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南方医科大学皮肤病医院化妆品检测中心 CT240010-01
Cosmetics Testing Center, Dermatology Hospital, Southern Medical University, CT240010-01

南方医科大学皮肤病医院化妆品检测中心
Cosmetics Testing Center, Dermatology Hospital, Southern Medical University

检 验 报 告
Inspection report

检验受理编号
Inspection acceptance number

CT240010

检验报告编号
Inspection report number

CT240010-01

样品中文名称
Sample Chinese name

JCprogram弹润水光精华液、JCprogram弹润水光霜、JCprogram弹润水光面膜
JCprogram Hydrating Serum, JCprogram Hydrating Cream, JCprogram Hydrating Mask

样品外文名称
The foreign name of the sample

/

检 单 位
Sending unit

花安堂生物科技集团有限公司
Hua'an Tang Biotechnology Group Co., Ltd

国家化妆品不良反应监测评价基地
National Cosmetics Adverse Reaction Monitoring and Evaluation Base

国家药品监督管理局化妆品安全评价重点实验室副主任单位
Deputy Director Unit of the Key Laboratory of Cosmetics Safety Evaluation of the State Drug Administration

广东省药品监督管理局化妆品安全与功效关键技术重点实验室组成单位
It is a member of the Key Laboratory of Key Technologies of Cosmetic Safety and Efficacy of Guangdong Provincial Drug Administration

20240703
07/03/2024


Voice

一、本检验报告仅对接收样品负责。
1. This inspection report is only responsible for the receipt of samples.

二、本检验报告涂改增删无效;无检测人、校核人、技术负责人、授权签字人签名无效;未加盖检验检测专用章无效;复印件无效。
2. The alteration, addition or deletion of this inspection report is invalid; The signatures of no detector, verifier, technical person in charge, and authorized signatory are invalid; Failure to stamp the special seal for inspection and testing is invalid; Photocopies are not accepted.

三、本检验报告及本检验检测机构(或本医院)名称不得用于商业广告、产品标签、评优及商品宣传等其他用途。
3. The inspection report and the name of the inspection and testing institution (or the hospital) shall not be used for other purposes such as commercial advertising, product labeling, evaluation and commodity promotion.

四、对本检验报告有任何异议,应在收到报告之日起15个工作日内提出复核申请,逾期不予受理。
4. If there is any objection to this inspection report, an application for review shall be submitted within 15 working days from the date of receipt of the report, and it will not be accepted after the deadline.

五、本检验报告一式三份,二份交送检单位,一份由检验检测机构存档。
5. The inspection report shall be submitted in triplicate, two copies shall be submitted to the inspection unit, and one copy shall be filed by the inspection and testing institution.

联系地址:广东省广州市越秀区麓景路2
Address: No. 2, Lujing Road, Yuexiu District, Guangzhou City, Guangdong Province

邮政编码:510091
Postal code: 510091

联系电话:020-83028375/15360666806
Contact number: 020-83028375/15360666806

南方医科大学皮肤病医院化妆品检测中心
Cosmetics Testing Center, Dermatology Hospital, Southern Medical University

南方医科大学皮肤病医院化妆品检测中心
Cosmetics Testing Center, Dermatology Hospital, Southern Medical University

检 验 报 告
Inspection report

检验受理编号:CT240010 检验报告编号:CT240010-01
Inspection acceptance number: CT240010 Inspection report number: CT240010-01

样品中文名称
Sample Chinese name

JCprogram弹润水光精华液、JCprogram弹润水光霜、JCprogram弹润水光面膜
JCprogram Hydrating Serum, JCprogram Hydrating Cream, JCprogram Hydrating Mask

样品数量及规格
Sample quantity and specifications

精华液70, 30ml/
Essence 70 bottles, 30ml/bottle

水光霜70, 50g/
70 bottles of water cream, 50g/bottle

面膜560
Mask 560 sheets

进口产品外文名称
Foreign name of the imported product

/

生产日期或批号
Date of manufacture or lot number

精华液:N1013Z1
Serum: N1013Z1

水光霜:N1024Z1
Water Cream: N1024Z1

膜:N1108H1
Mask: N1108H1

颜色和物态
Colors and state of matter

精华液:无色透明液体
Serum: Colorless transparent liquid

水光霜:淡黄色膏体
Water Cream: Pale yellow paste

面膜:无色透明液体浸润膜布
Mask: Colorless transparent liquid soaked mask cloth

保质期或限期
Shelf life or expiration date

使用日期
Date of use

精华液:20261012
Serum: 20261012

水光霜:20261023
Hydration Cream: 20261023

膜:20261107
Mask: 20261107

受理日期
Date of acceptance

20240307
07.03.2024

检验开始日期
The inspection start date

20240319
2024-03-19

检验完成日期
The date on which the inspection was completed

20240516
2024-05-16

报告完成日期
Report completion date

20240703
07/03/2024

送检单位
Submit for inspection

花安堂生物科技集团有限公司
Hua'an Tang Biotechnology Group Co., Ltd

地址
address

广州市番禺区化龙镇柳围街13号(厂房)
No. 13, Liuwei Street, Hualong Town, Panyu District, Guangzhou City (factory).

生产企业
Manufacturers

日本禾基株式会社
Japan Heji Co., Ltd

地址
address

群马县馆林市楠町3966-5
3966-5, Kusucho, Tatebayashi City, Gunma Prefecture


Territorial Responsible

/

地址
address

/

测试样品外观图
Diagram of the appearance of the test sample

试验目的
Purpose of the trial

通过对比使用测试样品后与水光针治疗后皮肤状态及生理参数的变化,比较使用测试样品与水光针治疗对皮肤状态改善效果的差异。
By comparing the changes in skin condition and physiological parameters after the use of test samples and after skin booster treatment, the difference between the use of test samples and skin booster treatment on skin condition improvement was compared.

试验依据
Test basis

本项目依据实验室自建方法开展。
This project is carried out according to the laboratory's own methodology.

试验材料和方法
Test materials and methods

受试物
Test object

测试样品为JCprogram弹润水光精华液、JCprogram弹润水光霜及JCprogram弹润水光面膜终产品原物。以下简称为JC测试样品组合。
The test samples were JCprogram Hydrating Serum, JCprogram Hydrating Cream and JCprogram Hydrating Mask final product. Hereinafter referred to as the JC test sample combination.

对照样品为相应测试样品的基质配方。
The control sample is the matrix formulation of the corresponding test sample.

使用方法:
How to Use:

JCprogram弹润水光精华液,取1-2泵精华液于掌心温热后,平滑涂抹于半边面部肌肤,干燥部位可重点多次涂抹。一天使用2次,早晚各一次。
JCprogram Hydrating Serum, take 1-2 pumps of serum in the palm of your hand and warm it, then smoothly apply it to half of the face, focusing on dry areas and applying it multiple times. Use 2 times a day, once in the morning and once in the evening.

JCprogram弹润水光霜,取2-3颗珍珠粒大小的水光霜,点涂于脸颊、额头、鼻子、下巴5点处,由内向外侧打圈均匀涂抹至吸收。一天使用2次,早晚各一次。
JCprogram Moisturizing Cream: Take 2-3 pearl-sized moisturizing creams, apply them to 5 points on the cheeks, forehead, nose and chin, and apply evenly from the inside to the outside in a circular motion until absorbed. Use 2 times a day, once in the morning and once in the evening.

JCprogram弹润水光面膜清洁面部肌肤后,取少许膜袋精华液涂抹于面部,脸颊加厚面膜纸朝外,将面膜布贴敷于面部,享受15-20分钟护理,取下膜布,用清水洗净。每周使用2次,晚上使用。
After cleansing the facial skin, apply a small amount of mask bag essence to the face, thicken the cheeks with the mask paper facing outward, apply the mask cloth to the face, enjoy 15-20 minutes of treatment, remove the mask cloth, and rinse off with water. Use 2 times a week and in the evening.

使用顺序依次为面膜、精华液、面霜,不需使用面膜的时候洁面后依次使用精华液、面霜即可。
The order of use is mask, serum, and cream, and when you do not need to use a mask, you can use essence and cream after cleansing.

受试者
Subjects

受试者入选标准
Subject Inclusion Criteria

年龄30-55岁,健康状况良好;
Age 30-55 years old, in good health;

干性皮肤;
dry skin;

毛孔粗大、肤色暗沉、皮肤粗糙;
Enlarged pores, dull complexion, rough skin;

面部有明显细纹;
Visible fine lines on the face;

两侧面部皮肤状态一致;
The skin condition of both sides of the face is the same;

能够理解试验过程,自愿参加试验并签署书面知情同意书,愿意积极配合完成
Able to understand the trial process, voluntarily participate in the trial and sign a written informed consent form, and willing to actively cooperate with the completion

研究内容并能在研究期间保持健康规律的生活作息。
The content of the study and the ability to maintain a healthy and regular daily routine during the study period.

受试者排除标准
Subject exclusion criteria

计划怀孕或妊娠或哺乳期以及产后六个月内的妇女;
Women who plan to become pregnant or pregnant or lactating and within six months postpartum;

油性皮肤,面部容易长痘;
Oily skin, prone to acne on the face;

面部皮肤敏感急性发作期或有其他炎症性皮肤病临床未愈者;
Those who have acute attacks of facial skin sensitivity or other inflammatory skin diseases that have not been clinically cured;

瘢痕体质或极易出现色素沉着者;
Those who have scarring constitution or are prone to hyperpigmentation;

1个月内使用过维A酸、剥脱类护肤品或药物制剂者;
Those who have used tretinoin, exfoliative skin care products or pharmaceutical preparations within 1 month;

3个月内接受过医美项目治疗(光电类、紧致类、填充类等)或计划在本项目期
Have received medical aesthetic treatment (photoelectric, firming, filling, etc.) within 3 months or plan to be in the current project period

间接受其他医美治疗项目及药物;
Receiving other aesthetic treatments and medications;

体质高度敏感者,已知对透明质酸或利多卡因不耐受或过敏者;
Those who are highly sensitive, and those who are known to be intolerant or allergic to hyaluronic acid or lidocaine;

患有活动性自身免疫性疾病、恶性肿瘤、免疫缺陷、严重心脑血管疾病、严重心
Patients with active autoimmune diseases, malignant tumors, immunodeficiencies, severe cardiovascular and cerebrovascular diseases, severe cardiac disease

理障碍或精神疾病者;
Persons with physical impairment or mental illness;

1周有使用抗组胺药或其他影响研究结果的药物;
Use of antihistamines or other drugs that affect the results of the study in the past 1 week;

2个月受试部位参加过或正在参加其他临床试验者;
Those who have participated in or are participating in other clinical trials in the past 2 months;

其他经研究者评估不适合参与本研究的受试者;
Other subjects who are not suitable to participate in this study as assessed by the investigator;

非志愿参加者或不能按要求完成规定试验内容者。
Those who are not voluntary participants or who cannot complete the prescribed test content as required.

