中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2000035708
最近更新日期： Date of Last Refreshed on：	2020-08-16 12:02:20
注册时间： Date of Registration：	2020-08-16 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	吴昊医师：该研究尚未获得伦理委员会批准，请于批准后再开始纳入参试者，并与我们联系上传批件。双氢青蒿素治疗盘状红斑狼疮的应用研究
Public title：	Clinical trials of Dihydroartemisinin in the treatment of Discoid Lupus Erythematosus
注册题目简写：	CTDDLE
English Acronym：	CTDDLE
研究课题的正式科学名称：	双氢青蒿素治疗盘状红斑狼疮的应用研究
Scientific title：	Clinical trials of Dihydroartemisinin in the treatment of Discoid Lupus Erythematosus
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：	吴昊	研究负责人：	吴昊
Applicant：	Hao Wu	Study leader：	Hao Wu
申请注册联系人电话： Applicant telephone：	+86 13917708028	研究负责人电话： Study leader's telephone：	+86 13917708028
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：	seaseewh@163.com	研究负责人电子邮件： Study leader's E-mail：	seaseewh@163.com
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：	上海市乌鲁木齐中路12号	研究负责人通讯地址：	上海市乌鲁木齐中路12号
Applicant address：	12 Urumqi middle Road, Jing'an District, Shanghai, China	Study leader's address：	12 Urumqi Middle Road, Jing'an District, Shanghai, 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：	复旦大学附属华山医院北院
Applicant's institution：	North Hospital of Huashan Hospital, Fudan University
研究负责人所在单位：	复旦大学附属华山医院北院
Affiliation of the Leader：	North Hospital of Huashan Hospital, Fudan University

是否获伦理委员会批准：	否
Approved by ethic committee：	No
伦理委员会批件文号： Approved No. of ethic committee：		伦理委员会批件附件： Approved file of Ethical Committee：
批准本研究的伦理委员会名称：
Name of the ethic committee：
伦理委员会批准日期： Date of approved by ethic committee：	2013-08-26 00:00:00
伦理委员会联系人：
Contact Name of the ethic committee：
伦理委员会联系地址：
Contact Address of the ethic committee：
伦理委员会联系人电话： Contact phone of the ethic committee：		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：

复旦大学附属华山医院北院

Primary sponsor：

North Hospital of Huashan Hospital, Fudan University

研究实施负责（组长）单位地址：

上海市宝山区陆翔路108号

Primary sponsor's address：

108 Luxiang Road, Baoshan District, Shanghai, 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)：	上海	市(区县)：	上海
Country：	China	Province：	Shanghai	City：	Shanghai
单位(医院)：	复旦大学附属华山医院北院	具体地址：	上海市宝山区陆翔路108号
Institution hospital：	North Hospital of Huashan Hospital, Fudan University	Address：	108 Luxiang Road, Baoshan District, Shanghai

经费或物资来源：

上海申康医院发展中心

Source(s) of funding：

Shanghai Shenkang Hospital Development Center

研究疾病：

红斑狼疮

Target disease：

Lupus Erythematosus

研究疾病代码：

L93.001

Target disease code：

L93.001

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：

本研究拟以DLE相关皮肤损害治疗的有效率为主要研究指标，通过随机、双盲、安慰剂对照研究设计方法，评价羟氯喹联合DHA vs. 羟氯喹联合安慰剂在DLE患者治疗中的有效性和安全性，为应用DHA治疗DLE提供依据，并通过监测血尿免疫指标初步探索羟氯喹、DHA之间可能存在的协同治疗机制。

Objectives of Study：

Discoid lupus erythematosus (DLE) is a common type of autoimmune skin disease that can involve both mucous and skin. About 10% of patients can develop systemic lupus erythematosus (SLE) and 4.6% can change to squamous cells cancer. Nowadays the first-line treatment for DLE is hydroxychloroquine, and the treatment efficiency is about 50-70%. Patients who fail to response to hydroxychloroquine need to use oral glucocorticoid, which is easy to cause side effects. How to improve the effective rate of hydroxychloroquine and reduce the use rate of glucocorticoids is an urgent problem in the treatment of DLE. Dihydroartemisinin (DHA) is a classic antimalarial drug. In recent years, it has shown great potential in the laboratorial and clinical research of immune diseases such as SLE. We intend to compare the efficacy and safety of hydroxychloroquine combined with DHA and hydroxychloroquine combined with placebo in the treatment of patients with DLE through randomized, double-blind, placebo-controlled clinical trials, as well as to evaluate whether hydroxychloroquine combined with DHA can replace hydroxychloroquine as a single agent for DLE. Furthermore, we would try to find the synergistic mechanisms between hydroxychloroquine and DHA.

药物成份或治疗方案详述：

（1）羟氯喹：片剂，200mg/片，一天两次，一次一片，口服。（2）DHA：片剂，20mg/片，一天一次，一次四片，口服。（3）安慰剂：DHA模拟剂，片剂，主要成分淀粉等，外形与DHA相似，一天一次，一次四片，口服。

Description for medicine or protocol of treatment in detail：

(1) Hydroxychloroquine: tablet, 200mg/tablet, one tablet once a day, orally. (2) DHA: tablet, 20mg/tablet, once a day, four tablets at a time, orally. (3) Placebo: DHA simulant, tablet, main ingredient starch, etc., similar in appearance to DHA, four tablets once a day, orally.

