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一项评价YH001胶囊在白癜风患者中的疗效和安全性的临床研究
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注册号：

Registration number：

 ChiCTR2400088848 

最近更新日期：

Date of Last Refreshed on：

 2024-08-28 08:55:19 

注册时间：

Date of Registration：

 2024-08-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项评价YH001胶囊在白癜风患者中的疗效和安全性的临床研究

Public title：

A clinical study to evaluate the efficacy and safety of YH001 capsule in patients with vitiligo

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项评价YH001胶囊在白癜风患者中的疗效和安全性的临床研究

Scientific title：

A clinical study to evaluate the efficacy and safety of YH001 capsule in patients with vitiligo

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：

景海霞 

研究负责人：

景海霞 

Applicant：

Jing Haixia 

Study leader：

JingHaixia 

申请注册联系人电话：

Applicant telephone：

 +86 13872808991

研究负责人电话：

Study leader's
telephone：

+86 13872808991

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：

 jinghaixia1210@163.com

研究负责人电子邮件：

Study leader's E-mail：

 jinghaixia121@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：

湖北省十堰市茅箭区人民南路32号

研究负责人通讯地址：

湖北省十堰市人民南路32号

Applicant address：

32 Renmin South Road, Maojian District, Shiyan City, Hubei Province

Study leader's address：

NO. 32, RENMIN SOUTH ROAD, SHIYAN CITY, HUBEI PROVINCE

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：

十堰市太和医院

Applicant's institution：

Shiyan City Taihe Hospital

研究负责人所在单位：

十堰市太和医院

Affiliation of the Leader：

TaiHe Hospital

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：

 2024KY10

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：

十堰市太和医院伦理委员会

Name of the ethic committee：

Ethics Committee of Shiyan Taihe Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-06-12 00:00:00

伦理委员会联系人：

王莉博

Contact Name of the ethic committee：

Wang LiBo

伦理委员会联系地址：

湖北省十堰市人民南路32号

Contact Address of the ethic committee：

NO. 32, RENMIN SOUTH ROAD, SHIYAN CITY, HUBEI PROVINCE

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 719 8801630

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 1973518428@qq.com

研究实施负责（组长）单位：

十堰市太和医院

Primary sponsor：

TaiHe Hospital

研究实施负责（组长）单位地址：

湖北省十堰市人民南路32号

Primary sponsor's address：

NO. 32, RENMIN SOUTH ROAD, SHIYAN CITY, HUBEI PROVINCE

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖北

市(区县)：

Country：

China

Province：

Hubei

City：

单位(医院)：

十堰市太和医院

具体地址：

湖北省十堰市人民南路32号

Institution
hospital：

TaiHe Hospital

Address：

NO. 32, RENMIN SOUTH ROAD, SHIYAN CITY, HUBEI PROVINCE

经费或物资来源：

杭州禹泓医药科技有限公司

Source(s) of funding：

Hangzhou Yuhong Medical Technology Co., LTD

研究疾病：

非节段型白癜风（Non-segmental vitiligo）患者  

Target disease：

Non-segmental vitiligo

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：

评估YH001胶囊在非节段型白癜风患者中的初步有效性，安全性和耐受性  

Objectives of Study：

To evaluate the initial efficacy, safety and tolerability of YH001 capsule in patients with non-segmental vitiligo

