Long-term effects of Ultherapy Prime using multiple depths versus a single 1.5 mm depth for the lower face and neck

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

This trial will test whether Ultherapy Prime delivered at multiple depths works better than a single 1.5 mm depth to lift, tighten, and smooth the lower face and neck in adults aged 25–65 with moderate to severe skin laxity.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 25 Years to 65 Years
• Sex: All
• Sponsor: The Levine Center for Plastic Surgery (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT07224308 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-center, randomized trial enrolling 20 adults aged 25–65 with moderate to severe lower-face and neck laxity. Participants receive a single Ultherapy Prime (MFU-V) treatment using either a multi-depth protocol or a single 1.5 mm depth protocol and are followed for 12 months. Outcomes include standardized 2D and 3D photography, investigator-assessed scales such as GAIS, cutometer elasticity measures, and patient-reported outcome measures to track safety, lifting, tightening, and collagen-related skin changes. The trial compares the durability and magnitude of clinical and patient-reported improvements between the two delivery approaches.

Who should consider this trial

Good fit: Adults 25–65 with moderate to severe laxity, fine lines, or crepiness of the lower face, submentum, and/or neck who are appropriate candidates for non-invasive MFU-V treatment and willing to avoid other elective facial procedures for 12 months.

Not a fit: People whose skin laxity is advanced enough to require surgical correction, those with contraindications to ultrasound treatment or pregnancy, or those unwilling to comply with study visit and procedure restrictions are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the approach could offer a non-surgical option that produces more durable or noticeable lifting and tightening of the lower face and neck.

How similar studies have performed: Ultherapy (MFU-V) is FDA-cleared for lifting the brow, neck, and submentum and prior studies have shown skin tightening and collagen stimulation, but direct comparisons of multi-depth versus single-depth protocols are limited.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Exclusion Criteria:

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.

Intention to gain or lose ≥ 2 BMI units during the 12-month study period.

Known allergy or hypersensitivity to any component of the device or ultrasound coupling gel.

History of chronic drug or alcohol abuse or opioid dependence.

Recent aesthetic procedures to the lower face, submentum, or neck that may confound study outcomes (e.g., fillers, neurotoxins, lasers, threads, RF, ultrasound) within the protocol-specified washout period.

Participation in another clinical study involving an investigational device or drug within 30 days prior to treatment.

Pregnancy, breastfeeding, or plans to become pregnant during the study.

Any condition that, in the opinion of the investigator, would increase risk or interfere with study participation or data interpretation.

Where this trial is running

New York, New York

• The Levine Center for Plastic Surgery — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Jennifer Levine, MD — Principal Investigator
• Study coordinator: Jennifer M Levine, MD

Conditions: Laxity, Skin