[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CLASSYS Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":112},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100629186","safety-and-efficacy-assessment-for-the-temporary-facial-skin-tightening-improvement-effect-using-the-monopolar-radiofrequency-device-100629186",false,"NCT07471399","Safety and Efficacy Assessment for the Temporary Facial Skin Tightening Improvement Effect Using the Monopolar Radiofrequency Device","Safety and Efficacy Assessment for the Temporary Facial(Both Cheeks) Skin Tightening Improvement Effect Using the Monopolar Radiofrequency Device: Prospective, Single Center, Compared, Randomized, Evaluator-Blinded, Superiority, Pivotal Clinical Trial","Inclusion Criteria:\n\n1. Participants who are at least 19 years old and under 65 years of age as of the date of written informed consent.\n2. Participants whose average Cutometer R7 value for both checks is ≤0.6.\n3. Participants who consent to photographic documentation for verification of skin type(Fitzpatrick skin scale) and evaluation of treatment efficacy.\n4. Participants who agree to refrain from receiving any procedures or therapies that could influence skin elasticity improvement throughout the study period.\n5. Participants who agree to employ medically acceptable contraception for up to 4 weeks following the end of the study\n6. Participants who have adequately understood the objectives and procedures of the clinical trial, voluntarily consent in writing to participate, and are able to complete the study as required.\n\nExclusion Criteria:\n\n1. Participants who have any medical or dermatologic condition at the investigational medical device application area that may influence the conduct or results of the study.\n2. Participants who have scars or open lesions at the investigational medical device application area that may influence the conduct or results of the study.\n3. Participants who have metal stents or implants at the investigational medical device application area.\n4. Participants with severe solar elastosis.\n5. Participants judged by the investigator to have excessive facial subcutaneous fat requiring surgical intervention.\n6. Participants with a history of anaphylaxis or severe complex allergic reactions.\n7. Participants with a history of or predisposition to hypertrophic scars or keloid formation.\n8. Participants with a history of adverse reactions to EMLA cream or local anesthetics (However, this criterion does not apply to participants who will not use anesthetics such as EMLA cream).\n9. Participants who have clinically significant disorders in the cardiovascular, gastrointestinal, respiratory, endocrine, or central nervous system that are not controlled by medication, or who have a history of or are currently receiving treatment for psychiatric disorders that may significantly affect this study.\n10. Participants with active herpes virus infection or autoimmune disease.\n11. Participants currently diagnosed with diabetes mellitus or epilepsy.\n12. Participants taking more than 100 mg of aspirin or aspirin-containing medication per day.\n13. Participants with bleeding disorders or blood coagulation-related diseases, such as thrombosis.\n14. Participants who have received Botox or filler injections at the investigational medical device application area\\* within 24 weeks prior to screening (\\*Investigational medical device application area: For participants undergoing facial (both cheeks) treatment - Mid-face (eyes to upper lip), Lower-face (lower lip to chin)) (However, if Botox or fillers were injected into the face but not within the application area, at least 12 weeks must have elapsed since the procedure).\n15. Participants who have undergone laser or light therapy at the investigational medical device application area within 24 weeks prior to screening.\n16. Participants who have undergone surgical or non-surgical treatments, such as deep chemical peels or liposuction, at the investigational medical device application area within 24 weeks prior to screening.\n17. Participants who have used topical agents (steroids, retinoids; limited to medicinal products, excluding cosmetics) at the investigational medical device application area within 4 weeks prior to screening, or who plan to continue use during the study.\n18. Participants who have smoked 100 or more cigarettes in their lifetime (However, those who have abstained from smoking for 24 weeks prior to screening are eligible for enrollment).\n19. Participants who are currently participating in another interventional clinical trial within 4 weeks prior to screening, or who plan to participate in another interventional clinical trial during this study.