ChiCTR2600122338 版本V1.0 版本创建时间2026/04/13 08:24:11 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：

ChiCTR2600122338 

最近更新日期：

Date of Last Refreshed on：

2026-04-13 08:24:03 

注册时间：

Date of Registration：

2026-04-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项评价注射用聚己内酯面部填充剂用于面部真皮组织填充以纠正眼部鱼尾纹的安全性和有效性的多中心、随机、受试者-评估者双盲、平行对照临床试验

Public title：

To evaluate the safety and effectiveness of polycaprolactone dermal filler for injection manufactured by DEXLEVO INC. in the correction of periorbital crow's feet wrinkles when used for facial dermal tissue augmentation

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项评价注射用聚己内酯面部填充剂用于面部真皮组织填充以纠正眼部鱼尾纹的安全性和有效性的多中心、随机、受试者-评估者双盲、平行对照临床试验

Scientific title：

To evaluate the safety and effectiveness of polycaprolactone dermal filler for injection manufactured by DEXLEVO INC. in the correction of periorbital crow's feet wrinkles when used for facial dermal tissue augmentation

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：

翟伟志 

研究负责人：

齐向东 

Applicant：

Zhai Weizhi 

Study leader：

Qi Xiangdong 

申请注册联系人电话：

Applicant telephone：

+86 185 1568 7777

研究负责人电话：

Study leader's telephone：

+86 138 2841 8380

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：

13805457198@139.com

研究负责人电子邮件：

Study leader's E-mail：

create_beauty@hotmail.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：

山东省烟台市莱州市文昌路街道光州东路

研究负责人通讯地址：

广东省广州市工业大道中253号

Applicant address：

Guangzhou East Road, Wenchang Road Street, Laizhou City, Yantai City, Shandong Province, the PRC

Study leader's address：

No. 253, Middle Gongye Road, Haizhu District, Guangzhou, Guangdong Province, P.R. 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：

山东永洲丰友科技发展有限公司

Applicant's institution：

Department Manager of Shandong Yongzhou Fengyou Technology Development Co., Ltd.

研究负责人所在单位：

南方医科大学珠江医院

Affiliation of the Leader：

Director of Plastic and Cosmetic Surgery Department, Zhujiang Hospital of Southern Medical University

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：

2025-QX-030

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：

南方医科大学珠江医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Zhujiang Hospital, Southern Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-12-19 00:00:00

伦理委员会联系人：

徐世元

Contact Name of the ethic committee：

Xu Shiyuan

伦理委员会联系地址：

广东省广州市工业大道中253号

Contact Address of the ethic committee：

No. 253, Middle Gongye Road, Haizhu District, Guangzhou, Guangdong Province, P.R. China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 155 8022 9603

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：

南方医科大学珠江医院

Primary sponsor：

Shandong Yongzhou Fengyou Technology Development Co., Ltd.

研究实施负责（组长）单位地址：

广东省广州市工业大道中253号

Primary sponsor's address：

Guangzhou East Road, Wenchang Road Street, Laizhou City, Yantai City, Shandong Province, the PRC

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

山东省

市(区县)：

烟台市

Country：

China

Province：

Shandong Province

City：

Yantai City

单位(医院)：

山东永洲丰友科技有限发展公司

具体地址：

山东省烟台市莱州市文昌路街道光州东路

Institution
hospital：

Shandong Yongzhou Fengyou Technology Development Co., Ltd.

Address：

Guangzhou East Road, Wenchang Road Street, Laizhou City, Yantai City, Shandong Province, the PRC

经费或物资来源：

山东永洲丰友科技有限发展公司提供全部资金

Source(s) of funding：

Funding was provided entirely by Shandong Yongzhou Fengyou Technology Development Co., Ltd.

