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瓶, 30ml/瓶 Essence 70 bottles, 30ml/bottle 水光霜70瓶, 50g/瓶 70 bottles of water cream, 50g/bottle 面膜560片 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 面 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 面 膜:20261107 Mask: 20261107 |
受理日期 Date of acceptance | 2024年03月07日 07.03.2024 | 检验开始日期 The inspection start date | 2024年03月19日 2024-03-19 |
检验完成日期 The date on which the inspection was completed | 2024年05月16日 2024-05-16 | 报告完成日期 Report completion date | 2024年07月03日 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 |
境 内 责 任 人 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;
近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;
近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.
表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.
表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±标准误,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=0.05,P<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
表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人 33 people | 0人 0 people | 33人 33 people |
非水光针治疗 Non-skinbooster treatment JC测试样品组 JC test sample set | 33人 33 people | 1人 1 person | 32人 32 people |
年龄
age
表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值 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66名30-55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.