ChiCTR2400087495 版本V1.0 版本创建时间2024/07/29 14:30:45 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：

ChiCTR2400087495 

最近更新日期：

Date of Last Refreshed on：

2024-07-29 14:28:58 

注册时间：

Date of Registration：

2024-07-29 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

联合微针倍他米松透皮给药治疗斑秃的有效性和安全性：一项随机对照试验

Public title：

Microneedle Transdermal Delivery of Compound Betamethasone in Alopecia Areata - A Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

联合微针倍他米松透皮给药治疗斑秃的有效性和安全性的临床研究

Scientific title：

Clinical study on the efficacy and safety of transdermal administration of combined microneedle betamethasone in the treatment of alopecia areata

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：

姜祎群 

研究负责人：

姜祎群 

Applicant：

Jiang Yiqun 

Study leader：

Jiang Yiqun 

申请注册联系人电话：

Applicant telephone：

+86 135 1251 2661

研究负责人电话：

Study leader's telephone：

+86 135 1251 2661

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：

yiqunjiang2017@163.com

研究负责人电子邮件：

Study leader's E-mail：

yiqunjiang2017@163.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：

江苏省南京市玄武区蒋王庙街12号

研究负责人通讯地址：

江苏省南京市玄武区蒋王庙街12号

Applicant address：

12 Jiangwangmiao Street, Nanjing, Jiangsu, 210042, China

Study leader's address：

12 Jiangwangmiao Street, Nanjing, Jiangsu, 210042, China

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：

中国医学科学院皮肤病医院(皮肤病研究所)

Applicant's institution：

Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College

研究负责人所在单位：

中国医学科学院皮肤病医院(皮肤病研究所)

Affiliation of the Leader：

Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

(2021)临快审第(019)号

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：

中国医学科学院皮肤病医院（中国医学科学院皮肤病研究所）医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Hospital for Skin Diseases, Institute of Dermatology, Chinae Academy of Medical Sciences and Peking Union Medical College

伦理委员会批准日期：

Date of approved by ethic committee：

2021-06-04 00:00:00

伦理委员会联系人：

聂瑾

Contact Name of the ethic committee：

Nie Jin

伦理委员会联系地址：

江苏南京蒋王庙街12号

Contact Address of the ethic committee：

12 Jiangwangmiao Street, Nanjing, Jiangsu, 210042, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 25 8547 0763

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：

中国医学科学院皮肤病医院（皮肤病研究所）

Primary sponsor：

Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College

研究实施负责（组长）单位地址：

江苏南京蒋王庙街12号

Primary sponsor's address：

12 Jiangwangmiao Street, Nanjing, Jiangsu, 210042, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏省

市(区县)：

南京市

Country：

China

Province：

Jiangsu

City：

Nanjing

单位(医院)：

中国医学科学院皮肤病医院（皮肤病研究所）

具体地址：

江苏南京蒋王庙街12号

Institution
hospital：

Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College

Address：

12 Jiangwangmiao Street, Nanjing, Jiangsu, 210042, China

经费或物资来源：

南京市国家级临床医学中心培养计划；研究者自筹

Source(s) of funding：

Nanjing Incubation Program for National Clinical Research Center (2019060001); Researchers fund themselves

Target disease：

Alopecia Areata

Target disease code：

ICD-11-ED70.27

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

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

探究联合微针透皮给药治疗斑秃的有效性和安全性；探究斑秃病人临床表现、毛发镜特征与组织病理学之间的相关性以及毛发镜检查在斑秃治疗疗效评估中的作用。  

Objectives of Study：

To evaluate the efficacy and safety of microneedle-based transdermal delivery of Compound Betamethasone in the treatment of alopecia areata;to evaluate the correlation between the clinical presentation, the trichoscopy, the histopathology and the treatment outcomes.