Target disease：

Adults seeking correction of periocular crow's feet

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

评价DEXLEVO 生产的注射用聚己内酯面部填充剂在面部真皮组织填充以纠正眼部鱼尾纹的安全性和有效性。并遵循《医疗器械注册与备案管理办法》（市场监管总局令第 47号）、《医疗器械监督管理条例》（国务院令739）、《医疗器械临床试验质量管理规范》（2022年第28号）、《透明质酸钠类面部注射填充材料临床试验指导原则》，本临床试验采用多中心、随机、盲法、平行对照临床试验设计。评价注射用聚己内酯面部填充剂在面部真皮组织填充以纠正眼部鱼尾纹的安全性和有效性，为产品注册提供依据。  

Objectives of Study：

To evaluate the safety and effectiveness of injectable polycaprolactone facial filler manufactured by DEXLEVO for facial dermal tissue augmentation in the correction of periorbital crow’s feet wrinkles.This clinical trial is conducted in compliance with the Measures for the Administration of Medical Device Registration and Filing (Order No. 47 of the State Administration for Market Regulation), the Regulations on the Supervision and Administration of Medical Devices (Decree No. 739 of the State Council), the Good Clinical Practice for Medical Devices (No. 28 [2022]), and the Guiding Principles for Clinical Trials of Sodium Hyaluronate Facial Injectable Filling Materials.A multicenter, randomized, blinded, parallel-controlled clinical trial design is adopted. This trial aims to evaluate the safety and effectiveness of injectable polycaprolactone facial filler for facial dermal tissue augmentation in the correction of periorbital crow’s feet wrinkles, and to provide evidence for the product registration.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1: 年龄≥18周岁且≤70周岁，性别不限 2: 在有意愿改善两侧眼周皱纹（鱼尾纹）的人中，静息时眼周皱纹评估标准（皱纹严重程度评定量表（WSRS）得分≥2分，和鱼尾纹分级量表（CFGS））得分≥1分，微笑时的眼周皱纹评估标准（皱纹严重程度评定量表（WSRS）≥3分和鱼尾纹分级量表（CFGS））得分≥2分，且两侧鱼尾纹评分差异≤1分者 3: 同意在临床试验期间除本临床试验外不进行任何可能影响眼部鱼尾纹改善的操作或治疗，能理解并遵循指示，并接受在研究阶段内不接受任何其他面部手术，并能参与整个试验期者 4: 自愿放弃试验期间采用与试验不符的其他美容治疗者 5: 受试者自愿同意参与本临床试验及按照方案要求进行随访，并签署知情同意书

Inclusion criteria

1. Subjects aged >=18 and <=70 years, with no gender restriction. 2. Subjects willing to improve bilateral periorbital wrinkles (crow's feet), meeting the following severity criteria: At rest: Wrinkle Severity Rating Scale (WSRS) score >=2, and Crow's Feet Grading Scale (CFGS) score >=1; At smiling: Wrinkle Severity Rating Scale (WSRS) score >=3, and Crow's Feet Grading Scale (CFGS) score >=2; Inter-side difference in crow's feet scores <=1. 3. Subjects who agree not to undergo any other procedures or treatments that may affect the improvement of periorbital crow's feet wrinkles outside this clinical trial during the study period; who can understand and comply with study instructions; who agree not to receive any other facial surgeries during the study; and who are able to participate throughout the entire trial period. 4. Subjects who voluntarily agree to abstain from any aesthetic procedures inconsistent with the study during the trial period. 5. Subjects who provide voluntary written informed consent to participate in this clinical trial and comply with the follow-up requirements specified in the protocol.

