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NCT07224308 · ClinicalTrials.gov registry record · NA
Long-Term Efficacy and Duration of MFU-V at Multiple Depths and at 1.5 mm
A NA study of Laxity; Skin, sponsored by The Levine Center for Plastic Surgery.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT07224308 is a NA study of Laxity; Skin that is actively recruiting participants, run by The Levine Center for Plastic Surgery. The registered enrollment target is 20 participants. The trial reports 1 study location across 1 state.
The verdict
NCT07224308, a NA study of Laxity; Skin, is actively recruiting participants, sponsored by The Levine Center for Plastic Surgery.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
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
Conditions Studied
Interventions
- DEVICE Ultherapy Prime
Study Locations (1)
New York
- The Levine Center for Plastic Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-10-24 |
| Est. Completion | 2026-12-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07224308
The ClinicalTrials.gov registry entry for NCT07224308 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Levine Center for Plastic Surgery, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Laxity; Skin appearing as the primary indexed condition, and to 1 intervention - of which Ultherapy Prime is the first listed.
NCT07224308 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT07224308 about?
NCT07224308 is a clinical study titled "Long-Term Efficacy and Duration of MFU-V at Multiple Depths and at 1.5 mm". 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-...
What is the current status of trial NCT07224308?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2025-10-24. Estimated completion is 2026-12-30.
What conditions does trial NCT07224308 study?
This clinical trial studies the following conditions: Laxity; Skin.
What interventions are being tested in trial NCT07224308?
The interventions under investigation include: Ultherapy Prime (DEVICE).
Who is sponsoring clinical trial NCT07224308?
This trial is sponsored by The Levine Center for Plastic Surgery, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07224308 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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