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

排除标准：

1. 存在临床显著的多种或严重药物过敏，或严重的治疗后过敏反应者（包括但不限于严重多形性红斑、线性免疫球蛋白A [IgA]皮肤病、中毒性表皮坏死松解症和剥脱性皮炎等），或研究者预计受试者对研究药物或其任何成分过敏者；
2. 诊断为节段型白癜风、混合型白癜风或其他类型的白癜风者；
3. 白斑只发生在无毛发区域或者白斑部位的无毛发区域≥30%，如嘴唇、手掌、手指、阴唇等部位；
4. 面部或身体病变部位毛发脱色（白色毛发）占总脱色部位≥33%者（即皮损面积中超过33%出现白发）；
5. 筛选期有其他活动的色素性皮肤病者，包括但不限于白色糠疹，老年性白斑，化学/药物引起的白癜风，Vogt-Koyanagi-Harada病，恶性肿瘤引起的色素沉着（如黑色素瘤和蕈样肉芽肿），炎症后色素沉着共济失调毛细血管扩张，结节性硬化症，黄褐斑和先天性色素沉着障碍，包括皮疹，瓦登堡综合征，伊藤黑色素沉着症，色素失禁，对称性色素沉着异常，色素干皮症和色素沉着痣等。注意：允许晕痣（也称为萨顿痣）共存；
6. 筛选期有活动的炎症性皮肤病或皮肤状况的证据者，包括但不限于特应性皮炎、银屑病、盘状狼疮、麻风病、梅毒、脂溢性皮炎等，经研究者评估会干扰对白癜风治疗反应和安全性评价；
7. 既往病史或现病史中合并以下任何一种疾病者：自身免疫性甲状腺炎、系统性红斑狼疮、类风湿性关节炎、炎症性肠病、间质性肺炎、Addison病、内因子抗体导致的恶性贫血、I型糖尿病等，经研究者评估认为这些疾病或病史在使用研究药物的情况下会带来风险，或者会干扰数据的解读；
8. 有活动性感染（包括局部感染），或复发感染史（不包括甲藓），或需要处理的感染者，如下： (1) 目前正在接受任何抗微生物（如肺囊虫、巨细胞病毒、单纯疱疹病毒、带状疱疹及非典型分枝杆菌）治疗； (2) 筛选前4周内使用静脉输注（IV）或肌内注射（IM）抗微生物药（抗生素、抗病毒药、抗真菌药或抗寄生虫药）或首次给药前2周内口服抗微生物药（除用于潜伏性肺结核治疗的异烟肼）； (3) 筛选前4周内因感染接受住院治疗； (4) 筛选前3个月内内有播散性带状疱疹或播散性单纯疱疹史（单次发作）或者复发性（发作超过一次）带状疱疹者； (5) 遗传性或获得性免疫功能缺陷疾病，包括免疫球蛋白缺乏症； (6) 筛选时已知感染人类免疫缺陷病毒（HIV）或HIV抗体阳性、梅毒非特异性抗体阳性（快速血浆反应素环状卡片试验[RPR]或甲苯胺红不加热血清试验[TRUST]）； (7) 任何时间的关节假体感染病史，且假体仍留在原位；慢性腿部溃疡、永久性留置导管、慢性鼻窦炎、复发性胸部感染或复发性尿路感染病史；
9. 存在以下与结核分枝杆菌（TB）感染相关者； (1) 目前或既往存在活动性结核分枝杆菌（TB）； (2) 有患有潜伏性肺结核证据（由筛选时 QuantiFERON-TB Gold plus 检测或 T-SPOT检测阳性证实，未发现与活动性肺结核一致的病史或临床检查结果，且胸片正常），除了受试者有以下两种情况之一：  愿意在首次给药之前按照WHO或国家指南完成至少4周的抗结核治疗，并同意在研究期间完成后续抗结核治疗或；  经研究者审查在过去5年内记录有令人满意的根据WHO或国家指南的抗结核治疗的证据； (3) 曾与活动性肺结核患者密切接触史，且未接受根据WHO或国家指南推荐的满意的抗结核治疗；
10. 筛选时经研究者判断，存在不稳定的肝脏或胆道疾病者，定义为腹水、脑病、凝血障碍、低白蛋白血症、食管或胃静脉曲张、持续性黄疸或肝硬化；
11. 筛选时患有恶性肿瘤，需要治疗（如手术、化疗或放疗）者；
12. 过去10年内曾罹患乳腺癌，或过去5年内曾罹患淋巴瘤、白血病或任何其它恶性肿瘤者，除外已切除且无复发或转移性疾病证据的宫颈原位癌，或已切除且至少3年无复发或转移性疾病证据的皮肤基底细胞癌或鳞状上皮癌；
13. 有淋巴组织增生性疾病病史者，如EB病毒相关的淋巴增生性疾病，或存在提示淋巴增生性疾病的各种症状或体征者；
