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Clinical study of tranexamic acid drug-infiltrated threads for the treatment of melasma

注册号：

Registration number：

ITMCTR2022000039

最近更新日期：

Date of Last Refreshed on：

2022-07-19

注册时间：

Date of Registration：

2022-06-27

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

氨甲环酸药物浸润式埋线治疗黄褐斑的临床研究

Public title：

Clinical study of tranexamic acid drug-infiltrated threads for the treatment of melasma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

氨甲环酸药物浸润式埋线治疗黄褐斑的临床研究

Scientific title：

Clinical study of tranexamic acid drug-infiltrated threads for the treatment of melasma

研究课题的正式科学名称简写：

Scientific title acronym：

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：

ChiCTR2200061943 ; ChiMCTR2200006357

申请注册联系人：

宋奥林

研究负责人：

周双琳

Applicant：

Song Ao-lin

Study leader：

Zhou Shuang-lin

申请注册联系人电话：

Applicant telephone：

18810016756

研究负责人电话：

Study leader's telephone：

13911055110

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：

153397370@qq.com

研究负责人电子邮件：

Study leader's E-mail：

13911055110@163.com

申请单位网址(自愿提供)：

Study leader's 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：

北京市西城区北线阁5号中国中医科学院广安门医院

研究负责人通讯地址：

北京市西城区北线阁5号中国中医科学院广安门医院

Applicant address：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 North Line Pavilion, Xicheng District, Beijing

Study leader's address：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 North Line Pavilion, Xicheng District, Beijing

申请注册联系人邮政编码：

Applicant postcode：

100029

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

北京中医药大学

Applicant's institution：

Beijing University of Chinese Medicine

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

2022-100-KY-01

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

中国中医科学院广安门医院伦理委员会

Name of the ethic committee：

Ethics Committee of Guang'anmen Hospital, China Academy of Chinese Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

2022/6/21 0:00:00

伦理委员会联系人：

乔洁

Contact Name of the ethic committee：

Qiao Jie

伦理委员会联系地址：

北京市西城区北线阁5号中国中医科学院广安门医院

Contact Address of the ethic committee：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 North Line Pavilion, Xicheng District, Beijing

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：

中国中医科学院广安门医院

Primary sponsor：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

研究实施负责（组长）单位地址：

北京市西城区北线阁5号中国中医科学院广安门医院

Primary sponsor's address：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 North Line Pavilion, Xicheng District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京市

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

中国中医科学院广安门医院

具体地址：

北京市西城区北线阁5号中国中医科学院广安门医院

Institution
hospital：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Address：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 North Line Pavilion, Xicheng District, Beijing

经费或物资来源：

中国中医科学院科技创新工程项目

Source(s) of funding：

Science and Technology Innovation Project of China Academy of Chinese Medical Sciences

研究疾病：

黄褐斑

研究疾病代码：

Target disease：

melasma

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

评价氨甲环酸药物浸润式埋线治疗黄褐斑的疗效及安全性，为本病的治疗提供新思路和新方法，为开发新型的氨甲环酸药物线体提供客观依据。

Objectives of Study：

Evaluate the efficacy and safety of tranexamic acid drug infiltration thread treatment of melasma, and provide new ideas and new ideas for the treatment of this disease Methods, to provide an objective basis for the development of a new type of tranexamic acid drug line body.

药物成份或治疗方案详述：

（1）药线组 取穴：参照普通高等教育“十一五”国家级规划教材，石学敏主编《针灸学》（北京: 中国中医药出版社，2007年）。选取面部局部五个穴位（太阳、下关、颧髎、四白、阿是穴）。 操作方法：①药线制备：面部共十个穴位点，需要十根线，每1根线需要浸润在0.2ml药液中；提前一小时将10根线泡在2ml的氨甲环酸注射液中；取一段医用可吸收线，放入针头的前端，线在针管孔内、孔外的长度基本保持相同，剩余的药液可以用吸进针管；制备过程中保证无菌条件。②治疗步骤：嘱患者取仰卧位，佩戴不透光眼罩，穴位皮肤常规消毒，以针头刺入穴位时，线在针尖处被压形成对折，随着针尖快速刺入穴位；在确保针孔外的线体进入皮肤并获得针感后，边退边注入药物（每个穴位约0.2ml），直至退出针体，线体随即留存在穴位处，即同时完成了一次药物浸润式埋线。 （2）药物组 取穴：同药线组。 操作方法：选用上述氨甲环酸注射液，用量同药线组，面部穴位注射。 （3）埋线组 取穴：同药线组。 操作方法：选用上述可吸收性外科缝线，植入的穴位、层次、方法同药线组，只注线，不推注药。