排除标准：

1）基线前24周内在治疗区域进行线雕或肉毒素治疗，或基线前12周内接受过剥脱性皮肤表面重修、激光治疗、微针、化学剥脱，或基线前48周内接受过可吸收填充剂（玻尿酸、胶原蛋白）等可能干扰研究注射和/或评价的美容操作。 2）既往在治疗区域使用任何永久性（不可生物降解，如硅胶、聚丙烯酰胺等）或半永久性（即，羟基磷灰石钙、聚左旋乳酸或聚甲基丙烯酸甲酯）产品、提拉线或自体脂肪进行软组织填充。 3）患有未控制的青光眼、需要手术治疗的白内障、活动性眼部感染、眼部肿瘤等严重眼部疾病者。 4）明显的面部不对称或眼周或眉毛不对称者。 5）根据研究者判断，治疗区域或治疗区域周围存在可能会干扰研究评价的瘢痕或纹身（包括纹眉或眼线）。 6）治疗区域或其邻近部位存在以下问题：急性炎症（如红肿热痛），感染、湿疹、中重度痤疮、慢性或复发性皮肤疾病（如玫瑰痤疮、面部银屑病、带状疱疹）等皮肤疾病。 7）面部存在癌或癌前病变。 8）计划在研究期间进行面部手术、眼部手术（包括LASIK术）或进行面部美容操作 （如，消融性皮肤表面重修、激光治疗、微针、化学剥脱、肉毒毒素治疗或皮肤填充剂）。 9）患有出血性疾病或目前正在使用抗凝剂的受试者。 10）既往或现在确诊过以下任一系统疾病，且经研究者判断可能影响试验疗效评估或增加安全性风险者，需排除： a）心血管系统：如未控制的高血压（收缩压≥160 mmHg 或舒张压≥100 mmHg）、充血性心力衰竭（NYHA 分级≥III 级）； b）呼吸系统：如慢性阻塞性肺疾病（COPD GOLD 分级≥II 级）、中重度哮喘（需规律使用口服糖皮质激素）； c）消化系统：如活动性胃溃疡、缺血性肠病或炎症性肠病（如克罗恩病、溃疡性结肠炎）处于活动期等； d）肝胆系统：如肝硬化（Child-Pugh 分级 B 级及以上）、活动性病毒性肝炎； e）内分泌系统：如未控制的糖尿病（空腹血糖≥8.3 mmol/L 或糖化血红蛋白≥8.0%）； f）肾脏及泌尿系统：如严重肾功能损害、长期血液透析、腹膜透析或肾移植； g）自身免疫性疾病：如系统性红斑狼疮（活动期）、类风湿关节炎（需免疫抑制剂治疗）； 11）根据研究者判断，一些其它伴随的医疗状况、治疗或其他状况可能会干扰研究药物评价、安全性或有效性、和/或如果受试者参与研究会使其面临风险； 12）筛选前1年内有药物滥用史或酒精依赖史； 13）受试者明确表示在研究治疗前3个月内参与过其他研究器械或药物试验计划，或在本试验整个研究周期内（从入组至末次随访结束）参与其他任何临床试验者； 14）既往属过敏体质或有严重的过敏史疾病，或对利多卡因局麻药、本产品及相关成分过敏者； 15）易于形成瘢痕疙瘩、增生性瘢痕或其他任何愈合异常者； 16）妊娠期、哺乳期女性以及试验期间有生育计划者； 17）患有严重精神疾病或认知功能障碍，无法理解和签署知情同意书，或者躯体变形障碍或不切实际的治疗期望者； 18）研究者认为不宜参加本试验的其他情况。

