ChiCTR2500111274 版本V1.0 版本创建时间2025/10/29 08:32:36 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：

 ChiCTR2500111274 

最近更新日期：

Date of Last Refreshed on：

 2025-10-29 08:32:28 

注册时间：

Date of Registration：

 2025-10-29 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

舒敏治疗（喜辽妥导入后黄光治疗）联合口服托法替布与单纯口服托法替布相比在中国成人轻中度红斑毛细血管扩张型玫瑰痤疮患者中的有效性和安全性：一项前瞻性平行对照研究者盲队列研究

Public title：

The efficacy and safety of the combination of Anti-inflammation Treatment (Hirudoid introduction followed by yellow light therapy) and oral tofacitinib versus oral tofacitinib alone in the treatment of mild to moderate erythematotelangiectatic rosacea in Chinese adults : A prospective parallel controlled single-blind cohort study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

舒敏治疗（喜辽妥导入后黄光治疗）联合口服托法替布与单纯口服托法替布相比在中国成人轻中度红斑毛细血管扩张型玫瑰痤疮患者中的有效性和安全性：一项前瞻性平行对照研究者盲队列研究

Scientific title：

The efficacy and safety of the combination of Anti-inflammation Treatment (Hirudoid introduction followed by yellow light therapy) and oral tofacitinib versus oral tofacitinib alone in the treatment of mild to moderate erythematotelangiectatic rosacea in Chinese adults : A prospective parallel controlled single-blind cohort 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：

潘佳瑶 

研究负责人：

刘伦飞 

Applicant：

Pan Jiayao 

Study leader：

Liu Lunfei 

申请注册联系人电话：

Applicant telephone：

 +86 180 5770 0657

研究负责人电话：

Study leader's
telephone：

+86 138 5803 6789

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：

 22418663@zju.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 2197055@zju.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：

浙江省义乌市商城大道N1号

研究负责人通讯地址：

浙江省义乌市商城大道N1号

Applicant address：

N1 Shangcheng Avenue, Yiwu, China

Study leader's address：

N1 Shangcheng Avenue, Yiwu, 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：

浙江大学医学院附属第四医院

Applicant's institution：

The Fourth Affiliated Hospital, Zhejiang University School of Medicine

研究负责人所在单位：

浙江大学医学院附属第四医院

Affiliation of the Leader：

The Fourth Affiliated Hospital, Zhejiang University School of Medicine

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：

 K2025257

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：

浙江大学医学院附属第四医院人体研究伦理委员会

Name of the ethic committee：

The Human Research Ethics Committee of the Fourth Affiliated Hospital Zhejiang University School of Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-10-24 00:00:00

伦理委员会联系人：

叶嘉仪

Contact Name of the ethic committee：

Yi Jiayi

伦理委员会联系地址：

浙江省义乌市商城大道N1号

Contact Address of the ethic committee：

N1 Shangcheng Avenue, Yiwu, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 579 8993 5006

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：

浙江大学医学院附属第四医院

Primary sponsor：

The Fourth Affiliated Hospital Zhejiang University School of Medicine

研究实施负责（组长）单位地址：

浙江省义乌市商城大道N1号

Primary sponsor's address：

N1 Shangcheng Avenue, Yiwu, 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)：

浙江省

市(区县)：

义乌

Country：

China

Province：

Zhejiang

City：

Yiwu

单位(医院)：

浙江大学医学院附属第四医院

具体地址：

浙江省义乌市商城大道N1号

Institution
hospital：

The Fourth Affiliated Hospital Zhejiang University School of Medicine

Address：

N1 Shangcheng Avenue, Yiwu, China

经费或物资来源：

LC25016-临床科学家和创新人才B类

Source(s) of funding：

LC25016- Clinical Scientists and Innovative Talents Category B

研究疾病：

玫瑰痤疮  

Target disease：

Rosacea

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：

 上市后药物 

Study phase：

4

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

1. 主要目的：评价舒敏治疗（喜辽妥导入后黄光治疗）联合口服托法替布与单纯口服托法替布相比治疗中国成人轻中度红斑毛细血管扩张型玫瑰痤疮的有效性； 2. 次要目的：评价舒敏治疗（喜辽妥导入后黄光治疗）联合口服托法替布与单纯口服托法替布相比治疗中国成人轻中度红斑毛细血管扩张型玫瑰痤疮的安全性。  

Objectives of Study：

1. The primary objective: To evaluate the efficacy of the combination of Anti-inflammation Treatment (Hirudoid introduction followed by yellow light therapy) and oral tofacitinib compared with oral tofacitinib alone in the treatment of mild to moderate erythematotelangiectatic rosacea in Chinese adults. 2. The secondary objective: To evaluate the safety of the combination of Anti-inflammation Treatment (Hirudoid introduction followed by yellow light therapy) and oral tofacitinib compared with oral tofacitinib alone in the treatment of mild to moderate erythematotelangiectatic rosacea in Chinese adults.

