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：	ChiCTR2600127232
最近更新日期： Date of Last Refreshed on：	2026-06-26 17:51:43
注册时间： Date of Registration：	2026-06-26 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	在成人非节段型白癜风患者中评价RSS0393软膏和SHR0302碱凝胶单药或联合局部外用的疗效和安全性的临床研究
Public title：	A clinical study evaluating the efficacy and safety of RSS0393 ointment and SHR0302 Base gel as monotherapy or in combination for topical use in adult patients with non‑segmental vitiligo
注册题目简写：
English Acronym：
研究课题的正式科学名称：	在成人非节段型白癜风患者中评价RSS0393软膏和SHR0302碱凝胶单药或联合局部外用的疗效和安全性的临床研究
Scientific title：	A clinical study evaluating the efficacy and safety of RSS0393 ointment and SHR0302 Base gel as monotherapy or in combination for topical use in adult patients with non‑segmental 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：	顾军	研究负责人：	顾军
Applicant：	Jun Gu	Study leader：	Jun Gu
申请注册联系人电话： Applicant telephone：	+86 18930939371	研究负责人电话： Study leader's telephone：	+86 18930939371
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：	gujun79@163.com	研究负责人电子邮件： Study leader's E-mail：	gujun79@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：	江苏省苏州市道前街26号	研究负责人通讯地址：	江苏省苏州市道前街26号
Applicant address：	26 Daoqian Street, Suzhou, Jiangsu Province	Study leader's address：	26 Daoqian Street, Suzhou, Jiangsu 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：	苏州市立医院
Applicant's institution：	Suzhou Municipal Hospital
研究负责人所在单位：	苏州市立医院
Affiliation of the Leader：	Suzhou Municipal 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：	K-2026-011-K01	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：	苏州市立医院伦理委员会
Name of the ethic committee：	Ethics Committee Suzhou Municipal Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2026-03-05 00:00:00
伦理委员会联系人：	周蓦
Contact Name of the ethic committee：	Zhou Mo
伦理委员会联系地址：	江苏省苏州市道前街26号
Contact Address of the ethic committee：	26 Daoqian Street, Suzhou, Jiangsu Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 512 62362550	伦理委员会联系人邮箱： Contact email of the ethic committee：	szslyyec@163.com

研究实施负责（组长）单位：

苏州市立医院

Primary sponsor：

Suzhou Municipal Hospital

研究实施负责（组长）单位地址：

江苏省苏州市道前街26号

Primary sponsor's address：

26 Daoqian Street, Suzhou, Jiangsu 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)：	江苏省	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	苏州市立医院	具体地址：	江苏省苏州市道前街26号
Institution hospital：	Suzhou Municipal Hospital	Address：	26 Daoqian Street, Suzhou, Jiangsu Province

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Funds and trial materials raised independently

研究疾病：

非节段性白癜风

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：

II期临床试验

Study phase：

2

研究设计：

非随机对照试验

Study design：

Non randomized control

研究目的：

评价RSS0393软膏和SHR0302碱凝胶单药或联合局部外用在成人非节段型白癜风患者中的有效性

Objectives of Study：

To evaluate the efficacy of RSS0393 ointment and SHR0302 alkaline gel, either as monotherapy or in combination for topical application, in adult 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

1. Participants must be between 18 and 75 years old on the day they sign the informed consent, and can be male or female;
2. Clinically diagnosed with non-segmental vitiligo;
3. Disease has been stable for over 3 months (90 days) (stable disease is defined as no enlargement of existing lesions and no new lesions);
4. At screening and baseline, the affected BSA (Body Surface Area) must meet the following two points at the same time:
   (1) Facial BSA affected >=0.3%; and 
   (2) Non-facial BSA affected <=10% (Note: lesions on palms, fingers, dorsal side of thumbs including metacarpophalangeal joints, soles or dorsal feet, toes, genitals, and mucous membranes are not included in the assessment); (Remark: 1% BSA is roughly equal to the area of one participant's handprint [palm plus 5 fingers]);
5. At screening and baseline, the Facial Vitiligo Area Scoring Index (F-VASI) >=0.15;
6. Participants agree to stop using all vitiligo-related treatments and any camouflaging cosmetics with therapeutic effects throughout the study (except for non-prescription preparations and cosmetics approved by the investigator);
7. Participants voluntarily sign informed consent before any study-related procedures, can communicate well with the investigators, understand and are willing to strictly follow the requirements of this clinical study to complete it;
8. Female participants of childbearing potential or male participants with partners of childbearing potential must agree to not conceive, donate sperm/eggs from the time of signing the informed consent until 6 months after the last medication, and voluntarily use effective contraception (including for partners).

