中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500111199
最近更新日期： Date of Last Refreshed on：	2025-10-28 08:53:01
注册时间： Date of Registration：	2025-10-28 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	碘代BDP光敏剂治疗甲真菌病的临床研究
Public title：	Clinical Study on Iodinated BDP Photosensitizer for the Treatment of Onychomycosis
注册题目简写：
English Acronym：
研究课题的正式科学名称：	碘代BDP光敏剂治疗甲真菌病的临床研究
Scientific title：	Clinical Study on Iodinated BDP Photosensitizer for the Treatment of Onychomycosis
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：	台宗光	研究负责人：	台宗光
Applicant：	Tai Zongguang	Study leader：	Tai Zongguang
申请注册联系人电话： Applicant telephone：	+86 186 2119 7993	研究负责人电话： Study leader's telephone：	+86 186 2119 7993
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：	taizongguang@126.com	研究负责人电子邮件： Study leader's E-mail：	taizongguang@126.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：	上海市保德路1278号	研究负责人通讯地址：	上海市保德路1278号
Applicant address：	1278 Baode Road, Jing 'an District, Shanghai	Study leader's address：	1278 Baode Road, Jing 'an District, Shanghai
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：	上海市皮肤病医院
Applicant's institution：	Shanghai Skin Disease Hospital, Tongji University School of Medicine
研究负责人所在单位：	上海市皮肤病医院
Affiliation of the Leader：	Shanghai Skin Disease Hospital, Tongji University School of Medicine

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：	2025-24(科)	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：	上海市皮肤病医院临床试验伦理委员会
Name of the ethic committee：	Ethics Committee of Shanghai Skin Disease Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2025-07-31 00:00:00
伦理委员会联系人：	刘硕
Contact Name of the ethic committee：	Liu Shuo
伦理委员会联系地址：	上海市保德路1278号
Contact Address of the ethic committee：	1278 Baode Road, Jing 'an District, Shanghai
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 21 3680 3156	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：

上海市皮肤病医院

Primary sponsor：

Shanghai Skin Disease Hospital, Tongji University School of Medicine

研究实施负责（组长）单位地址：

上海市保德路1278号

Primary sponsor's address：

1278 Baode Road, Jing 'an District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	上海市	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海市皮肤病医院	具体地址：	上海市保德路1278号
Institution hospital：	Shanghai Skin Disease Hospital, Tongji University School of Medicine	Address：	1278 Baode Road, Jing 'an District, Shanghai

经费或物资来源：

上海市卫生健康委员会科研项目计划

Source(s) of funding：

Research Project Program of Shanghai Municipal Health Commission

研究疾病：

甲真菌病

Target disease：

onychomycosis

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：

单臂

Study design：

Single arm

研究目的：

主要目的:评价新型碘代BDP光敏剂BIL-1治疗甲真菌病的有效性。次要目的:评价新型碘代BDP光敏剂BIL-1治疗甲真菌病的安全性

Objectives of Study：

Primary Objective: To evaluate the efficacy of BIL-1, a novel iodinated BDP photosensitizer, in the treatment of onychomycosis. Secondary Objective: To assess the safety profile of BIL-1, a novel iodinated BDP photosensitizer, in the treatment of onychomycosis.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Provide a signed and dated informed consent form (ICF).
2. The patient indicates willingness and completes all study procedures and study intervention cycles.
3. Male or female, aged 18–65 years (inclusive).
4. In good general health, diagnosed with onychomycosis according to the Chinese Guidelines for the Diagnosis and Treatment of Onychomycosis (2021 Edition), based on clinical manifestations, positive fungal microscopy, and positive fungal culture.
5. The patient has eligible target fingernail(s) and/or toenail(s) affected by the disease. Target toenails must be the great toe (big toe), while there are no specific requirements for target fingernails.
6. As judged by the investigator, the patient is suitable for systemic drug treatment for onychomycosis.
7. Adequate organ function, including:Liver function: total bilirubin (TBIL) <=1.5 × ULN, alanine
aminotransferase (ALT) <=1.5 × ULN, and aspartate aminotransferase (AST) <=1.5 × ULN;Renal function: serum creatinine and urea/urea nitrogen levels within normal limits;Hematology: platelet count >=75 × 10⁹/L (excluding transfusion-dependent patients), and hemoglobin >=90g/L.
8. For women of childbearing potential: use of highly effective contraception (hormonal, barrier method, or abstinence) for at least 30 days prior to screening, and agreement to use such methods during the study and for 30 days after the end of the study treatment. The blood human chorionic gonadotropin (hCG) pregnancy test result for women of childbearing potential must be negative within 14 days prior to enrollment. During the trial and for at least one month after the end of the study treatment, women of childbearing potential may not donate oocytes, and all male subjects may not donate sperm.
9. For men of childbearing potential: use of condoms or other methods to ensure effective contraception for their partners.
10. No history of alcohol or drug abuse or dependence.