药物成份或治疗方案详述：

A 组为对照组,采用普通注射器进行皮损内注射给药。治疗所用 regime 为:复方倍他米 松注射液(1ml/支,含二丙酸倍他米松 5mg 和倍他米松磷酸酯二钠 2mg,制造商:先灵葆雅,上海, 中国)与盐酸利多卡因注射液(5ml/支,含盐酸利多卡因 0.1g。制造商:华北制药,石家庄,中国) 各 1ml,均匀混合。每个治疗区域大小为 1.5*1.5cm,给药量为 0.1ml。 B 组为试验组,接受经中空微针(PA-NDL9P34G1 9PIn Screw Multi Needle 制造商:Derma Shine,韩国)的给药。微针长度设定为 2.0mm。除给药方式外,B 组在给药种类、剂量和频率等 方面与 A 组保持完全一致。 

Description for medicine or protocol of treatment in detail：

Group A served as the control group, with the drug administered intralesionally using a standard syringe. The treatment regimen consisted of 1 ml of compound betamethasone injection (1 ml/vial, containing 5 mg of betamethasone dipropionate and 2 mg of betamethasone disodium phosphate, manufactured by Schering-Plough, Shanghai, China) and 1 ml of lidocaine hydrochloride injection (5 ml/vial, containing 0.1 g of lidocaine hydrochloride, manufactured by North China Pharmaceutical, Shijiazhuang, China), mixed evenly. Each treatment area measured 1.5 x 1.5 cm, with a dosage of 0.1 ml. Group B was the experimental group, with the drug administered through a hollow microneedle (PA-NDL9P34G1 9PIn Screw Multi Needle, manufactured by Derma Shine, South Korea) set to a length of 2.0 mm. Aside from the administration method, Group B was identical to Group A in terms of drug type, dosage, and frequency. 

纳入标准：

A.年龄在 18 至 55 周岁之间。 B.由临床表现及毛发镜检查诊断为斑秃。 C.疾病分型为斑片型斑秃。 D.疾病严重程度为轻-中度(Severity of Alopecia Tools score,即 SALT<50)。 E,拉发试验阴性。 F.病程持续时间≥6 月。

Inclusion criteria

A. Age between 18 and 55 years. B. Diagnosis of alopecia areata (AA) based on clinical presentation and trichoscopy. C. Disease type classified as patchy alopecia areata. D. Disease severity classified as mild to moderate (Severity of Alopecia Tool score, i.e., SALT < 50). E. Negative hair pull test. F. Disease duration ≥ 6 months.

排除标准：

A.SALT 评分≥50 的重度斑秃,包括全秃。 B.累及头皮以外毛发,包括眉毛、睫毛、胡须、腋毛、阴毛、其他部位毳毛等,包括普秃。 C.存在其他可能引起斑秃样脱发的疾病,如雄激素性脱发、梅毒性脱发、拔毛癖、休止期脱发、继发于甲状腺或其他内分泌疾病的脱发、瘢痕性脱发等。 D.在入组前 4 周内接受过其他针对斑秃的局部治疗,如梅花针、滚针、光疗、激光治疗、冷冻治疗、毛发移植、局部外用促毛发生长剂(如米诺地尔溶液、富血小板血浆、贝美前列腺素等)、局部外用刺激剂(如地蒽酚、他扎罗汀、辣椒酊等)、局部免疫疗法(如 DPCP、SADBE)、局部外用糖皮质激素、局部外用他克莫司软膏等免疫抑制剂、皮损内注射糖皮质激素,或皮损内注射免疫抑制剂等。 E.在入组前12周内接受过其他针对斑秃的系统治疗,包括口服和注射给药,如他汀类药物、抗组胺药、糖皮质激素、JAK 抑制剂、PDE4 抑制剂、生物制剂(如阿巴西普、IFN-γ单克隆抗体等)、免疫抑制剂(如甲氨蝶呤、环孢素等)、中药等。 F.存在可能影响疗效评价或安全性评价的其他疾病,如其他活动期炎症性皮肤病、其他累及头皮的疾病、头皮外伤等。 G.存在严重的未经控制的高血压、糖尿病、心血管疾病、脑血管疾病,或其他严重基础疾病。 H.存在其他糖皮质激素应用禁忌症或过敏史。 I.妊娠期、哺乳期及计划在近期妊娠的女性。 J.经研究者评估不适合参与研究的其他情形。

