ChiCTR2600117720 版本V1.0 版本创建时间2026/01/28 09:29:05 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：

 ChiCTR2600117720 

最近更新日期：

Date of Last Refreshed on：

 2026-01-28 09:28:59 

注册时间：

Date of Registration：

 2026-01-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

2%辛伐他汀对比2%辛伐他汀2%胆固醇乳膏治疗播散性光化性浅表型汗孔角化症的探索性临床试验

Public title：

Exploratory Clinical Trial of 2% Simvastatin Versus 2% Simvastatin/2% Cholesterol Cream in the Treatment of Disseminated Superficial Actinic Porokeratosis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

2%辛伐他汀对比2%辛伐他汀2%胆固醇乳膏治疗播散性光化性浅表型汗孔角化症的探索性临床试验

Scientific title：

Exploratory Clinical Trial of 2% Simvastatin Versus 2% Simvastatin/2% Cholesterol Cream in the Treatment of Disseminated Superficial Actinic Porokeratosis

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：

王馨漪 

研究负责人：

林志淼 

Applicant：

Wang Xinyi 

Study leader：

Lin Zhimiao 

申请注册联系人电话：

Applicant telephone：

 +86 159 8916 2610

研究负责人电话：

Study leader's
telephone：

+86 136 8143 8841

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：

 erwinholmes@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 zhimiaolin@bjmu.edu.cn

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：

广东省广州市越秀区麓景路2号

研究负责人通讯地址：

广东省广州市越秀区麓景路2号

Applicant address：

No. 2, Lujing Road, Yuexiu District, Guangzhou City, Guangdong Province

Study leader's address：

No. 2, Lujing Road, Yuexiu District, Guangzhou City, Guangdong Province

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

南方医科大学皮肤病医院

Applicant's institution：

Dermatology Hospital of Southern Medical University

研究负责人所在单位：

南方医科大学皮肤病医院

Affiliation of the Leader：

Dermatology Hospital of Southern Medical University

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：

 IIT-2025-113

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：

南方医科大学皮肤病医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Dermatology Hospital of Southern Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-01-07 00:00:00

伦理委员会联系人：

南方医科大学皮肤病医院医学伦理委员会

Contact Name of the ethic committee：

Medical Ethics Committee of the Dermatology Hospital of Southern Medical University

伦理委员会联系地址：

广州市麓景路7号老干大厦2楼

Contact Address of the ethic committee：

2nd Floor, Laogan Building, No. 7 Lujing Road, Guangzhou City

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 8302 7645

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

南方医科大学皮肤病医院

Primary sponsor：

Dermatology Hospital of Southern Medical University

研究实施负责（组长）单位地址：

广东省广州市越秀区麓景路2号

Primary sponsor's address：

No. 2, Lujing Road, Yuexiu District, Guangzhou City, Guangdong Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东

市(区县)：

广州

Country：

China

Province：

Guagdong

City：

Guangzhou

单位(医院)：

南方医科大学皮肤病医院

具体地址：

广东省广州市越秀区麓景路2号

Institution
hospital：

Dermatology Hospital of Southern Medical University

Address：

No. 2, Lujing Road, Yuexiu District, Guangzhou City, Guangdong Province

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

研究疾病：

汗孔角化症  

Target disease：

Disseminated Superficial Actinic Porokeratosis

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：

主要目的：比较单方乳膏（2%辛伐他汀乳膏）与复方乳膏（2%辛伐他汀2%胆固醇乳膏）在自身对照下对DSAP皮损的疗效差异，以DSAP-GASI评分下降百分比量化。 次要目的： 评估两种药物对DSAP皮损各维度的改善情况。 评估患者主观感受（瘙痒、疼痛）的变化。 评估两种治疗方案的安全性。  

