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

Part of paid clinical trials in New York, New York.

Sponsor
The Levine Center for Plastic Surgery
Study ID
NCT07224308
Status
Recruiting
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Conditions

  • Laxity; Skin

Eligibility Criteria

Sex
ALL
Age
25 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Ultherapy Prime — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Oct 24, 2025
Status verified
Oct 2025
Primary completion
Nov 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Multi-Depth Ultherapy Prime Treatment
    Participants in this arm will receive a single full-face and neck Ultherapy Prime treatment delivered at multiple depths according to the manufacturer's guidelines for MFU-V energy placement. Energy will be applied using the appropriate transducers for each anatomical depth to target multiple layers of tissue beneath the skin surface. The goal is to stimulate collagen production at varying focal points to enhance lifting, tightening, and overall skin quality.
  • Experimental: Single-Depth Ultherapy Prime Treatment (1.5 mm)
    Participants in this arm will receive a single full-face and neck Ultherapy Prime treatment delivered exclusively at the 1.5 mm depth, which is one of the FDA-cleared depths for treatment of the lower face and neck. This protocol evaluates whether single-depth energy delivery can achieve meaningful skin improvement compared with multi-layer treatment.

Primary Outcome Measure

Change in Skin Laxity and Wrinkle Severity of the Lower Face and Neck [ Time Frame: Baseline to 3 months post-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Levine Center for Plastic SurgeryNew YorkNew York10075
Amelia Adamska
[email protected]
212-517-9400

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By research site
The Levine Center for Plastic Surgery· New York, NY

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