Exclusion criteria：

1: Received thread lifting or botulinum toxin treatment in the treatment area within 24 weeks prior to baseline; or ablative skin resurfacing, laser therapy, microneedling, or chemical peeling within 12 weeks prior to baseline; or absorbable fillers (hyaluronic acid, collagen, etc.) within 48 weeks prior to baseline — any aesthetic procedures that may interfere with study injections and/or evaluations. 2: Previous soft tissue augmentation in the treatment area using any permanent (non-biodegradable, e.g., silicone, polyacrylamide, etc.) or semi-permanent products (i.e., calcium hydroxylapatite, poly-L-lactic acid, or polymethylmethacrylate), lifting sutures, or autologous fat. 3: Subjects with severe ocular diseases including uncontrolled glaucoma, cataracts requiring surgery, active ocular infection, ocular tumor, etc. 4: Subjects with significant facial asymmetry or asymmetry of the periorbital region or eyebrows. 5: Presence of scars or tattoos (including eyebrow tattoos or eyeliner) in or around the treatment area that, in the investigator’s judgment, may interfere with study evaluations. 6: Presence of the following conditions in or adjacent to the treatment area: acute inflammation (e.g., redness, swelling, heat, pain), infection, eczema, moderate-to-severe acne, chronic or recurrent skin diseases (e.g., rosacea, facial psoriasis, herpes zoster), or other dermatological disorders. 7: Presence of facial cancer or precancerous lesions. 8: Planning to undergo facial surgery, ocular surgery (including LASIK), or facial aesthetic procedures (e.g., ablative skin resurfacing, laser therapy, microneedling, chemical peeling, botulinum toxin treatment, or dermal fillers) during the study period. 9: Subjects with hemorrhagic disorders or currently using anticoagulants. 10: Subjects with a current or past diagnosis of any of the following systemic diseases that, in the investigator’s judgment, may affect efficacy evaluation or increase safety risks: a) Cardiovascular system: uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg), congestive heart failure (NYHA class ≥ III); b) Respiratory system: chronic obstructive pulmonary disease (COPD GOLD class ≥ II), moderate-to-severe asthma requiring regular oral corticosteroids; c) Digestive system: active gastric ulcer, ischemic bowel disease, or inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis) in active phase; d) Hepatobiliary system: liver cirrhosis (Child-Pugh class B or higher), active viral hepatitis; e) Endocrine system: uncontrolled diabetes (fasting blood glucose ≥8.3 mmol/L or HbA1c ≥8.0%); f) Renal and urinary system: severe renal impairment, long-term hemodialysis, peritoneal dialysis, or renal transplantation; g) Autoimmune diseases: systemic lupus erythematosus (active phase), rheumatoid arthritis requiring immunosuppressive therapy. 11: Any other concurrent medical conditions, treatments, or circumstances that, in the investigator’s judgment, may interfere with the evaluation of the study device’s safety or effectiveness, and/or may place the subject at risk if participating in the study. 12: History of drug abuse or alcohol dependence within 1 year prior to screening. 13: Subjects who participated in another investigational device or drug trial within 3 months before study treatment, or who intend to participate in any other clinical trial during the entire study period (from enrollment to the final follow-up). 14: Subjects with a known allergic constitution, history of severe allergies, or hypersensitivity to lidocaine local anesthetic, the study product, or its components. 15: Subjects prone to keloid formation, hypertrophic scarring, or any abnormal wound healing. 16: Females who are pregnant, breastfeeding, or planning pregnancy during the trial period. 17: Subjects with severe psychiatric disorders, cognitive impairment unable to understand and sign informed consent, body dysmorphic disorder, or unrealistic treatment expectations. 18: Any other conditions deemed inappropriate for study participation by the investigator.

研究实施时间：

Study execute time：

从 From 2025-12-01 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-04-13 00:00:00 至 To 2026-12-31 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

155

Group：

treatment group

Sample size：

干预措施：

试验组受试者使用试验器械（注射用聚己内酯面部填充剂（规格：1ml/支，生产厂家：DEXLEVO INC.））进行注射治疗。

干预措施代码：

Intervention：

Subjects in the experimental group received injection therapy with the investigational device: Injectable Polycaprolactone Facial Filler (Specification: 1 mL/syringe, Manufacturer: DEXLEVO INC.).

Intervention code：

组别：

对照组

样本量：

155

Group：

Control group

Sample size：

干预措施：

对照组受试者使用对照器械(双美生物科技股份有限公司生产的胶原蛋白植入剂“Sunmax”Collagen Implant I（国械注许20193130064）)进行注射治疗。

干预措施代码：

Intervention：

Subjects in the control group received injection therapy with the control device: Sunmax Collagen Implant I manufactured by Sunmax Biotechnology Co., Ltd. (Registration Certificate No. Guo Xie Zhu Xu 20193130064).

