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Enhancing hair growth in male androgenetic alopecia by a combination of fractional CO2 laser therapy and hair growth factors
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注册号:

Registration number:

ChiCTR-INR-17010873 

最近更新日期:

Date of Last Refreshed on:

2017-03-15 

注册时间:

Date of Registration:

2017-03-15 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

剥脱性CO2点阵激光联合毛发生长因子治疗雄激素源性脱发的临床疗效评价 

Public title:

Enhancing hair growth in male androgenetic alopecia by a combination of fractional CO2 laser therapy and hair growth factors 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

剥脱性CO2点阵激光联合毛发生长因子治疗雄激素源性脱发的临床疗效评价 

Scientific title:

Enhancing hair growth in male androgenetic alopecia by a combination of fractional CO2 laser therapy and hair growth factors 

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:

黄悦 

研究负责人:

李邻峰 

Applicant:

Yue Huang 

Study leader:

Linfeng Li 

申请注册联系人电话:

Applicant telephone:

+86 13720871286 

研究负责人电话:

Study leader's telephone:

+86 13693620186 

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:

huangyueyuran@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zoonli@sina.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:

北京市西城区永安路95号 

研究负责人通讯地址:

北京市西城区永安路95号 

Applicant address:

95 Yong An Road, Xicheng District, Beijing 

Study leader's address:

95 Yong An Road, Xicheng District, Beijing 

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:

首都医科大学附属北京友谊医院皮肤科 

Applicant's institution:

Department of Dermatology, Beijing Friendship Hospital, Capital 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:

2015-P2-107-01 

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:

首都医科大学附属北京友谊医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee,Beijing Friendship Hospital, Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-11-20 

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:

首都医科大学附属北京友谊医院皮肤科 

Primary sponsor:

Department of Dermatology, Beijing Friendship Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

北京市西城区永安路95号 

Primary sponsor's address:

95 Yong An Road, Xicheng District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

北京市自然基金 

Source(s) of funding:

Beijing Natural Science Foundation 

研究疾病:

雄激素源性脱发 

Target disease:

male androgenetic alopecia 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

探讨剥脱性CO2点阵激光联合毛发生长因子治疗雄激素源性脱发的临床疗效评价 

Objectives of Study:

Evaluation of efficacy in male androgenetic alopecia by a combination of fractional CO2 laser therapy and hair growth factors 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

招募中国雄激素源性脱发男性患者28名,MAA II-V期。 

Inclusion criteria

In this pilot study, we enrolled 28 Chinese patients with MAA II-V stage. 

排除标准:

近6个月有系统性疾病的患者;近三个月接受过能够影响毛发生长周期的治疗的;正在接受脱发的外科治疗的(例如毛发移植);在整个试验过程中不允许使用其他局部或者系统性干预。 

Exclusion criteria:

Patients with a history of a systemic disease in the past 6 months, those who had undergone treatment with any medication that could affect the hair cycle within the past 3 months, and those who had undergone surgical treatment for alopecia (such as hair transplantation) were excluded. The use of other topical agents and the administration of any medication were not permitted during the study period. 

研究实施时间:

Study execute time:

From2015-12-01To 2016-06-30 

征募观察对象时间:

Recruiting time:

From2015-12-01To 2015-10-31 

干预措施:

Interventions:

组别:

1

样本量:

28

Group:

one

Sample size:

干预措施:

剥脱性CO2点阵激光联合毛发生长因子超声头皮给药

干预措施代码:

Intervention:

Fractional CO2 laser combined with hair growth factors by using acoustic-pressure ultrasound

Intervention code:

组别:

2

样本量:

28

Group:

two

Sample size:

干预措施:

毛发生长因子超声透皮给药

干预措施代码:

Intervention:

hair growth factors by using acoustic-pressure ultrasound

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京友谊医院皮肤科 

单位级别:

三级甲等 

Institution
hospital:

Department of Dermatology, Beijing Friendship Hospital, Capital Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

大体照片

指标类型:

主要指标 

Outcome:

Global photographs

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

毛发密度

指标类型:

主要指标 

Outcome:

hair density

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

扫描电镜下毛囊状态变化

指标类型:

主要指标 

Outcome:

Change of stage of hair follicles under scanning electron microscopy

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

扫描电镜下发干直径的变化

指标类型:

主要指标 

Outcome:

Change of hair-shaft diameter under scanning electron microscopy,

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良反应的观察

指标类型:

主要指标 

Outcome:

evaluate the adverse effects

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:

毛发

组织:

Sample Name:

hair

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

随机数字表

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

Random number table

盲法:

Blinding:

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

20170304,上传文档到ResMan

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

20170304 Upload the document to ResMan

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:

Excel,spss

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

Excel,spss

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-03-15
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