受试者限制
Subject Limitations

测试期间需按要求使用测试样品,每次使用过程需拍视频打卡;
During the test, the test samples should be used as required, and a video should be taken to punch in each use process;

测试期间除洁面乳外,只能使用统一提供的测试样品,不能使用其他护肤品或药物
During the test, only test samples provided by the same provider can be used, and no other skin care products or medications can be used

制剂;
Preparation;

测试期间不能接受其他医美治疗,包括光电类、紧致类、填充类等;
During the test, you cannot receive other medical aesthetic treatments, including photoelectric treatment, firming treatment, filling, etc.;

测试期间需保持健康规律的生活作息。
During the test, you need to maintain a healthy and regular routine.

试验仪器及材料
Test Instruments and Materials

VISIA-CR5皮肤图像分析系统:基于多种光源模式对面部皮肤表面特征进行成像,
VISIA-CR5 Skin Image Analysis System: Imaging facial skin surface features based on multiple light source modes

并有配套软件对特征参数进行定量分析。
And there is supporting software for quantitative analysis of characteristic parameters.

Primos CR皮肤皱纹分析系统:基于数字显微条纹投影器对皮肤表面特征进行快速
Primos CR Skin Wrinkle Analysis System: Rapid performance of skin surface features based on a digital microscopy streak projector

三维成像,并有配套软件对特征参数进行定量分析,可分析皮肤粗糙度、皱纹面积、体积及深度等参数。
Three-dimensional imaging, and supporting software for quantitative analysis of characteristic parameters, can analyze skin roughness, wrinkle area, volume and depth and other parameters.

Biox AquaFlux200经表皮水分流失测试仪:通过在封闭式冷凝腔体中收集皮肤扩散
Biox AquaFlux200 Transepidermal Water Loss Tester: Spreads by collecting skin in a closed condensation chamber

的水蒸气进行测试的,封闭腔测试不受周围空气流动影响。
If the test is carried out with water vapor, the closed chamber test is not affected by the flow of the surrounding air.

CK Corneometer CM825皮肤角质层水分含量测试仪:基于电容原理,在探头和高导
CK Corneometer CM825 Skin Stratum Coreum Moisture Content Tester: Based on the principle of capacitance, the probe and high conductivity

电性的表皮层之间形成电容器极板,按照含水量的不同,电容器会随着皮肤的电容量的变化而变化。
Capacitor plates are formed between the layers of the electric epidermis, and the capacitor changes with the capacitance of the skin depending on the water content.

Delfin SkinGlossmeter皮肤光泽度测试仪:通过测量皮肤表面镜面反射回来的光,
Delfin SkinGlossmeter: By measuring the light reflected back from the mirror surface of the skin

反映测试区域皮肤表面对光的反射能力,反射光强度越大则测量值越大,表征皮肤表面越有光泽。
Reflects the ability of the skin surface in the test area to reflect light, and the greater the reflected light intensity, the greater the measured value, indicating that the skin surface is more shiny.

CK MPA580皮肤弹性测试仪:通过在垂直方向上对皮肤施以恒定负压,再消除负压,
CK MPA580 Skin Elasticity Tester: Negative pressure is eliminated by applying constant negative pressure to the skin in the vertical direction

测量规定时间段内皮肤的位移变化,得到反映皮肤弹性及紧致度的表征值。
The change in the displacement of the skin over a defined period of time is measured to obtain a characterization value that reflects the elasticity and firmness of the skin.

其他:BZ-1注射器辅助推进装置、注射用透明质酸钠复合溶液(嗨体)、医用敷料、
Others: BZ-1 syringe auxiliary propulsion device, sodium hyaluronate composite solution for injection (Hi body), medical dressings,

视觉评估镜、无屑吸水干纸巾、洁面乳、棉签等。
Visual evaluation mirrors, dant-free absorbent dry wipes, facial cleanser, cotton swabs, etc.

试验方法
Test Method

对照方案
Control protocol

本研究采用组间对照,按照受试者入选及排除标准招募合格受试者66人,随机分成两
In this study, 66 qualified subjects were recruited according to the subject selection and exclusion criteria, and they were randomly divided into two

组,每组33人。一组受试者接受水光针治疗,治疗后半脸使用对照样品,为水光针治疗对照样品组;一组受试者不接受水光针治疗,半脸使用JC测试样品组合,为非水光针治疗JC测试样品组。
group, 33 people per group. One group of subjects received skin booster treatment, and the control sample was used on the half of the face after treatment, which was the control sample group for skin booster treatment. One group of subjects did not receive skin booster treatment, and the half face was treated with a combination of JC test samples, which was the group of non-skin booster treated JC test samples.

3.4.2 测试时间点
3.4.2 Test time

水光针治疗对照样品组:筛选、治疗前(D0)、治疗后第7天(D7)、治疗后第14天(D14)、治疗后第28天(D28)、治疗后第56天(D56)。
Skin booster treatment control sample group: screening, pre-treatment (D0), post-treatment day 7 (D7), post-treatment day 14 (D14), post-treatment day 28 (D28), post-treatment day 56 (D56).

非水光针治疗JC测试样品组:筛选、使用测试样品前(D0)、使用测试样品第7天(D7)、使用测试样品第14天(D14)、使用测试样品第28天(D28)、使用测试样品第56天(D56)。
Non-skinbooster treatment JC test sample set: screening, before using test sample (D0), day 7 (D7) with test sample, day 14 (D14) with test sample, day 28 (D28) with test sample, day 56 with test sample (D56).

3.4.3 测试流程
3.4.3 Test Process

严格按照入选排除标准筛选合格的受试者,签署知情同意后进行正式试验,随机分成水光针治疗对照样品组和非水光针治疗JC测试样品组。
Qualified subjects were screened in strict accordance with the inclusion and exclusion criteria, and formal trials were conducted after signing informed consent, and they were randomly divided into the control sample group of skin booster treatment and the sample group of JC test of non-skin booster treatment.

3.4.3.1水光针治疗对照样品组
3.4.3.1 Skinbooster treatment control sample group

用温和洁面乳清洁面部,无屑干纸巾拭干水分,在恒温恒湿室静坐30分钟。
Cleanse your face with a gentle cleanser, wipe off with a drum-free paper towel and sit in a constant temperature and humidity room for 30 minutes.

视觉评估:研究者对受试者面部皮肤情况进行视觉评估,受试者对自身面部皮
Visual assessment: The investigator conducts a visual assessment of the subject's facial skin, and the subject's own facial skin

肤情况进行自我评估。
Self-assessment of skin condition.

面部图像采集:VISIA-CR采集受试者面部图像、Primos-CR采集面部细纹区域图
Facial image acquisition: VISIA-CR collected the subject's facial image, and Primos-CR collected the area of facial fine lines

像。
Resemble.

皮肤生理指标检测:随机在一侧面部标记测试区域检测经表皮水分流失、角质
Skin physiological index detection: Randomly mark the test area on one side of the face to detect transepidermal water loss and keratin

层含水量、光泽度、弹性及紧实度。以眼睛中线和鼻梁中线的交点作为测试区域检测光泽度和经表皮水分流失,在测试区域测量3次,取平均值;以外眼角和鼻翼下方连线的交点作为测试区域检测角质层含水量,在测试区域测量5次,取平均值;以颧骨下方作为测试区域检测紧实度,在测试区域测量3次,取平均值;以外眼角外侧作为测试区域检测弹性,在测试区域测量3次,取平均值。
Layer moisture content, gloss, elasticity and firmness. The intersection of the midline of the eye and the midline of the bridge of the nose was used as the test area to detect the gloss and transepidermal water loss, and the test area was measured 3 times, and the average value was taken. The intersection point of the outer corner of the eye and the line below the alar of the nose was used as the test area to detect the water content of the stratum corneum, and the measurement was carried out 5 times in the test area, and the average value was taken. The firmness was measured 3 times in the test area under the cheekbones and the average value was taken. The outer corner of the outer eye was used as the test area to detect elasticity, and the test area was measured 3 times, and the average value was taken.

敷麻药,进行水光针治疗。
Anesthetic is applied and skin boosters are applied.

指导术后护理,24小时内不洗脸,48小时内使用医用辅料两次。48小时后随机
Instruct postoperative care, do not wash your face within 24 hours, and use medical excipients twice within 48 hours. Random after 48 hours

一侧半脸使用对照样品。
Use a control sample on one side of the face.

于治疗后第7天、第14天、第28天及第56天返回检测中心随访,按照上述流
On the 7th, 14th, 28th and 56th days after treatment, they returned to the testing center for follow-up and followed the above flow

程(1-4)完成相应测试。每次回访测试,同一测试指标均由同一检测人员、在同一测试环境、用同一仪器进行测试。
Procedures (1)-(4) complete the corresponding tests. For each return visit test, the same test index is tested by the same inspector, in the same test environment, and with the same instrument.

3.4.3.2 非水光针治疗JC测试样品组
3.4.3.2 Non-skinbooster treatment JC test sample set

用温和洁面乳清洁面部,无屑干纸巾拭干水分,在恒温恒湿室静坐30分钟。
Cleanse your face with a gentle cleanser, wipe off with a drum-free paper towel and sit in a constant temperature and humidity room for 30 minutes.

