Actively Recruiting
Long-Term Efficacy and Duration of MFU-V at Multiple Depths and at 1.5 mm
Led by The Levine Center for Plastic Surgery · Updated on 2025-11-04
20
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Long-Term Efficacy and Duration of MFU-V at Multiple Depths and at 1.5 mm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects between 25 and 65 years of age at screening
- Moderate to severe laxity, fine lines, or crepiness of the lower face, submentum, or neck suitable for non-invasive MFU-V treatment
- Skin condition not severe enough to require surgery
- Willing to avoid elective aesthetic procedures on face, submentum, or neck during the 12-month study
- Able and willing to attend all study visits and follow-up
- Sufficient English proficiency to understand study instructions and complete questionnaires
- Negative pregnancy test on treatment day and willingness to use contraception if of childbearing potential
- Able to provide written informed consent
You will not qualify if you...
- Active systemic or local skin diseases (e.g., eczema, psoriasis, dermatitis, infection) affecting healing or evaluation
- Scarring, tattoos, or major pigment changes in treatment areas
- Metallic implants or electronic devices near treatment area
- Open wounds, lesions, active herpes simplex, or severe acne in treatment zone
- Use of oral retinoids in past 12 months or planned during study
- Microdermabrasion or medical-grade glycolic acid treatments in treatment area within 2 weeks prior
- Deep scarring, thick sebaceous skin, or severe sun damage interfering with treatment or evaluation
- Plans to gain or lose 2 or more BMI units during study
- Allergy or sensitivity to device components or ultrasound gel
- History of chronic drug/alcohol abuse or opioid dependence
- Recent aesthetic procedures on lower face, submentum, or neck not cleared by washout period
- Participation in another investigational study within 30 days prior
- Pregnancy, breastfeeding, or plans to become pregnant during study
- Any condition increasing risk or interfering with participation per investigator judgment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Levine Center for Plastic Surgery
New York, New York, United States, 10075
Actively Recruiting
Research Team
J
Jennifer M Levine, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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