\n20. Pregnant or lactating women.\n21. Participants who are otherwise deemed unsuitable for participation in this study by the investigator.",true,"ALL","19 Years","65 Years",{"count":21,"type":22},96,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of this clinical trial is to demonstrate the temporary improvement in skin elasticity and to evaluate the safety of the investigational medical device that uses radiofrequency current when applied to the face (both cheeks), compared with the control device.",[28],"Lifting Efficacy",[30,31],"monopolar radiofrequency","facial skin tightening","RECRUITING","2026-06-22",{"date":35,"type":36},"2026-06-25","ACTUAL",{"date":38,"type":36},"2026-02-23",{"date":40,"type":22},"2027-03-16",{"name":42,"class":43},"CLASSYS Inc.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":16,"sex":17,"minAge":52,"maxAge":19,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100639796","safety-and-efficacy-evaluation-of-the-radiofrequency-therapeutic-device-for-the-treatment-of-atrophic-acne-scars-100639796","NCT07620769","Safety and Efficacy Evaluation of the Radiofrequency Therapeutic Device for the Treatment of Atrophic Acne Scars","A Prospective, Multicenter, Randomized, Parallel-Controlled, Blinded-Assessment, Non-Inferiority Clinical Trial to Evaluate the Safety and Effectiveness of a Radiofrequency Therapeutic Device for the Treatment of Atrophic Acne Scars","Inclusion Criteria:\n\n1. Participants aged 18 to 65 years at the time of written informed consent.\n2. Participants with Fitzpatrick skin types II to V.\n3. Participants with facial atrophic acne scars and an ECCA score ≥60 as assessed by the investigator.\n4. Participants who are able to understand the purpose and procedures of the study, voluntarily agree to participate, and provide written informed consent.\n\nExclusion Criteria:\n\n1. Participants with a history of facial surgery or cosmetic surgical procedures, or those planning to undergo cosmetic surgical treatment during the study period, which in the investigator's judgment may increase treatment risk or affect efficacy evaluation, including any of the following:\n2. Participants with active or progressive skin diseases in the treatment area, or skin diseases associated with the Koebner phenomenon, such as eczema, psoriasis vulgaris, lichen planus, or vitiligo, which in the investigator's judgment may affect treatment or evaluation.\n3. Participants with open wounds, malignant or unspecified skin tumors, precancerous lesions, or viral, bacterial, or fungal infections in the treatment area, including herpes simplex, verruca vulgaris, verruca plana, cutaneous tuberculosis, or mycobacterial infections.\n4. Participants with scars, tattoos, piercings, excessive hair, or other conditions in the treatment area that, in the investigator's judgment, may interfere with treatment or evaluation.\n5. Participants with impaired skin barrier function in the treatment area that, in the investigator's judgment, may increase treatment risk or affect efficacy evaluation.\n6. Participants with a history of excessive sun exposure within 1 month prior to screening that, in the investigator's judgment, may increase treatment risk or affect efficacy evaluation.\n7. Participants with known hypersensitivity or allergy to lidocaine, other local anesthetics, or any device or medication components used in this study.\n8. Participants with severe hepatic or renal dysfunction, serious disease of other major organs, or uncontrolled diabetes mellitus.\n9. Participants with abnormal coagulation function during screening, use of medications affecting platelet or coagulation function, or platelet count below the lower limit of normal.\n10. Participants with active autoimmune disease or a history of autoimmune disease, including systemic lupus erythematosus, rheumatoid arthritis, scleroderma, or dermatomyositis.\n11. Participants with a history of keloid formation.\n12. Participants diagnosed with psychiatric disorders or active anxiety or depression that may impair the ability to understand or comply with study requirements.\n13. Participants with metallic implants such as cardiac pacemakers or implantable cardioverter-defibrillators.\n14. Participants planning pregnancy during the study period or unwilling to use medically acceptable contraception methods.\n15. Participants who are pregnant or breastfeeding.\n16. Participants who participated in another clinical trial involving a drug and\u002For medical device within 1 month prior to enrollment.