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Ultherapy Prime for Lower Face and Neck Laxity

This study is looking at how well Ultherapy Prime works to improve lines, wrinkles, and loose skin (laxity) on the lower face, under the chin (submentum), and neck. Ultherapy Prime is a device that uses focused ultrasound to tighten skin. Researchers want to see if using Ultherapy Prime at different depths works better than using it at just one depth (1.5 mm). They will enroll 20 adults, aged 25-65, who have moderate to severe loose skin in these areas and are suitable for non-surgical treatment. The main goal is to see how much skin laxity and wrinkles improve from the start of the study to three months after treatment.

Study design
This is a single-center study that will enroll 20 participants. You would be randomly assigned to receive Ultherapy Prime at either multiple treatment depths or at a single depth (1.5 mm).
What's involved
You would undergo a single Ultherapy Prime treatment. You would also have standardized 2D and 3D digital photography, clinical assessments, and complete patient surveys over a 12-month period.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for 12 months after your treatment, with the primary measurement of skin laxity and wrinkle severity taken at 3 months post-treatment.

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NCT07224308

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

Recruiting
NAAges 25–65InterventionalTreatment
The Levine Center for Plastic Surgery
~20 participants
Updated 2025-11-04 on ClinicalTrials.gov
What's tested:Ultherapy Prime

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Skin Laxity and Wrinkle Severity of the Lower Face and Neck
Measured over Baseline to 3 months post-treatment

Conditions

Laxity; Skin

Explore related trials

Cutis Laxa

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Jennifer Levine, MD · PRINCIPAL_INVESTIGATOR · Principal Investigator

Who to contact

Jennifer M Levine, MD
[email protected]
2125179400
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Eligibility criteria

Inclusion

Male or female subjects between 25 and 65 years of age at the time of screening.

Exclusion

Male or female subjects between 25 and 65 years of age at the time of screening.

What this trial measures

  • Change in Skin Laxity and Wrinkle Severity of the Lower Face and NeckBaseline to 3 months post-treatment

    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.