Safety and Efficacy Evaluation of the Radiofrequency Therapeutic Device for the Treatment of Atrophic Acne Scars

Inclusion criteria

• Participants aged 18 to 65 years at the time of written informed consent.
• Participants with Fitzpatrick skin types II to V.
• Participants with facial atrophic acne scars and an ECCA score ≥60 as assessed by the investigator.
• Participants who are able to understand the purpose and procedures of the study, voluntarily agree to participate, and provide written informed consent.

Exclusion criteria

• 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:
• 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.
• 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.
• 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.
• Participants with impaired skin barrier function in the treatment area that, in the investigator's judgment, may increase treatment risk or affect efficacy evaluation.
• 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.
• Participants with known hypersensitivity or allergy to lidocaine, other local anesthetics, or any device or medication components used in this study.
• Participants with severe hepatic or renal dysfunction, serious disease of other major organs, or uncontrolled diabetes mellitus.
• Participants with abnormal coagulation function during screening, use of medications affecting platelet or coagulation function, or platelet count below the lower limit of normal.
• Participants with active autoimmune disease or a history of autoimmune disease, including systemic lupus erythematosus, rheumatoid arthritis, scleroderma, or dermatomyositis.
• Participants with a history of keloid formation.
• Participants diagnosed with psychiatric disorders or active anxiety or depression that may impair the ability to understand or comply with study requirements.
• Participants with metallic implants such as cardiac pacemakers or implantable cardioverter-defibrillators.
• Participants planning pregnancy during the study period or unwilling to use medically acceptable contraception methods.
• Participants who are pregnant or breastfeeding.
• Participants who participated in another clinical trial involving a drug and/or medical device within 1 month prior to enrollment.
• Participants considered unsuitable for participation by the investigator for any other reason.