视觉评估:研究者对受试者面部皮肤情况进行视觉评估,受试者对自身面部皮
Visual assessment: The investigator conducts a visual assessment of the subject's facial skin, and the subject's own facial skin

肤情况进行自我评估。
Self-assessment of skin condition.

面部图像采集:VISIA-CR采集受试者面部图像、Primos-CR采集面部细纹区域
Facial image acquisition: VISIA-CR collected the subject's face image, and Primos-CR collected the facial fine line area

图像。
Image.

皮肤生理指标检测:随机在一侧半脸标记测试区域检测经表皮水分流失、角
Skin physiological index detection: Randomly detect transepidermal water loss and angle in the test area marked on one side of the face

质层含水量、光泽度、弹性及紧实度。以眼睛中线和鼻梁中线的交点作为测试区域检测光泽度和经表皮水分流失,在测试区域测量3次,取平均值;以外眼角和鼻翼下方连线的交点作为测试区域检测角质层含水量,在测试区域测量5次,取平均值;以颧骨下方作为测试区域检测紧实度,在测试区域测量3次,取平均值;以外眼角外侧作为测试区域检测弹性,在测试区域测量3次,取平均值。
Moisture content, gloss, elasticity and compactness of the texture. The intersection of the midline of the eye and the midline of the bridge of the nose was used as the test area to detect the gloss and transepidermal water loss, and the test area was measured 3 times, and the average value was taken. The intersection point of the outer corner of the eye and the line below the alar of the nose was used as the test area to detect the water content of the stratum corneum, and the measurement was carried out 5 times in the test area, and the average value was taken. The firmness was measured 3 times in the test area under the cheekbones and the average value was taken. The outer corner of the outer eye was used as the test area to detect elasticity, and the test area was measured 3 times, and the average value was taken.

发放测试样品并指导使用方法,随机一侧半脸使用JC测试样品组合。
Test samples are distributed and instructions are given on how to use them, and a combination of JC test samples is used on one side of the face at random.

受试者按要求居家使用测试样品,于第7天、第14天、第28天及第56天返回
Subjects were required to use the test samples at home and return on days 7, 14, 28 and 56

检测中心随访,按照上述流程(1-4)完成相应测试。每次回访测试,同一测试指标均由同一检测人员、在同一测试环境、用同一仪器进行测试。
The testing center will follow up and complete the corresponding tests according to the above process (1)-(4). For each return visit test, the same test index is tested by the same inspector, in the same test environment, and with the same instrument.

1. 评价参数列表
Table 1 List of evaluation parameters

指标类型
Indicator type

测量参数
Measurement parameters

测量时间点
Measurement time points

仪器
instrument

客观
objective

评价
appraise

光泽度
Glossiness

D0/D7/D14/D28/D56

Delfin SkinGlossmeter

经表皮水分流失
Transepidermal water loss

D0/D7/D14/D28/D56

Biox AquaFlux200

角质层含水量
Moisture content of the stratum corneum

D0/D7/D14/D28/D56

CM825

粗糙度
roughness

D0/D7/D14/D28/D56

Primos CR

皱纹
wrinkles

D0/D7/D14/D28/D56

Primos CR

弹性
elasticity

D0/D7/D14/D28/D56

MPA580

紧实度
Firmness

D0/D7/D14/D28/D56

MPA580

主观
subjective

评价
appraise

研究者视觉评估
Investigator visual assessment

D0/D7/D14/D28/D56

视觉评估镜
Visual evaluation mirrors

受试者自我评估
Subject self-assessment

D0/D7/D14/D28/D56

视觉评估镜
Visual evaluation mirrors

3.5 安全性和不良反应处理
3.5 Safety and Adverse Reaction Management

受试者均签署知情同意书,使用产品过程中出现任何不适,及时返回检测中心由医生面
The subjects all signed the informed consent form, and any discomfort during the use of the product should be returned to the testing center in time for a doctor's meeting

诊评估;每天线上随访询问受试者是否出现不适反应,所有的不良反应均如实记录。
diagnostic assessment; The subjects were asked whether they had any unpleasant reactions at the daily online follow-up, and all adverse reactions were recorded truthfully.

2. 人体试用试验皮肤反应分级标准
Table 2 Human trial test skin reaction grading criteria

皮肤反应
Skin reactions

分级
grading

无反应
No response

0

微弱红斑
Faint erythema

1

红斑、浸润、丘疹
erythema, infiltrates, papules

2

红斑、水肿、丘疹、水疱
Erythema, edema, papules, blisters

3

红斑、水肿、大疱
erythema, edema, bullae

4

参考《化妆品安全技术规范2015》人体试用试验皮肤反应分级标准。
Refer to the "Safety and Technical Specifications for Cosmetics 2015" human trial test skin reaction grading standard.

3.6 统计方法
3.6 Statistical Methods

使用SPSS25统计软件进行数据分析。
Data analysis was performed using the SPSS25 statistical software.

对于仪器测量定量数据表示为:均值±标准若服从正态分布则采用t检验,不符合正
For the quantitative data measured by the instrument, it is expressed as: the mean value ± standard error, if it obeys the normal distribution, the t-test is used, and it does not conform to the positive

态分布则采用非参数检验;研究者评估和受试者自我评估的等级评分数据,采用非参数检验。上述统计分析均为双尾检验,显著性水平为α=0.05P<0.05标记*P<0.01标记**P<0.001标记***P < 0.05 为有统计学差异,P <0.01为有显著统计学差异,P <0.001为有极其显著的统计学差异。
The state distribution is tested by non-parametric test. Grade scoring data for investigator assessment and subject self-assessment, using non-parametric tests. The above statistical analyses were all two-tailed tests, and the significance levels were α=0.05, P<0.05 marker*, P<0.01 marker**, P<0.001 marker***, P < 0.05 was statistically significant, P <0.01 was statistically significant, and P <0.001 was statistically significant.

3.7 试验结论
3.7 Conclusions

根据数据分析结果,试验期间水光针治疗对照样品组和非水光针治疗JC测试样品组受试者在任一访视时间点,皮肤角质层含水量测量值显著高于使用前基础值,则可认为水光针治疗和JC测试样品均具有保湿功效。若非水光针治疗JC测试样品组皮肤角质层含水量测量值与水光针治疗对照样品组比较无差异,则可认为JC测试样品对皮肤的保湿功效与水光针治疗相当;若显著高于水光针治疗对照样品组,则可认为JC测试样品对皮肤的保湿功效优于水光针治疗;若显著低于水光针治疗对照样品组,则可认为测试样品对皮肤的保湿功效不及水光针治疗。
According to the results of data analysis, the measured water content of the stratum corneum of the skin in the control sample group and the non-skinbooster treatment JC test sample group during the trial period was significantly higher than the basic value before use, which can be considered to have moisturizing effect of both the skin booster treatment and the JC test sample. If there is no difference in the measurement of water content in the stratum corneum of the non-skinbooster treatment JC test group compared with the control sample group, it can be considered that the moisturizing effect of the JC test sample on the skin is comparable to that of the skinbooster treatment. If it is significantly higher than that of the control sample group of skin booster treatment, it can be considered that the moisturizing effect of the JC test sample on the skin is better than that of the skin booster treatment. If it is significantly lower than that of the control sample group, it can be considered that the moisturizing effect of the test sample on the skin is not as good as that of the skin booster treatment.

根据数据分析结果,试验期间非水光针治疗JC测试样品组受试者在任一访视时间点,皮肤经表皮水分流失测量值显著低于使用前基础值,则可认为JC测试样品具有促进皮肤屏障修护的功效。
According to the results of data analysis, the measured value of transepidermal water loss in the non-skinbooster JC test sample group during the trial period was significantly lower than the basic value before use, which can be considered to have the effect of promoting skin barrier repair.

根据数据分析结果,试验期间水光针治疗对照样品组和非水光针治疗JC测试样品组受试者在任一访视时间点,皮肤弹性评估参数测量值显著高于使用前基础值,则可认为水光针治疗和JC测试样品均具有提升皮肤弹性的功效。若非水光针治疗JC测试样品组皮肤弹性评估参数测量值(或与使用前基础值的变化率)与水光针治疗对照样品组测量值(或与使用前基础值的变化率)比较无差异,则可认为JC测试样品对皮肤弹性提升的效果与水光针治疗相当;若显著高于水光针治疗对照样品组,则可认为JC测试样品对皮肤弹性提升的效果优于水光针治疗;若显著低于水光针治疗对照样品组,则可认为JC测试样品对皮肤弹性提升的效果不及水光针治疗。
According to the results of data analysis, during the trial, the measured values of skin elasticity evaluation parameters in the control sample group and the non-skinbooster treatment JC test sample group were significantly higher than the basic values before use, which can be considered to have the effect of improving skin elasticity in both the skin booster treatment and the JC test samples. If there is no difference between the measured values of skin elasticity assessment parameters (or the rate of change from the basal value before use) of the non-skinbooster treatment sample group and the measurement (or the rate of change from the basal value before use) of the control sample group of the skinbooster treatment, it can be considered that the effect of the JC test sample on the improvement of skin elasticity is comparable to that of the skinbooster treatment. If it was significantly higher than that of the control sample group of skin booster treatment, it could be considered that the effect of JC test sample on skin elasticity improvement was better than that of skin booster treatment. If it is significantly lower than that of the control sample group of skin booster treatment, it can be considered that the effect of JC test sample on skin elasticity improvement is not as good as that of skin booster treatment.