14. 在首次给药前8周内进行任何重大手术者，或在研究期间需要进行在研究者与医学监察员讨论后认为将对受试者构成不可接受风险的重大手术；
15. 首次给药前4周内有严重外伤史者；
16. 筛选前3个月内有过献血或失血≥ 400 mL者，或筛选前4周内接受过输血；
17. 应用过以下治疗者： (1) 应用过脱色治疗； (2) 接受过黑色素细胞-角化细胞移植手术； (3) 4周内接受过皮肤染棕剂（二羟丙酮）治疗； (4) 既往接受过任何Janus激酶（JAK）抑制剂（试验性或已获批），包括但不限于芦可替尼、托法替布、巴瑞替尼、利特昔替尼、乌帕替尼、菲尔替尼和培非替尼等； (5) 既往接受过IL12/23抑制剂（如乌司奴单抗）和任何B细胞消耗剂（如利妥昔单抗）； (6) 首次给药前4周内使用免疫调节口服或全身药物（如皮质类固醇、甲氨蝶呤、环孢素） (7) 首次给药前2周可能影响白癜风的局部治疗（如皮质激素、他克莫司/吡美莫司、类视黄醇）； (8) 首次给药前4周内，曾进行光疗（包括晒床）或使用过光敏治疗药物； (9) 首次给药前1周内，使用过任何含有中（草）药成分的药物； (10) 首次给药前12周或药物的5个半衰期（以短者为准）使用过生物制剂；根据研究者的判断，使用上文未列出的任何可能干扰研究目标的既往和伴随治疗，包括筛选后8周内引起光敏性或皮肤色素沉着的药物（如抗生素，如四环素、抗真菌药）；
18. 在筛选前4周内参加过其他干预性临床研究并用药者；
19. 筛选时经研究者判断，存在或有其它重要伴随疾病病史者，例如，但不限于： (1) 心血管事件：包括根据纽约心脏病协会分级的III或IV级心力衰竭、3个月内心肌梗死、不稳定型心绞痛等； (2) QTcF＞470 ms（女性）或＞450 ms（男性）或先天性长QT综合征病史或家族史； (3) 未得到控制的高血压（药物治疗下仍收缩压＞160 mmHg或舒张压＞100 mmHg）； (4) 未得到控制的糖尿病（糖化血红蛋白（hemoglobin A1C，HbA1c）≥7.0%）； (5) 未得到控制的甲状腺功能亢进症； (6) 需要抗凝治疗的静脉血栓栓塞； (7) 神经系统、内分泌系统、胃肠（包括憩室炎）、肝脏疾病、代谢疾病、淋巴系统疾病或既往肾移植，对受试者参与本研究有不利影响的；
20. 筛选前12周内胸部影像学检查异常，且经研究者评估不适合入组者，包括但不限于肺结核、全身感染、心力衰竭或恶性肿瘤；
21. 筛选时临床确诊乙型肝炎（HBV）或丙型肝炎（HCV）感染者。包括活动性和非活动性： (1) 乙型肝炎病毒（HBV）：乙型肝炎表面抗原（HBs Ag）阳性，或对于乙型肝炎核心抗体（HBc Ab）阳性受试者（以及对于乙型肝炎表面抗体阳性的受试者，如果有当地要求）的HBV脱氧核糖核酸（DNA）聚合酶链反应（PCR）检测具有可检测结果； (2) 丙型肝炎病毒（HCV）：在任何具有抗HCV抗体（HCV Ab）的受试者中可检测到HCV核糖核酸（RNA）；
22. 筛选时TSH、游离T4、游离T3异常有临床意义且研究者评估不适合入组者；
23. 实验室检查检测值有以下任一特定异常情况者：  血红蛋白≤90 g/L；白细胞（WBC）计数≤3.0×109 /L；血小板计数≤100×109 /L；中性粒细胞绝对值（ANC）<1.2×109 /L；淋巴细胞计数≤0.75×109 /L；  丙氨酸转氨酶（ALT）或者天冬氨酸转氨酶（AST）>1.5倍ULN；  胆红素>1.5倍ULN（Gilbert综合症受试者的总胆红素应＜3倍ULN）；  国际标准化比值INR＞1.5倍ULN；  采用慢性肾脏病流行病学协作公式（CKD-EPI）计算的估算肾小球滤过率（eGFR）<60 mL/min/1.73m2  血肌酸激酶＞3倍ULN或尿肌红蛋白阳性；
24. 在研究前、研究期间或研究的4周安全性随访期间，预期不依从药物限制者；
25. 妊娠或哺乳，或计划妊娠或开始哺乳的女性；
26. 有药物或酒精滥用史或患有精神疾病者（包括自杀想法和行为、临床显著抑郁等）；
27. 研究者认为不适合参加本次试验的其他情况。

