Condition: Skin Laxity (Submental and Neck) · Facial Skin Laxity · Submental Tissue Laxity · Sponsor: CLASSYS Inc.
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.
This description comes directly from the study's public registry record.
Megan Kim · +82-10-3723-4829 · jihyekim@classys.com
James Lim · h.lim@classys.com
Always discuss trial participation with your own doctor first.
| Dermatology | Los Angeles, California, United States | Recruiting |
| Dermatology | Charlotte, North Carolina, United States | Recruiting |
| Dermatology | Wilmington, North Carolina, United States | Recruiting |
| Dermatology | Nashville, Tennessee, United States | Recruiting |
| Dermatology | Spokane, Washington, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07229430