根据数据分析结果,试验期间水光针治疗对照样品组和非水光针治疗JC测试样品组受试者在任一访视时间点,皮肤紧实度评估参数测量值与使用前基础值比较显著降低,则可认为水光针治疗和JC测试样品均具有提升皮肤紧实度的功效。若非水光针治疗JC测试样品组皮肤紧实度评估参数测量值(或与使用前基础值的变化率)与水光针治疗对照样品组(或与使用前基础值的变化率)比较无差异,则可认为JC测试样品对皮肤紧实度提升的效果与水光针治疗相当;若显著低于水光针治疗对照样品组,则可认为JC测试样品对皮肤紧实度提升的效果优于水光针治疗;若显著高于水光针治疗对照样品组,则可认为JC测试样品对皮肤紧实度提升的效果不及水光针治疗。
According to the results of data analysis, during the trial, the measured values of skin firmness evaluation parameters in the control sample group and the non-skinbooster treatment JC test sample group were significantly lower than the basic values before use, which can be considered to have the effect of improving skin firmness. If there is no difference between the measurement of skin firmness evaluation parameters (or the rate of change from the basal value before use) in the non-skinbooster treatment JC test group and the control sample group (or the rate of change from the basal value before use), it can be considered that the effect of the JC test sample on skin firmness improvement is comparable to that of the skinbooster treatment. If it was significantly lower than that of the control sample group of skin booster treatment, it can be considered that the effect of JC test sample on skin firmness improvement is better than that of skin booster treatment. If it is significantly higher than that of the control sample group of skin booster treatment, it can be considered that the effect of JC test sample on skin firmness improvement is not as good as that of skin booster treatment.

根据数据分析结果,试验期间水光针治疗对照样品组和非水光针治疗JC测试样品组受试者在任一访视时间点,皮肤皱纹评估参数测量值与使用前基础值比较显著降低,则可认为水光针治疗和JC测试样品均具有改善皮肤皱纹的功效。若JC测试样品侧皮肤皱纹评估参数测量值(或与使用前基础值的变化率)与水光针治疗对照样品组(或与使用前基础值的变化率)比较无差异,则可认为JC测试样品改善皮肤皱纹的效果与水光针治疗相当;若显著低于水光针治疗对照样品组,则可认为JC测试样品改善皮肤皱纹的效果优于水光针治疗;若显著高于水光针治疗对照样品组,则可认为JC测试样品改善皮肤皱纹的效果不及水光针治疗。
According to the results of data analysis, during the trial, the measured values of skin wrinkle evaluation parameters in the control sample group and the non-skinbooster treatment JC test sample group were significantly lower than the basic values before use, and it can be considered that both the skin wrinkle treatment and the JC test samples have the effect of improving skin wrinkles. If there is no difference between the measured value of the skin wrinkle assessment parameter on the side of the JC test sample (or the rate of change from the base value before use) and the control sample group (or the rate of change from the base value before use), the effect of the JC test sample in improving skin wrinkles is considered to be comparable to that of skin booster treatment. If it was significantly lower than that of the control sample group of skin booster treatment, it can be considered that the effect of JC test sample in improving skin wrinkles is better than that of skin booster treatment. If it is significantly higher than that of the control sample group of skin booster treatment, it can be considered that the effect of JC test sample in improving skin wrinkles is not as good as that of skin booster treatment.

根据数据分析结果,试验期间水光针治疗对照样品组和非水光针治疗JC测试样品组受试者在任一访视时间点,皮肤光泽度测量值与使用前基础值比较显著升高,则可认为水光针治疗和JC测试样品均具有提升皮肤光泽度的效果。若JC测试样品侧皮肤光泽度测量值(或与使用前基础值的变化率)与水光针治疗对照样品组(或与使用前基础值的变化率)无差异,则可认为JC测试样品改善皮肤光泽度的效果与水光针治疗相当;若显著高于水光针治疗对照样品组,则可认为JC测试样品改善皮肤光泽度的效果优于水光针治疗;若显著低于水光针治疗对照样品组,则可认为JC测试样品改善皮肤光泽度的效果不及水光针治疗。
According to the results of data analysis, the skin radiance measurement value of the control sample group and the non-skinbooster treatment JC test sample group during the trial period was significantly higher than the basic value before use, which can be considered to have the effect of improving skin radiance in both the skin booster treatment and the JC test sample. If there is no difference between the measured skin radiance (or the rate of change from the basal value before use) on the side of the JC test sample and the control sample group (or the rate of change from the basal value before use), the effect of the JC test sample in improving skin radiance is considered to be comparable to that of the skinbooster treatment; If it was significantly higher than that of the control sample group of skin booster treatment, it could be considered that the effect of JC test sample in improving skin radiance was better than that of skin booster treatment. If it is significantly lower than that of the control sample group of skin booster treatment, it can be considered that the effect of JC test sample on improving skin radiance is not as good as that of skin booster treatment.

根据数据分析结果,试验期间水光针治疗对照样品组和非水光针治疗JC测试样品组受试者在任一访视时间点,皮肤粗糙度评估参数测量值与使用前基础值比较显著降低,则可认为水光针治疗和JC测试样品均具有改善皮肤粗糙度的效果。若JC测试样品侧皮肤粗糙度测量值(或与使用前基础值的变化率)与水光针治疗对照样品组比较无差异,则可认为JC测试样品改善皮肤粗糙度的效果与水光针治疗相当;若显著低于水光针治疗对照样品组,则可认为JC测试样品改善皮肤粗糙度的效果优于水光针治疗;若显著高于水光针治疗对照样品组,则可认为JC测试样品改善皮肤粗糙度的效果不及水光针治疗。
According to the results of data analysis, the measured values of skin roughness evaluation parameters in the control sample group and the non-skinbooster treatment JC test sample group during the trial period were significantly lower than the basic values before use, which can be considered to have the effect of improving skin roughness in both the skin skin booster treatment and the JC test samples. If there is no difference between the measured skin roughness of the JC test sample (or the rate of change from the basal value before use) and the control sample group of the skin booster treatment, it can be considered that the improvement effect of the JC test sample is comparable to that of the skin booster treatment. If it was significantly lower than that of the control sample group of skin booster treatment, it can be considered that the effect of JC test sample in improving skin roughness is better than that of skin booster treatment. If it was significantly higher than that of the control sample group, it can be considered that the effect of the JC test sample in improving skin roughness is not as good as that of the skin booster treatment.

试验结果
Test results

受试者情况描述
Description of the subject's condition

4.1.1 入组人数及完成情况
4.1.1 Number of enrollees and completion

3. 受试者例数及完成情况
Table 3 Number of subjects and their completion

组别
Constituencies

入组人数
Number of enrollees

退出人数
Number of people who quit

完成人数
Number of completions

水光针治疗
Skinbooster treatment

对照样品组
Control sample set

33
33 people

0
0 people

33
33 people

非水光针治疗
Non-skinbooster treatment

JC测试样品组
JC test sample set

33
33 people

1
1 person

32
32 people

年龄
age

4. 受试者年龄分布情况
Table 4 Age distribution of participants

组别
Constituencies

最小值
minimum

最大值
maximum

平均值
average value

标准差
standard deviation

P
P-value

水光针治疗
Skinbooster treatment

对照样品组
Control sample set

30

55

39.85

1.015

0.083

非水光针治疗
Non-skinbooster treatment

JC测试样品组
JC test sample set

31

55

42.39

1.026

安全性评估
Safety Assessment

本研究共招募6630-55岁的亚洲成年健康女性受试者,随机分成水光针治疗对照样品组和非水光针治疗JC测试样品组,非水光针治疗JC测试样品组随机一侧面部连续使用测试样品56天,水光针治疗对照样品组受试者接受水光针治疗2天后随机一侧面部连续使用对照样品。非水光针治疗JC测试样品组1名受试者因个人原因退出试验,32名受试者按要求完成全程测试,水光针治疗对照样品组33名受试者均按要求完成全程测试。两组受试者试验过程中均未出现任何与测试样品相关的不适反应。
In this study, a total of 66 Asian adult healthy female subjects aged 30-55 years were recruited and randomly divided into the control sample group of skin booster treatment and the non-skin booster treatment JC test sample group, the non-skin booster treatment JC test sample group was randomly used on one side of the face for 56 days, and the subjects in the water booster treatment control group were randomly treated with one side of the face for continuous use of control samples after 2 days of skin booster treatment. One subject in the non-skinbooster JC test sample group withdrew from the trial due to personal reasons, 32 subjects completed the full test as required, and 33 subjects in the control sample group completed the whole test as required. Neither group of subjects experienced any discomfort related to the test samples during the trial.

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5. 测试过程不良事件发生率
Table 5 Incidence of adverse events during the test process


item

不良事件比例
Proportion of adverse events

水光针治疗
Skinbooster treatment

对照样品组
Control sample set

非水光针治疗JC测试样品组
Non-skinbooster treatment JC test sample set

测试过程发生的不良事件
Adverse events that occurred during the testing process

0%0/33

0%0/32

通过皮肤科医生评定为与测试样品有关联的
Assessed by a dermatologist to be associated with the test sample

不良事件
Adverse events

0%0/33

0%0/32

通过皮肤科医生评定为与测试样品有关联的
Assessed by a dermatologist to be associated with the test sample

严重不良事件
Serious adverse events

0%0/33

0%0/32

受试者自觉的不适反应
Subject's perceived discomfort

0%0/33

0%0/32

客观评价-仪器测试结果
Objective evaluation - instrumental test results

角质层含水量
Moisture content of the stratum corneum

皮肤角质层含水量通过CK Corneometer CM825测定,测量值越大,表明测试部位皮肤角质层含水量越高。本项目在使用前/治疗前、第7天、第14天、第28天及第56天访视时分别测定各组受试者同一测试区域皮肤角质层含水量,通过对比测量值的变化来评估
The water content of the stratum corneum of the skin was determined by the CK Corneometer CM825, and the larger the measurement, the higher the water content of the stratum corneum of the skin at the test site. In this project, the water content of the stratum corneum of the skin in the same test area of subjects in each group was measured at the pre-use/pre-treatment, day 7, day 14, day 28 and day 56 visits, and was evaluated by comparing the changes in the measured values

水光针治疗及非水光针治疗JC测试样品对测试区域皮肤角质层含水量的影响。
Effect of skin booster treatment and non-skin booster treatment JC test samples on the water content of the stratum corneum of the skin in the test area.

