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: |
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English Acronym: |
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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: |
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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: |
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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): |
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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: |
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申请人所在单位: |
南方医科大学皮肤病医院 |
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Applicant's institution: |
Dermatology Hospital of Southern Medical University |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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 |
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Name of the ethic committee: |
Medical ethics committee of Southern Medical University Dermatology Hospital |
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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 |
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Contact Name of the ethic committee: |
Lv Ping |
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伦理委员会联系地址: |
广东省越秀区麓景路2号 |
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Contact Address of the ethic committee: |
2 Lujing Road, Yuexiu District, Guangzhou, Guangdong, China |
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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 |
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Primary sponsor: |
Dermatology Hospital of Southern Medical University |
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研究实施负责(组长)单位地址: |
广东省越秀区麓景路2号 |
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Primary sponsor's address: |
2 Lujing Road, Yuexiu District, Guangzhou, Guangdong, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
医院自筹及所属大学赞助 |
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Source(s) of funding: |
Hospital self financing and sponsorship of its universities |
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研究疾病: |
手部湿疹 |
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Target disease: |
hand eczema |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
病因学/相关因素研究 |
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Study type: |
Cause/Relative factors study |
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研究所处阶段: |
探索性研究/预试验 | ||||||||||||||||||||||
Study phase: |
0 |
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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 。 |
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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. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
单臂 |
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Study design: |
Single arm |
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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 |
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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. |
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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 |
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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: |
从From2018-10-25至To 2019-10-25 |
征募观察对象时间: Recruiting time: |
从From2018-10-25至To 2019-10-25 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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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 |
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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 |