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
CLASSYS Inc.
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.
Description
This prospective, multicenter, randomized, evaluator-blinded, parallel-controlled, non-inferiority clinical investigation is conducted under an FDA Investigational Device Exemption (IDE #G250041) to evaluate the safety and effectiveness of the ULTRAFORMER MPT PLUS (Class II high-intensity focused ultrasound system) for aesthetic improvement of submental and neck tissue laxity. A total of approximately 273 subjects aged 30-65 years with mild-to-moderate skin laxity in the submental and neck areas will be enrolled across up to 5 U.S. investigational sites. Subjects will be randomized 1:1 to rec…
Eligibility
- Age range
- 30–65 years
- Sex
- All
- Healthy volunteers
- Yes
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 sub…
Interventions
- DeviceULTRAFORMER MPT PLUS
ULTRAFORMER 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.
- DeviceUlthera System
The 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.
Locations (5)
- DermatologyLos Angeles, California
- DermatologyCharlotte, North Carolina
- DermatologyWilmington, North Carolina
- DermatologyNashville, Tennessee
- DermatologySpokane, Washington