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
2024年07月03日 07/03/2024
声明 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 15working 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号 Address: No.2, Lujing Road, Yuexiu District, Guangzhou City, Guangdong Province
群马县馆林市楠町3966-5 3966-5, Kusucho, Tatebayashi City, Gunma Prefecture
境内责任人 Territorial Responsible
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地址 address
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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;
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 3monthsor 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-CR5Skin 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.
PrimosCR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 AquaFlux200Transepidermal 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 testis 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 CM825Skin 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 MPA580Skin 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-1syringe auxiliary propulsion device, sodium hyaluronate composite solution for injection (Hi body), medical dressings,
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 3.4.3.1Skinbooster 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 30minutes.
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 treatmentJCtest 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 30minutes.
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 Table1List 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 Table2Human 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 Cosmetics2015" 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 usingthe SPSS25statistical 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 Table3 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 33people
0人 0people
33人 33people
非水光针治疗 Non-skinbooster treatment
JC测试样品组 JCtest sample set
33人 33people
1人 1person
32人 32people
年龄 age
表4. 受试者年龄分布情况 Table4 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 JCtest 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.
表5. 测试过程不良事件发生率 Table5 Incidence of adverse events during the test process
项目 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 treatmentJCtest 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 treatmentJCtest samples on the water content of the stratum corneum of the skin in the test area.
表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 treatmentJCtest sample set
P3值 P3value
测量值 Measurements
P1值 P1value
测量值 Measurements
P2值 P2value
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天/治疗后第7天;D14表示使用测试样品第14天/治疗后第14天;D28表示使用测试样品第28天/治疗后第28天;D56表示使用测试样品第56天/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 TheP1value 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)
图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 Figure1 Comparison of the measured values of stratum corneum moisture content of the two groups of test sites at different visit time points
图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 Figure2Changes in the measured moisture content of the stratum corneum of the skin at each group of test sites at different visit time points
表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 treatmentJCtest sample set
P值 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D7、D14、D28或D56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)
图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.
表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 treatmentJCtest sample set
P3值 P3value
测量值 Measurements
P1值 P1value
测量值 Measurements
P2值 P2value
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**
图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 Figure4Comparison of transepidermal water loss measurements from the skin at the two groups at different visit times
图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 Figure5 Changes in the measured value of transepidermal water loss from the skin at each group of test sites at different visit time points
表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 treatmentJCtest sample set
P值 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*
图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.
表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 treatmentJCtest sample set
P3值 P3value
测量值 Measurements
P1值 P1value
测量值 Measurements
P2值 P2value
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
图7. 不同访视时点两组测试部位皮肤光泽度测量值比较 Figure7Comparison of skin gloss measurements at two groups of test sites at different visit time points
图8. 不同访视时点各组测试部位皮肤光泽度测量值变化 Figure8Changes in the measurement of skin gloss at each group of test sites at different visit time points
表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 treatmentJCtest sample set
P值 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
图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Ra及Rq。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.
表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 treatmentJCtest sample set
P3值 P3value
测量值 Measurements
P1值 P1value
测量值 Measurements
P2值 P2value
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
图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
图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
图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
图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
表13. 不同访视时点测试部位皮肤粗糙度测量值变化率 Table13The 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 treatmentJCtest sample set
P值 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*
图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
表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Ra及Rq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Ra及Rq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及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<0.05)。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Ra及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Ra及Rq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Ra及Rq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及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Ra及Rq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及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.
表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 treatmentJCtest sample set
P3值 P3value
测量值 Measurements
P1值 P1value
测量值 Measurements
P2值 P2value
平均深度(um) Average depth (um).
D0
40.567±1.761
-
40.839±1.269
-
0.767
D7
40.967±1.389
0.638
39.516±1.204
0.248
0.398
D14
40.467±1.597
0.919
39.161±1.087
0.099
0.499
D28
40.633±1.550
0.940
40.226±1.435
0.481
0.848
D56
40.367±1.414
0.841
39.774±1.452
0.292
0.639
长度(mm) Length (mm).