6. 不同访视时点测试部位皮肤角质层含水量测量值(均值±标准误
Table 6. Measurement of water content of stratum corneum at the test site at different visit time points (mean ± standard error)

时间
Time

水光针治疗对照样品组
Skinbooster treatment control sample group

非水光针治疗JC测试样品组
Non-skinbooster treatment JC test sample set

P3
P3 value

测量值
Measurements

P1
P1 value

测量值
Measurements

P2
P2 value

D0

58.129±2.512

-

58.736±2.512

-

0.546

D7

65.815±2.475

<0.001***

61.768±2.373

<0.001***

0.045*

D14

68.210±2.177

<0.001***

65.459±2.173

<0.001***

0.107

D28

70.094±2.093

<0.001***

68.078±2.152

<0.001***

0.160

D56

70.595±1.835

<0.001***

69.125±1.998

<0.001***

0.123

注:1. D0表示治疗前/使用前;D7表示使用测试样品第7/治疗后第7天;D14表示使用测试样品第14/治疗后第14天;D28表示使用测试样品第28/治疗后第28天;D56表示使用测试样品第56/治疗后第56天。(下同)
Notes:1. D0 indicates pre-treatment and pre-use; D7 indicates the 7th day after treatment on the 7th day of the test sample; D14 indicates the 14th day after treatment on the 14th day of the test sample; D28 indicates the 28th day after treatment on the 28th day of the test sample; D56 indicates the use of test samples on day 56 after treatment day 56. (the same below)

P1值分别表示水光针治疗对照样品组测试区域皮肤治疗后不同访视时点测量值与治疗前测量值比较的统计分析显著性结
TheP1 value represents the statistically significant knots of the comparison of the measured values at different visit time points after skin treatment in the test area of the control sample group treated with skin and the measured values before treatment, respectively

果;P2值分别表示非水光针治疗JC测试样品组使用后不同访视时点测量值与使用前测量值比较的统计分析显著性结果;P3值分别表示不同访视时点水光针治疗对照样品组与非水光针治疗JC测试样品组测量值比较的统计分析显著性结果。(下同)
Fruit; The P2 value represents the statistical significance results of the comparison of the measured values at different visit time points after use and the measured values before use in the sample group of non-skin booster treatment JC tests. The P3 values represent the statistical significance results of the comparison of the measured values of the control sample group and the non-skinbooster treatment JC test sample group at different visit points. (the same below)

1. 不同访视时点两组测试部位皮肤角质层含水量测量值比较
Figure 1 Comparison of the measured values of stratum corneum moisture content of the two groups of test sites at different visit time points

2. 不同访视时点各组测试部位皮肤角质层含水量测量值变化
Figure 2 Changes in the measured moisture content of the stratum corneum of the skin at each group of test sites at different visit time points

7. 水光针治疗对照样品组和非水光针治疗JC测试样品组皮肤角质层含水量测量值变化率(%
Table 7. Rate of change (%) in the measured value of water content in the stratum corneum of the skin in the control sample group and the non-skinbooster treatment JC test sample group (%)

时间
Time

水光针治疗对照样品组
Skinbooster treatment control sample group

非水光针治疗JC测试样品组
Non-skinbooster treatment JC test sample set

P
P-value

D7

14.411±1.956

5.745±0.740

<0.001***

D14

20.813±3.091

12.903±1.433

0.036*

D28

24.849±3.703

17.684±1.734

0.352

D56

26.510±4.201

20.074±2.305

0.564

注:变化率表示受试者D7D14D28D56测量值相对于D0基础值的变化率,计算公式为[Dn测量值- D0测量值)/ D0测量值]*100%。(下同)
Note: The rate of change represents the rate of change of the measured value of the subject's D7, D14, D28 or D56 relative to the base value of D0, and is calculated as (Dn measurement - D0 measurement) / D0 measurement]*100%. (the same below)

3. 水光针治疗对照样品组和非水光针治疗JC测试样品组皮肤角质层含水量测量值变化率
Figure 3. Rate of change in measured water content of skin stratum corneum in the control sample group and non-skinbooster treatment JC test sample group

【小结】
【Summary】

统计结果显示:
The statistical results show that:

非水光针治疗JC测试样品组使用测试样品前D0测试区域皮肤角质层含水量测量值与水光针治疗对照样品组治疗前测量值比较无明显差异(P>0.05)。
There was no significant difference between the measured moisture content of the stratum corneum in the D0 test area before the use of the test samples in the non-skinbooster treatment JC test group and the pre-treatment measurement in the control sample group (P>0.05).

在第7天访视时,非水光针治疗JC测试样品组受试者测试区域皮肤角质层含水量测量值与使用前基础值比较升高,差异具有极显著性P<0.001);水光针治疗对照样品组受试者测试区域皮肤角质层含水量测量值与治疗前基础值比较升高,差异具有极显著性P<0.001);非水光针治疗JC测试样品组角质层含水量测量值低于水光针治疗对照样品组,差异具有显著性P<0.05;非水光针治疗JC测试样品组测量值与使用前基础值的变化率低于水光针治疗对照样品组,差异具有极显著性P<0.001)。由此提示,在该研究条件下,JC测试样品使用7天与水光针治疗后7天对受试者测试部位皮肤均具有保湿功效,水光针治疗对受试者测试部位皮肤保湿功效优于JC测试样品。
At the 7th day visit, the measured water content of the stratum corneum in the test area of the subjects in the JC test group was significantly higher than that before the use (P<0.001). Compared with the basic value before treatment, the measured water content of the stratum corneum in the test area of the control group was significantly different from that before treatment (P<0.001). The measurement of stratum corneum water content in the non-skinbooster JC test group was lower than that in the control group, and the difference was significant (P<0.05). The change rate between the measured value and the basal value before use in the non-skinbooster treatment JC test group was lower than that in the control group, and the difference was extremely significant (P<0.001). The results suggest that under the study conditions, the JC test samples had moisturizing effect on the skin of the test site after 7 days of use and 7 days after the treatment with skin boosters, and the moisturizing effect of the skin treatment on the test site of the subjects was better than that of the JC test samples.

在第14天访视时,非水光针治疗JC测试样品组受试者测试区域皮肤角质层含水量测量值与使用前基础值比较升高,差异具有极显著性P<0.001);水光针治疗对照样品组受试者测试区域皮肤角质层含水量测量值与治疗前基础值比较升高,差异具有极显著性P<0.001);非水光针治疗JC测试样品组角质层含水量测量值与水光针治疗对照样品组比较无明显差异P>0.05;非水光针治疗JC测试样品组测量值与使用前基础值的变化率低于水光针治疗对照样品组,差异具有显著性P<0.05)。由此提示,在该研究条件下,JC测试样品使用14天与水光针治疗后14天对受试者测试部位皮肤均具有保湿功效,水光针治疗对受试者测试部位皮肤保湿功效优于JC测试样品。
At the 14-day visit, the measured water content of the stratum corneum in the test area of the subjects in the non-skin skin treatment JC test group was higher than the basal value before use, and the difference was extremely significant (P<0.001). The measurement of stratum corneum water content in the test area of the control group was significantly higher than that before treatment (P<0.001), while there was no significant difference between the measurement of stratum corneum water content in the non-skinbooster treatment JC test group and the control sample group (P>0.05). The change rate between the measured value and the basal value before use in the non-skinbooster treatment JC test group was lower than that in the control group, and the difference was significant (P<0.05). The results suggest that under the study conditions, the JC test samples had moisturizing effect on the skin of the test site after 14 days of use and 14 days after the treatment of skin boosters, and the moisturizing effect of skin booster treatment on the skin of the test site was better than that of the JC test samples.

在第28天访视时,非水光针治疗JC测试样品组受试者测试区域皮肤角质层含水量测量值与使用前基础值比较升高,差异具有极显著性P<0.001);水光针治疗对照样品组受试者测试区域皮肤角质层含水量测量值与治疗前基础值比较升高,差异具有极显著性P<0.001);非水光针治疗JC测试样品组D28测量值与水光针治疗对照样品组比较无明显差异P>0.05;非水光针治疗JC测试样品组D28测量值与使用前基础值的变化率与水光针治疗对照样品组比较无明显差异P>0.05)。由此提示,在该研究条件下,JC测试样品使用28天与水光针治疗后28天对受试者测试部位皮肤均具有保湿功效,JC测试样品对受试者测试部位皮肤保湿功效与水光针治疗相当。
At the 28-day visit, the measured water content of the stratum corneum in the test area of the subjects in the non-skin light injection treatment JC test group was higher than the basal value before use, and the difference was extremely significant (P<0.001). The measurement of water content in the stratum corneum of the test area of the subjects in the control group was significantly higher than that before treatment (P<0.001), and there was no significant difference between the D28 measurement in the non-skinbooster treatment JC test group and the control group (P>0.05). There was no significant difference between the D28 measurement value and the basal value before use in the non-skinbooster treatment JC test group and the control sample group (P>0.05). It was suggested that under the study conditions, the JC test samples had moisturizing effect on the skin of the test site for 28 days and 28 days after the skin booster treatment, and the moisturizing effect of the JC test sample on the skin of the test site was comparable to that of the skin of the skin of the subject under the treatment of skin boosters.

在第56天访视时,非水光针治疗JC测试样品组受试者测试区域皮肤角质层含水量测量值与使用前基础值比较升高,差异具有极显著性P<0.001);水光针治疗对照样品组受试者测试区域皮肤角质层含水量测量值与治疗前基础值比较升高,差异具有极显著性P<0.001);非水光针治疗JC测试样品组D56测量值与水光针治疗对照样品组比较无明显差异P>0.05;非水光针治疗JC测试样品组D56测量值与使用前基础值的变化率与水光针治疗对照样品组比较无明显差异P>0.05)。由此提示,在该研究条件下,JC测试样品使用56天与水光针治疗后56天对受试者测试部位皮肤均具有保湿功效,JC测试样品对受试者测试部位皮肤保湿功效与水光针治疗相当。
At the 56-day visit, the measured water content of the stratum corneum in the test area of the subjects in the non-skin light injection treatment JC test group was higher than the basal value before use, and the difference was extremely significant (P<0.001). Compared with the basic value before treatment, the measured value of stratum corneum in the test area of the control group was significantly different (P<0.001), while there was no significant difference between the D56 value of the non-skinbooster treatment JC test group and the control group (P>0.05). There was no significant difference between the measured value of D56 and the basal value before use in the non-skinbooster treatment JC test group and the control sample group (P>0.05). This suggests that under the study conditions, the JC test samples had moisturizing effect on the skin of the test site for 56 days and 56 days after the skin booster treatment, and the moisturizing effect of the JC test sample on the skin of the test site was comparable to that of the skin booster treatment.

