ChiCTR2600117782 版本V1.0 版本创建时间2026/01/28 17:16:03 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：

 ChiCTR2600117782 

最近更新日期：

Date of Last Refreshed on：

 2026-01-28 17:15:56 

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%胆固醇乳膏治疗线性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 Linear 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%胆固醇乳膏治疗线性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 Linear 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：

广东省广州市白云区沙太南路1023号

研究负责人通讯地址：

广东省广州市白云区沙太南路1023号

Applicant address：

No. 1023, Shatai South Road, Baiyun District, Guangzhou City, Guangdong Province, China

Study leader's address：

No. 1023, Shatai South Road, Baiyun District, Guangzhou City, Guangdong Province, China

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-2025-114

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：

 2026-01-20 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：

广东省广州市白云区沙太南路1023号

Contact Address of the ethic committee：

No. 1023, Shatai South Road, Baiyun District, Guangzhou City, Guangdong Province, China

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：

广东省广州市白云区沙太南路1023号

Primary sponsor's address：

No. 1023, Shatai South Road, Baiyun District, Guangzhou City, Guangdong Province, China

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：

Guangdong

City：

Guangzhou

单位(医院)：

南方医科大学皮肤病医院

具体地址：

广东省越秀区麓景路2号

Institution
hospital：

Dermatology Hospital of Southern Medical University

Address：

No. 1023, Shatai South Road, Baiyun District, Guangzhou City, Guangdong Province, China

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

研究疾病：

线性汗孔角化  

Target disease：

Linear 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：

 探索性研究/预试验 

Study phase：

0

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LP皮损的疗效差异。 次要目的： 评估两种药物对LP皮损各维度（角化嵴高度、范围、新发皮损、角化程度）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 LP lesions under a self-controlled design. Secondary Objectives: To assess the improvement brought by both medications across various dimensions of LP lesions (height of the cornoid lamella, extent, new lesion development, degree of hyperkeratosis). 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：

1. 年龄5-60岁，性别不限； 2. 临床及病理确诊为线性汗孔角化症(LP)； 3. 至少存在一条连续、长度>=12cm的线性皮损，可供划分三个区段（近端区段5cm、中间缓冲区2cm、远端区段5cm）； 4. 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）； 5. 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； 6. 声明愿意遵守方案，受试者或其监护人自愿签署知情同意书。

Inclusion criteria

1. Allergy to statins or any excipients in creams; 2. There are open wounds or active infections in the target area; 3. Within 4 weeks before the baseline visit (V0), any topical active drugs (including but not limited to retinoids, 5-fluorouracil, vitamin D derivatives, immunomodulators, etc.) were used in the target area; 4. Within 8 weeks prior to the baseline visit (V0), any systemic treatment for LP (such as oral tretinoin, immunosuppressants) or any form of local destructive treatment (such as cryotherapy, laser therapy, photodynamic therapy) was received; 5. Within 12 weeks prior to the baseline visit (V0), any systemic immunomodulators or biologics were used for other diseases; 6. Pregnant or lactating women; 7. Those with severe systemic diseases or those deemed unsuitable for participation by the researchers, including but not limited to: severe liver or kidney insufficiency (defined as ALT/AST > 2 times the upper limit of the normal value, or creatinine clearance rate < 60 mL/min); 8. The researcher determines that the subject has any circumstances that may interfere with the research evaluation, increase the subject's risk or affect their compliance (such as high-intensity sun exposure during the trial, etc.).

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LP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 in creams; 2. There are open wounds or active infections in the target area; 3. Within 4 weeks before the baseline visit (V0), any topical active drugs (including but not limited to retinoids, 5-fluorouracil, vitamin D derivatives, immunomodulators, etc.) were used in the target area; 4. Within 8 weeks prior to the baseline visit (V0), any systemic treatment for LP (such as oral tretinoin, immunosuppressants) or any form of local destructive treatment (such as cryotherapy, laser therapy, photodynamic therapy) was received; 5. Within 12 weeks prior to the baseline visit (V0), any systemic immunomodulators or biologics were used for other diseases; 6. Pregnant or lactating women; 7. Those with severe systemic diseases or those deemed unsuitable for participation by the researchers, including but not limited to: severe liver or kidney insufficiency (defined as ALT/AST > 2 times the upper limit of the normal value, or creatinine clearance rate < 60 mL/min); 8. The researcher determines that the subject has any circumstances that may interfere with the research evaluation, increase the subject's risk or affect their compliance (such as high-intensity sun exposure during the trial, etc.).

