Safety and Efficacy Evaluation of High Intensity Focused Ultrasound Device in Eyebrow Lifting

概要

The goal of this clinical trial is to assess the safety and efficacy of the high-intensity focused ultrasound (HIFU) device, ULTRAFORMER MPT (UF4-M400), developed by CLASSYS Inc., for eyebrow lifting. This study is a prospective, multicenter, evaluator-blinded, randomized, non-treatment-controlled, superiority clinical trial. The main questions the study seeks to answer are: Does the ULTRAFORMER MPT device effectively lift eyebrows? Is the safety profile of the ULTRAFORMER MPT device acceptable? Researchers will compare the investigational device to a non-treatment control group to determine whether the HIFU device demonstrates superiority in eyebrow lifting outcomes. Participant Details: Participants will receive a single treatment session using the investigational device or be assigned to the non-treatment control group. Follow-up will occur over 3 months to evaluate the effectiveness and safety of the treatment. Outcomes: Primary Outcome: Eyebrow lifting improvement, assessed through standardized photographic evaluation and other aesthetic measurement tools. Secondary Outcomes: Participant satisfaction using the Global Aesthetic Improvement Scale (GAIS) and pain assessment using a Visual Analog Scale (VAS). Safety Measures: Monitoring for adverse events (AEs) and serious adverse events (SAEs) throughout the study period. This trial aims to provide robust evidence supporting the use of the ULTRAFORMER MPT for non-invasive eyebrow lifting.