Exclusion criteria：

A. Severe AA with a SALT score ≥ 50, including alopecia totalis. B. Involvement of hair beyond the scalp, including eyebrows, eyelashes, beard, axillary hair, pubic hair, or other body hair, including alopecia universalis. C. Presence of other conditions that could cause alopecia-like hair loss, such as androgenetic alopecia, syphilitic alopecia, trichotillomania, telogen effluvium, hair loss secondary to thyroid or other endocrine diseases, or scarring alopecia. D. Receipt of other localized treatments for AA within 4 weeks prior to enrollment, such as plum-blossom needle, roller needle, phototherapy, laser treatment, cryotherapy, hair transplantation, topical hair growth promoters (e.g., minoxidil solution, platelet-rich plasma, bimatoprost), topical irritants (e.g., anthralin, tazarotene, capsaicin tincture), topical immunotherapy (e.g., DPCP, SADBE), topical corticosteroids, topical tacrolimus ointment, or intralesional injections of corticosteroids or immunosuppressants. E. Receipt of systemic treatments for AA within 12 weeks prior to enrollment, including oral or injectable medications such as statins, antihistamines, corticosteroids, JAK inhibitors, PDE4 inhibitors, biologics (e.g., abatacept, IFN-γ monoclonal antibody), immunosuppressants (e.g., methotrexate, cyclosporine), or traditional Chinese medicine. F. Presence of other conditions that may affect efficacy or safety evaluations, such as other active inflammatory skin diseases, other scalp-involving diseases, or scalp trauma. G. Presence of serious uncontrolled hypertension, diabetes, cardiovascular diseases, cerebrovascular diseases, or other severe underlying conditions. H. Presence of other contraindications to corticosteroid use or history of allergies to corticosteroids. I. Pregnancy, breastfeeding, or planning to become pregnant in the near future. J. Any other conditions deemed unsuitable for study participation by the investigator.

研究实施时间：

Study execute time：

从 From 2021-06-04 00:00:00至 To 2023-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2021-06-05 00:00:00 至 To 2023-06-21 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

40

Group：

Control group

Sample size：

干预措施：

采用普通注射器进行皮损内注射给药。治疗所用 regime 为:复方倍他米松注射液(1ml/支,含二丙酸倍他米松 5mg 和倍他米松磷酸酯二钠 2mg,制造商:先灵葆雅,上海, 中国)与盐酸利多卡因注射液(5ml/支,含盐酸利多卡因 0.1g。制造商:华北制药,石家庄,中国)各 1ml,均匀混合。每个治疗区域大小为 1.5*1.5cm,给药量为 0.1m

干预措施代码：

 A

Intervention：

The drug was administered intralesionally using a standard syringe. The treatment regimen consisted of 1 ml of compound betamethasone injection (1 ml/vial, containing 5 mg of betamethasone dipropionate and 2 mg of betamethasone disodium phosphate, manufactured by Schering-Plough, Shanghai, China) mixed with 1 ml of lidocaine hydrochloride injection (5 ml/vial, containing 0.1 g of lidocaine hydrochloride, manufactured by North China Pharmaceutical, Shijiazhuang, China). Each treatment area measured 1.5 x 1.5 cm, with a dosage of 0.1 ml.

Intervention code：

组别：

试验组

样本量：

40

Group：

Experimental group

Sample size：

干预措施：

接受经中空微针(PA-NDL9P34G1 9PIn Screw Multi Needle 制造商:Derma Shine,韩国)的给药。微针长度设定为 2.0mm。除给药方式外,试验组在给药种类、剂量和频率等方面与对照组保持完全一致。

干预措施代码：

 B

Intervention：

The drug was administered using a hollow microneedle (PA-NDL9P34G1 9PIn Screw Multi Needle, manufactured by Derma Shine, South Korea). The microneedle length was set to 2.0 mm. Apart from the administration method, the experimental group was completely consistent with the control group in terms of drug type, dosage, and frequency.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏省 

市(区县)：

 南京市 

Country：

China 

Province：

Jiangsu 

City：

Nanjing 

单位(医院)：

中国医学科学院皮肤病医院（皮肤病研究所） 

单位级别：

三甲 

Institution
hospital：

Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

脱发严重程度工具评分（SALT评分）

指标类型：

主要指标

Outcome：

Severity of Alopecia Tools (SALT) score

Type：

Primary indicator

测量时间点：

每次治疗前和治疗结束后1月

测量方法：

由2名以上皮肤科医生分别给出评分并核对，对比SALT评分治疗前后变化的情况

Measure time point of outcome：

Before each treatment and 1 month after treatment

Measure method：

More than 2 dermatologists will give scores and check them, and compare the changes in SALT scores before and after treatment.