排除标准：

1.已知对 BODIPY 类药物过敏。 2.正在接受或在研究治疗开始前3个月内接受过系统抗真菌治疗，或在研究治疗开始前1个月内接受过针对手部、指甲、足部或趾甲的局部抗真菌治疗。 3.在研究治疗开始前的 28 天内，接受过既往临床研究中的研究药物。 4.在研究治疗开始前的 28 天内，接受过大手术或发生重大外伤性损伤，或者预计在研究期间接受大手术。 5.在研究治疗开始前的 7 天内，接受过活检或其他小型外科手术。 6.合并心脑血管、肝、肾和造血系统等严重原发性疾病及精神病患者。 7.筛选时处于妊娠期或哺乳期的女性。 8.除甲真菌病外，经研究者判断，患者存在会干扰研究评估的任何有临床意义的情况[例如，患者存在其他可能导致临床指甲/趾甲异常的情况（患有银屑病，患有扁平苔藓，患有足部创伤，过度剪甲等），患有未控制好的糖尿病，患有严重的周围血管疾病，患有复发性蜂窝织炎，淋巴功能不全，免疫功能低下（无论是由于潜在的医学疾病或免疫抑制治疗）等。 9.正在进行或三个月内参与过其他临床试验。

Exclusion criteria：

1.Known history of allergy to BODIPY-class drugs. 2.Have received systemic antifungal treatment within 3 months prior to the start of the study treatment, or topical antifungal treatment targeting the hands, nails, feet, or toenails within 1 month prior to the start of the study treatment. 3.Have received investigational drugs from previous clinical studies within 28 days prior to the start of the study treatment. 4.Have undergone major surgery or experienced significant traumatic injury within 28 days prior to the start of the study treatment, or are scheduled to undergo major surgery during the study period. 5.Have undergone a biopsy or other minor surgical procedures within 7 days prior to the start of the study treatment. 6.Patients with severe primary diseases of the cardio-cerebrovascular, hepatic, renal, or hematopoietic systems, or patients with psychiatric disorders. 7.Females who are pregnant or breastfeeding at the time of screening. 8.Apart from onychomycosis, the patient has any clinically significant condition that, in the investigator's judgment, may interfere with the study evaluation [e.g., the patient has other conditions that may cause clinical nail/toenail abnormalities (such as psoriasis, lichen planus, foot trauma, excessive nail trimming, etc.), has poorly controlled diabetes, has severe peripheral vascular disease, has recurrent cellulitis, lymph insufficiency, is immunocompromised (whether due to an underlying medical condition or immunosuppressive therapy), etc. 9.Currently participating or have participated in another clinical trial within the past three months.

研究实施时间：

Study execute time：

从 From 2025-08-01 00:00:00至 To 2026-06-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-08-26 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	30
Group：	intervention group	Sample size：	30
干预措施：	在患处甲板涂上BIL-1药液1小时后，照灯15分钟	干预措施代码：
Intervention：	The target nail plate was irradiated for 15 minutes using the designated light device one hour after application of BIL-1 solution	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	上海市	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海市皮肤病医院	单位级别：	三甲专科
Institution hospital：	Shanghai Skin Disease Hospital, Tongji University School of Medicine	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	甲真菌病感染评估（包括靶病甲正常区长度、靶病甲正常区面积、甲板受累面积占靶病甲面积百分比	指标类型：	主要指标
Outcome：	Onychomycosis Infection Assessment (including: normal area length of the target diseased nail, normal area of the target diseased nail, and percentage of the nail plate involved area to the target diseased nail area)	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	真菌学检查，包括直接显微镜检查（真菌镜检）和真菌培养	指标类型：	主要指标
Outcome：	Mycological examination, including direct microscopic examination (fungal microscopy) and fungal culture	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	皮肤病生活质量指数（DLQI）评分	指标类型：	次要指标
Outcome：	Dermatology Life Quality Index (DLQI)	Type：	Secondary 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：	尿液	组织：
Sample Name：	urine	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

标本中文名：	血液	组织：
Sample Name：	blood	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

标本中文名：	指/趾甲	组织：
Sample Name：	nail	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	65	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）：

无

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

None

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：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	在2026年8月1日公开，采用临床试验公共管理平台ResMan并向公众开放，www.medresman.org
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	It will be publicly released on August 1, 2026, through the ResMan clinical trial public management platform and made available to the general public. www.medresman.org
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：	数据采集使用病例记录表，数据管理使用Resman临床试验公共管理平台
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	The study team collected data using case report forms and managed the data on the Resman clinical trial public management platform.
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：	2025-10-28 08:52:44