Description for medicine or protocol of treatment in detail：

(1) Drug line group Acupuncture: Referring to the "Eleventh Five-Year Plan" national planning textbook for general higher education, Edited by Shi Xuemin, Acupuncture and Moxibustion (Beijing: China Traditional Chinese Medicine Press, 2007). Select five acupuncture points on the face (Sun, Shimonoseki, Zygomatic, Four White, Ashi). Operation method: (1) Preparation of the drug line: a total of ten acupuncture points on the face, ten threads are needed, and each 1 thread needs to be infiltrated in 0.2 ml of the liquid medicine; 10 threads are soaked in the 2 ml of tranexamic acid injection one hour in advance; take a medical absorbable thread, put it into the front end of the needle, the length of the thread in the needle tube hole and outside the hole is basically the same, and the remaining liquid can be sucked into the needle tube; Sterile conditions are guaranteed during preparation. (2) Treatment steps: instruct the patient to take the supine position, wear an opaque eye mask, routinely disinfect the skin of the acupuncture point, and when the needle is pierced into the acupuncture point, the thread is pressed at the tip of the needle to form a fold in half, and the acupuncture point is quickly pierced with the needle tip; After ensuring that the thread outside the needlehole enters the skin and obtains a needle feeling, the drug is injected (about 0.2 ml per acupuncture point) while retreating, until the needle body is withdrawn, and the thread body remains at the acupuncture point, that is, a drug-infiltrated thread is completed at the same time. (2) Drug group Acupuncture: same line group. Operation method: the above-mentioned tranexamic acid injection is selected, the dosage is the same as the drug line group, and the facial acupuncture point is injected. (3) Buried wire group Acupuncture: same line group. Operation method: the above absorbable surgical sutures are selected, and the implanted acupuncture points, levels, and methods are the same as the drug thread group, only the thread is injected, not the drug is injected.

纳入标准：

（1）年龄18～60岁，女性； （2）既往未接受过穴位埋线治疗者； （3）符合黄褐斑诊断标准； （4）临床分期为稳定期； （5）每位患者试验前均了解本研究目的及方法，并自愿参加，同时签署该试验知情同意 书。

Inclusion criteria

(1) Age 18 to 60 years old, female; (2) Those who have not received acupuncture point burial thread treatment before; (3) Meet the diagnostic criteria for melasma; (4) The clinical stage is a stable stage; (5) Each patient understands the purpose and method of this study before the trial, and voluntarily participates in it, and signs the informed consent of the trial Book.

排除标准：

（1）妊娠或哺乳期女性； （2）对本次研究使用药物过敏的患者； （3）治疗部位合并炎症性或感染性皮肤病患者； （4）合并严重内分泌、妇科、心脑血管疾病、凝血功能异常、肝肾功能异常及肿瘤患者； （5）近1个月内接受激光治疗、口服或外用祛斑类药物治疗者； （6）如果治疗期间不能按要求做到防晒者。

Exclusion criteria：

(1) Pregnant or lactating women; (2) Patients who are allergic to the use of drugs in this study; (3) Patients with inflammatory or infectious skin diseases at the treatment site; (4) Patients with severe endocrine, gynecological, cardiovascular and cerebrovascular diseases, abnormal coagulation function, abnormal liver and kidney function and tumors; (5) Those who have received laser treatment, oral or topical freckle removal drugs in the past 1 month; (6) If the sunscreen cannot be achieved as required during the treatment.

研究实施时间：

Study execute time：

从From 2021-10-01

至To      2024-10-01

征募观察对象时间：

Recruiting time：

从From 2022-06-30

至To      2023-12-31

干预措施：

Interventions：

组别：

单纯埋线组

样本量：

30

Group：

Simple buried wire group

Sample size：

干预措施：

单纯埋线

干预措施代码：

Intervention：

Simply buried wire

Intervention code：

组别：

氨甲环酸药线植入组

样本量：

30

Group：

Tranexamic acid line implant group

Sample size：

干预措施：

氨甲环酸药线植入

干预措施代码：

Intervention：

Tranexamic acid line implantation

Intervention code：

组别：

氨甲环酸注射组

样本量：

30

Group：

Tranexamic acid injection group

Sample size：

干预措施：

氨甲环酸注射

干预措施代码：

Intervention：

Tranexamic acid injection

Intervention code：

样本总量 Total sample size ： 90

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

北京市

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

中国中医科学院广安门医院

单位级别：

三级甲等

Institution/hospital：

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Level of the institution：

Grade III A

测量指标：

Outcomes：

指标中文名：

黄褐斑面积及严重程度评分

指标类型：

主要指标

Outcome：

Melasma area severity index

Type：

Primary indicator

测量时间点：

入组0周、4周、8周及12周时

测量方法：

采用VISIA皮肤图像分析仪拍照

Measure time point of outcome：

When the group is 0 weeks, 4 weeks, 8 weeks and 12 weeks old

Measure method：

Take pictures with the VISIA Skin Image Analyzer

指标中文名：

患者满意度评价

指标类型：

主要指标

Outcome：

Patient satisfaction evaluation

Type：

Primary indicator

测量时间点：

入组12周时

测量方法：

问卷形式

Measure time point of outcome：

When the group is 12 weeks old

Measure method：

Questionnaire format

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 60 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

女性

Female

随机方法（请说明由何人用什么方法产生随机序列）：

医生借助SAS统计软件PROCPLAN过程语句，给定种子数，确定段长。产生90例受试者所接受处理的随机安排，即列出流水号为01-90所对应的治疗分配

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

With the help of the SAS statistical software PROCPLAN process statement, the doctor determines the segment length, given the number of seeds. A random arrangement of 90 subjects to be treated was produced, i.e. the treatment allocation corresponding to the serial number 01-90 was listed

盲法：

严格区分操作者与评价者，保证受试者、评价者及统计者盲

Blinding：

Strictly distinguish between operators and evaluators, and ensure that subjects, evaluators and statisticians are blind

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）：

原始数据暂不公开

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

The original data is not publicly available

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：

数据暂不公开

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

Data is not publicly available

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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