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

Официальное название

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

Обзор

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. This is a prospective, multicenter, randomized, parallel-controlled, blinded-assessment, non-inferiority trial design. The 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. Participants 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. The primary endpoint is Improvement in atrophic acne scars measured by the ECCA score compared with baseline, assessed 12 weeks after the final treatment. The 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)

Вмешательства

• Устройство Investigational Device with the function deactivated
  The investigational radiofrequency medical device with the function deactivated will be applied to acne scar areas according to the study protocol.
• Устройство Investigational Device with the function activated
  The investigational radiofrequency medical device with the function activated will be applied to acne scar areas according to the study protocol.
• Устройство Control Device
  The control device will be applied to acne scar areas according to the study protocol.

Первичные конечные точки

• Change in Échelle d'évaluation clinique des cicatrices d'acné(ECCA) Score From Baseline [Срок оценки: 12 weeks ±14 days after the final treatment]

Вторичные конечные точки (4)

• Change in Échelle d'évaluation cliniquedes cicatrices d'acné(ECCA) Score From Baseline [Срок оценки: before the second treatment, before the final treatment, 4 weeks after the final treatment, 12 weeks after the final treatment, 24 weeks after the final treatment]
• Global Aesthetic Improvement Scale(GAIS) Score [Срок оценки: before the second treatment, before the final treatment, 4 weeks after the final treatment, 12 weeks after the final treatment, and 24 weeks after the final treatment]
• Participant Satisfaction Assessment [Срок оценки: before the second treatment,(before the final treatment, 4 weeks after the final treatment, 12 weeks after the final treatment, 24 weeks after the final treatment]
• Pain Score Assessment [Срок оценки: Immediately following each treatment session at Week 0, Week 4, and Week 8]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 4 центра

• The Chengdu Second People's Hospital — Чэнду
• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• The First Hospital of Hebei Medical University — Hebei
• Huashan Hospital Affiliated to Fudan University — Шанхай

Идентификаторы

NCT: NCT07620769 · CLA-QD-CCBH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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