D0
313.333±9.412
-
315.323±8.181
-
0.874
D7
277.167±8.802
<0.001**
275.226±6.288
<0.001**
0.857
D14
277.333±8.306
<0.001**
275.097±5.713
<0.001**
0.824
D28
277.367±8.837
<0.001**
271.677±6.338
<0.001**
0.601
D56
275.833±8.433
<0.001**
273.032±6.611
<0.001**
0.794
面积(mm2) Area (mm2).
D0
149.375±3.955
-
150.446±3.162
-
0.833
D7
137.077±3.726
<0.001**
138.862±3.227
<0.001**
0.718
D14
137.038±3.672
<0.001**
139.391±3.239
<0.001**
0.632
D28
136.301±4.087
<0.001**
136.328±2.891
<0.001**
0.996
D56
135.627±3.649
<0.001**
136.186±3.162
<0.001**
0.908
体积(mm3) Volume (mm3).
D0
6.038±0.276
-
6.025±0.159
-
0.970
D7
5.628±0.235
0.002**
5.377±0.170
<0.001**
0.388
D14
5.538±0.259
0.001**
5.254±0.165
<0.001**
0.358
D28
5.558±0.266
0.001**
5.350±0.166
<0.001**
0.510
D56
5.458±0.234
<0.001***
5.298±0.178
<0.001**
0.586
图16. 不同访视时点两组测试部位皮肤皱纹平均深度测量值比较 Figure16Comparison of the average depth measurements of skin wrinkles at the two groups at different visit times
图17. 不同访视时点各组测试部位皮肤皱纹平均深度测量值变化 Figure17Change in the average depth measurement of skin wrinkles at each group of test sites at different visit time points
图18. 不同访视时点两组测试部位皮肤皱纹长度测量值比较 Figure18Comparison of the measurement of skin wrinkle length between the two groups at different visit time points
图19. 不同访视时点各组测试部位皮肤皱纹长度测量值变化 Figure19Change in the length of skin wrinkles at each group of test sites at different visit time points
图20. 不同访视时点两组测试部位皮肤皱纹面积测量值比较 Figure20Comparison of the measurement of skin wrinkle area between the two groups at different visit time points
图21. 不同访视时点各组测试部位皮肤皱纹面积测量值变化 Figure21Change in the measurement of skin wrinkle area at each group of test sites at different visit time points
图22.不同访视时点两组测试部位皮肤皱纹体积测量值比较 Figure22Comparison of the volume measurements of skin wrinkles at the two groups at different visit time points
图23. 不同访视时点各组测试部位皮肤皱纹体积测量值变化 Figure23Change in the volume measurement of skin wrinkles at each group of test sites at different visit time points
表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皱纹测量值变化率(%) Table 15. Change rate (%) of skin wrinkles measurements in subjects in the control sample group and non-skinbooster treatment JC test sample group (%)
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 treatmentJCtest sample set
P值 P-value
平均深度 Average depth
D7
2.734±2.333
-2.218±2.464
0.292
D14
1.021±2.573
-3.015±2.245
0.407
D28
1.408±2.466
-1.329±2.190
0.330
D56
1.028±2.395
-2.276±2.365
0.348
长度 length
D7
-11.598±0.802
-12.374±0.853
0.511
D14
-11.436±0.574
-12.279±0.962
0.455
D28
-11.609±0.710
-13.582±0.665
0.047*
D56
-11.970±0.724
-13.151±0.867
0.301
面积 area
D7
-8.175±0.688
-7.745±0.726
0.584
D14
-8.211±0.541
-6.964±2.025
0.676
D28
-8.965±0.657
-9.325±0.638
0.604
D56
-9.190±0.459
-9.468±0.893
0.445
体积 volume
D7
-5.439±2.182
-10.419±2.127
0.113
D14
-7.219±2.373
-12.468±1.923
0.157
D28
-7.459±2.379
-10.955±1.852
0.137
D56
-8.354±2.142
-11.896±2.022
0.162
图24. 水光针治疗对照样品组和非水光针治疗JC测试样品组皮肤皱纹平均深度测量值变化率 Figure 24. The rate of change in the mean depth measurement of skin wrinkles in the control sample group and the non-skinbooster treatment JC test sample group
图25. 水光针治疗对照样品组和非水光针治疗JC测试样品组皮肤皱纹长度测量值变化率 Figure 25. The rate of change in the measured value of skin wrinkle length in the control sample group and the non-skinbooster treatment JC test sample group
图26. 水光针治疗对照样品组和非水光针治疗JC测试样品组皮肤皱纹面积测量值变化率 Figure 26. The rate of change in the measurement of skin wrinkle area in the control sample group and the non-skinbooster treatment JC test sample group
图27. 水光针治疗对照样品组和非水光针治疗JC测试样品组皮肤皱纹体积测量值变化率 Figure 27. The rate of change in the volume measurement of skin wrinkles 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D0测试区域皮肤皱纹评估参数平均深度、长度、面积及体积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 in the average depth, length, area and volume measurements of skin wrinkles in the D0 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 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皱纹评估参数长度、面积及体积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皱纹评估参数长度及面积测量值与治疗前基础值比较降低,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皱纹评估参数体积测量值与治疗前基础值比较降低,差异具有显著性(P<0.01);非水光针治疗JC测试样品组皱纹平均深度、长度、面积及体积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测试样品组平均深度、长度、面积及体积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7天和水光针治疗后7天受试者测试部位皮肤皱纹长度、面积及体积均有一定程度改善,均具有抗皱功效。