High-intensity focused ultrasound lift for loose submental and neck skin

A Prospective, Multi-center, Randomized Controlled, Non-inferiority Study to Evaluate the Safety and Effectiveness of ULTRAFORMER MPT PLUS Treatment to Lift Lax Submental (Beneath the Chin) and Neck Tissue

This study will test whether the ULTRAFORMER MPT PLUS device can lift and tighten mild-to-moderate loose skin under the chin and on the neck in adults aged 30 to 65.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 273 (estimated)
• Ages: 30 Years to 65 Years
• Sex: All
• Sponsor: CLASSYS Inc. (Industry-sponsored)
• Locations: 5 sites (Los Angeles, California and 4 other locations)
• Trial ID: NCT07229430 on ClinicalTrials.gov

What this trial studies

This prospective, multicenter, randomized, evaluator-blinded, parallel-controlled non-inferiority study compares ULTRAFORMER MPT PLUS to the approved Ulthera System for improving submental and neck skin laxity. Approximately 273 adults aged 30–65 with mild-to-moderate laxity will be randomized 1:1 across up to five U.S. investigational sites, with two initial safety stages before a pivotal Stage 2. Primary endpoints include blinded investigator improvement on the Facial Laxity Grading Scale and device-related adverse events, with secondary endpoints of patient-reported outcomes, digital image analysis, and durability at 8- and 12-week follow-ups. Treatments are delivered by trained investigators under an FDA IDE with oversight by an independent Data Safety Monitoring Board.

Who should consider this trial

Good fit: Ideal candidates are adults 30–65 with mild-to-moderate submental or neck skin laxity, stable body weight, and no recent cosmetic procedures to the treatment area.

Not a fit: People with severe laxity, prior facelift/neck surgery, or recent energy-based or injectable treatments to the lower face or neck are unlikely to benefit from this device in this study.

Why it matters

Potential benefit: If successful, the device could provide a non-surgical option to reduce submental and neck laxity comparable to an existing approved HIFU system.

How similar studies have performed: Previous studies and the approved Ulthera HIFU system have shown benefit for skin tightening, so this trial compares a newer HIFU device against that established approach.

Eligibility criteria

Inclusion Criteria:

1. Male or female subjects aged 30 to 65 years, inclusive, at the time of informed consent.
2. Subjects presenting with mild to moderate submental and/or neck skin laxity, as determined by the investigator.
3. Subjects in good general health with stable body weight (±5%) for at least 6 months prior to screening.
4. Subjects willing to avoid other aesthetic or dermatologic procedures (surgical or non-surgical) to the treatment area during the study period.
5. Subjects able to understand and sign informed consent and comply with all study visits and procedures.
6. Female subjects of child-bearing potential who agree to use reliable contraception throughout study participation.

Exclusion Criteria:

1. Prior facelift, neck lift, liposuction, or contouring surgery involving the lower face, submental, or neck areas.
2. Receipt of any energy-based aesthetic treatment (e.g., HIFU, radiofrequency, laser) or injectable aesthetic treatment (e.g., botulinum toxin, dermal filler, collagen stimulator) to the treatment area within 6 months prior to baseline.
3. Presence of any implanted electronic medical device, such as a pacemaker, defibrillator, or neurostimulator.
4. Active skin infection, wound, cystic acne, inflammation, or severe scarring within or near the treatment area.
5. History of keloid formation or abnormal wound healing.
6. Known bleeding disorder, or use of anticoagulant or antiplatelet medications that cannot be safely discontinued for the procedure.
7. Pregnant or breastfeeding women.
8. Subjects with a known sensitivity or contraindication to ultrasound-based procedures.
9. Any medical or psychiatric condition that, in the investigator's judgment, could interfere with study participation, safety, or data integrity.
10. Participation in another investigational study within 30 days prior to screening.

Where this trial is running

Los Angeles, California and 4 other locations

• Dermatology — Los Angeles, California, United States (Recruiting)
• Dermatology — Charlotte, North Carolina, United States (Recruiting)
• Dermatology — Wilmington, North Carolina, United States (Recruiting)
• Dermatology — Nashville, Tennessee, United States (Recruiting)
• Dermatology — Spokane, Washington, United States (Recruiting)

Study contacts

• Study coordinator: Megan Kim

Conditions Skin Laxity; Facial Skin Laxity; Submental Tissue Laxity; ULTRAFORMER MPT PLUS; High-Intensity Focused Ultrasound; HIFU; Submental Lifting; Non-surgical Lift