指标中文名：

毛发镜检查结果

指标类型：

次要指标

Outcome：

Trichoscopy results

Type：

Secondary indicator

测量时间点：

每次治疗前和治疗结束后1月,及随访期间

测量方法：

利用毛发镜（南京，倍宁）记录黑点征等斑秃相关表现，毛囊密度、毛发直径、毛发生长状态等

Measure time point of outcome：

Before each treatment, 1 month after treatment, and during follow-up

Measure method：

Use a trichoscope (Beining, Nanjing) to record the black spot sign and other alopecia areata-related manifestations, hair follicle density, hair diameter, hair growth status, etc.

指标中文名：

头皮摄影

指标类型：

次要指标

Outcome：

Scalp Photography

Type：

Secondary indicator

测量时间点：

每次治疗前和治疗结束后1月,及随访期间

测量方法：

拍摄脱发区域的照片,包含头正面、左侧、右侧、正后和顶部

Measure time point of outcome：

Before each treatment, 1 month after treatment, and during follow-up

Measure method：

Take photos of the hair loss area, including the front, left side, right side, back, and top of the head

指标中文名：

疼痛视觉尺度量表评分（VAS评分）

指标类型：

次要指标

Outcome：

Pain visual analog scale score

Type：

Secondary indicator

测量时间点：

每次治疗结束后

测量方法：

由研究者向患者解释并询问

Measure time point of outcome：

After each treatment

Measure method：

The researchers explained to the patients and asked

指标中文名：

不良反应与安全性指标

指标类型：

次要指标

Outcome：

Adverse reactions and safety indicators

Type：

Secondary indicator

测量时间点：

每次治疗前和治疗结束后1月,及随访期间

测量方法：

研究者团队记录全身不良反应（如过敏反应、感染、重要的不良心血管事件），局部不良反应（如红肿、瘙痒、皮肤萎缩、色素变化），实验室指标（包括肝肾功能、电解质、血糖等）

Measure time point of outcome：

Before each treatment, 1 month after treatment, and during follow-up

Measure method：

The research team recorded systemic adverse reactions (such as allergic reactions, infections, and major adverse cardiovascular events), local adverse reactions (such as redness, swelling, itching, skin atrophy, and pigment changes), and laboratory indicators (including liver and kidney function, electrolytes, blood sugar, etc.)

采集人体标本：

Collecting sample(s)
from participants：

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：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 20 岁 years
最大 Max age 53 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）：

统计人员采取随机数表法将招募到的80名患者随机分为2组

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

A random number table was used to allocate 80 patients into two groups

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：

无

Blinding：

None

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

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）：

我们将主要采取研究者联系索取的方式，对于需要更详细或特定格式数据的请求，我们将设立专门的联系渠道，并依据合理的申请流程进行审核与提供。

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

We will mainly adopt the method of researchers contacting and requesting data. For requests that require more detailed or specific format data, we will establish a dedicated contact channel and review and provide them according to a reasonable application process.

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：

数据采集上，由研究者记录参与者在治疗与随访期间的基线与人口学资料、临床图像、毛发镜图像、疗效指标、安全性指标。数据管理上，本临床试验将采用规范化的数据采集与管理系统，即病例记录表（CRF）结合基于互联网的EDC系统。

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

In terms of data collection, the researchers recorded the baseline and demographic data, clinical images, hair mirror images, efficacy indicators, and safety indicators of participants during treatment and follow-up. In terms of data management, this clinical trial will adopt a standardized data acquisition and management system, that is, case record form (CRF) combined with Internet based EDC system.

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：

  2024-07-29 14:28:58