Safety and Effectiveness Evaluation of the High-intensity Focused Ultrasound Device for Lifting Lax Submental and Neck Tissue
Trial Parameters
Brief Summary
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.
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,