Safety and Effectiveness Evaluation of the High-intensity Focused Ultrasound Device for Lifting Lax Submental and Neck Tissue

Recruiting now · Not applicable

Conditions studied: Skin Laxity (Submental and Neck), Facial Skin Laxity, Submental Tissue Laxity

In brief

This is a prospective, multicenter, randomized, evaluator-blinded, parallel-controlled, non-inferiority clinical study designed to evaluate the safety and effectiveness of the ULTRAFORMER MPT PLUS, a high-intensity focused ultrasound (HIFU) device, for lifting and tightening lax submental (beneath the chin) and neck tissue in adult subjects. Approximately 273 subjects will be enrolled at multiple investigational sites across the United States. Participants will receive either the ULTRAFORMER MPT PLUS treatment or the predicate comparator device, and will be followed for safety and efficacy assessments including clinical photography, investigator evaluation, and patient-reported outcomes. The study aims to demonstrate that ULTRAFORMER MPT PLUS is non-inferior to the approved reference device in improving skin laxity and wrinkle appearance of the lower face and neck.

Key facts

Study ID

NCT07229430

Run by

CLASSYS Inc.

People needed

273

Starts

2025-10-16

Expected to finish

2026-11-26

Last updated by the study team

2026-04-20

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• Prior facelift, neck lift, liposuction, or contouring surgery involving the lower face, submental, or neck areas.
• 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.
• Presence of any implanted electronic medical device, such as a pacemaker, defibrillator, or neurostimulator.
• Active skin infection, wound, cystic acne, inflammation, or severe scarring within or near the treatment area.
• History of keloid formation or abnormal wound healing.
• Known bleeding disorder, or use of anticoagulant or antiplatelet medications that cannot be safely discontinued for the procedure.
• Pregnant or breastfeeding women.
• Subjects with a known sensitivity or contraindication to ultrasound-based procedures.
• Any medical or psychiatric condition that, in the investigator's judgment, could interfere with study participation, safety, or data integrity.
• Participation in another investigational study within 30 days prior to screening.

Where it is running

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

Full record on ClinicalTrials.gov

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