Exclusion criteria：

1. Clinically significant multiple or severe drug allergies, or severe post-treatment allergic reactions (including, but not limited to, severe erythema multiforme, linear immunoglobulin A [IgA] skin disease, toxic epidermal necrosis, and exfoliative dermatitis), or those who are expected by the investigator to be allergic to the investigational drug or any of its components;
2. Patients diagnosed with segmental vitiligo, mixed vitiligo or other types of vitiligo;
3. White spots only occur in hairless areas or hairless areas of white spots ≥30%, such as lips, palms, fingers, labia and other parts;
4. Facial or body lesions (white hair) accounted for more than 33% of the total decolorization (that is, more than 33% of the skin area has white hair);
5. Patients with other pigmentogenic skin diseases active during the screening period, including but not limited to pityriasis albus, senile leukoplakia, chemical/drug-induced vitiligo, Vogt-Koyanagi-Harada disease, hyperpigmentation due to malignant tumors (such as melanoma and mycosis fungoides), post-inflammatory hyperpigmentation ataxia telangiectasia, Nodular sclerosis, melasma, and congenital pigmentation disorders, including rashes, Wardenburg syndrome, Itoh melanosis, pigment incontinence, symmetrical dyspigmentation, xeroderma pigmenti, and pigmented moles, among others. Note: Allow halo nevus (also known as Sutton's nevus) to coexist;
6. Evidence of active inflammatory skin diseases or skin conditions during the screening period, including but not limited to atopic dermatitis, psoriasis, discoid lupus, leprosy, syphilis, seborrheic dermatitis, etc., is estimated by investigators to interfere with the treatment response and safety evaluation of vitiligo;
7. Patients with pre-existing or present medical history combined with any of the following diseases: Autoimmune thyroiditis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, interstitial pneumonia, Addison's disease, pernymia caused by endogenous factor antibodies, type I diabetes mellitus, etc., which the investigator has assessed to pose a risk with the use of the investigational drug or which may interfere with the interpretation of the data;
8. Infected persons who have an active infection (including local infection), or a history of recurrent infection (excluding sphagnum moss), or who require treatment, are: (1) currently receiving any antimicrobial treatment (such as pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, and Mycobacterium atypical); (2) intravenous infusion (IV) or intramuscular injection (IM) of antimicrobials (antibiotics, antivirals, antifungals, or antiparasites) within 4 weeks prior to screening or oral antimicrobials (except isoniazid for latent tuberculosis treatment) within 2 weeks prior to initial administration; (3) hospitalization for infection within 4 weeks prior to screening; (4) Patients with a history of disseminated shingles or disseminated herpes simplex (single episode) or recurrent shingles (more than one episode) within 3 months prior to screening; (5) Hereditary or acquired immunodeficiency diseases, including immunoglobulin deficiency; (6) Known infection with human immunodeficiency virus (HIV) or HIV antibody positive, syphilis non-specific antibody positive at the time of screening (rapid plasmapherin ring card test [RPR] or toluidine red unheated serum test [TRUST]); (7) A history of infection of the joint prosthesis at any time while the prosthesis remains in place; A history of chronic leg ulcers, permanent catheterization, chronic sinusitis, recurrent chest infections, or recurrent urinary tract infections;
9. The presence of the following persons associated with Mycobacterium tuberculosis (TB) infection; (1) Current or past presence of active Mycobacterium tuberculosis (TB); (2) Evidence of latent tuberculosis (confirmed by a positive QuantiFERON-TB Gold plus test or T-SPOT test at screening, no history or clinical findings consistent with active tuberculosis, and a normal chest radiograph), except when the subject has one of the following:  Be willing to complete at least 4 weeks of anti-TB therapy in accordance with WHO or national guidelines prior to initial dosing and agree to complete follow-up anti-TB therapy during the study period or;  Satisfactory evidence of documented anti-TB treatment according to WHO or national guidelines within the last 5 years, reviewed by the investigator; (3) have a history of close contact with a person with active tuberculosis and have not received satisfactory anti-tuberculosis treatment as recommended by WHO or national guidelines;
10. Patients with unstable liver or biliary tract diseases judged by researchers during screening were defined as ascites, encephalopathy, coagulation disorders, hypoalbuminemia, esophageal or gastric varicose veins, persistent jaundice or cirrhosis;
11. Patients who have malignant tumors at the time of screening and require treatment (such as surgery, chemotherapy or radiotherapy);
12. Patients who have had breast cancer within the last 10 years, or lymphoma, leukaemia or any other malignancy within the last 5 years, other than carcinoma in situ of the cervix, which has been resected and has no evidence of recurrent or metastatic disease, or basal cell carcinoma or squamous epithelial carcinoma of the skin, which has been resected and has no evidence of recurrent or metastatic disease for at least 3 years;