JC测试样品对测试部位皮肤抗皱功效与水光针治疗相当。 At the 7th day visit, the length, area and volume measurements of skin wrinkles in the test area of the subjects in the non-skinbooster treatment JC test sample group were significantly lower than those before use (P<0.001). Compared with the basic values before treatment, the measured values of the length and area of skin wrinkles in the control sample group were significantly lower than those before treatment (P<0.001). Compared with the basic value before treatment, the volume measurement of skin wrinkles in the control group was significantly different (P<0.01), and there was no significant difference in the average depth, length, area and volume of wrinkles in the non-skinbooster treatment JC test group compared with the control sample group (P>0.05). There was no significant difference between the average depth, length, area and volume of the measured values of the non-skinbooster JC test group and the basal values before use compared with the control sample group (P>0.05). It was suggested that under the conditions of this study, the length, area and volume of skin wrinkles at the test site of the subjects were improved to a certain extent after 7 days of JC test samples and 7 days after skin booster treatment, all of which had anti-wrinkle effects. The anti-wrinkle effect of the JC test sample on the skin at the test site is comparable to that of the skinbooster 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皱纹评估参数长度、面积及体积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皱纹评估参数长度及面积测量值与治疗前基础值比较降低,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皱纹评估参数体积测量值与治疗前基础值比较降低,差异具有显著性(P<0.01);非水光针治疗JC测试样品组皱纹平均深度、长度、面积及体积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测试样品组平均深度、长度、面积及体积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天和水光针治疗后14天受试者测试部位皮肤皱纹长度、面积及体积均有一定程度改善,均具有抗皱功效。JC测试样品对测试部位皮肤抗皱功效与水光针治疗相当。 At the 14th day visit, the length, area and volume measurements of skin wrinkles in the test area of the subjects in the non-skin booster treatment JC test sample group were significantly lower than those before use (P<0.001). Compared with the basic values before treatment, the measured values of the length and area of skin wrinkles in the control sample group were significantly lower than those before treatment (P<0.001). Compared with the basic value before treatment, the volume measurement of skin wrinkles in the control group was significantly different (P<0.01), and there was no significant difference in the average depth, length, area and volume of wrinkles in the non-skinbooster treatment JC test group compared with the control sample group (P>0.05). There was no significant difference between the average depth, length, area and volume of the measured values of the non-skinbooster JC test group and the basal values before use compared with the control sample group (P>0.05). It was suggested that under the study conditions, the length, area and volume of skin wrinkles in the test site of the subjects were improved to a certain extent after 14 days of JC test samples and 14 days after skin booster treatment, all of which had anti-wrinkle effects. The anti-wrinkle effect of the JC test sample on the skin at the test site is comparable to that of the skinbooster 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皱纹评估参数长度、面积及体积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皱纹评估参数长度及面积测量值与治疗前基础值比较降低,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皱纹评估参数体积测量值与治疗前基础值比较降低,差异具有显著性(P<0.01);非水光针治疗JC测试样品组皱纹平均深度、长度、面积及体积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测试样品组平均深度、长度、面积及体积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皱纹长度、面积及体积均有一定程度改善,均具有抗皱功效。JC测试样品对测试部位皮肤抗皱功效与水光针治疗相当。 