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

  

Country：

China 

Province：

Guangdong Province 

City：

 

单位(医院)：

南方医科大学珠江医院 

单位级别：

三甲 

Institution
hospital：

Zhujiang Hospital of Southern Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 河北省 

市(区县)：

  

Country：

China 

Province：

Hebei Province 

City：

 

单位(医院)：

河北医科大学第三医院 

单位级别：

三甲 

Institution
hospital：

The Third Hospital of Hebei Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

  

Country：

China 

Province：

Guangdong Province 

City：

 

单位(医院)：

高州市人民医院 

单位级别：

三甲 

Institution
hospital：

Gaozhou People's Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

中国医学科学院北京协和医院 

单位级别：

三甲 

Institution
hospital：

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 湖南省 

市(区县)：

  

Country：

China 

Province：

Hubei Province 

City：

 

单位(医院)：

华中科技大学同济医学院附属协和医院 

单位级别：

三甲 

Institution
hospital：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

不良事件

指标类型：

副作用指标

Outcome：

Adverse Event

Type：

Adverse events

测量时间点：

从签署知情开始，试验期间全程记录

测量方法：

不良事件（Adverse Event，AE），是指在医疗器械临床试验过程中出现的不良医学事件，无论是否与试验医疗器械相关。在填写eCRF的不良事件时，将按照常见不良反应术语评定标准（Common Terminology Criteria for Adverse Events，CTCAE）5.0版进行分级判断，没有列入CTCAE5.0版的不良事件将按照CTCAE不良事件通用分级标准即表5-4进行判断。

Measure time point of outcome：

Record the whole process of the test from the signing of the knowledge

Measure method：

An Adverse Event (AE) is any unfavorable medical occurrence that appears in a subject during a clinical trial of a medical device, regardless of whether it is related to the investigational medical device.When documenting adverse events in the eCRF, grading will be performed in accordance with the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Adverse events not listed in CTCAE version 5.0 will be graded according to the general CTCAE grading criteria for adverse events, as

指标中文名：

器械操作性能评价

指标类型：

次要指标

Outcome：

Evaluation of Device Operational Performance

Type：

Secondary indicator

测量时间点：

注射填充治疗当天

测量方法：

完成治疗后，由研究者对整个试验过程中的试验器械/对照器械操作性能，详见表5-5器械操作性能评价表，按照满意、一般、不满意进行评价。

Measure time point of outcome：

Treatment Day

Measure method：

Upon completion of treatment, the investigator shall evaluate the operational performance of the investigational device / control device throughout the entire trial process. The evaluation shall be conducted in accordance with Table 5?5: Device Operational Performance Evaluation Form, with ratings of Satisfactory, Fair, and Unsatisfactory.

指标中文名：

皱纹改善率

指标类型：

主要指标

Outcome：

Wrinkle Improvement Rate

Type：

Primary indicator

测量时间点：

筛选期和随访期3

测量方法：

对受试者随访期3（12周±7天）和筛选期（-7-0天）静息时WSRS评分差值和CFGS 评分差值分别进行评估，进行皱纹改善率统计

Measure time point of outcome：

Screening and Follow-up Visit 3

Measure method：

The differences in WSRS and CFGS scores at rest between Follow-up Visit 3 (12 weeks ± 7 days) and Screening (Day -7 to Day 0) were evaluated respectively, and the wrinkle improvement rate was statistically analyzed.

指标中文名：

器械缺陷

指标类型：

次要指标

Outcome：

Device Defect

Type：

Secondary indicator

测量时间点：

治疗后（治疗过程中观察，治疗结束后记录）

测量方法：

器械缺陷是指临床试验过程中医疗器械在正常使用情况下存在可能危及人体健康和生命安全的不合理风险，如标签错误、质量问题、故障等。临床试验过程中是否有器械缺陷发生，记录发生数目。

Measure time point of outcome：

Post-treatment (observed during treatment, recorded at the end of treatment).

Measure method：

Device Defect refers to an unreasonable risk that may endanger human health and personal safety associated with a medical device under normal use during a clinical trial, including but not limited to labeling errors, quality issues, malfunctions, etc. Record whether any device defects occurred during the clinical trial and the number of occurrences.

