ChiCTR2500104020 版本V1.0 版本创建时间2025/06/10 10:22:45 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：

 ChiCTR2500104020 

最近更新日期：

Date of Last Refreshed on：

 2025-06-10 10:22:36 

注册时间：

Date of Registration：

 2025-06-10 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

氢分子缓解光电技术治疗痤疮/痤疮瘢痕不良反应的研究

Public title：

A study of hydrogen water alleviating the adverse effects of acne/acne scar treated by photoelectric technology

注册题目简写：

English Acronym：

研究课题的正式科学名称：

氢分子缓解光电技术治疗痤疮/痤疮瘢痕不良反应的研究

Scientific title：

A study of hydrogen water alleviating the adverse effects of acne/acne scar treated by photoelectric technology

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：

何磊 

研究负责人：

何磊 

Applicant：

Lei he 

Study leader：

Lei he 

申请注册联系人电话：

Applicant telephone：

 +86 139 3246 8485

研究负责人电话：

Study leader's
telephone：

+86 139 3246 8485

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：

 13932468485@139.com

研究负责人电子邮件：

Study leader's E-mail：

 13932468485@139.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：

承德市双桥区南营子大街36号

研究负责人通讯地址：

承德市双桥区南营子大街36号

Applicant address：

36 Nanyingzi Street, Shuangqiao District, Chengde

Study leader's address：

36 Nanyingzi Street, Shuangqiao District, Chengde

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：

承德医学院附属医院

Applicant's institution：

the Affiliated Hospital of Chengde Medical University

研究负责人所在单位：

承德医学院附属医院

Affiliation of the Leader：

the Affiliated Hospital of Chengde 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：

 CYFYLL2022312

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：

承德医学院附属医院伦理委员会

Name of the ethic committee：

Ethics Committee of Chengde Medical College Affiliated Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-09-01 00:00:00

伦理委员会联系人：

杨悦

Contact Name of the ethic committee：

Yue Yang

伦理委员会联系地址：

承德市双桥区南营子大街36号

Contact Address of the ethic committee：

36 Nanyingzi Street, Shuangqiao District, Chengde

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 314 227 9322

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：

承德医学院附属医院

Primary sponsor：

the Affiliated Hospital of Chengde Medical University

研究实施负责（组长）单位地址：

承德市双桥区南营子大街36号

Primary sponsor's address：

36 Nanyingzi Street, Shuangqiao District, Chengde

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

河北

市(区县)：

Country：

China

Province：

HeBei

City：

单位(医院)：

承德医学院附属医院

具体地址：

承德市双桥区南营子大街36号

Institution
hospital：

the Affiliated Hospital of Chengde Medical University

Address：

36 Nanyingzi Street, Shuangqiao District, Chengde

经费或物资来源：

2023年河北省政府资助优秀人才项目，5万元

Source(s) of funding：

The Project for Funding Outstanding Talents by the Government of Hebei Province in 2023,50000yuan

研究疾病：

光电技术治疗痤疮/痤疮瘢痕的不良反应  

Target disease：

the adverse effects of acne/acne scar treated by photoelectric technology

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究主要探讨氢水是否可以用于缓解光电技术治疗痤疮/痤疮瘢痕的不良反应，促进皮肤屏障修复，缩短误工期，改善痤疮/痤疮瘢痕患者激光治疗的不适感，增加患者激光治疗的舒适性和依从性。  

Objectives of Study：

This study explored whether hydrogen water could be used to alleviate adverse reactions after phototherapy treatment of acne/acne scar, promote skin barrier repair, shorten downtime, improve the discomfort of laser treatment for acne/acne scar and increase the comfort and compliance of laser treatment for patients.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

痤疮组纳入标准 （1）男女不限，年龄10-40岁； （2）参照《中国临床皮肤病学》诊断及分级标准，按照痤疮改良 Pillsbury 分类法，患者确诊为Pillsbury II-IV级痤疮（中-重度），病史超过3个月; （3）对本次治疗内容知情，同意入组后使用420nm强脉冲光治疗，且激光治疗后使用纯净水/纳米气泡氢水修复； （4）受试者愿意在整个研究期间不使用其他护肤品、化妆品及接受其他面部治疗（如：药物、化学剥脱术、激光等）； （5）整个研究期间遵守试验要求完成整个试验，能够按要求完成随访； （6）已经签署知情同意书并愿意完成本研究过程。 痤疮瘢痕组纳入标准 （1）男女不限，年龄16-40岁； （2）患者确诊为萎缩性痤疮瘢痕，病程超过3个月； （3）对本次治疗内容知情，同意入组后使用CO2点阵激光治疗，且激光治疗后使用纯净水/纳米气泡氢水修复； （4）受试者愿意在整个研究期间不使用其他护肤品、化妆品及接受其他面部治疗（如：药物、化学剥脱术、激光等）； （5）整个研究期间遵守试验要求完成整个试验，能够按要求完成随访； （6）已经签署知情同意书并愿意完成本研究过程。