排除标准：

1.存在下列任何皮肤异常或疾病： (1)确诊为节段型、混合型或未分化型白癜风的参与者；或既往诊断为其他皮肤色素沉着障碍（如斑疹、白斑病、白色糠疹、斑状白化病、无色素痣、麻风、炎症后色素沉着减退、贫血痣、化学性白斑病、花斑癣等）的参与者（晕痣除外）； (2)白癜风导致的面部皮损面积超过33%出现白色毛发，或白癜风导致的总体皮损面积超过33%出现白色毛发； (3)筛选期或基线时患有可能干扰研究药物使用或研究药物疗效评价的其他活动性皮肤病变（银屑病、皮炎、湿疹、痤疮、特应性皮炎、发育不良痣、硬斑病、盘状狼疮或其他皮肤病变、皮肤破溃等）或皮肤感染（细菌、真菌、病毒等）； (4)参与者存在可能影响研究药物给药部位评估的皮肤损伤或异常，如皮炎、纹身、疤痕、毛发过多、胎记、损伤、不均匀肤色、晒伤等； 2. 下列任何药物或参加临床研究（定义为签署了知情同意书并至少接受过一次药物或器械治疗）： (1) 在基线前 4 周内接受针对白癜风的任何激光或光学治疗（包括 NB-UVB、308nm准分子光、308nm 准分子激光、日光浴床等）的参与者； (2) 在基线前 4 周内接受旨在控制/改善白癜风症状的口服或全身用药物的参与者，包括糖皮质激素、刺激黑素细胞的药物、免疫调节剂（环孢素、甲氨蝶呤、他克莫司等）、其他可能增加皮肤对紫外线/可见光敏感性或影响皮肤色素沉着的全身治疗（如四环素、甲氧补骨脂素等）； (3) 在基线前 2 周内接受旨在控制/改善白癜风症状的外用治疗，包括外用糖皮质激素、钙调磷酸酶抑制剂（如他克莫司、吡美莫司等）、维生素 D3 衍生物（如卡泊三醇、他卡西醇等）等的参与者； (4) 在基线前 4 周内，接受过全身性中药治疗； (5) 在基线前 4 周内接受过口服 JAK 抑制剂/PDE4 抑制剂，或在基线前 2 周内接受过外用 JAK 抑制剂/PDE4 抑制剂，或既往对口服/外用 JAK 抑制剂/PDE4 抑制剂无效或不耐受（经研究者判断）； (6) 基线前 4 周内使用过中效、强效 CYP3A4 抑制剂或诱导剂类药物（包括处方药、非处方药及膳食补充剂）的全身性治疗（详见附录 11.3）； (7) 在基线前 12 周或 5 个半衰期（以更长者为准）内使用过任何生物制剂的参与者； (8) 基线前 4 周内参加其他干预性临床研究的参与者，或基线时仍处在干预性临床研究药物末次给药 5 个半衰期内的参与者； (9) 曾经使用过皮肤脱色治疗（如氢醌单本醚、对苯二甲酚单苯醚等）的参与者； (10) 既往接受过皮肤移植治疗的参与者； 3. 存在下列影响安全性的重要病史或基础疾病： (1) 参与者在筛选访视之前的 5 年内有任何活动性恶性肿瘤或恶性肿瘤病史，经治疗已痊愈的皮肤鳞癌或基底细胞癌或原位宫颈癌除外； (2) 基线前 2 周内存在活动性感染需要全身抗感染治疗，或其他经研究者判断不适合参加本研究的慢性、复发性、活动性感染等； (3) 既往发作过两次及以上带状疱疹、发生过一次播散性带状疱疹史或其他研究者认为可能会因参与研究而出现加重的感染史； (4) 已知或疑似免疫抑制史，包括侵袭性机会性感染史（如结核病、组织胞浆菌病、李斯特菌病、球孢子菌病、肺囊虫病、曲霉菌病），尽管感染已缓解； (5) 当前患有活动性结核感染，或胸片影像学检查提示存在活动性结核感染； (6) 筛选前 1 个月内接受过任何手术，或经研究者判定尚未恢复者，或在研究期间计划任何手术者； (7) 目前患有甲状腺疾病（包括甲状腺功能亢进，甲状腺功能减退）或正在接受甲状腺替代疗法的参与者。