指标中文名：

整体美学改善量表（GAIS）评价-注射研究者

指标类型：

次要指标

Outcome：

Global Aesthetic Improvement Scale (GAIS) Assessment by Injecting Investigators

Type：

Secondary indicator

测量时间点：

随访期1、2、3

测量方法：

根据WSRS对受试者面部鱼尾纹进行面评，分别计算随访期1（1周±2天）、随访期2（4周±3天）、随访期4（24周±10天）的CFGS评分较筛选期的变化量和皱纹改善率； 计算随访期1（1周±2天）、随访期2（4周±3天）、随访期3（12周±7天）、随访期4（24周±10天）CFGS评分的平均值。

Measure time point of outcome：

V1, V2, V3

Measure method：

Facial crow’s feet of subjects were evaluated using the WSRS. The changes in CFGS scores and the wrinkle improvement rate relative to the Screening phase at Follow-up Visit 1 (1 week ± 2 days), Follow-up Visit 2 (4 weeks ± 3 days), and Follow-up Visit 4 (24 weeks ± 10 days) were calculated respectively. The mean CFGS scores at Follow-up Visit 1 (1 week ± 2 days), Follow-up Visit 2 (4 weeks ± 3 days), Follow-up Visit 3 (12 weeks ± 7 days), and Follow-up Visit 4 (24 weeks ± 10 days) were calculate

指标中文名：

整体美学改善量表（GAIS）评价-受试者

指标类型：

次要指标

Outcome：

Global Aesthetic Improvement Scale (GAIS) Assessment by Subjects

Type：

Secondary indicator

测量时间点：

随访期1、2、3

测量方法：

受试者采用采用整体美学改善量表（Global Aesthetic Improvement Scale，GAIS），在随访期1（1周±2天）、随访期2（4周±3天）、随访期3（12周±7天）对进行现场自评。

Measure time point of outcome：

V1, V2, V3

Measure method：

Subjects conducted on-site self-assessment using the Global Aesthetic Improvement Scale (GAIS) at Follow-up Visit 1 (1 week ± 2 days), Follow-up Visit 2 (4 weeks ± 3 days), and Follow-up Visit 3 (12 weeks ± 7 days).

指标中文名：

WSRS评价-第三方盲态评分研究者

指标类型：

次要指标

Outcome：

WSRS Assessment by Blinded Third-Party Investigators

Type：

Secondary indicator

测量时间点：

筛选期、随访期1、2、3、4

测量方法：

根据WSRS对受试者面部鱼尾纹照片进行评分，分别计算随访期1（1周±2天）、随访期2（4周±3天）、随访期4（24周±10天）的WSRS评分较筛选期的变化量和皱纹改善率； 计算随访期1（1周±2天）、随访期2（4周±3天）、随访期3（12周±7天）、随访期4（24周±10天）WSRS评分的平均值。

Measure time point of outcome：

Screening, V1, V2, V3, V4

Measure method：

The facial crow's feet photographs of subjects were scored according to WSRS. The changes in WSRS scores and wrinkle improvement rates at Follow-up Visit 1 (1 week ± 2 days), Follow-up Visit 2 (4 weeks ± 3 days), and Follow-up Visit 4 (24 weeks ± 10 days) compared with Screening were calculated respectively. The mean values of WSRS scores at Follow-up Visit 1 (1 week ± 2 days), Follow-up Visit 2 (4 weeks ± 3 days), Follow-up Visit 3 (12 weeks ± 7 days), and Follow-up Visit 4 (24 weeks ± 10 days)

指标中文名：

CFGS评价-第三方盲态评分研究者

指标类型：

次要指标

Outcome：

CFGS Assessment by Blinded Third-Party Investigators

Type：

Secondary indicator

测量时间点：

筛选期、随访期1、2、3、4

测量方法：

根据WSRS对受试者面部鱼尾纹照片进行评分，分别计算随访期1（1周±2天）、随访期2（4周±3天）、随访期4（24周±10天）的CFGS评分较筛选期的变化量和皱纹改善率； 计算随访期1（1周±2天）、随访期2（4周±3天）、随访期3（12周±7天）、随访期4（24周±10天）CFGS评分的平均值。