Objectives of Study：

Primary Objective:? To compare the efficacy difference between the single-agent cream (2% Simvastatin Cream) and the compound cream (2% Simvastatin 2% Cholesterol Cream) on DSAP lesions under a self-controlled design, quantified by the percentage reduction in the DSAP-GASI score. Secondary Objectives: To assess the improvement brought by both medications across various dimensions of DSAP lesions. To evaluate changes in patients' subjective feelings (itching, pain). To evaluate the safety of both treatment regimens.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

受试者必须满足以下所有标准方可入组 ： 1) 年龄25-65岁，性别不限； 2) 临床诊断为DSAP，双侧肢体（如双前臂或双小腿）对称或相似皮损； 3) 基因检测确认甲羟戊酸合成通路基因突变； 4) 每侧肢体目标区域皮损数>=5个。 5) 对既往常规局部治疗（如外用维A酸类、5-氟尿嘧啶、水杨酸等）疗效不足（定义为连续规律使用≥8周后皮损改善＜50%）、无法耐受或拒绝接受局部破坏性治疗（如冷冻、激光、手术）。 6) 同意在基线访视（V0）前完成至少 4 周的洗脱期，期间停止在目标皮损区域使用任何外用活性药物（如维A酸、5-氟尿嘧啶等）及可能影响病情的系统性治疗。 7) 声明愿意遵守方案，自愿签署知情同意书。

Inclusion criteria

Subject must meet all of the following criteria to be enrolled: 1) Age between 25 and 65 years, regardless of gender; 2) Clinical diagnosis of Disseminated Superficial Actinic Porokeratosis (DSAP), with symmetrical or similar lesions on bilateral limbs (e.g., both forearms or both lower legs); 3) Genetic testing confirming a mutation in the mevalonate synthesis pathway gene; 4) Five or more target lesions per side in the target area of each limb. 5) Inadequate response (defined as less than 50% improvement after continuous and regular use for ≥8 weeks), intolerance, or refusal to previous conventional topical treatments (such as topical retinoids, 5-fluorouracil, salicylic acid, etc.) or local destructive therapies (e.g., cryotherapy, laser, surgery). 6) Agreement to complete at least a 4-week washout period before the baseline visit (V0), during which any topical active medications (e.g., retinoids, 5-fluorouracil, etc.) and any systemic treatments that may affect the condition are discontinued in the target lesion areas. 7) Declaration of willingness to comply with the protocol and voluntary signing of the informed consent form.

排除标准：

1) 对他汀类药物或乳膏的任何辅料过敏 。 2) 目标区域存在开放性创面或活动性感染 。 3) 在基线访视（V0）前4周内，在目标区域使用过任何外用活性药物（包括但不限于维A酸类、5-氟尿嘧啶、维生素D衍生物、免疫调节剂等）。 4) 在基线访视（V0）前8周内，接受过任何针对DSAP的系统性治疗（如口服维A酸、免疫抑制剂）或任何形式的局部破坏性治疗（如冷冻、激光、光动力疗法）。 5) 在基线访视（V0）前12周内，使用过任何系统性免疫调节剂或生物制剂用于其他疾病。 6) 妊娠或哺乳期女性 。 7) 合并严重全身疾病或研究者认为不适合参与 ，包括但不限于：严重的肝、肾功能不全（定义为ALT/AST > 2倍正常值上限，或肌酐清除率 < 60 mL/min）。 8) 研究者判断认为受试者存在任何可能干扰研究评估、增加受试者风险或影响其依从性的情况（如在试验期间高强度日晒等）。

Exclusion criteria：

1) Allergy to statins or any excipients of the cream.? 2) Presence of open wounds or active infection in the target area.? 3) Use of any topical active medications (including but not limited to retinoids, 5-fluorouracil, vitamin D derivatives, immunomodulators, etc.) in the target area within 4 weeks before the baseline visit (V0).? 4) Receipt of any systemic treatment for DSAP (such as oral retinoids, immunosuppressants) or any form of local destructive therapy (e.g., cryotherapy, laser, photodynamic therapy) within 8 weeks before the baseline visit (V0).? 5) Use of any systemic immunomodulators or biologics for other diseases within 12 weeks before the baseline visit (V0).? 6) Pregnant or lactating women.? 7) Coexisting severe systemic diseases or conditions deemed unsuitable for participation by the investigator, including but not limited to: severe hepatic or renal insufficiency (defined as ALT/AST > 2 times the upper limit of normal, or creatinine clearance < 60 mL/min).? 8) Any condition judged by the investigator as likely to interfere with study evaluation, increase subject risk, or affect compliance (e.g., intense sun exposure during the trial period).