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：

自身对照组

样本量：

 12

Group：

Self-control group

Sample size：

干预措施：

1. 干预设计模式 本研究采用单中心、随机、双盲、单条皮损分段自身对照（Split-lesion）设计。筛选受试者身体（四肢或躯干）存在的一条连续、长度>=12cm的典型线性汗孔角化症（LP）皮损作为目标皮损。将该皮损沿长轴方向划分为三个区段： 近端试验区（Proximal Zone）：长度5cm，随机接受试验药物或对照药物。 中间缓冲区（Buffer Zone）：长度2cm，涂抹非活性润肤剂（凡士林），用于物理隔离两端药物。 远端试验区（Distal Zone）：长度5cm，接受与近端不同的另一种药物。 2. 干预分组 根据随机分配表，受试者目标皮损的近端和远端区段将被随机分配至以下两组之一： 试验组（A组）：涂抹 2%辛伐他汀乳膏（单方制剂）。 对照组（B组）：涂抹 2%辛伐他汀 2%胆固醇乳膏（复方制剂，阳性对照）。 缓冲区处理：始终涂抹凡士林（Vaseline）。 3. 给药操作流程（防沾染特殊控制策略） 鉴于线性皮损各区段邻近，为彻底消除因肢体活动、衣物摩擦或出汗导致的药物交叉沾染（Contamination），本研究采取严格的“封包-清洗”给药策略。受试者需在每日早、晚各进行一次给药（BID），具体步骤如下： 区域标记：研究者在基线访视时使用皮肤标记笔明确画出近端、缓冲区和远端的界线，受试者需在居家期间保持界线清晰（必要时补画）。为防止混淆，试验药物的外包装将采用颜色区分或大字号标识（如显著标注‘近端/上段’与‘远端/下段’），并由研究者在基线期对患者进行强化培训。 药物涂抹：受试者需严格按照药物标签指示（如“近端用”、“远端用”），分别用不同的手指或棉签，将约0.5指尖单位（FTU）的试验药和对照药薄层均匀涂抹于对应的5cm皮损区段。在中间2cm缓冲区涂抹凡士林。注意：严禁将两端药物涂抹越界。 封包促进吸收（Occlusion）：药物涂抹完毕后，立即使用独立保鲜膜覆盖目标皮损区域（分别覆盖近端和远端），保持封包状态30分钟。此步骤旨在利用封包促进药物在短时间内高效渗透入角质层。 清洗移除（Wash-off）：封包30分钟结束后，受试者需立即揭除保鲜膜，并使用温水将皮损区域的所有残留药物及凡士林彻底清洗干净，随后轻轻擦干皮肤。 衣物穿着：确认皮肤无药物残留后，方可穿着覆盖该部位的衣物（如长袖、长裤），以此从物理上杜绝非给药时间的药物移位风险。 4. 依从性与调整 受试者需在日记卡中记录每次“涂药-封包-清洗”的完成情况。 若受试者在封包期间出现无法耐受的刺激症状（如剧烈灼痛），应提前移除封包并清洗，并记录为不良事件。 研究者将在随访期间通过回收空药管称重及检查日记卡来评估依从性。

干预措施代码：

Intervention：

1. Intervention Design This study employs a single-center, randomized, double-blind, split-lesion, within-patient controlled design. A single continuous linear lesion of linear porokeratosis (LP) with a length of >=12 cm, located on the limbs or trunk of the subject, is selected as the target lesion. The lesion is divided along its longitudinal axis into three segments: Proximal Test Zone: 5 cm in length, randomly assigned to receive either the investigational drug or control drug. Buffer Zone: 2 cm in length, treated with inactive emollient (petrolatum) to physically isolate the two drug zones. Distal Test Zone: 5 cm in length, assigned to receive the alternative drug (opposite to the proximal zone). 2. Intervention Groups Based on the randomization schedule, the proximal and distal segments of the target lesion will be randomly assigned to one of the following two groups: Trial Group (Group A): Application of 2% simvastatin cream (single-agent formulation). Control Group (Group B): Application of 2% simvastatin 2% cholesterol cream (combination formulation, positive control). Buffer Zone Treatment: Always treated with petrolatum (Vaseline). 3. Drug Administration Protocol (Contamination Prevention Strategy) Due to the proximity of segments along the linear lesion, to completely eliminate drug cross-contamination caused by limb movement, clothing friction, or sweating, this study implements a strict "occlusion-wash-off" administration protocol. Subjects must apply medication twice daily (BID) according to the following steps: Segment Marking: At baseline visit, the investigator clearly marks the boundaries of the proximal, buffer, and distal zones using a skin marker. Subjects must maintain clear boundaries at home (re-marking as needed). To prevent confusion, investigational drug packaging will be color-coded or labeled with large-font identifiers (e.g., clearly marked "Proximal/Upper" and "Distal/Lower"), and subjects will receive intensive training at baseline. Drug Application: Subjects must strictly follow drug labels (e.g., "For Proximal Use," "For Distal Use") and apply approximately 0.5 fingertip units (FTU) of the investigational or control drug as a thin layer onto the respective 5-cm lesion segment using separate fingers or cotton swabs. Apply petrolatum to the central 2-cm buffer zone. Note: Strictly prohibit cross-application beyond designated zones. Occlusion for Enhanced Absorption: Immediately after drug application, independent plastic wrap is applied to cover each target segment (proximal and distal separately) and maintained for 30 minutes. This step enhances rapid drug penetration into the stratum corneum. Wash-Off: After 30 minutes of occlusion, subjects must immediately remove the plastic wrap and thoroughly rinse the lesion area with warm water to remove all residual drug and petrolatum, then gently pat dry. Clothing: Subjects may only wear clothing covering the treated area (e.g., long sleeves, pants) after confirming no drug residue remains on the skin, thereby physically preventing drug migration during non-application periods. 4. Adherence and Adjustments Subjects must record completion of each "application-occlusion-wash-off" step in a daily diary. If subjects experience intolerable irritation (e.g., severe burning) during occlusion, they should remove the wrap and wash the area immediately and document it as an adverse event. Adherence will be assessed during follow-up visits through weighing returned empty tubes and reviewing diary records.