经表皮水分流失
Transepidermal water loss

经表皮水分流失是指单位时间内测试部位皮肤水分蒸发速率,可间接反应表皮通透屏障功能,测量值越低,表明测试部位皮肤单位时间内经表皮水分流失越少,间接反应表皮通透屏障功能越好。敏感性皮肤该数值常增高。本项目在使用前/治疗前、第7天、第14天、第28天及第56天分别测定各组受试者同一测试区域皮肤经表皮水分流失,通过对比两组测量值的变化来评估水光针治疗对照样品及非水光针治疗JC测试样品对测试区域皮肤经表皮水分流失的影响。
Transepidermal water loss refers to the rate of skin water evaporation per unit time of the test site, which can indirectly reflect the epidermal permeable barrier function, and the lower the measured value, the lower the transepidermal water loss of the skin at the test site per unit time, and the better the indirect reaction epidermal permeable barrier function. This is often elevated in sensitive skin. In this study, the transepidermal water loss of the same test area was measured by the subjects in each group before use/treatment, day 7, day 14, day 28 and day 56, and the effect of skin transepidermal water loss in the test area was evaluated by comparing the changes of the measured values between the two groups.

8. 不同访视时点测试部位皮肤经表皮水分流失测量值(均值±标准误
Table 8. Measurement of transepidermal water loss from skin at different visit time points (mean ± standard error)

时间
Time

水光针治疗对照样品组
Skinbooster treatment control sample group

非水光针治疗JC测试样品组
Non-skinbooster treatment JC test sample set

P3
P3 value

测量值
Measurements

P1
P1 value

测量值
Measurements

P2
P2 value

D0

26.354±1.593

-

26.161±0.866

-

0.276

D7

26.522±1.243

0.598

24.376±0.709

0.020*

0.447

D14

24.952±0.890

0.526

23.920±0.726

0.001**

0.374

D28

23.614±0.833

0.057

23.269±0.794

0.008**

0.765

D56

24.326±0.739

0.280

21.489±0.650

<0.001**

0.005**

4. 不同访视时点两组测试部位皮肤经表皮水分流失测量值比较
Figure 4 Comparison of transepidermal water loss measurements from the skin at the two groups at different visit times

5. 不同访视时点各组测试部位皮肤经表皮水分流失测量值变化
Figure 5 Changes in the measured value of transepidermal water loss from the skin at each group of test sites at different visit time points

9. 水光针治疗对照样品组和非水光针治疗JC测试样品组皮肤经表皮水分流失测量值变化率(%
Table 9. Change rate of measured transepidermal water loss from skin in the control sample group and non-skinbooster treatment JC test group (%)

时间
Time

水光针治疗对照样品组
Skinbooster treatment control sample group

非水光针治疗JC测试样品组
Non-skinbooster treatment JC test sample set

P
P-value

D7

4.285±3.735

-5.132±3.047

0.037*

D14

-0.269±4.250

-6.987±2.909

0.232

D28

-5.254±4.311

-8.647±3.748

0.556

D56

-2.803±3.566

-15.355±3.515

0.015*

6. 水光针治疗对照样品组和非水光针治疗JC测试样品组皮肤经表皮水分流失测量值变化率
Figure 6. The rate of change in the measured value of transepidermal skin water loss in the control sample group and the non-skinbooster treatment JC test sample group

【小结】
【Summary】

统计结果显示:
The statistical results show that:

非水光针治疗JC测试样品组使用测试样品前D0测试区域皮肤经表皮水分流失测量值与水光针治疗对照样品组治疗前测量值比较无明显差异(P>0.05)。
There was no significant difference between the measured transepidermal water loss in the D0 test area before the use of the test samples in the non-skinbooster treatment JC test group and the pretreatment measurement in the control sample group (P>0.05).

在第7天访视时,非水光针治疗JC测试样品组受试者测试区域皮肤经表皮水分流失测量值与使用前基础值比较降低,差异具有统计学意义P<0.05);水光针治疗对照样品组受试者测试区域皮肤经表皮水分流失测量值与治疗前基础值比较升高,但差异无统计学意义P>0.05);非水光针治疗JC测试样品组经表皮水分流失测量值与水光针治疗对照样品组比较无明显差异P>0.05;非水光针治疗JC测试样品组测量值与使用前基础值的变化率低于水光针治疗对照样品组,差异具有统计学意义P<0.05)。由此提示,在该研究条件下,JC测试样品使用7天对受试者测试部位皮肤屏障功能具有修护功效。
At the 7th day visit, the measured value of transepidermal water loss in the test area of the subjects in the JC test group was significantly lower than the basal value before use (P<0.05), and the measured value of transepidermal water loss in the test area of the subjects in the control group was higher than that before treatment, but the difference was not statistically significant (P>0.05). There was no significant difference in the measured transepidermal water loss between the non-skinbooster JC test group and the control group (P>0.05). The change rate between the measured value and the basal value before use in the non-skinbooster treatment JC test group was lower than that in the control group, and the difference was statistically significant (P<0.05). This suggests that under the study conditions, the JC test samples were used for 7 days to repair the skin barrier function of the test site.

在第14天访视时,非水光针治疗JC测试样品组受试者测试区域皮肤经表皮水分流失测量值与使用前基础值比较降低,差异具有显著性P<0.01);水光针治疗对照样品组受试者测试区域皮肤经表皮水分流失测量值与治疗前基础值比较降低,但差异无统计学意义P>0.05);非水光针治疗JC测试样品组经表皮水分流失测量值与水光针治疗对照样品组比较无明显差异P>0.05;非水光针治疗JC测试样品组D14测量值与使用前基础值的变化率与水光针治疗对照样品组比较无明显差异P>0.05)。由此提示,在该研究条件下,JC测试样品使用14天对受试者测试部位皮肤屏障功能具有修护功效。
At the visit on the 14th day, the measured value of transepidermal water loss in the test area of the subjects in the non-skinbooster treatment JC test group was significantly lower than the basal value before use (P<0.01), and the measured value of transepidermal water loss in the test area of the subjects in the control group was significantly lower than that before treatment, but the difference was not statistically significant (P>0.05). There was no significant difference in the measured transepidermal water loss between the non-skinbooster JC test group and the control group (P>0.05). There was no significant difference in the rate of change between the measured value of D14 and the basal value before use in the non-skinbooster treatment JC test group compared with the control sample group (P>0.05). This suggests that under the study conditions, the JC test sample used for 14 days has a repair effect on the skin barrier function of the subject's test site.

在第28天访视时,非水光针治疗JC测试样品组受试者测试区域皮肤经表皮水分流失测量值与使用前基础值比较降低,差异具有显著性P<0.01);水光针治疗对照样品组受试者测试区域皮肤经表皮水分流失测量值与治疗前基础值比较降低,但差异无统计学意义P>0.05);非水光针治疗JC测试样品组D28测量值与水光针治疗对照样品组比较无明显差P>0.05;非水光针治疗JC测试样品组D28测量值与使用前基础值的变化率与水光针治疗对照样品组比较无明显差异P>0.05)。由此提示,在该研究条件下,JC测试样品使用28天对受试者测试部位皮肤屏障功能具有修护功效。
At the visit on the 28th day, the measured value of transepidermal water loss in the test area of the subjects in the non-skinbooster treatment JC test group was significantly lower than the basal value before use (P<0.01), and the measured value of transepidermal water loss in the test area of the subjects in the control group was significantly lower than that before treatment (P>0.05). There was no significant difference in the D28 measurement value between the non-skinbooster JC test group and the control group (P>0.05). There was no significant difference between the D28 measurement value and the basal value before use in the non-skinbooster treatment JC test group and the control sample group (P>0.05). This suggests that under the study conditions, the JC test samples were used for 28 days to repair the skin barrier function of the test site.

在第56天访视时,非水光针治疗JC测试样品组受试者测试区域皮肤经表皮水分流失测量值与使用前基础值比较降低,差异具有极显著性P<0.001);水光针治疗对照样品组受试者测试区域皮肤经表皮水分流失测量值与治疗前基础值比较降低,但差异无统计学意义P>0.05);非水光针治疗JC测试样品组D28测量值低于水光针治疗对照样品组,差异具有显著性P<0.01;非水光针治疗JC测试样品组D28测量值与使用前基础值的变化率低于水光针治疗对照样品组,差异具有统计学意义P<0.05)。由此提示,在该研究条件下,JC测试样品使用56天对受试者测试部位皮肤屏障功能具有修护功效。
At the visit on the 56th day, the measured value of transepidermal water loss in the test area of the subjects in the non-skinbooster treatment sample group was significantly lower than that before use (P<0.001), and the measured value of skin transepidermal water loss in the test area of the subjects in the control group was significantly lower than that before treatment (P>0.05). The D28 measurement value of the non-skinbooster JC test group was lower than that of the control group, and the difference was significant (P<0.01). The change rate of D28 measurement and the basal value before use in the non-skinbooster treatment JC test group was lower than that in the control group, and the difference was statistically significant (P<0.05). This suggests that under the study conditions, the JC test sample used for 56 days has a repair effect on the skin barrier function of the subject's test site.

光泽度
Glossiness

通过SkinGlossMeter测量皮肤表面镜面反射回来的光,可反映测试区域皮肤表面对光的反射能力,反射光强度越大则测量值越大,表征皮肤表面越有光泽,反之则皮肤越晦暗。本项目在使用前/治疗前、第7天、第14天、第28天及第56天分别测定各组受试者同一测试区域皮肤光泽度,通过对比两组测量值的变化来评估水光针治疗对照样品及非水光针治疗JC测试样品对测试区域皮肤光泽度的影响。
The greater the intensity of the reflected light, the greater the measured value, the more shiny the skin surface, and the darker the skin. In this study, the skin gloss of the same test area was measured in each group before use/treatment, day 7, day 14, day 28 and day 56, and the effect of skin radiance on the skin radiance of the test area was evaluated by comparing the changes of the measured values between the two groups.

