【ChiCTR2600125772】Fractional Radiofrequency Microneedling Combined With Low-Dose Isotretinoin Versus Standard-Dose Isotretinoin in Moderate-to-Severe Acne A Randomized Controlled Pilot Study

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基本信息

登记号

ChiCTR2600125772

试验状态

尚未开始

药物名称

分数射频微针治疗仪

药物类型

规范名称

首次公示信息日的期

2026-05-31

临床申请受理号

靶点

适应症

Acne

试验通俗题目

Fractional Radiofrequency Microneedling Combined With Low-Dose Isotretinoin Versus Standard-Dose Isotretinoin in Moderate-to-Severe Acne A Randomized Controlled Pilot Study

试验专业题目

Fractional Radiofrequency Microneedling Combined With Low-Dose Isotretinoin Versus Standard-Dose Isotretinoin in Moderate-to-Severe Acne A Randomized Controlled Pilot StudyFractional Radiofrequency Microneedling Combined With Low-Dose Isotretinoin Versus Standard-Dose Isotretinoin in Moderate-to-Severe Acne A Randomized Controlled Pilot Study

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

41002

联系人通讯地址

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临床试验信息

试验目的

To compare the efficacy of fractional RF microneedling combined with low-dose isotretinoin versus standard-dose isotretinoin monotherapy. To evaluate the safety of RF microneedling during concurrent isotretinoin therapy. To assess the impact of body mass index on treatment response. To examine the influence of lifestyle-related confounders on clinical outcomes

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

Randomization was done by a computer-generated permuted block randomization method (block size = 6).The research team used sealed envelopes, which they had prepared in sequential order, to conduct 1:1 patient randomization between the two treatment groups

盲法

None

试验项目经费来源

None

试验范围

目标入组人数

实际入组人数

第一例入组时间

2026-05-30

试验终止时间

2027-05-01

是否属于一致性

入选标准

The study included patients aged 18 to 33 years with moderate-to-severe acne vulgaris of the face, as defined by an Investigator Global Assessment (IGA) score of 3 or 4. All patients had failed or were unsuitable for conventional topical therapy alone. The study included patients aged 18 to 33 years with moderate-to-severe acne vulgaris of the face, as defined by an Investigator Global Assessment (IGA) score of 3 or 4. All patients had failed or were unsuitable for conventional topical therapy alone.；

排除标准

Patients were excluded from the study when they met any of these criteria: 1.They had used isotretinoin during the last 12 months; 2.They had documented hypersensitivity to retinoids; 3.They were currently suffering from active hepatic or renal or metabolic diseases; 4.Females were pregnant or they refused to follow birth control rules; 5.They had an existing skin infection at the sites where RF treatment was scheduled; 6.They had received RF microneedling treatment within the 6 months before their enrollment date.；

研究者信息

研究负责人姓名

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试验机构

University of Mosul

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

41002

联系人通讯地址