ChiCTR2600125772 版本V1.0 版本创建时间2026/05/31 21:54:39 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600125772 

最近更新日期：

Date of Last Refreshed on：

 2026-05-31 21:54:35 

注册时间：

Date of Registration：

 2026-05-31 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

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

Public title：

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

注册题目简写：

English Acronym：

研究课题的正式科学名称：

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

Scientific title：

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

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Qasim S. Al Chalabi 

研究负责人：

Ahmed M. Al Obaidi 

Applicant：

Qasim S. Al Chalabi 

Study leader：

Ahmed M. Al Obaidi 

申请注册联系人电话：

Applicant telephone：

 +964 770 161 8688

研究负责人电话：

Study leader's
telephone：

+964 770 161 8688

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 qasimalchalabi@uomosul.edu.iq

研究负责人电子邮件：

Study leader's E-mail：

 qasimalchalabi@uomosul.edu.iq

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

94QJ+XWG, 80, Mosul, Nineveh Governorate

研究负责人通讯地址：

94QJ+XWG, 80, Mosul, Nineveh Governorate

Applicant address：

94QJ+XWG, 80, Mosul, Nineveh Governorate

Study leader's address：

94QJ+XWG, 80, Mosul, Nineveh Governorate

申请注册联系人邮政编码：

Applicant postcode：

 41002

研究负责人邮政编码：

Study leader's postcode：

 41002

申请人所在单位：

University of Mosul

Applicant's institution：

University of Mosul

研究负责人所在单位：

University of Mosul

Affiliation of the Leader：

University of Mosul

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 UOM\COM\MERC\25-26\MAY8

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Medical Ethics Research Committee (MERC) of University of Mosul

Name of the ethic committee：

Medical Ethics Research Committee (MERC) of University of Mosul

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-05-19 00:00:00

伦理委员会联系人：

Professor Dr. Azzam Abdul-kadir Ahmed

Contact Name of the ethic committee：

Professor Dr. Azzam Abdul-kadir Ahmed

伦理委员会联系地址：

94QJ+XWG, 80, Mosul, Nineveh Governorate

Contact Address of the ethic committee：

94QJ+XWG, 80, Mosul, Nineveh Governorate

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +964 770 457 9617

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 medicine@uomosul.edu.iq

研究实施负责（组长）单位：

University of Mosul

Primary sponsor：

University of Mosul

研究实施负责（组长）单位地址：

94QJ+XWG, 80, Mosul, Nineveh Governorate

Primary sponsor's address：

94QJ+XWG, 80, Mosul, Nineveh Governorate

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Iraq

省(直辖市)：

Nineveh

市(区县)：

Mosul

Country：

Iraq

Province：

Nineveh

City：

Mosul

单位(医院)：

University of Mosul

具体地址：

Al Majmoah Street, Mosul, Iraq

Institution
hospital：

University of Mosul

Address：

Al Majmoah Street, Mosul, Iraq

经费或物资来源：

None

Source(s) of funding：

None

研究疾病：

Acne  

Target disease：

Acne

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

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  

Objectives of Study：

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

药物成份或治疗方案详述：

The patients in Group A received a fixed daily dose of 20 mg isotretinoin, which resulted in an actual dose range of 0.18 to 0.36 mg/kg/day based on their weight between 55 and 110 kg. The patients also received fractional RF microneedling sessions using the Virtue RF device (ShenB Co., Ltd, Seoul, South Korea). A total of three RF microneedling sessions were conducted every four weeks. Isotretinoin treatment was initiated during the first RF session and continued for the entire treatment duration. 

