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

NCT07224308 | Recruiting FDA Device

• 1 other identifier: IIT10912
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 lower face, submentum, or neck during the study period.

Conditions

Laxity; Skin

Outcome Measures

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.

  Baseline to 3 months post-treatment

Secondary Outcomes (1)

• Change in Skin Laxity, Lines, and Wrinkle Severity at 6 and 12 Months

  Baseline to 6 months, and Baseline to 12 months

Study Arms (2)

Multi-Depth Ultherapy Prime Treatment

EXPERIMENTAL

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.

Device: Ultherapy Prime

Single-Depth Ultherapy Prime Treatment (1.5 mm)

EXPERIMENTAL

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.

Device: Ultherapy Prime

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.

Multi-Depth Ultherapy Prime Treatment; Single-Depth Ultherapy Prime Treatment (1.5 mm)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects between 25 and 65 years of age at the time of screening.
• Presence of moderate to severe laxity, fine lines, or crepiness of the lower face, submentum, and/or neck that is appropriate for improvement with non-invasive MFU-V treatment.
• Skin condition not advanced enough to require surgical correction.
• Willingness to refrain from elective aesthetic procedures involving the face, submentum, or neck for the entire 12-month duration of the study.
• Ability and willingness to comply with all study visits, procedures, and follow-up requirements.
• Sufficient English language proficiency to understand study instructions and complete questionnaires.
• For participants of childbearing potential: negative urine pregnancy test on the day of treatment and willingness to use adequate contraception during the study.
• Ability to provide written informed consent.

You may not qualify if:

• Male or female subjects between 25 and 65 years of age at the time of screening.
• Presence of moderate to severe laxity, fine lines, or crepiness of the lower face, submentum, and/or neck that is appropriate for improvement with non-invasive MFU-V treatment.
• Skin condition not advanced enough to require surgical correction.
• Willingness to refrain from elective aesthetic procedures involving the face, submentum, or neck for the entire 12-month duration of the study.
• Ability and willingness to comply with all study visits, procedures, and follow-up requirements.
• Sufficient English language proficiency to understand study instructions and complete questionnaires.
• For participants of childbearing potential: negative urine pregnancy test on the day of treatment and willingness to use adequate contraception during the study.
• Ability to provide written informed consent.
• Active systemic or local skin disease (e.g., eczema, psoriasis, dermatitis, infection) that may affect wound healing or the evaluation of results.
• Scarring, tattoos, or significant pigmentary alterations in the planned treatment areas.
• Metallic implants or other implanted electronic devices (e.g., pacemakers) in or near the treatment area.
• Open wounds, lesions, active herpes simplex, or active cystic/severe inflammatory acne in the treatment area.
• Use of isotretinoin or other oral retinoids within the past 12 months or planned use during the study.
• Microdermabrasion or medical-grade glycolic acid treatments to the treatment area within 2 weeks prior to participation.
• Deep dermal scarring, thick sebaceous skin, or severe solar elastosis in the treatment area that may interfere with treatment or evaluation.

Sponsors & Collaborators

• The Levine Center for Plastic Surgery: lead

Study Sites (1)

The Levine Center for Plastic Surgery

New York, New York, 10075, United States

RECRUITING

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Jennifer Levine, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer M Levine, MD

CONTACT

2125179400; info@drjenniferlevine.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2025
• First Posted: November 4, 2025
• Study Start: October 24, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)