筛选期 TSH 水平异常，并同时存在 fT4 或 fT3 值异常的参与者。筛选期 TSH 或 fT4 或 fT3 值异常且具有临床意义（体征和/或症状提示甲状腺功能减退或甲状腺功能亢进）的参与者； (8) 患有其它任何持续性活动性自身免疫性疾病，或有需要/可能需要长期给予系统激素/免疫抑制剂治疗的临床疾病，包括但不限于类风湿关节炎、系统性红斑狼疮、硬皮病或多肌炎、多发性硬化症或其它中枢性脱髓鞘疾病、原发干燥综合征、免疫缺陷综合征（如费尔蒂综合征）等； (9) 任何经研究者判断存在严重的、进行性的、未控制的心脑血管、呼吸、肝脏、肾脏、胃肠道、泌尿生殖、神经、精神、骨骼肌肉、皮肤、感觉、内分泌或血液系统异常或疾病，或可能影响参与试验的医疗措施、身体状况等，或可能置参与者于不适当的风险之中； 4. 筛选时实验室检查和/或 12-导联心电图中出现下述情况： (1) 血红蛋白（男性）＜100.0 g/L，或（女性）＜90.0 g/L； (2) 白细胞计数＜3.0×10^9/L； (3) 中性粒细胞计数＜1.5×10^9/L； (4) 血小板计数＜100×10^9/L； (5) 绝对淋巴细胞计数<0.5×10^9/L； (6) 丙氨酸氨基转移酶（ALT）或天门冬氨酸氨基转移酶（AST）＞2 倍正常值上限（ULN）； (7) 总胆红素（TBIL）＞1.5 倍正常值上限（ULN）； (8) 简化肾脏病饮食调整（MDRD）公式计算的估计的肾小球滤过率（eGFR）＜60mL/min/1.73 m^2（详见附录 11.2），或者正在进行常规血液透析或腹膜透析，或血肌酐超出正常值范围，经研究者判定不适合参与本研究者； (9) 乙肝表面抗原（HBsAg）、人免疫缺陷病毒抗体（HIV）、梅毒抗体检查、抗丙型肝炎病毒（HCV）抗体检查阳性；如果 HBsAg 阴性，但乙型肝炎核心抗体（HBcAb）阳性并且乙肝病毒脱氧核糖核酸（HBV DNA）阳性或超出正常值上限； (10) 12-导联心电图检查提示有临床意义的可能影响参与者安全的异常，包括但不限于急性心肌缺血、心肌梗死、严重心律失常或显著 QTc 延长（QTc>500 ms）； 5. 一般情况： (1) 妊娠或哺乳期女性，妊娠定义为怀孕后到终止妊娠前的女性状态且筛选期或基线血β-人绒毛膜促性腺激素（β-HCG）检测阳性； (2) 对研究药物或研究药物中的任何成分过敏； (3) 在筛选前一年内有酗酒或非法药物滥用史； (4) 基线前 8 周内献血约 500 mL 或在研究期间有献血计划； (5) 经研究者判断，预计本研究治疗期间治疗区域将接受可能影响疗效评估的人工光照或日光浴等； (6) 研究者判断存在影响研究药物安全性和疗效评价或其他不适合入组的情况。