At the 28-day visit, the length, area and volume measurements of skin wrinkles in the test area of the subjects in the non-skin booster treatment JC test sample group were significantly lower than those before use (P<0.001). Compared with the basic values before treatment, the measured values of the length and area of skin wrinkles in the control sample group were significantly lower than those before treatment (P<0.001). Compared with the basic value before treatment, the volume measurement of skin wrinkles in the control group was significantly different (P<0.01), and there was no significant difference in the average depth, length, area and volume of wrinkles in the non-skinbooster treatment JC test group compared with the control sample group (P>0.05). There was no significant difference between the average depth, length, area and volume of the measured values of the non-skinbooster JC test group and the basal values before use compared with the control sample group (P>0.05). The results suggest that under the study conditions, the length, area and volume of skin wrinkles in the test site of the subjects were improved to a certain extent after 28 days of JC test samples and 28 days after skin booster treatment, all of which had anti-wrinkle effects. The anti-wrinkle effect of the JC test sample on the skin at the test site is comparable to that of the skinbooster 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皱纹评估参数长度、面积及体积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皱纹评估参数长度、面积及体积测量值与治疗前基础值比较降低,差异具有极显著性(P<0.001);非水光针治疗JC测试样品组皱纹平均深度、长度、面积及体积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测试样品组平均深度、长度、面积及体积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皱纹长度、面积及体积均有一定程度改善,均具有抗皱功效。JC测试样品对测试部位皮肤抗皱功效与水光针治疗相当。 At the 56-day visit, the length, area and volume measurements of skin wrinkles in the test area of the subjects in the non-skin booster treatment JC test sample group were significantly lower than those before use (P<0.001). Compared with the basic values before treatment, the measured values of the length, area and volume of skin wrinkles in the control group were significantly different (P<0.001), while there was no significant difference in the average depth, length, area and volume of wrinkles in the non-skinbooster JC test group compared with the control group (P>0.05). There was no significant difference between the average depth, length, area and volume of the measured values of the non-skinbooster JC test group and the basal values before use compared with the control sample group (P>0.05). It was suggested that under the conditions of this study, the length, area and volume of skin wrinkles in the test site of the subjects were improved to a certain extent after 56 days of JC test samples and 56 days after skin booster treatment, all of which had anti-wrinkle effects. The anti-wrinkle effect of the JC test sample on the skin at the test site is comparable to that of the skinbooster treatment.
弹性 elasticity
皮肤弹性用Cutometer MPA580的参数R2、R5、R7及Q1来评估。R2值是无负压时皮 Skin elasticity was assessed using the parameters R2, R5, R7 and Q1 of the Cutometer MPA580. The R2 value is the skin without negative pressure
肤的回弹量和有负压时的最大拉伸值之比,它越接近1,弹性越好;R5值是皮肤测试的第一次循环中,皮肤恢复过程的弹性部分与加负压过程的弹性部分之比,越接近1,说明皮肤弹性越好;R7值是皮肤测试过程的第一次循环中,皮肤恢复过程的弹性部分与这次循环过程中皮肤的最大拉伸量之比,越接近1,说明皮肤弹性越好;Q1值是在皮肤测试的第一次循环中,皮肤恢复过程的弹性部分的面积加上皮肤恢复过程的塑性部分的面积与第一次负压时皮肤被拉伸的最大幅度的面积之比,比值越接近1,弹性越好。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区域皮肤弹性评估参数,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弹性的影响。 The ratio of the rebound amount of the skin to the maximum tensile value when there is negative pressure, the closer it is to 1, the better the elasticity; The R5 value is the ratio of the elastic part of the skin recovery process to the elastic part of the negative pressure process in the first cycle of the skin test, the closer to 1, the better the skin elasticity; The R7 value is the ratio of the elastic part of the skin recovery process to the maximum stretch of the skin during this cycle in the first cycle of the skin testing process, the closer to 1, the better the skin elasticity; The Q1 value is the ratio of the area of the elastic part of the skin recovery process plus the area of the plastic part of the skin recovery process to the area of the maximum amplitude of the skin stretching during the first negative pressure in the first cycle of the skin test, the closer the ratio is to 1, the better the elasticity. In this project, the skin elasticity assessment parameters of the subjects in the same area were measured before use/treatment, day 7, day 14, day 28 and day 56, and the effects of skin elasticity in the test area were evaluated by comparing the changes of the measured values of the two groups.
