ChiCTR2300072840 版本V1.0 版本创建时间2023/06/26 16:56:07 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：

 ChiCTR2300072840 

最近更新日期：

Date of Last Refreshed on：

 2023-06-26 16:56:02 

注册时间：

Date of Registration：

 2023-06-26 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

EFFICACY OF 308 NM MONOCHROMATIC EXCIMER LAMP AND TOPICAL TACROLIMUS COMBINATION THERAPY IN LOCALISED VITILIGO: A STUDY IN VIETNAM

Public title：

EFFICACY OF 308 NM MONOCHROMATIC EXCIMER LAMP AND TOPICAL TACROLIMUS COMBINATION THERAPY IN LOCALISED VITILIGO: A STUDY IN VIETNAM

注册题目简写：

English Acronym：

研究课题的正式科学名称：

EFFICACY OF 308 NM MONOCHROMATIC EXCIMER LAMP AND TOPICAL TACROLIMUS COMBINATION THERAPY IN LOCALISED VITILIGO: A STUDY IN VIETNAM

Scientific title：

EFFICACY OF 308 NM MONOCHROMATIC EXCIMER LAMP AND TOPICAL TACROLIMUS COMBINATION THERAPY IN LOCALISED VITILIGO: A STUDY IN VIETNAM

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：

Do Thi Thu Hien 

研究负责人：

Do Thi Thu Hien 

Applicant：

Do Thi Thu Hien 

Study leader：

Do Thi Thu Hien 

申请注册联系人电话：

Applicant telephone：

 +84 91 580 72 14

研究负责人电话：

Study leader's
telephone：

+84 91 580 72 14

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：

 hienphuonglinh@yahoo.com

研究负责人电子邮件：

Study leader's E-mail：

 hienphuonglinh@yahoo.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：

Vietnam

研究负责人通讯地址：

National Hospital of Dermatology and Venereology, 15 A Phuong mai, Dong Da, Hanoi, Vietnam

Applicant address：

Vietnam

Study leader's address：

National Hospital of Dermatology and Venereology, 15 A Phuong mai, Dong Da, Hanoi, Vietnam

申请注册联系人邮政编码：

Applicant postcode：

 10000

研究负责人邮政编码：

Study leader's postcode：

 10000

申请人所在单位：

Hanoi Medical University

Applicant's institution：

Hanoi Medical University

研究负责人所在单位：

Hanoi Medical University

Affiliation of the Leader：

Hanoi 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：

 2610/QD-DHYHN

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：

Hanoi Medical University

Name of the ethic committee：

Hanoi Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-07-04 00:00:00

伦理委员会联系人：

Hanoi Medical University

Contact Name of the ethic committee：

Hanoi Medical University

伦理委员会联系地址：

No.1, Ton That Tung Street, Dong Da District, Hanoi City, Vietnam

Contact Address of the ethic committee：

No.1, Ton That Tung Street, Dong Da District, Hanoi City, Vietnam

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +84 24 3852 3798

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：

Hanoi Medical University

Primary sponsor：

Hanoi Medical University

研究实施负责（组长）单位地址：

No.1, Ton That Tung Street, Dong Da District, Hanoi City, Vietnam

Primary sponsor's address：

No.1, Ton That Tung Street, Dong Da District, Hanoi City, Vietnam

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Vietnam

省(直辖市)：

Hanoi

市(区县)：

Hanoi

Country：

Vietnam

Province：

--- Select One ---

City：

Hanoi

单位(医院)：

National Hospital of Dermatology and Venereology, 15 A Phuong mai, Dong Da, Hanoi, Vietnam

具体地址：

15A, Phuong Mai, Dong Da, Hanoi, Vietnam

Institution
hospital：

National Hospital of Dermatology and Venereology, 15 A Phuong mai, Dong Da, Hanoi, Vietnam

Address：

15A, Phuong Mai, Dong Da, Hanoi, Vietnam

经费或物资来源：

Giving permission to conduct the study. Money is not given.

Source(s) of funding：

Giving permission to conduct the study. Money is not given.

研究疾病：

Localised vitiligo  

Target disease：

Localised vitiligo

研究疾病代码：

L80

Target disease code：

L80

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

单臂 

Study design：

Single arm 

研究目的：

Combination therapy of a 308 nm monochromatic excimer lamp and topical tacrolimus is widely used in the treatment of localised vitiligo; however, there are no published studies investigating this combination therapy in Vietnamese patients with vitiligo. This study was performed to evaluate the efficacy of combined excimer lamp and topical tacrolimus therapy for patients with localised vitiligo in Vietnam.  

Objectives of Study：

Combination therapy of a 308 nm monochromatic excimer lamp and topical tacrolimus is widely used in the treatment of localised vitiligo; however, there are no published studies investigating this combination therapy in Vietnamese patients with vitiligo. This study was performed to evaluate the efficacy of combined excimer lamp and topical tacrolimus therapy for patients with localised vitiligo in Vietnam.