Exclusion criteria：

1. Having any of the following skin abnormalities or conditions: (1) Participants diagnosed with segmental, mixed, or unclassified vitiligo; or previously diagnosed with other skin pigmentation disorders (such as rashes, leukoderma, pityriasis alba, macular hypomelanosis, achromic nevi, leprosy, post-inflammatory hypopigmentation, nevus anemicus, chemical leukoderma, tinea versicolor, etc.) (except halo nevi); (2) Participants with more than 33% of facial lesions from vitiligo showing white hair, or over 33% of total body lesions showing white hair due to vitiligo; (3) Participants who, during screening or baseline, have other active skin conditions that could interfere with the use of the study drug or evaluation of its efficacy (psoriasis, dermatitis, eczema, acne, atopic dermatitis, dysplastic nevi, morphea, discoid lupus, or other skin lesions, skin ulceration, etc.) or skin infections (bacterial, fungal, viral, etc.); (4) Participants with skin injuries or abnormalities that could affect the assessment of the drug application site, such as dermatitis, tattoos, scars, excess hair, birthmarks, injuries, uneven skin tone, sunburn, etc. 2. Any participant who has taken the following medications or participated in clinical studies (defined as having signed an informed consent form and received at least one treatment with a drug or device): (1) Participants who received any laser or light therapy for vitiligo (including NB-UVB, 308nm excimer light, 308nm excimer laser, sunbeds, etc.) within 4 weeks before baseline; (2) Participants who received oral or systemic medications aimed at controlling/improving vitiligo symptoms within 4 weeks before baseline, including glucocorticoids, drugs that stimulate melanocytes, immunomodulators (cyclosporine, methotrexate, tacrolimus, etc.), or any other systemic treatments that might increase skin sensitivity to UV/visible light or affect skin pigmentation (such as tetracyclines, methoxsalen, etc.); (3) Participants who received topical treatments aimed at controlling/improving vitiligo symptoms within 2 weeks before baseline, including topical glucocorticoids, calcineurin inhibitors (like tacrolimus, pimecrolimus, etc.), and vitamin D3 derivatives (like calcipotriol, tacalcitol, etc.); (4) Participants who received systemic Chinese medicine treatments within 4 weeks before baseline; (5) Participants who took oral JAK inhibitors/PDE4 inhibitors within 4 weeks before baseline, or topical JAK inhibitors/PDE4 inhibitors within 2 weeks before baseline, or those previously unresponsive or intolerant to oral/topical JAK inhibitors/PDE4 inhibitors (as judged by the investigator); (6) Participants who used moderate or strong CYP3A4 inhibitors or inducers (including prescription drugs, over-the-counter drugs, and dietary supplements) systemically within 4 weeks before baseline (see Appendix 11.3 for details); (7) Participants who used any biologics within 12 weeks or 5 half-lives before baseline, whichever is longer; (8) Participants who took part in other interventional clinical studies within 4 weeks before baseline, or who were still within 5 half-lives of the last dose of an interventional study drug at baseline; (9) Participants who have ever used skin depigmentation treatments (such as monobenzyl ether of hydroquinone, monobenzyl ether of hydroxyphenol, etc.); (10) Participants who have previously undergone skin graft treatments. 3. Presence of the following significant medical history or underlying conditions that may affect safety: (1) Participants who have had any active malignancy or history of malignant tumors in the 5 years prior to the screening visit, excluding treated and cured skin squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the cervix; (2) Active infection requiring systemic anti-infective treatment within 2 weeks before baseline, or other chronic, recurrent, or active infections deemed unsuitable for the study by the investigator; (3) History of two or more outbreaks of shingles, at least one instance of disseminated shingles, or other infection history that the investigator considers could worsen due to participation in the study; (4) Known or suspected immunosuppression, including a history of invasive opportunistic infections (such as tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), even if the infection has resolved; (5) Currently having an active tuberculosis infection, or chest imaging suggesting active tuberculosis infection; (6) Any surgery within 1 month before screening, or not fully recovered as judged by the investigator, or planning any surgery during the study; (7) Currently having thyroid disease (including hyperthyroidism or hypothyroidism) or receiving thyroid replacement therapy. Participants with abnormal TSH during screening and simultaneous abnormal fT4 or fT3 values. Participants with clinically significant abnormalities in TSH, fT4, or fT3 during screening (with signs and/or symptoms indicating hypo- or hyperthyroidism); (8) Having any other persistent active autoimmune disease, or a clinical condition requiring/potentially requiring long-term systemic steroid or immunosuppressive treatment, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, scleroderma or polymyositis, multiple sclerosis or other central demyelinating diseases, primary Sjögren’s syndrome, immunodeficiency syndromes (like Felty’s syndrome), etc.; (9) Any severe, progressive, uncontrolled cardiovascular, cerebrovascular, respiratory, liver, kidney, gastrointestinal, genitourinary, neurological, psychiatric, musculoskeletal, skin, sensory, endocrine, or hematologic disorders or diseases as judged by the investigator, or conditions that may affect medical procedures in the trial, physical condition, or may put the participant at undue risk. 4. During screening, if any of the following appear in laboratory tests and/or a 12-lead ECG: (1) Hemoglobin (men) <100.0 g/L, or (women) <90.0 g/L; (2) White blood cell count <3.0×10^9/L; (3) Neutrophil count <1.5×10^9/L; (4) Platelet count <100×10^9/L; (5) Absolute lymphocyte count <0.5×10^9/L; (6) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times the upper limit of normal (ULN); (7) Total bilirubin (TBIL) >1.5 times the upper limit of normal (ULN); (8) Estimated glomerular filtration rate (eGFR) calculated using the simplified MDRD formula <60 mL/min/1.73 m² (see Appendix 11.2), or if the person is undergoing routine hemodialysis or peritoneal dialysis, or if serum creatinine is out of the normal range and the investigator deems the person unsuitable for the study; (9) Positive results for hepatitis B surface antigen (HBsAg), HIV antibody, syphilis antibody, or anti-HCV antibody; if HBsAg is negative but hepatitis B core antibody (HBcAb) is positive and HBV DNA is positive or above the normal range. (10) The 12-lead ECG suggests abnormalities that may be clinically significant and could affect the participant's safety, including but not limited to acute myocardial ischemia, myocardial infarction, serious arrhythmias, or marked QTc prolongation (QTc > 500 ms); 5. General situations: (1) Women who are pregnant or breastfeeding. Pregnancy is defined as the state of a woman from conception to termination of pregnancy, and screening or baseline blood β-human chorionic gonadotropin (β-HCG) tests positive; (2) Allergy to the study drug or any ingredient in the study drug; (3) History of heavy drinking or illegal drug use within one year before screening; (4) Donated about 500 mL of blood within 8 weeks before baseline or plan to donate blood during the study; (5) The investigator expects that during the study treatment, the treatment area will be exposed to artificial lighting or sunbathing that may affect efficacy assessment; (6) The investigator judges there are other situations that may affect the safety or efficacy evaluation of the study drug or otherwise make the participant unsuitable for enrollment.