表16. 不同时间点测试部位皮肤弹性测量值(均值±标准误) Table 16. Measurements of skin elasticity at test sites 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 treatmentJCtest sample set
P3值 P3value
测量值 Measurements
P1值 P1value
测量值 Measurements
P2值 P2value
R2
D0
0.624±0.011
-
0.608±0.010
-
0.279
D7
0.645±0.009
0.006**
0.645±0.009
<0.001***
0.978
D14
0.649±0.013
0.002**
0.642±0.009
<0.001***
0.644
D28
0.644±0.012
0.005**
0.673±0.009
<0.001***
0.047*
D56
0.649±0.010
0.002**
0.675±0.010
<0.001***
0.080
R5
D0
0.654±0.016
-
0.636±0.014
-
0.396
D7
0.660±0.016
0.597
0.667±0.012
0.001**
0.726
D14
0.677±0.016
0.030*
0.649±0.013
0.298
0.173
D28
0.661±0.016
0.519
0.687±0.013
<0.001***
0.223
D56
0.673±0.012
0.050
0.679±0.015
<0.001***
0.749
R7
D0
0.455±0.012
-
0.444±0.012
-
0.522
D7
0.473±0.013
0.106
0.475±0.011
<0.001***
0.918
D14
0.483±0.015
0.006**
0.471±0.012
0.002**
0.542
D28
0.479±0.015
0.003**
0.499±0.011
<0.001***
0.269
D56
0.480±0.013
0.006**
0.509±0.013
<0.001***
0.118
Q1
D0
0.572±0.011
-
0.560±0.011
-
0.425
D7
0.594±0.010
0.012*
0.593±0.010
<0.001***
0.967
D14
0.596±0.013
0.009**
0.591±0.010
<0.001***
0.739
D28
0.599±0.013
0.001**
0.623±0.009
<0.001***
0.150
D56
0.598±0.011
0.003**
0.623±0.011
<0.001***
0.095
图28. 不同访视时点两组测试部位皮肤弹性评估参数R2测量值比较 Figure 28. Comparison of R2 measurements of skin elasticity evaluation parameters between the two groups at different visit times
图29. 不同访视时点各组测试部位皮肤弹性评估参数R2测量值变化 Figure 29. Changes in R2 measurements of skin elasticity evaluation parameters at each group at different visit time points
图30. 不同访视时点两组测试部位皮肤弹性评估参数R5测量值比较 Figure 30. Comparison of R5 measurements of skin elasticity evaluation parameters at two groups at different visit times
图31. 不同访视时点各组测试部位皮肤弹性评估参数R5测量值变化 Figure 31. Changes in the measurement value of skin elasticity evaluation parameter R5 at each group at different visit time points
图32. 不同访视时点两组测试部位皮肤弹性评估参数R7测量值比较 Figure 32. Comparison of R7 measurements of skin elasticity evaluation parameters between the two groups at different visit times
图33. 不同访视时点各组测试部位皮肤弹性评估参数R7测量值变化 Figure 33. Changes in the measurement value of skin elasticity evaluation parameter R7 at each group at different visit time points
图34. 不同访视时点两组测试部位皮肤弹性评估参数Q1测量值比较 Figure 34. Comparison of Q1 measurements of skin elasticity evaluation parameters at two groups at different visit times
图35. 不同访视时点各组测试部位皮肤弹性评估参数Q1测量值变化 Figure 35. Changes in Q1 measurements of skin elasticity evaluation parameters at each group at different visit time points
表17. 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弹性测量值变化率(%) Table 17. Change rate (%) of skin elasticity measurements in subjects in the control sample group and non-skinbooster treatment JC test sample group (%)
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 treatmentJCtest sample set
P值 P-value
R2
D7
3.648±1.232
6.238±0.966
0.031*
D14
4.156±1.254
6.084±1.704
0.358
D28
3.297±1.048
11.124±1.418
<0.001***
D56
4.332±1.215
11.106±0.983
<0.001***
R5
D7
1.383±1.787
5.524±1.423
0.076
D14
3.877±1.553
2.833±2.062
0.529
D28
1.427±1.720
8.725±1.719
0.004**
D56
3.653±1.492
7.169±1.420
0.093
R7
D7
4.469±1.987
7.751±1.631
0.172
D14
6.238±2.107
6.992±2.395
0.969
D28
5.176±1.581
13.330±1.792
0.001**
D56
5.917±1.775
15.019±1.378
<0.001***
Q1
D7
4.340±1.532
6.366±1.171
0.109
D14
4.462±1.600
6.180±1.832
0.386
D28
4.921±1.456
11.736±1.487
0.300
D56
4.953±1.419
11.603±1.022
<0.001***
图36.水光针治疗对照样品组和非水光针治疗JC测试样品组皮肤弹性评估参数R2测量值变化率 Figure 36: Rate of change in the R2 measurement of skin elasticity assessment parameters in the control sample group and the non-skinbooster treatment JC test sample group
