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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CLASSYS Inc.
- 入组人数
- 273
- 试验地点
- 10
- 主要终点
- Submental Area Lift [Time Frame: 90 Days Post-Treatment]
研究概览
简要总结
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.
详细描述
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 receive either ULTRAFORMER MPT PLUS or the comparator device (ULTHERA® System, Merz Aesthetics, USA).
Primary endpoints include blinded investigator-assessed improvement using the validated Facial Laxity Grading Scale and safety outcomes based on the incidence and severity of device-related adverse events. Secondary endpoints include participant-reported improvement scores, digital image analysis, and durability of effect at 8-week and 12-week follow-ups.
The study consists of two sequential safety stages (Stage 1A and 1B; 20 subjects total) followed by the pivotal Stage 2 phase (approximately 253 subjects). Data from the safety stages will be reviewed by an independent Data Safety Monitoring Board (DSMB) prior to progression to Stage 2.
All treatments will be performed by trained investigators according to the protocol-defined parameters. Subjects will be evaluated at baseline, post-treatment, and during follow-up visits up to 6 months. The final statistical analysis will assess non-inferiority of ULTRAFORMER MPT PLUS to the predicate device with respect to the primary efficacy endpoint and confirm overall safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This study is evaluator-blinded. Participants and outcomes assessors will remain blinded to treatment allocation, while treatment providers will be unblinded to operate the assigned device.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
ULTRAFORMER MPT PLUS Group
ULTRAFORMER MPT PLUS (Classys Inc., Seoul, Korea) delivers high-intensity focused ultrasound (HIFU) energy to the subdermal tissue to induce neocollagenesis and tissue contraction for non-surgical skin tightening and lifting.
干预措施: ULTRAFORMER MPT PLUS (Device)
Ulthera Comparator Group
The Ulthera® System (Merz Aesthetics, USA) uses focused ultrasound energy to lift and tighten submental and neck skin and serves as the reference comparator in this non-inferiority clinical trial.
干预措施: Ulthera System (Device)
结局指标
主要结局
Submental Area Lift [Time Frame: 90 Days Post-Treatment]
时间窗: 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.).
次要结局
- Change in Overall Lifting of Treated Tissue on Submental and Neck Regions [Time Frame: 60 and 90 Days Post-Treatment](60 and 90 Days Post-Treatment)
- Subject Satisfaction Questionnaire[Time Frame: 60 and 90 Days Post-Treatment](60 and 90 Days Post-Treatment)
- Submental Area Lift [Time Frame: 60 Days Post-Treatment](60 Days Post-Treatment)
- Global Aesthetic Improvement Scale (GAIS) Results [Time Frame: 60 and 90 Days Post-Treatment](60 and 90 Days Post-Treatment)
- Submental Area Lift [Time Frame: 90 Days Post-Treatment](90 Days Post-Treatment)
- Visual Analog Scale (VAS) - Pain Score[Time Frame:Immediately Post-Treatment](Immediately Post-Treatment)