Evaluating ULTRAFORMER MPT PLUS for Neck and Chin Tightening
This study is testing a new device called ULTRAFORMER MPT PLUS to see how safe and effective it is for lifting and tightening loose skin under the chin (submental) and on the neck. It uses high-intensity focused ultrasound (HIFU) to encourage new collagen growth. Researchers will compare it to an existing FDA-cleared device, the Ulthera System. You might be able to join if you are between 30 and 65 years old and have mild to moderate loose skin in these areas. The main goal is to see if ULTRAFORMER MPT PLUS can lift the submental area after 90 days. The study aims to enroll about 273 people, but its current status is unclear.
- Study design
- This is a randomized study where participants will receive either the ULTRAFORMER MPT PLUS or the Ulthera System. About 273 participants will be enrolled, and neither the participant nor the evaluator will know which treatment is given.
- What's involved
- Participants will receive a treatment and be followed for safety and effectiveness, including clinical photos, investigator evaluations, and reporting their own outcomes. The primary endpoint is measured 90 days post-treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety and efficacy assessments, with primary effectiveness measured 90 days after treatment. Secondary endpoints include durability of effect at 8-week and 12-week follow-ups.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety and Effectiveness Evaluation of the High-intensity Focused Ultrasound Device for Lifting Lax Submental and Neck Tissue
At a glance
Conditions
Where it's being run
5 sites across 4 statesWho to contact
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What this trial measures
- Submental Area Lift [Time Frame: 90 Days Post-Treatment]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.).