ChiCTR2300071155 版本V1.1 版本创建时间2023/07/21 12:10:53 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：

 ChiCTR2300071155 

最近更新日期：

Date of Last Refreshed on：

 2023-05-06 11:20:12 

注册时间：

Date of Registration：

 2023-05-06 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

双极多通道射频联合负压提升面部年轻化的前瞻性研究

Public title：

bipolar multichannel radiofrequency combined with vacuum device in improving facial rejuvenation :A prospective study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

双极多通道射频联合负压提升面部年轻化的前瞻性研究

Scientific title：

bipolar multichannel radiofrequency combined with vacuum device in improving facial rejuvenation :A prospective study

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：

白玉冰 

研究负责人：

姚敏 

Applicant：

Yubing Bai 

Study leader：

Min Yao 

申请注册联系人电话：

Applicant telephone：

 +86 17611289085

研究负责人电话：

Study leader's
telephone：

+86 18917797606

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：

 shiro_yubing@sjtu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 my058@vip.sina.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：

中国上海市制造局路639号

研究负责人通讯地址：

中国上海市制造局路639号

Applicant address：

639 Zhizaoju Road, Shanghai, China.

Study leader's address：

639 Zhizaoju Road, Shanghai, China.

申请注册联系人邮政编码：

Applicant postcode：

 200011

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

上海市第九人民医院

Applicant's institution：

Shanghai Ninth People’s Hospital affiliated to Shanghai Jiao Tong University School of Medicine

研究负责人所在单位：

上海市第九人民医院

Affiliation of the Leader：

Shanghai Ninth People’s Hospital affiliated to Shanghai Jiao Tong 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：

 SH9H-2023-T155-1

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：

上海交通大学医学院附属第九人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of the Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-05-04 00:00:00

伦理委员会联系人：

甄红

Contact Name of the ethic committee：

Hong Zhen

伦理委员会联系地址：

上海市黄浦区制造局路639号8号楼531

Contact Address of the ethic committee：

531, Building 8, 639 Zhizaoju Road, Huangpu District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 21 63057795

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：

上海市第九人民医院

Primary sponsor：

Shanghai Ninth People’s Hospital affiliated to Shanghai Jiao Tong University School of Medicine

研究实施负责（组长）单位地址：

中国上海市制造局路639号

Primary sponsor's address：

639 Zhizaoju Road, Shanghai, 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)：

上海

市(区县)：

上海

Country：

China

Province：

Shanghai

City：

Shanghai

单位(医院)：

上海市第九人民医院

具体地址：

中国上海市制造局路639号

Institution
hospital：

Shanghai Ninth People’s Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Address：

639 Zhizaoju Road, Shanghai, China.

经费或物资来源：

自筹

Source(s) of funding：

Self-financing

研究疾病：

面部衰老  

Target disease：

Facial Aging

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：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

单臂 

Study design：

Single arm 

研究目的：

随着社会的发展和技术的进步，面部年轻化受到越来越多的关注。目前，改善面部老化的手段包括除皱手术、软组织填充、肉毒素注射等有创治疗方法，以及化学剥脱术、声光电疗法等治疗技术。虽然这些技术均能不同程度地提升面部年轻化状态，但其有创性或治疗副作用，不适的治疗过程以及差强人意的效果影响了临床应用。射频作为一种新型无创治疗手段，被越来越多地用于皮肤美容领域。研究表明双极射频可更好的控制能量分布，实现目标疗效所需的能量更小，从而减少单极射频带来的副作用风险。同时联合负压技术也弥补了双极射频比单极对皮肤穿透更浅的劣势。多通道联合更能靶向针对不同深度的组织，以达到最佳的疗效。本研究拟设计前瞻性研究，对双极多通道射频联合负压对皱纹和皮肤松弛的应用价值进行探讨，为无创性提升面部年轻化提供新的治疗手段。  

Objectives of Study：

As society develops and technology advances, facial rejuvenation is receiving more and more attention. Current means of improving facial ageing include invasive treatments such as wrinkle surgery, soft tissue fillers and Botox injections, as well as treatment techniques such as chemical peels and acousto-optical therapy. Although all these techniques can enhance facial rejuvenation to varying degrees, their invasive nature or treatment side effects, uncomfortable treatment procedures and poor results have affected their clinical application. Radiofrequency is increasingly being used as a new non-invasive treatment in the field of dermatological aesthetics. Studies have shown that bipolar radiofrequency allows for better control of energy distribution and requires less energy to achieve the target effect, thus reducing the risk of side effects associated with monopolar radiofrequency. The combination of negative pressure technology also compensates for the fact that bipolar RF penetrates the skin more superficially than monopolar. The combination of multiple channels is better able to target tissues at different depths to achieve optimal efficacy. This study will be designed as a prospective study to investigate the value of bipolar multichannel RF combined with negative pressure for wrinkles and skin laxity, providing a new treatment for non-invasive facial rejuvenation.