13. People with a history of lymphoproliferative diseases, such as Epstein-Barr virus-related lymphoproliferative diseases, or with symptoms or signs suggestive of lymphoproliferative diseases;
14. Any major surgery performed within 8 weeks prior to the first dosing, or required during the study period that, after discussion between the investigator and the medical Ombudsman, would pose an unacceptable risk to the subject;
15. Patients with a history of severe trauma within 4 weeks prior to the first dose;
16. Patients who have donated blood or lost blood ≥ 400 mL within 3 months before screening, or received blood transfusions within 4 weeks before screening;
17. Patients who have applied the following treatments: (1) decolorization therapy; (2) Have received melanocyte-keratinocyte transplantation; (3) Received skin brown dye (dihydroxyacetone) treatment within 4 weeks; (4) Prior acceptance of any Janus kinase (JAK) inhibitors (investigational or approved), including but not limited to rucotinib, Tofacitib, Bariatinib, litxitinib, Upatinib, Feltinib, and pefitinib; (5) Prior IL12/23 inhibitor (e.g. Ulinumab) and any B-cell depleting agent (e.g. Rituximab); (6) Use of immunomodulatory oral or systemic drugs (e.g., corticosteroids, methotrexate, cyclosporine) within 4 weeks prior to initial administration (7) local treatments that may affect vitiligo (e.g., corticosteroids, tacrolimus/pimeclimus, retinoids) within 2 weeks prior to initial administration; (8) Use of phototherapy (including bed tanning) or photosensitizing drugs within 4 weeks before the first dose; (9) Use of any drug containing Chinese (herbal) ingredients within 1 week before the first dose; (10) Use of biologics in the 12 weeks prior to the first dosing or in the 5 half-lives of the drug (whichever is shorter); Use, in the investigator's judgment, any prior and concomitant treatment not listed above that may interfere with the study objective, including drugs that cause photosensitivity or skin pigmentation within 8 weeks of screening (e.g., antibiotics, e.g., tetracycline, antifungal agents);
18. Participants who participated in other interventional clinical studies and used drugs within 4 weeks prior to screening;
19. Patients who, as determined by the investigator at the time of screening, had or had a history of other significant concomitant diseases, such as, but not limited to: (1) cardiovascular events, including heart failure of Class III or IV according to the New York Heart Association, myocardial infarction within 3 months, and unstable angina pectoris; (2) QTcF > 470 ms (female) or > 450 ms (male) or congenital long QT syndrome history or family history; (3) Uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg despite medical treatment); (4) Uncontrolled diabetes (hemoglobin A1C, HbA1c ≥7.0%); (5) Uncontrolled hyperthyroidism; (6) Venous thromboembolism requiring anticoagulant treatment; (7) Nervous system, endocrine system, gastrointestinal (including diverticulitis), liver disease, metabolic disease, lymphatic system disease, or previous kidney transplantation, which have adverse effects on participants' participation in this study;
20. Patients with abnormal chest imaging within 12 weeks prior to screening and assessed by the investigators as unsuitable for inclusion, including but not limited to tuberculosis, systemic infection, heart failure, or malignancy;
21. Patients with hepatitis B (HBV) or hepatitis C (HCV) were clinically confirmed at the time of screening. Including active and inactive: (1) Hepatitis B virus (HBV) : Hepatitis B surface antigen (HBs Ag) positive, or have a detectable result for HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) testing for hepatitis B core antibody (HBc Ab) positive subjects (and for hepatitis B surface antibody positive subjects, if locally required); Hepatitis C virus (HCV) : HCV ribonucleic acid (RNA) is detectable in any subject with anti-HCV antibodies (HCV Ab);
22. Patients with abnormal TSH, free T4 and free T3 were clinically significant during screening and were not suitable for inclusion as assessed by the investigators;
23. Laboratory tests have any of the following specific abnormalities:  hemoglobin ≤90 g/L; White blood cell (WBC) count ≤3.0×109 /L; Platelet count ≤100×109 /L; The absolute value of neutrophil (ANC) was <1.2×109 /L. Lymphocyte count ≤0.75×109 /L;  alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times ULN;  bilirubin >1.5 ULN (total bilirubin < 3 ULN in subjects with Gilbert syndrome);  International normalized ratio INR > 1.5 times ULN;  Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2  blood creatine kinase > triple ULN or urine myoglobin positive using the Collaborative Formula for the Epidemiology of Chronic Kidney Disease (CKD-EPI);
24. People who are not expected to adhere to the drug restriction before, during, or during the 4-week safety follow-up of the study;
25. Women who are pregnant or breastfeeding, or who plan to become pregnant or start breastfeeding;
26. A history of drug or alcohol abuse or mental illness (including suicidal thoughts and behaviour, clinically significant depression, etc.);
27. Other conditions deemed unsuitable for participation in this trial by the investigator.