Measure time point of outcome：

Screening, V1, V2, V3, V4

Measure method：

The facial crow's feet photographs of subjects were scored according to WSRS. The changes in CFGS scores and wrinkle improvement rates at Follow-up Visit 1 (1 week ± 2 days), Follow-up Visit 2 (4 weeks ± 3 days), and Follow-up Visit 4 (24 weeks ± 10 days) compared with Screening were calculated respectively. The mean values of CFGS scores at Follow-up Visit 1 (1 week ± 2 days), Follow-up Visit 2 (4 weeks ± 3 days), Follow-up Visit 3 (12 weeks ± 7 days), and Follow-up Visit 4 (24 weeks ± 10 days)

指标中文名：

WSRS评价-研究中心盲态评分研究者

指标类型：

次要指标

Outcome：

WSRS Assessment by Blinded Investigators at the Study Site

Type：

Secondary indicator

测量时间点：

筛选期、随访期1、2、3、4

测量方法：

根据WSRS对受试者面部鱼尾纹进行面评，分别计算随访期1（1周±2天）、随访期2（4周±3天）、随访期3（12周±7天）、随访期4（24周±10天）的WSRS评分较筛选期的变化量和皱纹改善率； 计算随访期1（1周±2天）、随访期2（4周±3天）、随访期3（12周±7天）、随访期4（24周±10天）WSRS评分的平均值；

Measure time point of outcome：

Screening, V1, V2, V3, V4

Measure method：

Subjects were evaluated for facial crow’s feet using the WSRS. The changes in WSRS scores and the wrinkle improvement rate at Follow-up Visit 1 (1 week ± 2 days), Follow-up Visit 2 (4 weeks ± 3 days), Follow-up Visit 3 (12 weeks ± 7 days), and Follow-up Visit 4 (24 weeks ± 10 days) compared with Screening were calculated respectively. The mean WSRS scores at Follow-up Visit 1 (1 week ± 2 days), Follow-up Visit 2 (4 weeks ± 3 days), Follow-up Visit 3 (12 weeks ± 7 days), and Follow-up Visit 4 (24

指标中文名：

生命体征

指标类型：

次要指标

Outcome：

Vital signs

Type：

Secondary indicator

测量时间点：

筛选期、注射填充治疗当天、随访期1、2、3、4

测量方法：

记录受试者生命体征，包括体温、脉搏、呼吸、血压。体温:体温以摄氏度(°C)记录。按中心情况选择体温测量方式并记录。脉搏和呼吸频率:在不活动安静的状态下测量。血压:根据临床血压测量标准，测量坐位血压。

Measure time point of outcome：

Screening, Treatment Day, V1, V2, V3, V4

Measure method：

The vital signs of the subjects in the test group were recorded, including body temperature, pulse, respiration and blood pressure. Bodytemperature: Body temperature is recorded in degres Celsius ("C). Select and record the body temperature measurement method according tothe situation of the center. Pulse and respiratory rate: measured in a quiet state of inactivity. Blood pressure: Sitting blood pressure wasmeasured according to clinical blood pressure measurement standards.

指标中文名：

心电图

指标类型：

次要指标

Outcome：

Electrocardiogram

Type：

Secondary indicator

测量时间点：

筛选期、注射填充治疗当天、随访期1、2、3、4

测量方法：

按中心心电图检查要求进行心电图检查。

Measure time point of outcome：

Screening, Treatment Day, V4

Measure method：

ECG examination shall be performed in accordance with the requirements for central ECG assessment.