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. 受试者为男性或女性，年龄18 周岁-70 周岁（含边界）；受试者自愿参加本研究并签署知情同意书； 2. 确诊为红斑血管扩张型，符合《中国玫瑰痤疮诊疗指南（2021）》诊断要点； 3. 筛选和基线时IGA 评分为2（轻度）或3（中度） 4. 受试者接受在研究期间不使用任何其他治疗玫瑰痤疮药物（处方药或非处方药）； 5. 受试者愿意尽量减少可能引发玫瑰痤疮的外部因素（如辛辣食物、酒精饮料、长时间阳光照射等）； 6. 受试者同意（包括伴侣）在签署知情同意书后至末次治疗后3 个月内无生育计划且自愿采取有效避孕措施。

Inclusion criteria

1. The subjects are male or female, aged 18 to 70 years (inclusive); they voluntarily participate in this study and sign the informed consent form. 2. They are diagnosed with erythematous telangiectatic rosacea, meeting the diagnostic criteria in the "Chinese Guidelines for the Diagnosis and Treatment of Rosacea (2021)". 3. At screening and baseline, the IGA score is 2 (mild) or 3 (moderate). 4. The subjects agree not to use any other rosacea treatment drugs (prescription or over-the-counter) during the study period. 5. The subjects are willing to minimize external factors that may trigger rosacea (such as spicy food, alcoholic beverages, prolonged sun exposure, etc.). 6. The subjects (including their partners) agree that they have no plans to conceive within 3 months after signing the informed consent form until the end of the last treatment and are willing to take effective contraceptive measures voluntarily.

排除标准：

1.诊断为丘疹-脓疱型、肥厚型、眼部玫瑰痤疮或其他特殊类型玫瑰痤疮 2.在筛选期或基线时处于活动状态的其他面部皮肤病，可能干扰红斑血管扩张型玫瑰痤疮的疗效 / 安全性评估，包括但不限于口周皮炎、面部毛周角化、脂溢性皮炎、寻常痤疮。若上述皮肤病在筛选期和基线均处于临床缓解，并经研究者判断不会影响本研究评估，则可纳入。 3.受试者患有潜在的已知疾病或医疗状况，或筛选前6 个月内接受过重大手术者，其中根据研究者的判断，会使受试者处于风险之中（例如癌症、白血病或血液系统恶液质）； 4.在筛选期或基线时，研究者评估具有显著临床意义的异常实验室检查结果; 5.过去2 周接受过发光二极管光源(LED)照光治疗面部者； 6.过去6 周接受激光、强脉冲光（IPL）、点阵微针射频治疗、二氧化碳剥脱性点阵激光治疗、电凝术、磨皮术、化学换肤、任何面部操作（如热玛吉等）治疗面部者； 7.正在接受或需要接受系统治疗（全身抗生素、抗真菌、抗病毒药物）的面部活动性感染者—包括细菌性脓疱、真菌性毛囊炎、疱疹样皮损及蠕形螨大量增殖； 8.在基线前未完成足够的洗脱期的局部/系统治疗，包括：糖皮质激素（皮质类固醇）、钙调磷酸酶抑制剂（如他克莫司、吡美莫司）、Janus 激酶抑制剂、表皮生长因子（如市售含重组人 EGF 的修复敷料）、痤疮治疗药物（如壬二酸、维A 酸类、过氧化苯甲酰、中药/中成药治疗，如丹参酮、百藓夏塔热片等）、免疫调节剂、外用收敛剂/磨砂产品、抗生素（如四环素类、大环内酯类、甲硝唑）、高浓度维生素A（10,000 单位/天）、抗瘙痒药（如抗组胺药）等； 9.同时使用引起痤疮样皮疹的药物（例如硫唑嘌呤、氟哌啶醇、卤素、锂、全身性皮质类固醇、苯妥英钠、苯巴比妥、睾酮、合成代谢类固醇、异烟肼）； 10.过去2 天内使用过收敛剂/磨砂产品（含水杨酸或酒精的洁面、去角质产品）或在研究期间计划使用者； 11.受试者过去2 年内存在酗酒史（饮酒超过14 个单位）或过去5 年内有药物滥用史； 12.人免疫缺陷病毒(HIV)感染者、丙肝病毒(HCV)感染活动期(anti-HCV 阳性)或乙肝病毒(HBV)感染活动期(HBV-DNA＞2000IU/mL 或104 拷贝/ml)或梅毒螺旋体抗体阳性并显示感染活动期； 13.在研究期间计划怀孕或哺乳的女性受试者； 14.对光敏感或使用光敏药物者； 15.对喜辽妥、托法替布或其成分过敏者。