Inclusion criteria

Inclusion criteria for the acne group: (1) No gender restrictions; age range 10-40 years old; (2) According to the diagnostic and grading standards of "Clinical Dermatology in China" and the modified Pillsbury classification method for acne, patients are diagnosed with Pillsbury II-IV grade acne (moderate to severe) with a history of more than 3 months; (3) Informed about the treatment content of this study, agreed to participate in the study and receive 420nm intense pulsed light treatment, and use pure water/nano bubble hydrogen water for repair after laser treatment; (4) Subjects are willing to refrain from using other skin care products, cosmetics and other facial treatments (such as: drugs, chemical peels, lasers, etc.) throughout the study period; (5) Comply with the trial requirements throughout the study period, complete the entire trial and be able to complete follow-up as required; (6) Have signed the informed consent form and are willing to complete the entire study process. Inclusion criteria for the acne scar group: (1) No gender restrictions; age range 16-40 years old; (2) Patients are diagnosed with atrophic acne scars, with a disease course of more than 3 months; (3) Informed about the treatment content of this study, agreed to participate in the study and receive CO2 fractional laser treatment, and use pure water/nano bubble hydrogen water for repair after laser treatment; (4) Subjects are willing to refrain from using other skin care products, cosmetics and other facial treatments (such as: drugs, chemical peels, lasers, etc.) throughout the study period; (5) Comply with the trial requirements throughout the study period, complete the entire trial and be able to complete follow-up as required; (6)Have signed the informed consent form and are willing to complete the entire study process.

排除标准：

痤疮组排除标准 （1）处于妊娠期、哺乳期、或备孕期； （2）入组前3个月内系统性使用维甲酸类药物，或在1个月内局部外用过维甲酸类药物； （3）光过敏者； （4）近6个月服用或注射过光敏性药物者； （5）近1个月有接受其他皮肤光电治疗者； （6）心、肝、肾功能不全者或糖尿病、肾病、血液疾病等系统性疾病、精神病患者； （7）恶性肿瘤者。 痤疮瘢痕组排除标准 （1）处于妊娠期、哺乳期、或备孕期； （2）面部有感染或有全身感染表现； （3）光过敏或增生性瘢痕体质； （4）凝血功能障碍者； （5）近1个月有接受其他面部治疗（如：药物、射频激光、填充、磨削等）者； （6）心、肝、肾功能不全者或糖尿病、肾病、血液疾病等系统性疾病、精神病患者； （7）恶性肿瘤者。

Exclusion criteria：

Exclusion criteria for the acne group: (1) Pregnant, lactating, or in the preconception period; (2) Using systemic retinoid drugs within 3 months before enrollment or having used topical retinoid drugs within 1 month before enrollment; (3) Phototoxic individuals; (4) Using photosensitive drugs within 6 months before enrollment or having received phototoxic treatments within 1 month before enrollment; (5) Having received other facial phototherapies within 1 month before enrollment (such as drugs, radiofrequency laser, filling, dermabrasion, etc.); (6) Individuals with impaired heart, liver, or kidney function or with systemic diseases such as diabetes, nephropathy, hematological diseases, or mental disorders; (7) Individuals with malignant tumors. Exclusion criteria for the acne scar group: (1) Pregnant, lactating, or in the preconception period; (2) Having facial infections or showing signs of systemic infections; (3) Phototoxic or individuals with hypertrophic scar constitution; (4) Individuals with coagulation dysfunction; (5) Having received other facial treatments (such as drugs, radiofrequency laser, filling, dermabrasion, etc.) within 1 month before enrollment; (6) Individuals with impaired heart, liver, or kidney function or with systemic diseases such as diabetes, nephropathy, hematological diseases, or mental disorders; (7)Individuals with malignant tumors.

