Evaluating Long-Term Safety and Effectiveness of Ultherapy Prime for Lifting and Tightening the Lower Face and Neck Using Multiple or Single Depth Ultrasound Treatment

What this Trial Is About

Researchers are evaluating the long-term safety and effectiveness of Ultherapy Prime, a micro-focused ultrasound device, for improving lines, wrinkles, and skin laxity of the lower face, submentum, and neck. The study aims to compare a multi-depth treatment approach with a single-depth 1.5 mm treatment to see which method provides better or longer-lasting skin lifting, tightening, and smoothing over a 12-month period. This trial involves adult men and women aged 25 to 65 with moderate to severe skin laxity who are suitable candidates for non-invasive ultrasound treatment. Participants will receive one Ultherapy Prime treatment session either delivered at multiple depths targeting different tissue layers or exclusively at the 1.5 mm depth. The device delivers precise ultrasound energy to stimulate new collagen production, promoting skin firmness and elasticity. The study includes five visits a combined Screening and Treatment visit, followed by follow-ups at 1, 3, 6, and 12 months after treatment. Participants must avoid lotions, moisturizers, or hair in the treatment area before visits and refrain from elective aesthetic procedures on the lower face, submentum, or neck during the study. During the study, participants will complete standardized 2D and 3D photography, clinical assessments including the Global Aesthetic Improvement Scale and skin elasticity measurements, and satisfaction questionnaires. Researchers will monitor changes in skin laxity and wrinkle severity at 3, 6, and 12 months post-treatment. Safety will be tracked through adverse event reports and clinical exams. The total participation duration is 12 months, allowing evaluation of the duration and extent of skin improvements from the treatment.

Long-Term Efficacy and Duration of MFU-V at Multiple Depths and at 1.5 mm