药物成份或治疗方案详述：

采用以色列Viora双极多通道射频负压治疗仪(Reaction, Viora)，根据不同部位和患者情况，选择ST(skin tightening)或FC(face contouring)治疗手具以及频率模式：Mode I (0.8兆赫)，Mode II (1.7兆赫)，Mode III (2.45兆赫)，Mode IV（三种射频频率，共同工作）。治疗前常规清洗面部，在对额部、眼眶周围区域进行治疗时，选用ST(skin tightening)手柄，在操作前于治疗区域涂抹适量耦合剂凝胶，以1-2mm厚为宜，然后使用模式3治疗，每个部位重复4-6遍，以肉眼可见治疗区域皮肤微微发红，受试者自觉有热感但可耐受为治疗终点。在对下颌角区域进行治疗时，选用FC(face contouring)手柄，在操作前于治疗区域涂抹适量甘油，调节手柄方向，使之与面部皮肤紧密贴合，从下颏部向颞部提拉，首先使用模式4进行约3-4min的治疗，接下来根据患者脂肪厚度进行模式1、2、3的选择，自下而上、由内及外均匀滑动，重复治疗过程中需注意探头勿在一处停留过久。治疗过程中使受试者局部有温热感为最佳。在对鼻唇沟、颧骨下方、眼角、口角等区域进行治疗时，根据每位受试者自身情况，酌情选择ST或FC手柄。治疗全程需保持探头端面紧贴面部皮肤，根据个人的耐受程度，适度调节射频和(或)负压能量。每次治疗约25min，每三周1次，共治疗3次。 

Description for medicine or protocol of treatment in detail：

Using the Viora bipolar multi-channel RF negative pressure device (Reaction, Viora), depending on the area and the patient, the ST (skin tightening) or FC (face contouring) treatment handpiece and the frequency modes are selected: Mode I (0.8 MHz), Mode II (1.7 MHz), Mode III (2.45 MHz), Mode IV (three RF frequencies, working together). Mode III (2.45 MHz), Mode IV (three RF frequencies, working together). The face is routinely cleansed prior to treatment. For the treatment of the forehead and periorbital area, the ST (skin tightening) handle is used and an appropriate amount of coupling agent gel, 1-2 mm thick, is applied to the treatment area prior to the procedure. Treatment endpoint. The FC (face contouring) handle is used for the treatment of the mandibular region. Before the treatment, an appropriate amount of glycerine is applied to the treatment area, the handle is oriented so that it fits closely to the facial skin and is lifted from the chin to the temporal region, The patient is then treated with Mode 1, 2 and 3, depending on the thickness of the fat, from the bottom up and evenly from the inside out. It is best to leave the subject with a localised warm sensation during the treatment. When treating the nasolabial folds, under the cheekbones, corners of the eyes and corners of the mouth, choose the ST or FC handle as appropriate for each subject. The end of the probe is kept close to the facial skin throughout the treatment and the RF and/or negative pressure energy is adjusted according to the individual's tolerance level. Each treatment lasts approximately 25 minutes and is performed once every three weeks for a total of three treatments. 

纳入标准：

1) 26周岁-65周岁的成年人伴有轻、中度面部松弛及皱纹，包括眼睑部、面颊部及下颏部皮肤松弛伴弹性下降，出现额纹、鱼尾纹、川字纹等细小皱纹，鼻唇沟加深，下颌轮廓不连贯； 2) 于2023年1月至2024年5月期间就诊患者，单部位至少进行过3次，三周1次； 3) 患者依从性好，并可配合完成随访。 4) 患者自愿参加双极多通道射频联合负压的前瞻性临床研究，并配合长期的随访，签署知情同意书。

Inclusion criteria

1) Adults aged 26 years to 65 years with mild to moderate facial laxity and wrinkles, including laxity of the eyelids, cheeks and chin with loss of elasticity, fine wrinkles such as forehead lines, crow's feet and Kawasaki lines, deepening of the nasolabial folds and discontinuous jaw contour; 2) Patients seen between January 2023 and May 2024 who have had at least three single-site procedures, one in three weeks; 3) Patients are compliant and cooperative in completing follow-up visits. 4) Patients voluntarily participate in a prospective clinical study of bipolar multichannel radiofrequency combined with negative pressure and cooperate with long-term follow-up by signing an informed consent form.