研究实施时间：

Study execute time：

从 From 2023-01-01 00:00:00至 To 2026-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-11-17 00:00:00 至 To 2024-11-30 00:00:00

干预措施：

Interventions：

组别：

痤疮纯净水组

样本量：

 30

Group：

acne of pure water group

Sample size：

干预措施：

痤疮纯净水组患者入组后给予1次420nm强脉冲光治疗，治疗后立刻给予纯净水喷雾，观察5分钟，此后每天湿敷两次，每次15分钟，共14天

干预措施代码：

Intervention：

The acne patients of pure water group were given 420nm intense pulsed light treatment after enrollment. Immediately after the treatment, they were sprayed with pure water and observed for 5 minutes. Subsequently, they were weted twice a day for 15 minutes each time for 14 days

Intervention code：

组别：

痤疮氢水组

样本量：

 30

Group：

acne of hydrogen water group

Sample size：

干预措施：

痤疮氢水组患者入组后给予1次420nm强脉冲光治疗，治疗后立刻给予氢水喷雾，观察5分钟，此后每天湿敷两次，每次15分钟，共14天

干预措施代码：

Intervention：

The acne patients of hydrogen water group were given 420nm intense pulsed light treatment after enrollment. Immediately after the treatment, they were sprayed with pure water and observed for 5 minutes. Subsequently, they were weted twice a day for 15 minutes each time for 14days

Intervention code：

组别：

痤疮瘢痕纯净水组

样本量：

 30

Group：

acne scar of pure water group

Sample size：

干预措施：

痤疮瘢痕纯净水组患者入组后给予CO2点阵激光治疗，治疗后立刻给予纯净水喷雾，观察5分钟，此后每天湿敷两次，每次15分钟,共14天

干预措施代码：

Intervention：

The acne scar patients of pure water were given CO2 fractional laser treatment after enrollment. Immediately after the treatment, they were sprayed with pure water and observed for 5 minutes. Subsequently, they were weted twice a day for 15 minutes each time for 14 days

Intervention code：

组别：

痤疮瘢痕氢水组

样本量：

 30

Group：

acne scar of hydrogen water group

Sample size：

干预措施：

痤疮瘢痕氢水组患者入组后给予CO2点阵激光治疗，治疗后立刻给予氢水喷雾，观察5分钟，此后每天湿敷两次，每次15分钟,共14天

干预措施代码：

Intervention：

The acne scar patients of hydrogen water group were given CO2 fractional laser treatment after enrollment. Immediately after the treatment, they were sprayed with nano bubble hydrogen water and observed for 5 minutes. Subsequently, they were weted twice a day for 15 minutes each time for 14days

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河北 

市(区县)：

  

Country：

China

Province：

Hebei

City：

单位(医院)：

 承德医学院附属医院 

单位级别：

 三甲 

Institution
hospital：

the Affiliated Hospital of Chengde Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

瘙痒数字评分量表

指标类型：

主要指标

Outcome：

pruritus,Numerical rating scale

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

干燥数字评分量表

指标类型：

主要指标

Outcome：

dryness,EEMCO Guidance

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疼痛数字评分量表

指标类型：

主要指标

Outcome：

pain,Numerical rating scale

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

斑点

指标类型：

主要指标

Outcome：

spots

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

棕色斑

指标类型：

主要指标

Outcome：

brown spots

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

红色区

指标类型：

主要指标

Outcome：

red area

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：

无

组织：

Sample Name：

no

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 10 岁 years
最大 Max age 40 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）：

在研究中的每名受试者接受氢水或纯净水的顺序将由随机表确定。随机表由统计单位应用R 3.6.1统计软件按1:1区组随机产生。在筛选时，每名受试者将使用筛选号进行识别。每名合格的受试者将按照时间的先后顺序获得试验号（即：受试者编号）。

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

The order in which each subject in the study receives either hydrogen water or purified water will be determined by a random table. Random tables are randomly generated by the statistical unit using R 3.6.1 statistical software in 1:1 blocks. During screening, each subject will be identified using a screening number. Each eligible subject will receive a trial number (i.e., subject number) in chronological order.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

单盲（对受试者实行盲法）

Blinding：

Single-blind(blind to patients)

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）：

结束6个月，临床试验公共管理平台 https://www.medicalresearch.org.cn/login

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

Within six months after the trial ends, https://www.medicalresearch.org.cn/login

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 Form, CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-06-10 10:22:36