10. 不同访视时点测试部位皮肤光泽度测量值(均值±标准误
Table 10. Measurements of skin gloss at test sites at different visit time points (mean ± standard error)

时间
Time

水光针治疗对照样品组
Skinbooster treatment control sample group

非水光针治疗JC测试样品组
Non-skinbooster treatment JC test sample set

P3
P3 value

测量值
Measurements

P1
P1 value

测量值
Measurements

P2
P2 value

D0

56.444±1.086

-

56.490±1.354

-

0.699

D7

58.707±1.106

<0.001***

56.719±1.190

0.490

0.153

D14

58.929±1.098

<0.001***

57.333±1.081

0.046*

0.192

D28

58.727±1.094

<0.001***

58.000±1.046

0.003**

0.660

D56

58.495±1.045

<0.001***

57.865±1.070

0.003**

0.699

7. 不同访视时点两组测试部位皮肤光泽度测量值比较
Figure 7 Comparison of skin gloss measurements at two groups of test sites at different visit time points

8. 不同访视时点各组测试部位皮肤光泽度测量值变化
Figure 8 Changes in the measurement of skin gloss at each group of test sites at different visit time points

11. 水光针治疗对照样品组和非水光针治疗JC测试样品组皮肤光泽度测量值变化率(%
Table 11. Skinbooster control sample group and non-skinbooster JC test sample group change rate (%)

时间
Time

水光针治疗对照样品组
Skinbooster treatment control sample group

非水光针治疗JC测试样品组
Non-skinbooster treatment JC test sample set

P
P-value

D7

4.076±0.515

0.664±0.614

<0.001***

D14

4.501±0.614

1.902±0.746

0.009**

D28

4.131±0.553

3.171±0.907

0.122

D56

3.757±0.551

2.899±0.865

0.131

9. 水光针治疗对照样品组和非水光针治疗JC测试样品组皮肤光泽度测量值变化率
Figure 9. Skinbooster treatment control sample group and non-skinbooster treatment JC test sample group skin radiance measurement change rate

【小结】
【Summary】

统计结果显示:
The statistical results show that:

非水光针治疗JC测试样品组使用测试样品前测试区域皮肤光泽度测量值与水光针治疗对照样品组治疗前测量值比较无明显差异(P>0.05)。
There was no significant difference between the measured skin gloss in the test area before the use of the test samples in the non-skinbooster treatment JC test group and the pre-treatment measurement in the control sample group (P>0.05).

在第7天访视时,非水光针治疗JC测试样品组受试者测试区域皮肤光泽度测量值与使用前基础值比较无明显差异P>0.05);水光针治疗对照样品组受试者测试区域皮肤光泽度测量值与治疗前基础值比较升高,差异具有极显著性P<0.001);非水光针治疗JC测试样品组光泽度测量值与水光针治疗对照样品组比较无明显差异P>0.05;非水光针治疗JC测试样品组测量值与使用前基础值的变化率低于水光针治疗对照样品组,差异具有极显著性P<0.001)。由此提示,在该研究条件下,水光针治疗后7天受试者测试部位皮肤光泽度有一定程度改善。
At the 7th day visit, there was no significant difference in the measured skin gloss in the test area of the subjects in the non-skinbooster treatment JC test sample group compared with the basic value before use (P>0.05). The measurement value of skin gloss in the test area of the control sample group was significantly higher than that before treatment (P<0.001), and there was no significant difference between the gloss measurement of the non-skin booster treatment JC test group and the control sample group (P>0.05). The change rate between the measured value and the basal value before use in the non-skinbooster treatment JC test group was lower than that in the control group, and the difference was extremely significant (P<0.001). This suggests that under the study conditions, the skin gloss of the test site of the subject improved to a certain extent 7 days after the skin booster treatment.

在第14天访视时,非水光针治疗JC测试样品组受试者测试区域皮肤光泽度测量值与使用前基础值比较升高,差异具有统计学意义P<0.05);水光针治疗对照样品组受试者测试区域皮肤光泽度测量值与治疗前基础值比较升高,差异具有极显著性P<0.001);非水光针治疗JC测试样品组光泽度测量值与水光针治疗对照样品组比较无明显差异P>0.05;非水光针治疗JC测试样品组测量值与使用前基础值的变化率低于水光针治疗对照样品组,差异具有显著性P<0.01)。由此提示,在该研究条件下,JC测试样品使用14天和水光针治疗后14天受试者测试部位皮肤光泽度均有一定程度改善,水光针治疗对受试者测试部位皮肤光泽度改善效果优于JC测试样品
At the 14-day visit, the measured value of skin gloss in the test area of the subjects in the non-skinbooster treatment JC test sample group was significantly higher than the basic value before use (P<0.05). The measurement value of skin gloss in the test area of the control sample group was significantly higher than that before treatment (P<0.001), and there was no significant difference between the gloss measurement of the non-skin booster treatment JC test group and the control sample group (P>0.05). The change rate between the measured value and the basal value before use in the non-skinbooster treatment JC test group was lower than that in the control group, and the difference was significant (P<0.01). The results suggest that under the conditions of this study, the skin gloss of the test site of the subjects was improved to a certain extent after 14 days of use of JC test samples and 14 days after the treatment of skin boosters, and the improvement effect of skin gloss treatment on the test sites of the subjects was better than that of the JC test samples.

在第28天访视时,非水光针治疗JC测试样品组受试者测试区域皮肤光泽度测量值与使用前基础值比较升高,差异具有显著性P<0.01水光针治疗对照样品组受试者测试区域皮肤光泽度测量值与治疗前基础值比较升高,差异具有极显著性P<0.001);非水光针治疗JC测试样品组光泽度测量值与水光针治疗对照样品组比较无明显差异P>0.05;非水光针治疗JC测试样品组测量值与使用前基础值的变化率与水光针治疗对照样品组比较无明显差异P>0.05)。由此提示,在该研究条件下,JC测试样品使用28天和水光针治疗后28天受试者测试部位皮肤光泽度均有一定程度改善,JC测试样品对受试者测试部位皮肤光泽度提升效果与水光针治疗相当。
At the 28-day visit, the measured value of skin gloss in the test area of the subjects in the non-skin booster treatment JC test sample group was significantly higher than the basic value before use (P<0.01). The measurement value of skin gloss in the test area of the control sample group was significantly higher than that before treatment (P<0.001), and there was no significant difference between the gloss measurement of the non-skin booster treatment JC test group and the control sample group (P>0.05). There was no significant difference between the measured value and the basal value before use in the non-skinbooster treatment JC test group and the control sample group (P>0.05). This suggests that under the conditions of this study, the skin gloss of the test site of the subjects was improved to a certain extent after 28 days of use of JC test samples and 28 days after skin booster treatment, and the effect of JC test samples on the skin gloss of the test site was comparable to that of skin booster treatment.

在第56天访视时,非水光针治疗JC测试样品组受试者测试区域皮肤光泽度测量值与使用前基础值比较升高,差异具有显著性P<0.01水光针治疗对照样品组受试者测试区域皮肤光泽度测量值与治疗前基础值比较升高,差异具有极显著性P<0.001);非水光针治疗JC测试样品组光泽度测量值与水光针治疗对照样品组比较无明显差异P>0.05;非水光针治疗JC测试样品组测量值与使用前基础值的变化率与水光针治疗对照样品组比较无明显差异P>0.05)。由此提示,在该研究条件下,JC测试样品使用56天和水光针治疗后56天受试者测试部位皮肤光泽度均有一定程度改善,JC测试样品对受试者测试部位皮肤光泽度提升效果与水光针治疗相当。
At the 56-day visit, the measured value of skin gloss in the test area of the subjects in the non-skin booster treatment JC test group was significantly higher than the basic value before use (P<0.01). The measurement value of skin gloss in the test area of the control sample group was significantly higher than that before treatment (P<0.001), and there was no significant difference between the gloss measurement of the non-skin booster treatment JC test group and the control sample group (P>0.05). There was no significant difference between the measured value and the basal value before use in the non-skinbooster treatment JC test group and the control sample group (P>0.05). This suggests that under the conditions of this study, the skin gloss of the test site of the subjects was improved to a certain extent after 56 days of use of JC test samples and 56 days after skin booster treatment, and the effect of JC test samples on the skin gloss of the test site of the subjects was comparable to that of the skin gloss treatment of water booster treatment.

粗糙度
roughness

通过Primos CR采集测试部位皮肤图像后,经软件分析计算得到粗糙度评估参数RaRq。测量值越大,表明测试部位皮肤越粗糙,反之则越平滑。本项目在使用前/治疗前、使用测试样品第7天、第14天、第28天及第56天分别采集同一区域皮肤图像并分析,通过对比两组测量值的变化来评估水光针治疗对照样品和非水光针治疗JC测试样品对测试区域皮肤粗糙度的影响
After the skin images of the test site were collected by Primos CR, the roughness evaluation parameters Ra and Rq were calculated by software analysis. The larger the measurement, the rougher the skin at the test site, and vice versa, the smoother it is. In this project, skin images in the same area were collected and analyzed before use/treatment, on the 7th, 14th, 28th and 56th days of the test samples, and the effect of the control samples and non-skinbooster JC test samples on the skin roughness of the test area was evaluated by comparing the changes of the measured values between the two groups.

