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Single-center prospective clinical trial of safety and effectiveness of skin and subcutaneous tissue elasticity improvement after high-intensity focused ultrasound
( Seha Park ) , ( Jaewoo Lim ) , ( Shinyoung Song ) , ( Seulki Lee ) , ( Heejoo Kim ) , ( Jooyoung Roh ) , ( Hyangjoon Park ) , ( Jinok Baek )
UCI I410-ECN-0102-2022-500-000283760
* 발행 기관의 요청으로 무료로 이용 가능한 자료입니다.

Background: High-intensity focused ultrasound (HIFU) is a noninvasive technology used to treat skin laxity and provide tightening with minimal risk and recovery time. Objectives: This clinical trial aimed to verify the safety and effectiveness of HIFU on skin and subcutaneous tissue elasticity by adding the applied areas to the eyebrow lifting already approved by the FDA. Methods: A total of 43 Korean subjects were enrolled in this prospective clinical trial and treated with HIFU on both the cheeks, arms, lower abdomen, and thighs. We used a HIFU device with 8 different cartridges. Skin elasticity was measured before and after treatment using a Cutometer. Three blinded, dermatologists evaluated paired pre- and post-treatment (weeks 4 and 12) photographs according to the Investigator Global Aesthetic Improvement Scale (IGAIS). Participants also completed self-assessments using the Subject GAIS (SGAIS). Subjects rated their pain on a numeric rating scale (NRS) immediately and 7 days after treatment. Results: Skin elasticity was significantly improved at 4 and 12 weeks after treatment at all treated sites. IGAIS and SGAIS scores improved significantly 12 weeks after treatment. Immediately after treatment, the mean NRS score was 4.90 ± 2.01, but pain was significantly reduced at 7 days post-treatment (0.45 ± 0.83). Conclusion: HIFU can meet the demand for noninvasive skin lifting and tightening of the face and body. Newly developed various transducers could effectively deliver HIFU energy.

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