图37.水光针治疗对照样品组和非水光针治疗JC测试样品组皮肤弹性评估参数R5测量值变化率 Fig. 37: Rate of change in the measurement of skin elasticity assessment parameter R5 in the control sample group and non-skinbooster treatment JC test sample group
图38.水光针治疗对照样品组和非水光针治疗JC测试样品组皮肤弹性评估参数R7测量值变化率 Figure 38: Rate of change in the measurement of skin elasticity assessment parameter R7 in the control sample group and non-skinbooster treatment JC test sample group
图39.水光针治疗对照样品组和非水光针治疗JC测试样品组皮肤弹性评估参数Q1测量值变化率 Figure 39: Rate of change in the measurement of skin elasticity assessment parameter Q1 in the control sample group and 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弹性评估参数R2、R5、R7及Q1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 skin elasticity evaluation parameters R2, R5, R7 and Q1 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 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弹性评估参数R2、R5、R7及Q1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弹性评估参数R2测量值与治疗前基础值比较升高,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弹性评估参数Q1测量值与治疗前基础值比较升高,差异具有统计学意义(P<0.05);非水光针治疗JC测试样品组R2测量值与使用前基础值的变化率高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天和水光针治疗后7天受试者测试部位皮肤弹性均有一定程度改善,JC测试样品对受试者皮肤弹性改善效果优于水光针治疗。 At the 7th day visit, the measured values of skin elasticity evaluation parameters R2, R5, R7 and Q1 in the test area of the subjects in the non-skin booster treatment JC test sample group were higher than those before use, and the difference was extremely significant (P<0.001). Compared with the basic value before treatment, the R2 measurement value of skin elasticity evaluation parameter in the control sample group was significantly higher (P<0.01). The measured value of Q1 in the test area of the subjects in the control group was significantly higher than that before treatment (P<0.05). The change rate of R2 measurement from the basal value before use in the non-skinbooster JC test group was higher than that in the control group, and the difference was statistically significant (P<0.05). The results suggest that under the conditions of this study, the skin elasticity of the test site of the subjects was improved to a certain extent after 7 days of use of JC test samples and 7 days after skin booster treatment, and the improvement effect of JC test samples on skin elasticity of subjects was better than that of 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弹性评估参数R2及Q1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);非水光针治疗JC测试样品组受试者测试区域皮肤弹性评估参数R7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弹性评估参数R2、R7及Q1测量值与治疗前基础值比较升高,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弹性评估参数R5测量值与治疗前基础值比较升高,差异具有统计学意义(P<0.05);非水光针治疗JC测试样品组受试者测试区域皮肤弹性评估参数R2、R5、R7及Q1测量值及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天和水光针治疗后14天受试者测试部位皮肤弹性均有一定程度改善,JC测试样品对受试者测试部位皮肤弹性改善效果与水光针治疗相当。 At the 14-day visit, the measured values of skin elasticity evaluation parameters R2 and Q1 in the test area of the non-skinbooster JC test group were significantly higher than those before use (P<0.001). Compared with the basic value before use, the measurement value of skin elasticity evaluation parameter R7 in the non-skin booster treatment JC test group was significantly higher than that before use (P<0.01). Compared with the basic values before treatment, the measured values of skin elasticity evaluation parameters R2, R7 and Q1 in the control sample group were significantly different from those before treatment (P<0.01). The R5 measurement value of skin elasticity