12. 不同访视时点测试部位皮肤粗糙度测量值(均值±标准误
Table 12. Measurements of skin roughness at test sites at different visit time points (mean ± standard error)

参数
parameter

时间
Time

水光针治疗对照样品组
Skinbooster treatment control sample group

非水光针治疗JC测试样品组
Non-skinbooster treatment JC test sample set

P3
P3 value

测量值
Measurements

P1
P1 value

测量值
Measurements

P2
P2 value

Ra

D0

30.378±1.342

-

30.719±1.068

-

0.844

D7

30.161±1.344

0.607

28.898±1.188

0.007**

0.783

D14

30.007±1.451

0.217

28.259±1.069

<0.001***

0.650

D28

30.705±1.461

0.535

28.170±1.134

0.001***

0.176

D56

30.759±1.428

0.506

29.043±1.249

0.050

0.369

Rq

D0

42.397±2.115

-

42.102±1.754

-

0.721

D7

42.298±2.098

0.853

39.923±2.064

0.024*

0.660

D14

42.209±2.325

0.489

38.339±1.780

<0.001***

0.433

D28

43.106±2.357

0.368

38.335±1.856

<0.001***

0.302

D56

43.222±2.317

0.477

39.320±2.019

0.027*

0.336

10. 不同访视时点两组测试部位皮肤粗糙度评估参数Ra测量值比较
Figure 10. Comparison of Ra measurements, the skin roughness evaluation parameters of the two groups at different visit times

11. 不同访视时点各组测试部位皮肤粗糙度评估参数Ra测量值变化
Figure 11. Changes in Ra measurements of skin roughness evaluation parameters at test sites in each group at different visit time points

12. 不同访视时点两组测试部位皮肤粗糙度评估参数Rq测量值比较
Figure 12. Comparison of Rq measurements of skin roughness evaluation parameters at two groups at different visit times

13. 不同访视时点各组测试部位皮肤粗糙度评估参数Rq测量值变化
Figure 13. Changes in Rq measurement values of skin roughness evaluation parameters at each group at different visit time points

13. 不同访视时点测试部位皮肤粗糙度测量值变化率
Table 13 The rate of change of the measured value of skin roughness at the test site at different visit time points

参数
parameter

时间
Time

水光针治疗对照样品组
Skinbooster treatment control sample group

非水光针治疗JC测试样品组
Non-skinbooster treatment JC test sample set

P
P-value

Ra

D7

-0.353±1.530

-5.814±2.070

0.038*

D14

-1.479±1.617

-7.744±1.716

0.029*

D28

1.169±1.901

-8.217±1.925

0.001**

D56

1.441±1.991

-5.193±2.654

0.049*

Rq

D7

0.109±1.341

-5.528±2.205

0.032*

D14

-0.961±1.566

-8.744±1.928

0.004**

D28

1.451±1.883

-8.827±2.192

0.001**

D56

1.736±1.835

-6.487±2.768

0.017*

14.水光针治疗对照样品组和非水光针治疗JC测试样品组受试者皮肤粗糙度评估参数Ra测量值变化率
Fig. 14: The rate of change of Ra measurements, a parameter for the evaluation of skin roughness in the control sample group and the non-skinbooster treatment JC test sample group

15.水光针治疗对照样品组和非水光针治疗JC测试样品组受试者皮肤粗糙度评估参数Rq测量值变化率
Table 15: The rate of change in the Rq measurement of the skin roughness evaluation parameter of subjects in the control sample group and the non-skinbooster treatment JC test sample group

【小结】
【Summary】

统计结果表明:
The statistical results show that:

非水光针治疗JC测试样品组使用测试样品前测试区域皮肤粗糙度评估参数RaRq测量值与水光针治疗对照样品组治疗前测量值比较无明显差异(P>0.05)。
There was no significant difference between the measured values of Ra and Rq, the skin roughness evaluation parameters in the test area before the use of the test samples in the non-skinbooster treatment JC test group and the pre-treatment measurements in the control group (P>0.05).

在第7天访视时,非水光针治疗JC测试样品组受试者测试区域皮肤粗糙度评估参数Ra测量值与使用前基础值比较降低,差异具有显著性P<0.01);非水光针治疗JC测试样品组受试者测试区域皮肤粗糙度评估参数Rq测量值与使用前基础值比较降低,差异具有统计学意义P<0.05);水光针治疗对照样品组受试者测试区域皮肤粗糙度评估参数RaRq测量值与治疗前基础值比较无明显差异P>0.05);非水光针治疗JC测试样品组RaRq测量值与使用前基础值的变化率低于水光针治疗对照样品组,差异具有显著性P<0.05)。由此提示,在该研究条件下,JC测试样品使用7天受试者测试部位皮肤粗糙度有一定程度改善,其效果优于水光针治疗。
At the 7-day visit, the measured value of Ra, the skin roughness evaluation parameter in the test area of the subjects in the non-skinbooster treatment JC test sample group was significantly lower than the basal value before use (P<0.01). There was a statistically significant difference between the Rq measurement values of the skin roughness evaluation parameters in the test area and the basic values before use in the non-skinbooster treatment JC test group (P<0.05), and there was no significant difference between the Ra and Rq measurements of the skin roughness evaluation parameters in the control group and the basic values before treatment (P>0.05). The change rate of Ra and Rq measurements in the non-skinbooster JC test group and the basal values before use was lower than that in the control group, and the difference was significant (P<0.05). This suggests that under the conditions of this study, the skin roughness of the test site of the JC test sample was improved to a certain extent after 7 days of use, and the effect was better than that of the skin booster treatment.

在第14天访视时,非水光针治疗JC测试样品组受试者测试区域皮肤粗糙度评估参数RaRq测量值与使用前基础值比较降低,差异具有极显著性P<0.001);水光针治疗对照样品组受试者测试区域皮肤粗糙度评估参数RaRq测量值与治疗前基础值比较无明显差异P>0.05);非水光针治疗JC测试样品组Ra测量值与使用前基础值的变化率低于水光针治疗对照样品组,差异具有显著性P<0.05)。非水光针治疗JC测试样品组Rq测量值与使用前基础值的变化率低于水光针治疗对照样品组,差异具有显著性P<0.01)。由此提示,在该研究条件下,JC测试样品使用14天受试者测试部位皮肤粗糙度有一定程度改善。,其效果优于水光针治疗。
At the 14-day visit, the measured values of Ra and Rq in the test area of the non-skinbooster treatment JC test group were significantly different from the basic values before use (P<0.001), and there was no significant difference between the Ra and Rq measurements of the skin roughness evaluation parameters in the control group and the basic values before treatment (P>0.05). The change rate of Ra measurement from the basal value before use in the non-skinbooster JC test group was lower than that in the control group, and the difference was significant (P<0.05). The change rate of Rq measurement between the non-skinbooster JC test group and the basal value before use was lower than that of the control group, and the difference was significant (P<0.01). This suggests that under the study conditions, the skin roughness of the test site of the subjects was improved to a certain extent after 14 days of use of the JC test samples. , which is more effective than skin booster treatment.

在第28天访视时,非水光针治疗JC测试样品组受试者测试区域皮肤粗糙度评估参数Ra测量值与使用前基础值比较降低,差异具有显著性P<0.01);非水光针治疗JC测试样品组受试者测试区域皮肤粗糙度评估参数Rq测量值与使用前基础值比较降低,差异具有极显著性P<0.001);水光针治疗对照样品组受试者测试区域皮肤粗糙度评估参数RaRq测量值与治疗前基础值比较无明显差异P>0.05);非水光针治疗JC测试样品组RaRq测量值与使用前基础值的变化率低于水光针治疗对照样品组,差异具有显著性P<0.01)。由此提示,在该研究条件下,JC测试样品使用28天受试者测试部位皮肤粗糙度有一定程度改善,其效果优于水光针治疗。
At the 28-day visit, the measured value of Ra, the skin roughness evaluation parameter in the test area of the subjects in the non-skinbooster treatment JC test sample group, was significantly lower than the basal value before use (P<0.01). Compared with the basic values before use, the Rq measurements of skin roughness evaluation parameters in the non-skinbooster treatment JC test group were significantly lower than those before use (P<0.001), and there was no significant difference between the Ra and Rq measurements of skin roughness evaluation parameters in the control group and the basic values before treatment (P>0.05). The change rate of Ra and Rq measurements in the non-skinbooster JC test group was lower than that in the control group (P<0.01). This suggests that under the conditions of this study, the skin roughness of the test site of the JC test sample was improved to a certain extent after 28 days of use, and the effect was better than that of the skin booster treatment.

在第56天访视时,非水光针治疗JC测试样品组受试者测试区域皮肤粗糙度评估参数Rq测量值与使用前基础值比较降低,差异具有统计学意义P<0.05);水光针治疗对照样品组受试者测试区域皮肤粗糙度评估参数RaRq测量值与治疗前基础值比较无明显差异P>0.05);非水光针治疗JC测试样品组RaRq测量值与使用前基础值的变化率低于水光针治疗对照样品组,差异具有统计学意义P<0.05)。由此提示,在该研究条件下,JC测试样品使用56天受试者测试部位皮肤粗糙度有一定程度改善,其效果优于水光针治疗。
At the visit on the 56th day, the Rq measurement of skin roughness evaluation parameters in the test area of the subjects in the non-skinbooster treatment JC test group was significantly lower than the basal value before use (P<0.05), and there was no significant difference between the Ra and Rq measurements of the skin roughness evaluation parameters in the control group and the basal value before treatment (P>0.05). The change rate of Ra and Rq measurements in the non-skinbooster JC test group was lower than that in the control group (P<0.05). This suggests that under the conditions of this study, the skin roughness of the test site of the JC test sample was improved to a certain extent after 56 days of use, and the effect was better than that of the skin booster treatment.

皱纹分析
Wrinkle analysis

通过Primos CR采集测试部位皮肤皱纹图像后,经软件分析计算得到皱纹面积、体积、平均深度及长度。测量值越大,表明测试部位皮肤皱纹越严重,反之则越轻微。本项目在使用前/治疗前、第7天、第14天、第28天及第56天分别采集各组受试者同一皱纹区域图像并分析,通过对比两组测量值的变化来评估水光针治疗对照样品及非水光针治疗JC测试样品对测试区域皮肤皱纹的影响
After the skin wrinkle images at the test site were collected by Primos CR, the wrinkle area, volume, average depth and length were calculated by software analysis. The larger the measurement, the more severe the skin wrinkles at the test site, and vice versa. In this project, images of the same wrinkle area were collected and analyzed in each group before use/treatment, day 7, day 14, day 28 and day 56, and the effect of skin wrinkles in the test area was evaluated by comparing the changes of the measured values of the two groups.

14. 不同时间点测试部位皮肤皱纹测量值(均值±标准误
Table 14. Measurements of skin wrinkles at different time points (mean ± standard error)

参数
parameter

时间
Time

水光针治疗对照样品组
Skinbooster treatment control sample group

非水光针治疗JC测试样品组
Non-skinbooster treatment JC test sample set

P3
P3 value

测量值
Measurements