药物成份或治疗方案详述：

Patients were treated by excimer lamp two times per week and topical tacrolimus (0.1% for patients ≥ 12 years old; 0.03% for patients < 12 years old) applied twice a day. One fingertip unit (FTU), equal to 0.5g, was enough to treat an area of skin of two adult hands, including the front and back of the hands and the fingers. The excimer lamp named GME ExSys 308 (German Medical Engineering, Erlangen, Germany, 308 nm monochromatic Excimer Pulse Light, 50-6000 mJ/cm2 energy density) was used with below protocol: an initial dose of 150 mJ/cm2 (75% ×?MED?for?Type I skin, 200 mJ/cm2 ); dose was increased by 50 mJ/cm 2 at each subsequent visit if the erythema lasted less than 24 hours, kept constant if the erythema lasted more than 24 to 48 hours, and decreased by 50 mJ/cm2 if the erythema lasted more than 49 hours. If erythema appeared with blisters, phototherapy was postponed until the symptoms were resolved, and the dose was reduced to 100 mJ/cm2 in the next session. Lesions were treated with MEL twice weekly for 12 weeks. The treatment efficacy was recorded by the same dermatologist at 6 and 12 weeks after the start of treatment. 

Description for medicine or protocol of treatment in detail：

Patients were treated by excimer lamp two times per week and topical tacrolimus (0.1% for patients ≥ 12 years old; 0.03% for patients < 12 years old) applied twice a day. One fingertip unit (FTU), equal to 0.5g, was enough to treat an area of skin of two adult hands, including the front and back of the hands and the fingers. The excimer lamp named GME ExSys 308 (German Medical Engineering, Erlangen, Germany, 308 nm monochromatic Excimer Pulse Light, 50-6000 mJ/cm2 energy density) was used with below protocol: an initial dose of 150 mJ/cm2 (75% ×?MED?for?Type I skin, 200 mJ/cm2 ); dose was increased by 50 mJ/cm 2 at each subsequent visit if the erythema lasted less than 24 hours, kept constant if the erythema lasted more than 24 to 48 hours, and decreased by 50 mJ/cm2 if the erythema lasted more than 49 hours. If erythema appeared with blisters, phototherapy was postponed until the symptoms were resolved, and the dose was reduced to 100 mJ/cm2 in the next session. Lesions were treated with MEL twice weekly for 12 weeks. The treatment efficacy was recorded by the same dermatologist at 6 and 12 weeks after the start of treatment. 

纳入标准：

The inclusion criteria were as follows: diagnosis of localised vitiligo, age ≥ 2 years, and acquiring the disease for at least 3 months, either in active or stable stage.

Inclusion criteria

The inclusion criteria were as follows: diagnosis of localised vitiligo, age ≥ 2 years, and acquiring the disease for at least 3 months, either in active or stable stage.

排除标准：

Exclusion criteria included pregnancy or breastfeeding, history of skin cancer, prior treatment with any phototherapy or systemic immunosuppressant drugs, not undergoing 3-months washout period from topical treatment before starting the combination therapy and contraindications for phototherapy and topical tacrolimus.

Exclusion criteria：

Exclusion criteria included pregnancy or breastfeeding, history of skin cancer, prior treatment with any phototherapy or systemic immunosuppressant drugs, not undergoing 3-months washout period from topical treatment before starting the combination therapy and contraindications for phototherapy and topical tacrolimus.

研究实施时间：

Study execute time：

从 From 2019-07-01 00:00:00至 To 2021-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-07-10 00:00:00 至 To 2021-07-13 00:00:00

干预措施：

Interventions：

组别：

Localised vitiligo patients

样本量：

 30

Group：

Localised vitiligo patients

Sample size：

干预措施：

Patients were treated by excimer lamp two times per week and topical tacrolimus (0.1% for patients ≥ 12 years old; 0.03% for patients < 12 years old) applied twice a day.

干预措施代码：

Intervention：

Patients were treated by excimer lamp two times per week and topical tacrolimus (0.1% for patients ≥ 12 years old; 0.03% for patients < 12 years old) applied twice a day.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Vietnam

省(直辖市)：

 Hanoi 

市(区县)：

 Hanoi 

Country：

Vietnam

Province：

Hanoi

City：

Hanoi

单位(医院)：

 National Hospital of Dermatology and Venereology 

单位级别：

 University 

Institution
hospital：

National Hospital of Dermatology and Venereology

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Treatment response

指标类型：

主要指标

Outcome：

Treatment response

Type：

Primary indicator

测量时间点：

after 6 and 12 weeks of treatment

测量方法：

Changes in VASI score before and after treatment

Measure time point of outcome：

after 6 and 12 weeks of treatment

Measure method：

Changes in VASI score before and after treatment

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

N/A

组织：

N/A

Sample Name：

N/A

Tissue：

N/A

人体标本去向

 其它  

说明

N/A

Fate of sample：

0thers  

Note：

N/A

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 4 岁 years
最大 Max age 52 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）：

Convenience sampling of the patients who met the inclusion and exclusion criteria

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

Convenience sampling of the patients who met the inclusion and exclusion criteria

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：

N/A

Blinding：

N/A

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）：

N/A

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

N/A

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：

Case Record Form

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

Hanoi Medical University

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-06-26 16:56:02