排除标准：

1) 合并全身系统性疾病者（肝脏、心血管疾病病史、血脂异常、贫血、伴凝血机制异常、合并有传染性疾病，银屑病，糖尿病等），治疗区及附近有皮肤病或变态反应疾病； 2) 严重的皮肤松弛需要手术治疗者； 3) 6个月内接受过面部化学剥脱术或激光治疗者; 6个月内接受过面部肉毒素注射或软组织填充者; 治疗期间面部皮肤出现活动性炎症者； 4) 对射频治疗用甘油或耦合剂凝胶过敏者； 5) 妊娠及哺乳期。 6) 不能按照规定疗程治疗者。

Exclusion criteria：

1) Persons with combined systemic diseases (history of liver, cardiovascular diseases, dyslipidemia, anaemia, with abnormal coagulation mechanisms, combined infectious diseases, psoriasis, diabetes, etc.), skin diseases or allergic diseases in and around the treatment area; 2) those with severe skin laxity requiring surgical treatment 3) persons who have undergone chemical peel or laser treatment of the face within 6 months; persons who have received facial botulinum toxin injections or soft tissue fillers within 6 months; persons with active inflammation of the facial skin during treatment 4) Those who are allergic to glycerin or coupling agent gel for radiofrequency treatment 5) Pregnancy and breastfeeding. 6) Those who are unable to follow the prescribed course of treatment.

研究实施时间：

Study execute time：

从 From 2023-05-07 00:00:00至 To 2024-05-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-05-07 00:00:00 至 To 2023-07-01 00:00:00

干预措施：

Interventions：

组别：

治疗组

样本量：

 44

Group：

Treatment group

Sample size：

干预措施：

多通道射频治疗联合负压

干预措施代码：

Intervention：

bipolar multichannel radiofrequency combined with vacuum device

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(区县)：

 上海 

Country：

China

Province：

Shanghai

City：

Shanghai

单位(医院)：

 上海市第九人民医院 

单位级别：

 三甲 

Institution
hospital：

Shanghai Ninth People’s Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

ACGS评分

指标类型：

主要指标

Outcome：

Alexiades Comprehensive Grading Scale

Type：

Primary indicator

测量时间点：

第1、2、3次治疗前以及第1次治疗后3个月

测量方法：

Measure time point of outcome：

Before the 1st, 2nd and 3rd treatments and 3 months after the 1st treatment

Measure method：

指标中文名：

Visia皮肤分析仪分析

指标类型：

次要指标

Outcome：

Visia Skin Analyser Analysis

Type：

Secondary indicator

测量时间点：

第1、2、3次治疗前以及第1次治疗后3个月

测量方法：

Measure time point of outcome：

Before the 1st, 2nd and 3rd treatments and 3 months after the 1st treatment

Measure method：

指标中文名：

总体面部改善度

指标类型：

次要指标

Outcome：

Overall facial improvement

Type：

Secondary indicator

测量时间点：

第1次治疗后3个月

测量方法：

Measure time point of outcome：

3 months after the 1st treatment

Measure method：

指标中文名：

视觉模拟评分量表

指标类型：

次要指标

Outcome：

Visual Analogue Scale

Type：

Secondary indicator

测量时间点：

第2、3次治疗前

测量方法：

Measure time point of outcome：

Before the 2nd and 3rd treatments

Measure method：

指标中文名：

患者满意度

指标类型：

次要指标

Outcome：

Patients' satisfaction

Type：

Secondary indicator

测量时间点：

第1次治疗后3个月

测量方法：

Measure time point of outcome：

3 months after the 1st treatment

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

不进行采集标本

组织：

Sample Name：

No specimen collection

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 26 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）：

无随机

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

No randomized

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）：

Calculated Results after
the Study Completed(upload file)：

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）：

不共享原始数据

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

No IPD sharing

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：

CRF和EDC

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

CRF and EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-05-06 11:20:06