NCT07224308

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The Levine Center for Plastic Surgery · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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 lower face, submentum, or neck during the study period.

Detailed description

This study is a prospective, single-center clinical trial designed to evaluate the long-term safety and effectiveness of Ultherapy Prime (MFU-V) for improving lines, wrinkles, and skin laxity of the lower face, submentum, and neck. Ultherapy Prime is an FDA-cleared focused ultrasound device indicated for non-invasive lifting and tightening of the skin under the chin, on the neck, and on the brow, as well as for improving lines and wrinkles of the décolleté. The device delivers precise micro-focused ultrasound energy at controlled depths beneath the skin's surface to stimulate neocollagenesis-the natural production of new collagen that contributes to skin firmness, elasticity, and support. The objective of this study is to assess clinical outcomes following a single Ultherapy Prime treatment using either a multi-depth protocol or a single-depth protocol at 1.5 mm. The study will enroll 20 adult subjects aged 25 to 65 with moderate to severe laxity or crepiness of the lower face and neck who are appropriate candidates for non-invasive energy-based treatment. Participants will be randomized to receive Ultherapy Prime at either multiple treatment depths or at the 1.5 mm depth alone. All subjects will undergo standardized 2D and 3D digital photography, clinical assessments, and patient-reported outcome measures over a 12-month follow-up period. Investigator-assessed and patient-reported evaluations-including the Global Aesthetic Improvement Scale (GAIS), cutometer elasticity measurements (if applicable), and satisfaction scales-will be used to assess changes in skin quality, lifting, tightening, and overall aesthetic improvement. The study includes five visits: a combined Screening/Treatment Visit, and follow-up visits at 1 month, 3 months, 6 months, and 12 months post-treatment. The Screening/Treatment Visit will include informed consent, eligibility confirmation, pregnancy testing if applicable, baseline imaging, and delivery of the assigned Ultherapy Prime treatment. Participants must avoid applying any lotions, moisturizers, or topical products to the treatment area prior to each visit. The treatment area must be free of hair; if shaving is required, participants must shave the day before treatment. To reduce confounding variables, subjects must refrain from undergoing elective aesthetic procedures involving the lower face, submentum, or neck for the duration of the 12-month study. Safety will be monitored throughout the trial through documentation of adverse events, subject-reported symptoms, and clinical examinations. Because Ultherapy Prime is already FDA-cleared for the anatomical regions being treated, and because treatment involves a single non-invasive procedure, the study is considered minimal risk. This research will contribute to a deeper understanding of the duration and extent of clinical benefits associated with Ultherapy Prime, as well as whether multi-depth treatment results in greater or longer-lasting improvement compared to treatment at a single depth.

Conditions

• Laxity; Skin

Interventions

Type	Name	Description
DEVICE	Ultherapy Prime	Ultherapy Prime is an FDA-cleared micro-focused ultrasound (MFU-V) device used for non-invasive lifting and tightening of the lower face, submentum, neck, brow, and improvement of décolleté lines. It delivers precise ultrasound energy at controlled depths to create thermal coagulation points that stimulate neocollagenesis, promoting new collagen and elastin for improved firmness and visible lifting. The system includes real-time DeepSEE® imaging to visualize tissue layers and ensure accurate energy placement. Ultherapy Prime uses transducers at FDA-cleared depths such as 1.5 mm, 2.0 mm, 3.0 mm, and 4.5 mm. For this study, treatment is delivered at multiple depths or only at 1.5 mm depending on randomization. It is non-surgical, non-ionizing, does not break the skin, and improvement develops gradually as collagen remodels.

Timeline

• Start date: 2025-10-24
• Primary completion: 2026-11-30
• Completion: 2026-12-30
• First posted: 2025-11-04
• Last updated: 2025-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study