研究实施时间：

Study execute time：

从 From 2024-05-15 00:00:00至 To 2025-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-08-30 00:00:00 至 To 2024-10-31 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 20

Group：

Intervention group

Sample size：

干预措施：

YH001胶囊200mg口服

干预措施代码：

Intervention：

YH001 capsule 200mg orally

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖北 

市(区县)：

  

Country：

China

Province：

Hubei

City：

单位(医院)：

 十堰市太和医院 

单位级别：

 三级甲等 

Institution
hospital：

TaiHe Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

全身白癜风面积评分指数（T-VASI）

指标类型：

主要指标

Outcome：

T-VASI

Type：

Primary indicator

测量时间点：

4/8/12/16/20/24周

测量方法：

全身VASI（T-VASI）使用公式计算，包括全部身体区域（可能的范围为0-100）； ???????? = Σ [手掌单位] * [脱色程度] 所有部位； 身体分为以下6个独立且互相区分的部位：（1）头/颈部，（2）手，（3）上肢（不包括手），（4）躯干，（5）下肢（不包括脚），（6）脚。在整个研究过程中，由同一位研究者估算白癜风的百分比（占BSA的百分比）。手掌单位基于受试者的手部表面积。确定

Measure time point of outcome：

week 4/8/12/16/20/24

Measure method：

Whole-body VASI (T-VASI) is calculated using a formula that includes all body areas (possible range 0-100); ???????? = Σ [palm unit] * [degree of decoloration] all parts; The body is divided into the following 6 separate and distinct parts: (1) head/neck, (2) hands, (3) upper limbs (excluding hands), (4) trunk, (5) lower limbs (excluding feet), and (6) feet. The percentage of vitiligo (as a percentage of BSA) was estimated by the same investigator throughout the study. The palm unit is based on

指标中文名：

不良事件

指标类型：

副作用指标

Outcome：

Adverse events

Type：

Adverse events

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：

NA

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 12 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:

不公开/Private

盲法：

无

Blinding：

None

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）：

数据不共享

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

Data not shared

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：

收录在研究中心的病历记录中

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

It's in the center's medical records

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2024-08-28 08:53:18
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