研究实施时间：

Study execute time：

从 From 2026-01-28 00:00:00至 To 2026-06-28 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-01-28 00:00:00 至 To 2026-04-28 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 12

Group：

Experimental group

Sample size：

干预措施：

对于每一位受试者，其双侧对称或相似的肢体区域（如左前臂与右前臂，或左小腿与右小腿）被选为目标区域 。 涂抹2%辛伐他汀2%胆固醇乳膏

干预措施代码：

Intervention：

For each subject, the bilateral symmetrical or similar limb regions (such as the left forearm and the right forearm, or the left calf and the right calf) were selected as the target areas. Apply 2% simvastatin 2% cholesterol cream

Intervention code：

组别：

对照组

样本量：

 12

Group：

Control group

Sample size：

干预措施：

对于每一位受试者，其双侧对称或相似的肢体区域（如左前臂与右前臂，或左小腿与右小腿）被选为目标区域 。 涂抹 2%辛伐他汀乳膏

干预措施代码：

Intervention：

For each subject, the bilateral symmetrical or similar limb regions (such as the left forearm and the right forearm, or the left calf and the right calf) were selected as the target areas. Apply 2% simvastatin cream

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

 广州 

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

 南方医科大学皮肤病医院 

单位级别：

 三甲 

Institution
hospital：

Dermatology Hospital of Southern Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

第6周DSAP-GASI总分较基线下降的百分比

指标类型：

主要指标

Outcome：

The percentage decrease from baseline in the total DSAP-GASI score at Week 6

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

第6周时，DSAP-GASI总分自基线的绝对变化

指标类型：

次要指标

Outcome：

The absolute change from baseline in the total DSAP-GASI score at Week 6

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

第6周时，DLQI生活质量评分自基线的变化

指标类型：

次要指标

Outcome：

The change from baseline in the DLQI quality of life score at Week 6

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

患者报告结局（PRO）：病变外观、颜色、大小的变化，以及疼痛和瘙痒的变化

指标类型：

次要指标

Outcome：

Patient-Reported Outcomes (PRO): Changes in lesion appearance, color, size, as well as pain and itching

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

安全性指标：局部不良事件（如红斑、灼热感）；系统性安全性指标：肝肾功能，血脂

指标类型：

次要指标

Outcome：

Safety indicators: Local adverse events (e.g., erythema, burning sensation.Systemic safety indicators: Liver and kidney function, blood lipids.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

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 25 岁 years
最大 Max age 65 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）：

本研究采用自身对照设计 。对于每一位受试者，其双侧对称或相似的肢体区域（如左前臂与右前臂，或左小腿与右小腿）被选为目标区域 。 两种试验药物（2%辛伐他汀乳膏与2%辛伐他汀2%胆固醇乳膏）将被随机分配至两侧目标区域进行涂抹治疗 。例如，区域A随机分配使用单方乳膏，区域B则分配使用复方乳膏 。 随机分配比例为1:1。将由不参与临床评估和患者照护的独立统计人员使用计算机软件产生随机分配表，规定每位受试者的左侧和右侧（或区域A和区域B）分别接受哪种编码的药物。为保证分配隐藏，随机分配表将由独立统计人员或指定的非盲态研究者严格保密保管，直至数据库锁定后揭盲。临床研究者和受试者无法接触到随机表。

