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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: jihyekim@classys.com
• Phone: +82-10-3723-4829

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.