Safety and Efficacy Evaluation of the Radiofrequency Therapeutic Device for the Treatment of Atrophic Acne Scars
2026年5月29日 更新者：CLASSYS Inc.
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
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)
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
252
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：SOYOUNG CHOI Clincal & Regulatory Affairs Team #1
- 电话号码：+821063465208
- 邮箱：sy.choi@classys.com
研究联系人备份
- 姓名：MOONHEE LEE
- 邮箱：mhlee@classys.com
学习地点
-
-
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Chengdu、中国
- The Chengdu Second People's Hospital
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Chongqing、中国
- The First Affiliated Hospital of Chongqing Medical University
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Hebei、中国
- The First Hospital of Hebei Medical University
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Shanghai、中国
- Huashan Hospital Affiliated to Fudan University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Investigational Device arm
Participants will receive treatment on acne scar areas using the investigational radiofrequency medical device according to the study protocol.
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The investigational radiofrequency medical device with the function deactivated will be applied to acne scar areas according to the study protocol.
The investigational radiofrequency medical device with the function activated will be applied to acne scar areas according to the study protocol.
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有源比较器：Control Device arm
Participants will receive treatment on acne scar areas using the control device according to the study protocol.
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The control device will be applied to acne scar areas according to the study protocol.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Échelle d'évaluation clinique des cicatrices d'acné(ECCA) Score From Baseline
大体时间：12 weeks ±14 days after the final treatment
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Evaluated by blinded evaluators, Atrophic scar only ECCA score: 0(minimum)~180(maximum), Improvement = Baseline in ECCA Score - Follow-up in ECCA Score
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12 weeks ±14 days after the final treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Échelle d'évaluation cliniquedes cicatrices d'acné(ECCA) Score From Baseline
大体时间：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
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Atrophic scar only ECCA: 0(minimum)~180(maximum), Improvement = Baseline in ECCA Score - Follow-up in ECCA Score
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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
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Global Aesthetic Improvement Scale(GAIS) Score
大体时间：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
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Evaluated using a 5-point scale ranging from 0 (minimum) to 5 (maximum), with lower scores indicating better improvement.
(1=Very much improved, 2=Much improved, 3=Improved, 4=No change, 5=Worse)
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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
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Participant Satisfaction Assessment
大体时间：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
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evaluated using a subject satisfaction questionnaire completed by the subjects. (1=Very Dissatisfied, 2=Dissatisfied, 3=Neutral, 4=Satisfied, 5=Very Satisfied) |
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
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Pain Score Assessment
大体时间：Immediately following each treatment session at Week 0, Week 4, and Week 8
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assessed by study participants using the Numeric Rating Scale (NRS).
Score range: 0-10 (0 = No pain, 1-3 = Mild pain, 4-6 = Moderate pain, 7-10 = Severe pain)
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Immediately following each treatment session at Week 0, Week 4, and Week 8
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Safety Assessment
大体时间：Screening Period, Prior to the first/second/third procedure, Following the first/second/third procedure, 4 weeks after the last procedure, 12 weeks after the last procedure, 24 weeks after the last procedure
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Incidence and rate (%) of AEs and SAEs were evaluated.
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Screening Period, Prior to the first/second/third procedure, Following the first/second/third procedure, 4 weeks after the last procedure, 12 weeks after the last procedure, 24 weeks after the last procedure
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Safety Assessment
大体时间：Periprocedurally at the first, second, and third procedures
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Incidence and rate (%) of device deficiencies were evaluated.
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Periprocedurally at the first, second, and third procedures
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Body Temperature (°C)
大体时间：Screening; prior to and following the first, second, and third procedures; and at 4, 12, and 24 weeks after the last procedure.
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Clinically significant changes in body temperature will be assessed and analyzed according to the methods specified in the Statistical Analysis Plan (SAP).
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Screening; prior to and following the first, second, and third procedures; and at 4, 12, and 24 weeks after the last procedure.
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Pulse Rate(beats/minute)
大体时间：Screening period; prior to and following the first, second, and third procedures; 4 weeks after the last procedure; 12 weeks after the last procedure; and 24 weeks after the last procedure.
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Clinically significant changes in pulse rate will be assessed and analyzed according to the methods specified in the Statistical Analysis Plan (SAP).
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Screening period; prior to and following the first, second, and third procedures; 4 weeks after the last procedure; 12 weeks after the last procedure; and 24 weeks after the last procedure.
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Blood Pressure (mmHg)
大体时间：Screening period; prior to and following the first, second, and third procedures; 4 weeks after the last procedure; 12 weeks after the last procedure; and 24 weeks after the last procedure.
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Clinically significant changes in blood pressure will be assessed and analyzed according to the methods specified in the Statistical Analysis Plan (SAP).
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Screening period; prior to and following the first, second, and third procedures; 4 weeks after the last procedure; 12 weeks after the last procedure; and 24 weeks after the last procedure.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Zhong Lu、Huashan Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2027年3月1日
研究完成 (估计的)
2027年10月1日
研究注册日期
首次提交
2026年5月11日
首先提交符合 QC 标准的
2026年5月29日
首次发布 (实际的)
2026年6月2日
研究记录更新
最后更新发布 (实际的)
2026年6月2日
上次提交的符合 QC 标准的更新
2026年5月29日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- CLA-QD-CCBH
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
IPD 计划说明
The sponsor has not yet determined whether individual participant data (IPD) will be shared.
Any future decision regarding IPD sharing will be made in accordance with applicable regulations, institutional policies, and participant confidentiality requirements.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.