Safety and Effectiveness Evaluation of the High-intensity Focused Ultrasound Device for Lifting Lax Submental and Neck Tissue
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorCLASSYS Inc.
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
ULTRAFORMER MPT PLUS
DeviceULTRAFORMER MPT PLUS (Classys Inc., Seoul, Korea) is a high-intensity focused ultrasound (HIFU) system that delivers focused energy at multiple depths to induce neocollagenesis and tissue contraction for non-surgical lifting and tightening of submental and neck tissue. The device includes both Default and MP modes and is under investigation under FDA IDE G250041.
Ulthera System
DeviceThe Ulthera System (Merz Aesthetics, USA) is an FDA-cleared high-intensity focused ultrasound (HIFU) device indicated for non-invasive lifting and tightening of lax tissue in the submental and neck areas. It serves as the active comparator for this non-inferiority clinical study.
Treatment groups
273 Participants
are divided into 2 treatment groupsGroup A: ULTRAFORMER MPT PLUS GroupExperimental treatment 1 intervention
Group B: Ulthera Comparator GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Submental Area Lift [Time Frame: 90 Days Post-Treatment]
The primary endpoint of the study is the Submental Area Lift "Success" evaluated at 90 days post-treatment. A "Success" is defined as a reduction in the measured submental area of ≥ 20 mm² compared with baseline. Both left and right lateral 2D images will be derived from 3D photographs and analyzed by certified technicians using the Submental Lift Application (Canfield Scientific Inc.).
Time frame
90 Days Post-TreatmentSecondary outcomes
1
Submental Area Lift [Time Frame: 60 Days Post-Treatment]
Submental Area Lift ≥ 20 mm² vs baseline.
Time frame
60 Days Post-Treatment2
Submental Area Lift [Time Frame: 90 Days Post-Treatment]
Submental Area Lift ≥ 20 mm² vs baseline.
Time frame
90 Days Post-Treatment3
Change in Overall Lifting of Treated Tissue on Submental and Neck Regions [Time Frame: 60 and 90 Days Post-Treatment]
Percentage of patients assessed to have improvement in skin laxity (lifted skin) by ≥ 2 of 3 independent blinded evaluators comparing pre-, 60-, and 90-day post-treatment images. Images will be prepared and randomized for review per Canfield SOPs (FDA K121700).
Time frame
60 and 90 Days Post-Treatment4
Global Aesthetic Improvement Scale (GAIS) Results [Time Frame: 60 and 90 Days Post-Treatment]
Overall aesthetic improvement rated on a 5-point scale (1 = Very Much Improved to 5 = Worse) by the investigator comparing pre- and post-treatment photographs. Assessed by PI or delegated qualified staff at each visit.
Time frame
60 and 90 Days Post-TreatmentSponsors and contacts
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Source ClinicalTrials.gov