Long-Term Efficacy and Duration of MFU-V at Multiple Depths and at 1.5 mm
ConditionLaxity; Skin
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-65
SponsorThe Levine Center for Plastic Surgery
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female subjects between 25 and 65 years of age at the time of screening.
Disqualifiers
Male or female subjects between 25 and 65 years of age at the time of screening.
Trial design
Design model
Single group
Treatments tested in this trial
Ultherapy Prime
DeviceUltherapy 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Multi-Depth Ultherapy Prime TreatmentExperimental treatment 1 intervention
Group B: Single-Depth Ultherapy Prime Treatment (1.5 mm)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Skin Laxity and Wrinkle Severity of the Lower Face and Neck
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 aesthetic improvement.
Time frame
Baseline to 3 months post-treatmentSecondary outcomes
1
Change in Skin Laxity, Lines, and Wrinkle Severity at 6 and 12 Months
Evaluation of whether aesthetic improvement persists at 12 months using GAIS, photography, and patient satisfaction surveys to assess the duration of clinical benefit following a single MFU-V treatment.
Time frame
Baseline to 6 months, and Baseline to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov