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中国基于医院门诊手部湿疹临床分类、流行病学调查及皮肤屏障 障碍机制研究
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注册号:

Registration number:

ChiCTR1800018943 

最近更新日期:

Date of Last Refreshed on:

2018-10-17 

注册时间:

Date of Registration:

2018-10-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中国基于医院门诊手部湿疹临床分类、流行病学调查及皮肤屏障 障碍机制研究 

Public title:

Clinical Classification, Epidemiological Investigation and Mechanism of Skin Barrier Dysfunction of Hand Eczema in Outpatient Clinics of Hospitals in China  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中国基于医院门诊手部湿疹临床分类、流行病学调查及皮肤屏障 障碍机制研究 

Scientific title:

Clinical Classification, Epidemiological Investigation and Mechanism of Skin Barrier Dysfunction of Hand Eczema in Outpatient Clinics of Hospitals in China  

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:

叶理 

研究负责人:

杨斌 

Applicant:

YE LI 

Study leader:

YANG BIN 

申请注册联系人电话:

Applicant telephone:

+86 15668692386 

研究负责人电话:

Study leader's telephone:

+86 13922207231 

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:

dlpfbyy@163.com 

研究负责人电子邮件:

Study leader's E-mail:

yangbin101@hotmail.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:

广东省越秀区麓景路2号 

研究负责人通讯地址:

广东省越秀区麓景路2号 

Applicant address:

2 Lujing Road, Yuexiu District, Guangzhou, Guangdong, China 

Study leader's address:

2 Lujing Road, Yuexiu District, Guangzhou, Guangdong, 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  

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:

GDDHLS-20180901 

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 Southern Medical University Dermatology Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-09-01 

伦理委员会联系人:

吕萍 

Contact Name of the ethic committee:

Lv Ping 

伦理委员会联系地址:

广东省越秀区麓景路2号 

Contact Address of the ethic committee:

2 Lujing Road, Yuexiu District, Guangzhou, Guangdong, China  

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:

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:

广东省越秀区麓景路2号 

Primary sponsor's address:

2 Lujing Road, Yuexiu District, Guangzhou, Guangdong, 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):

Country:

China

Province:

Guangdong

City:

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:

2 Lujing Road, Yuexiu District, Guangzhou, Guangdong, China

经费或物资来源:

医院自筹及所属大学赞助 

Source(s) of funding:

Hospital self financing and sponsorship of its universities  

研究疾病:

手部湿疹 

Target disease:

hand eczema 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

手部湿疹是由于接触外界各种刺激物质引起的手部皮肤炎症反应,一般较难确定病因。多数起病缓慢,发病率高,临床表现为手部干燥,出现暗红斑,局部浸润肥厚1-3。手部湿疹是临床上常见且易复发的顽固性皮肤病,在影响手部湿疹预后的因素中,除了外界环境、特应性素质等因素外,皮肤屏障功能的异常也是很重要的因素4-8。这些均提示了手部湿疹病因和治疗上探索的必要性。我们近期的研究证明了皮肤屏障功能的异常与免疫性皮肤病有直接的关系,屏障功能的修复对免疫性皮肤病的预防及治疗都有重要意义9-10。因此,从理论上讲,改善皮肤屏障功能的异常可以减轻和预防手部湿疹。在此研究,我们拟观察改善表皮功能是否可以预防或减轻手部湿疹的发生和发展 。  

Objectives of Study:

Hand eczema is due to contact with various stimuli outside the skin caused by hand inflammation, it is generally difficult to determine the cause. Most of them are slow onset and high incidence. The clinical manifestations are dry hands, dark red spots, and local infiltration hypertrophy of 1-3. Hand eczema is a common and recurrence of refractory dermatosis in clinical. Among the factors affecting the prognosis of hand eczema, the abnormal function of skin barrier is also a very important factor in addition to the external environment, the atopic quality and other factors. 4-8 All these suggest the necessity of exploring the etiology and treatment of hand eczema. Recent studies have shown that abnormal skin barrier function has a direct relationship with immune dermatosis, and the repair of barrier function is of great significance for the prevention and treatment of immune dermatosis, 9-10. Therefore, in theory, the improvement of skin barrier function can reduce and prevent hand eczema. In this study, we intend to observe whether improving skin function can prevent or reduce the occurrence and development of hand eczema.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

手部湿疹患者 1.年龄>18岁的从事易发手部湿疹的职业 2.有手部湿疹患者 3.能理解本次试验的全部内容,并按要求完成。 4.在过去一个月内没用过抗炎的药物 5.签署志愿者知情同意书 正常对照组纳入标准 1.上述手部湿疹患者的同事,年龄>18岁; 2.尚未发生手部湿疹及其他免疫性皮肤病 3. 能理解本次试验的全部内容,并按要求完成。 4. 在过去一个月内没用过抗炎的药物 5. 签署志愿者知情同意书  

Inclusion criteria

Patients with hand eczema: 1. Aged at least 18 years old with occupation which easy to suffer hand eczema; 2. patients: with hand eczema; 3. Normal people control: without hand eczema; 4. understand all the contents of the test and complete it as required; 5. no anti - inflammatory drugs have been used in the last month; 6. sign the volunteer informed consent.  

排除标准:

1.对屏障修复剂有不良反应 2.有系统或皮肤感染性疾病 3.长期使用抗炎制剂或药物  

Exclusion criteria:

1. adverse reactions to barrier restorant; 2. systemic or skin infectious diseases; 3. long term use of anti inflammatory agents or drugs.  

研究实施时间:

Study execute time:

From2018-10-25To 2019-10-25 

征募观察对象时间:

Recruiting time:

From2018-10-25To 2019-10-25 

干预措施:

Interventions:

组别:

Case series

样本量:

2500

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

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):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

南方医科大学皮肤病医院 

单位级别:

市级 

Institution
hospital:

Dermatology Hospital of Southern Medical University  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

中国医科大学附属第一医院 

单位级别:

市级 

Institution
hospital:

The First Affiliated Hospital of China Medical University  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

大连市皮肤病医院 

单位级别:

市级 

Institution
hospital:

Dalian Dermatosis Hospital  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

黑龙江省人民医院 

单位级别:

市级 

Institution
hospital:

Heilongjiang Provincial People's Hospital  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京协和医院 

单位级别:

市级 

Institution
hospital:

Peking Union Medical College Hospital  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学第一医院 

单位级别:

市级 

Institution
hospital:

The First Affiliated Hospital of Peking University  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

医科院南京皮肤研究所 

单位级别:

市级 

Institution
hospital:

Nanjing Institute of Dermatology  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

山东省皮肤病医院 

单位级别:

市级 

Institution
hospital:

Shandong Dermatology Hospital  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市皮肤病医院 

单位级别:

市级 

Institution
hospital:

Shanghai Dermatology Hospital  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

 

Country:

China 

Province:

Hunan 

City:

 

单位(医院):

中南大学湘雅附属二院 

单位级别:

市级 

Institution
hospital:

The Second Affiliated Hospital of Xiangya Central South University  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

 

Country:

China 

Province:

Hunan 

City:

 

单位(医院):

中南大学湘雅附属一院 

单位级别:

市级 

Institution
hospital:

The First Affiliated Hospital of Xiangya, Central South University  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉市协和医院 

单位级别:

市级 

Institution
hospital:

Wuhan Union Hospital  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉市第一医院 

单位级别:

市级 

Institution
hospital:

Wuhan 1st Hospital  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

陆军军医大学西南医院 

单位级别:

市级 

Institution
hospital:

Southwest Hospital, Army Military Medical University  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川大学华西医院 

单位级别:

市级 

Institution
hospital:

West China Hospital of Sichuan University  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

云南 

市(区县):

 

Country:

China 

Province:

Yunnan 

City:

 

单位(医院):

昆明医科大学附属一院 

单位级别:

市级 

Institution
hospital:

The First Affiliated Hospital of Kunming Medical University  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

中山大学第二医院 

单位级别:

市级 

Institution
hospital:

The second hospital of Zhongshan University  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

中山大学第三医院 

单位级别:

市级 

Institution
hospital:

The Third Hospital of Zhongshan University  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广州市皮肤病研究所 

单位级别:

市级 

Institution
hospital:

Guangzhou Institute of Dermatology  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广州医科大学附属二院 

单位级别:

市级 

Institution
hospital:

The Second Affiliated Hospital of Guangzhou Medical University  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

香港大学深圳医院 

单位级别:

市级 

Institution
hospital:

Shenzhen Hospital of University of Hong Kong  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

深圳市慢性病医院 

单位级别:

市级 

Institution
hospital:

Shenzhen chronic disease hospital  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

海南 

市(区县):

 

Country:

China 

Province:

Hainan 

City:

 

单位(医院):

海南省皮肤病医院 

单位级别:

市级 

Institution
hospital:

Hainan Dermatology Hospital  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

角质层含水量

指标类型:

主要指标 

Outcome:

Stratum corneum

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

透皮失水率

指标类型:

主要指标 

Outcome:

transepidermal water loss

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

斑贴实验

指标类型:

主要指标 

Outcome:

Patch experiment

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

点刺试验

指标类型:

主要指标 

Outcome:

point prick test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

微生物检测

指标类型:

主要指标 

Outcome:

microbial detection

Type:

Primary 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:

外周血样本

组织:

Sample Name:

Peripheral blood samples

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 15 years
最大 Max age 70 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):

无需分组,因为没有干预措施

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

There is no need for grouping because there is no intervention.

盲法:

N/A

Blinding:

N/A

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):

2020年12月1日

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

December 1, 2020

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:

病例记录表

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

Case record table

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2018-10-17
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