline (1st tx)~Phone-call visit (3 days after the first treatment)~4wk (2nd tx)~8wk (3rd tx)~12wk (4th tx)~4 weeks after the last treatment (1st FU)~12 weeks after the last treatment (2nd FU= 3 months FU, primary endpoint and study completion visit) Primary Efficacy Endpoint is the comparison of the proportion of subjects with a ≥ 1-score improvement on the FWCS at the 3-month visit compared to baseline as determined by at least 2 out of 3 blinded Independent Photographic Reviewers.~Primary Safety Endpoint is the evaluation of related adverse events up to the 3-month visit after treatment.
A Prospective, Multicenter, Single-Arm Clinical Study of 51 study subjects who are seeking a procedure to reduce the appearance of the peri-orbital wrinkles. Up to 5 investigational centers in Israel and the United States will participate in the recruitment. Each study subject will receive four (4) treatments with Tixel in a monthly interval. Follow-up will occur 1 month and 3 months following last treatment.