\n17. Participants considered unsuitable for participation by the investigator for any other reason.","18 Years",{"count":54,"type":22},252,[25],"The objective of this clinical trial is to evaluate the safety and effectiveness of a radiofrequency treatment device for the treatment of atrophic acne scars.\n\nThis is a prospective, multicenter, randomized, parallel-controlled, blinded-assessment, non-inferiority trial design.\n\nThe study aims to evaluate the effectiveness and safety of the radiofrequency therapeutic device manufactured by Sponsor for the treatment of atrophic acne scars, in comparison with the control device, the radiofrequency therapeutic device.\n\nParticipants will receive treatment sessions using either the investigational device or the control device, undergo follow-up evaluations after treatment to assess efficacy and safety outcomes.\n\nThe primary endpoint is Improvement in atrophic acne scars measured by the ECCA score compared with baseline, assessed 12 weeks after the final treatment.\n\nThe secondary efficacy endpoints include Global Aesthetic Improvement Scale (GAIS), Study Participant Satisfaction Assessment, Pain Score, Changes in skin characteristics compared with baseline Safety evaluations include Adverse events (AEs), Serious adverse events (SAEs)",[58,59,60,61],"Acne Scars","Acne Scars - Atrophic","Acne Scar","Acne Scarring",[63,64,65,66],"acne scar","atrophic acne scar","radiofreqency device","Radiofrequency Therapeutic Device","NOT_YET_RECRUITING","2026-05-29",{"date":70,"type":36},"2026-06-02",{"date":72,"type":22},"2026-06",{"date":74,"type":22},"2027-10",{"name":42,"class":43},4,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":16,"sex":17,"minAge":84,"maxAge":19,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100610580","safety-and-effectiveness-evaluation-of-the-high-intensity-focused-ultrasound-device-for-lifting-lax-submental-and-neck-tissue-100610580","NCT07229430","Safety and Effectiveness Evaluation of the High-intensity Focused Ultrasound Device for Lifting Lax Submental and Neck Tissue","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","Inclusion Criteria:\n\n1. Male or female subjects aged 30 to 65 years, inclusive, at the time of informed consent.\n2. Subjects presenting with mild to moderate submental and\u002For neck skin laxity, as determined by the investigator.\n3. Subjects in good general health with stable body weight (±5%) for at least 6 months prior to screening.\n4. Subjects willing to avoid other aesthetic or dermatologic procedures (surgical or non-surgical) to the treatment area during the study period.\n5. Subjects able to understand and sign informed consent and comply with all study visits and procedures.\n6. Female subjects of child-bearing potential who agree to use reliable contraception throughout study participation.\n\nExclusion Criteria:\n\n1. Prior facelift, neck lift, liposuction, or contouring surgery involving the lower face, submental, or neck areas.\n2. 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.\n3. Presence of any implanted electronic medical device, such as a pacemaker, defibrillator, or neurostimulator.\n4. Active skin infection, wound, cystic acne, inflammation, or severe scarring within or near the treatment area.\n5. History of keloid formation or abnormal wound healing.\n6. Known bleeding disorder, or use of anticoagulant or antiplatelet medications that cannot be safely discontinued for the procedure.\n7. Pregnant or breastfeeding women.\n8. Subjects with a known sensitivity or contraindication to ultrasound-based procedures.\n9. Any medical or psychiatric condition that, in the investigator's judgment, could interfere with study participation, safety, or data integrity.\n10. Participation in another investigational study within 30 days prior to screening.","30 Years",{"count":86,"type":22},273,[25],"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.\n\nApproximately 273 subjects will be enrolled at multiple investigational sites across the United States.\n\nParticipants 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.\n\nThe 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.",[90,91,92],"Skin Laxity (Submental and Neck)","Facial Skin Laxity","Submental Tissue Laxity",[94,95,96,97,98,99,100,101,102],"ULTRAFORMER MPT PLUS","High-Intensity Focused Ultrasound","HIFU","Submental Lifting","Skin Laxity","Non-surgical Lift","Aesthetic Device","Classys","Non-Inferiority Clinical Trial","2026-04-16",{"date":105,"type":36},"2026-04-20",{"date":107,"type":36},"2025-10-16",{"date":109,"type":22},"2026-11-26",{"name":42,"class":43},5,""]