纳入标准：

Inclusion criteria

1. Aged 12-60 years old;
2. Meet the diagnostic criteria for limited DLE, the number of skin lesions <3, and the skin lesions are mainly located in the exposed parts of the zygomatic, cheek, nose, and outer ear. All skin lesions must be examined by dermoscopy (DermLite DL3, California, 10 times magnification), and then pathological (HE staining). The results of dermoscopy and pathology must be confirmed by more than 2 dermatologists;
The main points of dermoscopy diagnosis include: white scales, follicle horn plugs, red spots, white halos around hair follicles, pigmentation, telangiectasia, and white unstructured areas.
The main points of histopathological diagnosis include: hair follicle horn plug, hyperkeratosis, basal cell liquefaction and degeneration, basement membrane thickening, pigment incontinence, upper dermal edema, vasodilation and mild red blood cell extravasation, diffuse dermal fibrosis, mucin deposition, hair follicles And lymphocyte infiltration around sweat glands.
3. The course of the disease is less than 1 year, and he has not taken any one or more of chloroquine, hydroxychloroquine, glucocorticoids, immunosuppressants or dihydroartemisinin in the past month;
4. During the trial period, the informed consent form must be signed in compliance with the medication requirements, and the process of obtaining the informed consent form meets the requirements of the quality management standards for drug clinical trials.

排除标准：

（1）患有全身性疾病包括恶性肿瘤或活动性结核、HIV感染等疾病者；
（2）患有慢性疾病,如:糖尿病、高血压、严重肝肾功能不全(心功能3-4级,ALT和/或AST超过正常上限1.5倍以上，Cr超过正常上限) ,病情不稳定或未控制者，眼底病变者；
（3）育龄女性(18-45岁)妊娠试验为阳性，或有妊娠意愿者；或哺乳期患者；
（4）对羟氯喹、青蒿素或双氢青蒿素过敏的患者；
（5）三个月内参加过其它药品临床试验者；
（6）研究者认为不适合入组的其它情况。

Exclusion criteria：

(1) Those suffering from systemic diseases including malignant tumors, active tuberculosis, HIV infection and other diseases;
(2) Suffer from chronic diseases, such as: diabetes, hypertension, severe liver and kidney dysfunction (heart function 3-4, ALT and/or AST more than 1.5 times the upper limit of normal, Cr exceeds the upper limit of normal), unstable condition or Uncontrolled ones, those with fundus disease;
(3) Women of childbearing age (18-45 years old) who have a positive pregnancy test, or are willing to become pregnant; or breastfeeding patients;
(4) Patients who are allergic to hydroxychloroquine, artemisinin or dihydroartemisinin;
(5) Those who have participated in other drug clinical trials within three months;
(6) Other situations that the investigator thinks are not suitable for inclusion in the group.

研究实施时间：

Study execute time：

从 From 2020-09-01 00:00:00至 To 2022-10-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2020-09-01 00:00:00 至 To 2021-09-30 00:00:00

干预措施：

Interventions：

组别：	实验组	样本量：	32
Group：	Experimental group	Sample size：	32
干预措施：	口服羟氯喹+口服DHA	干预措施代码：
Intervention：	Oral hydroxychloroquine + oral DHA	Intervention code：

组别：	对照组	样本量：	32
Group：	Control group	Sample size：	32
干预措施：	口服羟氯喹+口服安慰剂	干预措施代码：
Intervention：	Oral hydroxychloroquine + oral placebo	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	上海	市(区县)：	上海
Country：	China	Province：	Shanghai	City：	Shanghai
单位(医院)：	复旦大学附属华山医院北院	单位级别：	三级甲等
Institution hospital：	North Hospital of Huashan Hospital, Fudan University	Level of the institution：	Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：	皮肤镜	指标类型：	主要指标
Outcome：	Dermoscopy	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	血液	指标类型：	次要指标
Outcome：	Blood	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	尿液	指标类型：	次要指标
Outcome：	Urine	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：	血液
Sample Name：	Blood	Tissue：	Blood
人体标本去向	使用后销毁	说明	使用后销毁
Fate of sample：	Destruction after use	Note：	Destruction

标本中文名：	尿液	组织：	尿
Sample Name：	Urine	Tissue：	Urine
人体标本去向	使用后销毁	说明	使用后销毁
Fate of sample：	Destruction after use	Note：	Destruction

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	12	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）：

由生物统计学专业人员用统计软件模拟产生随机数字和相应的药品编码

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

Random numbers and corresponding drug codes are simulated by biostatisticians using statistical software

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：	随机双盲
Blinding：	Random double blind

是否共享原始数据： IPD sharing	是Yes
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）：	2022-12 电子病例报告表
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	2022-12 eCRF
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的第一页将送交参加本临床试验的数据管理人员统一建立数据库。每个试验中心应在完成至少5份CRF后，通过临床监查员及时送交数据管理员，以便建立相应的数据库，所有数据将采用计算机软件编制数据录人程序进行双份录人。在此期间，将有疑问表通过临床监查员转交研究者进行数据审核，研究者应尽快回答并返回。在盲态审核并认为所建立的数据库正确后，将由主要研究者、申办者、统计分析人员和药品监督管理人员对数据进行锁定。锁定后的数据文件不允许再作变动。数据库将交统计分析。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	The first page of the CRF will be sent to the data managers participating in this clinical trial to establish a unified database. After completing at least 5 CRFs, each test center should send it to the data manager in time through the clinical monitor to establish the corresponding database. All data will be recorded using computer software to compile a data recording program for double recording. During this period, the question form will be forwarded to the investigator through the clinical monitor for data review, and the investigator should answer and return as soon as possible. After the blind review and the conclusion that the established database is correct, the data will be locked by the main investigator, sponsor, statistical analyst, and drug supervisory and administrative personnel. The locked data file is not allowed to be changed. The database will be submitted for statistical analysis.
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：	2020-08-16 11:57:35