evaluation parameter in the test area of the subjects in the control sample group was significantly higher than that before treatment (P<0.05). There was no significant difference in the measurement and change rate of skin elasticity evaluation parameters R2, R5, R7 and Q1 in the test area of the non-skinbooster treatment JC test group compared with the control sample group (P>0.05). This suggests that under the conditions of this study, the skin elasticity 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 skin booster treatment, and the improvement effect of JC test samples on the skin elasticity of the test site was comparable to that of 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弹性评估参数R2、R5、R7及Q1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弹性评估参数R2、R7及Q1测量值与治疗前基础值比较升高,差异具有显著性(P<0.01);非水光针治疗JC测试样品组R2测量值高于水光针治疗对照样品组,差异具有统计学意义(P<0.05);非水光针治疗JC测试样品组R2测量值与使用前基础值的变化率高于水光针治疗对照样品组,差异具有极显著性(P<0.001)。非水光针治疗JC测试样品组R5及R7测量值与使用前基础值的变化率高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天和水光针治疗后28天受试者测试部位皮肤弹性均有一定程度改善, JC测试样品对受试者皮肤弹性改善效果优于水光针治疗。 At the 28-day visit, the measured values of skin elasticity evaluation parameters R2, R5, R7 and Q1 in the test area of the subjects in the non-skinbooster treatment JC test group were higher than those before use, and the difference was extremely significant (P<0.001). Compared with the basic values before treatment, the measured values of skin elasticity evaluation parameters R2, R7 and Q1 in the control sample group were significantly different from those before treatment (P<0.01). The R2 measurement value of the non-skinbooster JC test group was higher than that of the control group, and the difference was statistically significant (P<0.05). The change rate of R2 measurement value from the basal value before use in the non-skinbooster treatment JC test group was higher than that in the control group, and the difference was extremely significant (P<0.001). The change rate of R5 and R7 measurements in the non-skinbooster JC test group was higher than that in the control group (P<0.01). The results suggest that under the conditions of this study, the skin elasticity 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 improvement effect of JC test samples on skin elasticity of subjects was better than 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弹性评估参数R2、R5、R7及Q1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弹性评估参数R2、R7及Q1测量值与治疗前基础值比较升高,差异具有显著性(P<0.01);非水光针治疗JC测试样品组R2、R7及Q1测量值与使用前基础值的变化率高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56天和水光针治疗后56天受试者测试部位皮肤弹性均有一定程度改善,JC测试样品对受试者皮肤弹性改善效果优于水光针治疗。 At the 56-day visit, the measured values of skin elasticity evaluation parameters R2, R5, R7 and Q1 in the test area of the non-skinbooster JC test group were higher than those before use, and the difference was extremely significant (P<0.001). Compared with the basic values before treatment, the measured values of skin elasticity evaluation parameters R2, R7 and Q1 in the control sample group were significantly different from those before treatment (P<0.01). The change rate of R2, R7 and Q1 measurements in the non-skinbooster JC test group and the basal values before use was higher than that in the control group, and the difference was extremely significant (P<0.001). The results suggest that under the conditions of this study, the skin elasticity 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 improvement effect of JC test samples on skin elasticity of subjects was better than that of skin booster treatment.