Description for medicine or protocol of treatment in detail：

The patients in Group A received a fixed daily dose of 20 mg isotretinoin, which resulted in an actual dose range of 0.18 to 0.36 mg/kg/day based on their weight between 55 and 110 kg. The patients also received fractional RF microneedling sessions using the Virtue RF device (ShenB Co., Ltd, Seoul, South Korea). A total of three RF microneedling sessions were conducted every four weeks. Isotretinoin treatment was initiated during the first RF session and continued for the entire treatment duration. Patients in Group B received standard weight-based isotretinoin at 0.5 mg/kg/day (corresponding to an actual dose range of approximately 30 to 65 mg/day based on the patient's weight range of 60 to 130 kg). The group did not undergo any procedural treatment. The Virtue RF device operates as a fractional radiofrequency microneedling system, which uses both insulated and non-insulated needle tips to deliver precise dermal heating while protecting the epidermis from damage. The operators recorded the session details by measuring needle depth in millimetres, documenting energy settings in watts per millijoule and recording pulse duration, total passes and tip type, which included both insulated and non-insulated options.  

纳入标准：

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.

Inclusion criteria

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.

Exclusion criteria：

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.

研究实施时间：

Study execute time：

从 From 2026-05-30 00:00:00至 To 2027-05-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-05-31 00:00:00 至 To 2027-05-01 00:00:00

干预措施：

Interventions：

组别：

Group A

样本量：

 20

Group：

Group A

Sample size：

干预措施：

Received a fixed daily dose of 20 mg isotretinoin, which resulted in an actual dose range of 0.18 to 0.36 mg/kg/day based on their weight between 55 and 110 kg. The patients also received fractional RF microneedling sessions using the Virtue RF device

干预措施代码：

Intervention：

Received a fixed daily dose of 20 mg isotretinoin, which resulted in an actual dose range of 0.18 to 0.36 mg/kg/day based on their weight between 55 and 110 kg. The patients also received fractional RF microneedling sessions using the Virtue RF device

Intervention code：

组别：

Group B

样本量：

 20

Group：

Group B

Sample size：

干预措施：

Received standard weight-based isotretinoin at 0.5 mg/kg/day

干预措施代码：

Intervention：

Received standard weight-based isotretinoin at 0.5 mg/kg/day

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Iraq

省(直辖市)：

 Nineveh 

市(区县)：

 Mosul 

Country：

Iraq

Province：

Nineveh

City：

Mosul

单位(医院)：

 Al Salam Teaching Hospital 

单位级别：

 N/A 

Institution
hospital：

Al Salam Teaching Hospital

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

Change in Investigator's Global Assessment (IGA) score from baseline to week 16, on a validated 5-point scale (0 = clear, 4 = severe)

指标类型：

主要指标

Outcome：

Change in Investigator's Global Assessment (IGA) score from baseline to week 16, on a validated 5-point scale (0 = clear, 4 = severe)

Type：

Primary indicator

测量时间点：

8 weeks

测量方法：

Measure time point of outcome：

8 weeks

Measure method：

指标中文名：

counting inflammatory lesions at week 8 and at the end of the trial (EOT);

指标类型：

次要指标

Outcome：

counting inflammatory lesions at week 8 and at the end of the trial (EOT);

Type：

Secondary indicator

测量时间点：

8 weeks

测量方法：

Measure time point of outcome：

8 weeks

Measure method：

指标中文名：

Assessing treatment failure rate at 6 months, which occurred when IGA score remained above 2

指标类型：

次要指标

Outcome：

Assessing treatment failure rate at 6 months, which occurred when IGA score remained above 2

Type：

Secondary indicator

测量时间点：

6 months

测量方法：

Measure time point of outcome：

6 months

Measure method：

指标中文名：

Evaluating safety and tolerability through the documented adverse events.

指标类型：

次要指标

Outcome：

Evaluating safety and tolerability through the documented adverse events.

Type：

Secondary indicator

测量时间点：

6 months

测量方法：

Measure time point of outcome：

6 months

Measure method：

指标中文名：

Change in Patient Satisfaction Score (PSS) on a 10-point Likert scale at week 8

指标类型：

次要指标

Outcome：

Change in Patient Satisfaction Score (PSS) on a 10-point Likert scale at week 8

Type：

Secondary indicator

测量时间点：

8 weeks

测量方法：

Measure time point of outcome：

8 weeks

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

None

组织：

Sample Name：

None

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 33 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

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

Randomization Procedure (please state who generates the random number sequence and by what method)：

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

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

None

Blinding：

None

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

None

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

EDC

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-05-31 21:54:35