Exclusion criteria：

1. Diagnosed as papulopustular, hypertrophic, ocular rosacea or other special types of rosacea 2. Other facial skin diseases that were active during the screening period or baseline may interfere with the efficacy/safety assessment of erythematous vasodilating rosacea, including but not limited to perioral dermatitis, facial keratosis, seborrheic dermatitis, and acne vulgaris. If the above-mentioned skin diseases were in clinical remission both during the screening period and at baseline, and the investigators determined that they would not affect the assessment of this study, they could be included. 3. Subjects who have underlying known diseases or medical conditions, or who have undergone major surgeries within the six months prior to screening, where, based on the researcher's judgment, the subjects are at risk (such as cancer, leukemia or cachexia in the blood system); 4. During the screening period or at baseline, researchers evaluate abnormal laboratory test results with significant clinical significance; 5. Those who have received LED light therapy for their faces in the past two weeks; 6. Those who have received laser, intense pulsed light (IPL), fractional microneedle radiofrequency treatment, CO2 exfoliating fractional laser treatment, electrocoagulation, dermabrasion, chemical peels, or any facial procedures (such as Thermage, etc.) for facial treatment in the past 6 weeks; 7. Facial active infections who are currently receiving or require systemic treatment (systemic antibiotics, antifungal, antiviral drugs) - including bacterial pustules, fungal folliculitis, herpeder-like skin lesions and massive proliferation of Demodex mites; 8. Local/systemic treatment that did not complete an adequate elution period before baseline, including: Glucocorticoids (corticosteroids), calcineurin inhibitors (such as tacrolimus, pimecrolimus), Janus kinase inhibitors, epidermal growth factors (such as commercially available repair dressings containing recombinant human EGF), acne treatment drugs (such as azelaic acid, retinoids, benzoyl peroxide, traditional Chinese medicine/Chinese patent medicine treatment), Such as tanshinone, metronidazole tablets, etc.), immunomodulators, topical astringents/exfoliating products, antibiotics (such as tetracyclines, macrolides, metronidazole), high-concentration vitamin A (10,000 units per day), anti-pruritus drugs (such as antihistamines), etc. 9. Use drugs that cause acne-like rashes simultaneously (such as azathioprine, haloperidol, halogens, lithium, systemic corticosteroids, phenytoin sodium, phenobarbital, testosterone, anabolic steroids, isoniazid); 10. Those who have used astringents/exfoliating products (cleansing or exfoliating products containing salicylic acid or alcohol) within the past 2 days or are planned to use them during the study period; 11. The subject has a history of alcohol abuse (drinking more than 14 units) within the past 2 years or a history of drug abuse within the past 5 years; 12. Individuals infected with human immunodeficiency virus (HIV), those in the active stage of hepatitis C virus (HCV) infection (positive for anti-HCV), or those in the active stage of hepatitis B virus (HBV) infection (HBV-DNA > 2000IU/mL or 104 copies /ml), or those with positive Treponema pallidum antibodies showing an active stage of infection; 13. Female subjects who plan to become pregnant or breastfeed during the study period; 14. Those who are sensitive to light or use photosensitive drugs; 15. People who are allergic to Hirudoid, tofacitinib or their ingredients.

研究实施时间：

Study execute time：

从 From 2025-11-01 00:00:00至 To 2027-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-11-01 00:00:00 至 To 2027-03-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 46

Group：

Experimental Group

Sample size：

干预措施：

喜辽妥导入后黄光治疗（波长590nm、时间每次20分钟，每周1次），联合托法替布 5mg 口服 每日两次

干预措施代码：

Intervention：

Yellow light therapy (wavelength 590nm, time 20 minutes, once a week) after introduction of Hirudoid, combined with tofacitinib 5mg orally twice daily

Intervention code：

组别：

对照组

样本量：

 46

Group：

Control group

Sample size：

干预措施：

托法替布5mg 口服 每日两次

干预措施代码：

Intervention：

Tofacitinib 5mg orally twice daily

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

 义乌 

Country：

China

Province：

Zhejiang

City：

Yiwu

单位(医院)：

 浙江大学医学院附属第四医院 

单位级别：

 三甲 

Institution
hospital：

The Fourth Affiliated Hospital Zhejiang University School of Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

第12 周是否达到 IGA 治疗成功

指标类型：

主要指标

Outcome：

Achievement of IGA treatment success at Week 12

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

IGA 治疗成功的受试者比例

指标类型：

次要指标

Outcome：

The proportion of subjects achieving successful IGA treatment

Type：

Secondary indicator

测量时间点：

从基线到第 4、8、12 周,

测量方法：

Measure time point of outcome：

From baseline to weeks 4, 8, and 12

Measure method：

指标中文名：

VISIA 面部影像学

指标类型：

次要指标

Outcome：

VISIA photo

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生活质量指数评分（DLQI）

指标类型：

次要指标

Outcome：

DLQI

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

角质形成细胞形态

指标类型：

次要指标

Outcome：

Morphology of keratinocytes

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：

无创胶带剥离皮肤表皮层

组织：

Sample Name：

The epidermis of the skin by tape strips

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 70 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）：

本研究采用非随机分组，在充分知情同意后，由患者自行选择接受试验干预或对照干预。

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

This study employed non-randomized grouping. After obtaining fully informed consent, patients were allowed to choose to receive either the experimental intervention or the control intervention on their own.

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：

Blinding：

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）：

文章正式发表后，以合理的要求通过邮件联系通讯作者获得。

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

After the article is officially published, contact the corresponding author by email with reasonable requirements to obtain.

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：

本研究数据采集采用CRF表，数据管理采用Excel表。

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

In this study, CRF table was used for data collection, and excel table was used for data management.

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：

  2025-10-29 08:32:28