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

This study adopts a self-controlled design. For each subject, bilateral symmetrical or similar limb areas (e.g., left forearm and right forearm, or left lower leg and right lower leg) are selected as the target areas. The two investigational drugs (2% Simvastatin Cream and 2% Simvastatin 2% Cholesterol Cream) will be randomly assigned to the two sides of the target areas for topical application. For example, Area A is randomly assigned to receive the single-agent cream, while Area B is assigned to receive the compound cream. The randomization ratio is 1:1. An independent statistician not involved in clinical evaluation and patient care will generate the randomization list using computer software, specifying which coded drug will be applied to the left and right sides (or Area A and Area B) of each subject. To ensure allocation concealment, the randomization list will be kept strictly confidential by the independent statistician or a designated unblinded investigator until unblinding after database lock. Clinical investigators and subjects will not have access to the randomization list.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

本研究采用双盲（Double-blind）设计。受试者、临床研究者、负责给药和评估结局指标（特别是主要疗效评分）的研究人员均不知道受试者皮损的哪一侧接受的是试验药（单方），哪一侧接受的是对照药（复方）。 药物准备：试验药（2%辛伐他汀乳膏）和对照药（2%辛伐他汀2%胆固醇乳膏）由符合GMP条件的制备单位生产，确保两者在基质外观、颜色、气味、稠度以及包装容器上完全一致，使受试者和研究者无法通过感官区分。每批次药物在分发给受试者前，必须经过独立的第三方质量检测，出具质检报告（COA），重点核实辛伐他汀及胆固醇的浓度含量、微生物限度及重金属含量，确保药物质量合格且与方案设计一致，以此作为临床使用的放行标准。 药物编码与包装：药物将根据随机分配表进行设盲编码。每位受试者将获得一套特定编号的药物组合包，内含两管外观相同的药膏，分别标记为区别代码（例如“左侧/近端用药”和“右侧/远端用药”，或“A管”和“B管”）。仅非盲态研究者掌握编码对应的真实药物信息。 设盲的原因：本研究的主要终点（DSAP-GASI评分）和次要终点（患者报告结局如瘙痒、疼痛）均带有较强的主观性 。采用双盲设计旨在最大限度地减少研究者评估偏倚和受试者的安慰剂效应/心理预期对研究结果的影响，从而提高研究结果的科学性和可靠性。

Blinding：

This study employs a Double-blind design. The subjects, clinical investigators, and research personnel responsible for drug administration and outcome assessment (especially the primary efficacy scoring) are blinded to which side of the subject's lesions receives the investigational drug (single-agent) and which side receives the control drug (compound). Drug Preparation:? The investigational drug (2% Simvastatin Cream) and the control drug (2% Simvastatin 2% Cholesterol Cream) are manufactured by a preparation unit compliant with Good Manufacturing Practice (GMP) conditions, ensuring that the two are completely identical in terms of the excipient base in appearance, color, odor, consistency, and packaging containers, making it impossible for subjects and investigators to distinguish them by sensory means. Each batch of drugs must undergo independent third-party quality testing before being dispensed to subjects, with a Certificate of Analysis (COA) issued to verify key parameters such as the concentration content of Simvastatin and Cholesterol, microbial limits, and heavy metal content. This ensures the drugs meet quality standards and are consistent with the protocol design, serving as the release criterion for clinical use. Drug Coding and Packaging:? The drugs will be blinded and coded according to the randomization list. Each subject will receive a specific numbered drug kit containing two tubes of ointment identical in appearance, labeled with distinguishing codes (e.g., "Left/Proximal Application" and "Right/Distal Application", or "Tube A" and "Tube B"). Only the unblinded investigator holds the information regarding the actual drug identity corresponding to the codes. Rationale for Blinding:? Both the primary endpoint (DSAP-GASI score) and secondary endpoints (patient-reported outcomes such as itching and pain) of this study are subjective in nature. The implementation of a Double-blind design aims to minimize the impact of investigator assessment bias and subject placebo effects/psychological expectations on the study results, thereby enhancing the scientific validity and reliability of the findings.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

无

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：

CRF;EDC

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

CRF;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：

  2026-01-28 09:28:59