Study of Ulthera System Treatment for Improving Skin Laxity in the Lower Face, Under Chin, and Neck Areas

What this Trial Is About

Researchers are evaluating the Ulthera System to improve skin laxity in the lower face, submental area, and neck of adults aged 35 to 65 years. The study aims to show that treatment with the Ulthera System is better than no treatment and to assess its safety for these areas. Participants have mild to moderate skin laxity that can be improved without surgery. Participants are randomly assigned to one of two groups. One group receives a single treatment with the Ulthera System to the lower face, submental area, and neck on the first day. The other group remains untreated for 90 days before receiving the same single treatment. The device includes a control unit, handpiece, and interchangeable transducers. This design allows comparison between immediate and delayed treatment effects. During the study, participants are monitored for changes in skin laxity at 90 days compared to baseline using a Global Aesthetic Improvement Scale assessed by blinded evaluators, investigators, and the participants themselves. Researchers collect photographs and evaluate skin improvement. Participants need to avoid other aesthetic treatments and certain medications during the study. The total study duration includes treatment and evaluation up to day 90, with safety and effectiveness closely observed.

Effectiveness and Safety of the Ulthera® System for Skin Laxity in the Lower Face, Submentum and Neck