指标中文名：

注射反应

指标类型：

次要指标

Outcome：

Injection reaction

Type：

Secondary indicator

测量时间点：

通过受试者日记记录

测量方法：

通过受试者日记记录主要注射部位反应事件/症状，及严重程度（轻、中、重度）和持续时间等。受试者日记中列出的ISR包括但不限于：发红、疼痛、变硬、肿胀、肿块/凸起、淤青、瘙痒、变色等。上述局部反应通常在治疗当天开始，多数以轻度为主，并会在治疗后数天内自行减退或消失，无需干预。若治疗后以上症状持续时间超过7天，或7天内出现不得不采取治疗措施或严重程度超出预期的情形，则将需要由研究者进行评估是否记录为AE。若评估为AE，则研究者应跟进治疗部位反应直至其缓解，并将过程详细记录。如果事件的强度在一天内发生变化，应记录当日最大强度。

Measure time point of outcome：

Recorded via subject diary

Measure method：

Subjects recorded ISR (severity, duration) in diaries: erythema, pain, induration, swelling, mass, ecchymosis, pruritus, discoloration (not limited to these). Most mild reactions onset on treatment day and resolve spontaneously within days. Symptoms lasting >7 days, needing intervention or overly severe will be assessed for AE by investigators. Confirmed AEs require follow-up until resolution, with full details and daily peak intensity recorded.

指标中文名：

视力检查

指标类型：

次要指标

Outcome：

Visual acuity examination

Type：

Secondary indicator

测量时间点：

筛选期、随访期1、2、3、4

测量方法：

按中心视力检查要求进行视力检查。

Measure time point of outcome：

Screening, V1, V2, V3, V4

Measure method：

Visual acuity was examined in accordance with the requirements for central visual acuity assessment.

指标中文名：

CFGS评价-研究中心盲态评分研究者

指标类型：

次要指标

Outcome：

CFGS Assessment by Blinded Investigators at the Study Site

Type：

Secondary indicator

测量时间点：

筛选期、随访期1、2、3、4

测量方法：

根据WSRS对受试者面部鱼尾纹进行面评，分别计算随访期1（1周±2天）、随访期2（4周±3天）、随访期4（24周±10天）的CFGS评分较筛选期的变化量和皱纹改善率； 计算随访期1（1周±2天）、随访期2（4周±3天）、随访期3（12周±7天）、随访期4（24周±10天）CFGS评分的平均值。

Measure time point of outcome：

Screening, V1, V2, V3, V4

Measure method：

Facial crow’s feet of subjects were assessed using the WSRS. The changes in CFGS scores and the wrinkle improvement rate at Follow-up Visit 1 (1 week ± 2 days), Follow-up Visit 2 (4 weeks ± 3 days), and Follow-up Visit 4 (24 weeks ± 10 days) compared with Screening were calculated respectively. The mean values of CFGS scores at Follow-up Visit 1 (1 week ± 2 days), Follow-up Visit 2 (4 weeks ± 3 days), Follow-up Visit 3 (12 weeks ± 7 days), and Follow-up Visit 4 (24 weeks ± 10 days) were calculat

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血常规

组织：

Sample Name：

Complete Blood Count

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：

尿常规

组织：

Sample Name：

Urinalysis

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：

肝功能

组织：

Sample Name：

Liver Function Tests

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：

肾功能

组织：

Sample Name：

Renal Function Test

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：

凝血功能

组织：

Sample Name：

Coagulation Function Tests

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：

感染四项

组织：

Sample Name：

Four Infectious Disease Markers

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：

血妊娠试验

组织：

Sample Name：

serum pregnancy test

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 70 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）：

本试验随机分配编码由独立的随机化统计师采用SAS软件，产生所有受试者的随机分组安排表。研究者在核实受试者符合全部入选标准并且不符合任意一条排除标准后，申请随机号，并根据该编号序号所对应的组别方法进行治疗。

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

In this trial, the random allocation codes were generated by an independent randomization statistician using SAS software to produce the randomization schedule for all subjects. After verifying that subjects meet all inclusion criteria and none of the exclusion criteria, the investigator will request a random number and assign treatment according to the group corresponding to that number.

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：

双盲（对受试者和研究者均隐藏分组)

Blinding：

Double-blind (group allocation is masked from both subjects and investigators)

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

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）：

NA

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

NA

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：

电子采集和管理系统

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

Electronic Data Capture, EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-04-13 08:24:03