研究实施时间：

Study execute time：

从 From 2026-07-01 00:00:00至 To 2028-07-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-07-01 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：	RSS0393软膏联合SHR0302碱凝胶组	样本量：	6
Group：	RSS0393 ointment plus SHR0302 Base gel group	Sample size：	6
干预措施：	RSS0393软膏联合SHR0302碱凝胶	干预措施代码：
Intervention：	RSS0393 ointment plus SHR0302 Base gel	Intervention code：

组别：	SHR0302碱凝胶单药组	样本量：	6
Group：	SHR0302 Base gel group	Sample size：	6
干预措施：	SHR0302碱凝胶	干预措施代码：
Intervention：	SHR0302 Base gel	Intervention code：

组别：	RSS0393软膏单药组	样本量：	6
Group：	RSS0393 ointment group	Sample size：	6
干预措施：	RSS0393软膏	干预措施代码：
Intervention：	RSS0393 ointment	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)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	苏州市立医院	单位级别：	三级甲等
Institution hospital：	Suzhou Municipal Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	面部白癜风面积评分指数（F-VASI）较基线变化的值和百分比	指标类型：	次要指标
Outcome：	The absolute and percent change from baseline in the Facial Vitiligo Area Scoring Index (F-VASI)	Type：	Secondary indicator
测量时间点：	每4周或6周	测量方法：
Measure time point of outcome：	Every 4 or 6 weeks	Measure method：

