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

Study Summary

The goal of this clinical trial is to evaluate the long-term safety and effectiveness of Ultherapy Prime (MFU-V) for improving lines, wrinkles, laxity, and crepiness of the lower face, submentum, and neck. The study will enroll adult male and female subjects aged 25-65 with moderate to severe lower-face and neck skin laxity who are appropriate candidates for non-invasive ultrasound treatment. The main questions this study aims to answer are: Does Ultherapy Prime delivered at multiple depths compared to a single-depth (1.5 mm) treatment improve clinical lifting, tightening, and smoothing of the lower face and neck over a 12-month period? Does treatment with Ultherapy Prime stimulate measurable improvements in collagen-related skin quality, patient satisfaction, and investigator-assessed aesthetic outcomes? Because the study includes two treatment approaches, researchers will compare a multi-depth MFU-V treatment protocol versus a single-depth (1.5 mm) MFU-V treatment protocol to determine whether multi-depth energy delivery provides superior or longer-lasting clinical improvement. What Participants Will Do Participants will: Attend a total of 5 study visits over 12 months (Screening/Treatment, 1-month, 3-month, 6-month, and 12-month follow-ups). Undergo a single Ultherapy Prime treatment session at either multiple depths or at the 1.5 mm depth only. Complete standardized photography, including 2D and 3D images, at all timepoints. Participate in clinical assessments, including GAIS scoring, cutometer elasticity measurements (if applicable), and investigator- and patient-reported satisfaction scales. Follow pre-visit requirements, including: No moisturizers, lotions, or topical products on the treatment area before each visit No hair in the treatment area (shave the day prior if needed) Complete questionnaires evaluating satisfaction, comfort, and perceived treatment benefits. Adhere to follow-up schedules, avoiding elective aesthetic procedures to the l

Primary Outcome

Clinical improvement in skin laxity, lines, and wrinkles of the lower face, submentum, and neck will be assessed by the Principal Investigator using the Global Aesthetic Improvement Scale (GAIS) and standardized 2D/3D photographs. The primary endpoint evaluates whether treatment with Ultherapy Prime results in a measurable improvement in lifting, tightening, and skin smoothness compared with baseline. GAIS scores range from "Very Much Improved" to "Worse," with higher ratings indicating greater

Conditions Studied

Interventions

• DEVICE Ultherapy Prime

Study Locations (1)