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LP特异性评分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 LP-specific 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LP特异性评分的绝对变化

指标类型：

次要指标

Outcome：

The absolute change in LP-specific scores in the 6th week

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、大小变化，以及疼痛和瘙痒变化。

指标类型：

次要指标

Outcome：

Patient-reported outcome (PRO) : Changes in the appearance, color, and size of the lesion, as well as changes in pain and pruritus.

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 (such as erythema, burning sensation); Systemic safety indicators: liver and kidney functions, 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 5 岁 years
最大 Max age 60 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，其符合要求的一条连续线性皮损沿长轴被划分为三个区段：近端区段(5cm)、中间缓冲区(2cm)、远端区段(5cm) 。 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）将被随机分配至近端区段和远端区段进行涂抹治疗 。随机分配比例为1:1。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。该表规定了每位受试者的近端和远端区段分别接受哪种编码的药物（例如：药物A或药物B）。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, a single eligible continuous linear lesion is divided along its longitudinal axis into three segments: a proximal segment (5 cm), a central buffer zone (2 cm), and a distal segment (5 cm). The two investigational drugs (2% Simvastatin Cream and 2% Simvastatin 2% Cholesterol Cream) will be randomly assigned to the proximal and distal segments for topical application. 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. This list specifies which coded drug (e.g., Drug A or Drug B) will be applied to the proximal and distal segments of each subject, respectively. 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：

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（LP特异性评分）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：

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. This prevents subjects and investigators from distinguishing them by sensory means. Each batch of drugs must undergo independent third-party quality testing before being dispensed to subjects. A Certificate of Analysis (COA) is issued, focusing on verifying 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 (LP-specific 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）：

不共享

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

No sharing

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：

1. 收集方法 病例报告表（CRF）：所有研究数据，包括不良事件，必须始终记录在CRF中 。研究者将在患者的医疗记录和CRF中记录入组决定和日期 。 研究者评估：由研究者在特定访视点（V0, V2, V4, V6, V8）对DSAP-GASI评分进行评估记录 。 影像记录：在基线及后续每次访视时，对目标区域进行拍照记录，以辅助疗效评估 。 患者报告结局（PRO）：收集患者关于病变外观、颜色、大小及瘙痒、疼痛变化的主观报告 。 依从性检查：通过药品称量和药物回收来检查受试者的用药依从性 。 2. 数据管理 数据录入与核查：将制定数据录入、编码、保密及储存的方案 。为提高数据质量，可能采取双重录入或资料值范围检查等措施 。 数据存储与保密：受试者在研究期間的全部数据都会录入计算机保密储存并分析 。为保护隐私，受试者的姓名或任何可识别信息不会被分享，记录将使用唯一标识符 。仅获得授权的指定人员方可查看研究相关的记录 。 数据质量保证：需描述用于评估和收集结局指标及其他数据的工具（如问卷）的可靠性和准确性，以及提高数据质量的相关措施（如数据评估者的培训） 。 查阅权限：必要时，有关机构（如研究主管部门、伦理审查委员会、监管机构）可能对记录进行审核，以证实数据的真实、准确、完整性 。

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

1. Collection Methods Case Report Form (CRF):? All study data, including adverse events, must be consistently recorded in the CRF . Investigators will document the enrollment decision and date in the patient's medical records and the CRF . Investigator Assessment:? Investigators will assess and record the DSAP-GASI score at specific visit points (V0, V2, V4, V6, V8) . Imaging Documentation:? Photographic documentation of the target areas will be performed at baseline and each subsequent visit to aid efficacy evaluation . Patient-Reported Outcomes (PRO):? Subjective reports from patients regarding changes in lesion appearance, color, size, itching, and pain will be collected . Compliance Check:? Subject medication compliance will be checked through drug weighing and drug returns . 2. Data Management Data Entry and Verification:? A plan for data entry, coding, confidentiality, and storage will be established . To enhance data quality, measures such as double data entry or range checks for data values may be implemented . Data Storage and Confidentiality:? All subject data during the study will be entered into a computer for confidential storage and analysis . To protect privacy, subjects' names or any identifiable information will not be shared; records will use a unique identifier . Only authorized designated personnel will have access to study-related records . Data Quality Assurance:? The reliability and accuracy of tools (e.g., questionnaires) used to assess and collect outcome measures and other data, as well as related measures to improve data quality (e.g., training of data assessors), shall be described . Access Rights:? When necessary, relevant institutions (e.g., the study supervisory authority, ethics review committee, regulatory agencies) may audit the records to verify the authenticity, accuracy, and completeness of the data

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 17:15:56