指标中文名：	安全性：不良事件、生命体征、实验室检查和12导联心电图	指标类型：	次要指标
Outcome：	Safety: Adverse events, vital signs, laboratory tests, and 12-lead electrocardiograms	Type：	Secondary indicator
测量时间点：	每周期	测量方法：
Measure time point of outcome：	Every cycles	Measure method：

指标中文名：	面部白癜风面积（F-BSA）较基线变化的值和百分比	指标类型：	次要指标
Outcome：	The absolute and percent change from baseline in Facial Body Surface Area (F-BSA)	Type：	Secondary indicator
测量时间点：	每4周或6周	测量方法：
Measure time point of outcome：	Every 4 or 6 weeks	Measure method：

指标中文名：	白癜风可视化程度量表（VNS）为明显改善（4）或完全改善（5）的参与者比例	指标类型：	次要指标
Outcome：	The proportion of participants achieving a Vitiligo Noticeability Scale (VNS) score of 4 ("marked improvement") or 5 ("complete improvement")	Type：	Secondary indicator
测量时间点：	每4周或6周	测量方法：
Measure time point of outcome：	Every 4 or 6 weeks	Measure method：

指标中文名：	面部白癜风面积评分指数较基线至少改善50%/75%/90%（F-VASI50/75/90应答）的参与者比例	指标类型：	次要指标
Outcome：	The proportion of participants achieving at least 50%/75%/90% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI50/75/90 response)	Type：	Secondary indicator
测量时间点：	每4周或6周	测量方法：
Measure time point of outcome：	Every 4 or 6 weeks	Measure method：

指标中文名：	面部白癜风面积评分指数较基线至少改善75%（F-VASI75应答）的参与者比例	指标类型：	次要指标
Outcome：	The proportion of participants achieving at least 75% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI75 response)	Type：	Secondary indicator
测量时间点：	研究结束时	测量方法：
Measure time point of outcome：	At the end of the treatment period	Measure method：

指标中文名：	面部白癜风面积评分指数较基线至少改善50%（F-VASI50应答）的参与者比例	指标类型：	主要指标
Outcome：	The proportion of participants achieving at least 50% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI50 response)	Type：	Primary indicator
测量时间点：	研究结束时	测量方法：
Measure time point of outcome：	At the end of the treatment period	Measure method：

指标中文名：	面部白癜风面积评分指数较基线至少改善90%（F-VASI90应答）的参与者比例	指标类型：	次要指标
Outcome：	The proportion of participants achieving at least 90% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI90 response)	Type：	Secondary indicator
测量时间点：	研究结束时	测量方法：
Measure time point of outcome：	At the end of the treatment period	Measure method：

指标中文名：	总体白癜风面积评分指数（T-VASI）较基线变化的值和百分比	指标类型：	次要指标
Outcome：	The absolute and percent change from baseline in the Total Body Vitiligo Area Scoring Index (T-VASI)	Type：	Secondary indicator
测量时间点：	每4周或6周	测量方法：
Measure time point of outcome：	Every 4 or 6 weeks	Measure method：

指标中文名：	总体白癜风面积评分指数较基线至少改善50%/75%/90%（T-VASI50/75/90应答）的参与者比例	指标类型：	次要指标
Outcome：	The proportion of participants achieving at least 50%/75%/90% improvement from baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50/75/90 response)	Type：	Secondary indicator
测量时间点：	每4周或6周	测量方法：
Measure time point of outcome：	Every 4 or 6 weeks	Measure method：

指标中文名：	总体白癜风面积（T-BSA）较基线变化的值和百分比	指标类型：	次要指标
Outcome：	The absolute and percent change from baseline in Total Body Surface Area (T-BSA)	Type：	Secondary indicator
测量时间点：	每4周或6周	测量方法：
Measure time point of outcome：	Every 4 or 6 weeks	Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	血清	组织：
Sample Name：	Serum	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：	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：

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	18	岁 years
最大 Max age	75	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）：	无
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	None
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、电子采集与管理系统
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Case record form、Electronic collection and management system
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2026-06-26 17:51:31