紧实度 Firmness
皮肤紧实度用Cutometer MPA580的参数F4来评估。F4值是所有测试周期施加负压和 Skin firmness was assessed using the parameter F4 of the Cutometer MPA580. The F4 value is the sum of the negative pressure applied for all test cycles
消除负压过程中所形成的包络曲线内的面积值,值越小表征皮肤越紧实。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区域皮肤紧实度评估参数,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紧实度的影响。 The area value within the envelope curve formed during the elimination of negative pressure indicates that the skin is firmer. In this project, the skin firmness evaluation parameters of the subjects in the same area were measured before use/treatment, day 7, day 14, day 28 and day 56 respectively, and the effect of skin firmness treatment control samples and non-skin booster treatment JC test samples on the skin firmness of the test area was evaluated by comparing the changes of the measured values of the two groups.
表18. 不同访视时点测试部位皮肤紧实度测量值(均值±标准误) Table 18. Measurements of skin firmness 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 treatmentJCtest sample set
P3值 P3value
测量值 Measurements
P1值 P1value
测量值 Measurements
P2值 P2value
D0
8.007±0.203
-
7.932±0.229
-
0.806
D7
7.813±0.189
0.020*
7.854±0.210
0.306
0.884
D14
7.857±0.199
0.058
7.609±0.217
0.007**
0.403
D28
7.796±0.195
0.025*
7.522±0.214
<0.001***
0.346
D56
7.760±0.215
<0.001***
7.586±0.205
<0.001***
0.561
图40. 不同访视时点两组测试部位皮肤紧实度测量值比较 Figure40Comparison of skin firmness measurements between the two groups at different visit times
图41. 不同访视时点各组测试部位皮肤紧实度测量值变化 Figure41Changes in skin firmness measurements at each group of test sites at different visit time points
表19. 水光针治疗对照样品组和非水光针治疗JC测试样品组皮肤紧实度测量值变化率(%) Table 19. Change rate (%) of skin firmness measurements in the skinbooster control sample group and non-skinbooster 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 treatmentJCtest sample set
P值 P-value
D7
-2.126±1.018
-0.659±0.959
0.704
D14
-1.687±1.043
-3.593±1.536
0.733
D28
-2.374±1.176
-4.962±0.905
0.087
D56
-3.127±0.739
-4.044±1.012
0.465
图42. 水光针治疗对照样品组和非水光针治疗JC测试样品组皮肤紧实度测量值变化率 Figure 42. Skinbooster treatment control sample group and non-skinbooster treatment JC test sample group change rate of skin firmness measurement
【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紧实度评估参数F4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 measurement of F4, the evaluation parameter of skin firmness in the test area before the use of the test samples, and the pre-treatment measurements 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F4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F4测量值与治疗前基础值降低,差异具有统计学意义(P<0.05);非水光针治疗JC测试样品组F4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F4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,水光针治疗后7天受试者测试部位皮肤紧实度有一定程度改善,具有紧致功效。 At the 7th day visit, there was no significant difference in the measurement of skin F4 in the test area of the subjects in the non-skin booster treatment JC test sample group compared with the basic value before use (P>0.05). There was a statistically significant difference between the measurement of F4 in the test area and the basic value before treatment in the control group (P<0.05), while there was no significant difference between the F4 measurement in the non-skinbooster treatment and the control group (P>0.05). There was no significant difference between the measurement of F4 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 skin firmness of the test site of the subjects has improved to a certain extent 7 days after the skin booster treatment, which has a tightening effect.
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F4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F4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F4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F4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)。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紧实度有一定程度改善,具有紧致功效。 At the 14-day visit, the measurement of skin F4 in the test area of the non-skinbooster treatment group was significantly lower than that before use (P<0.01), and there was no significant difference between the skin F4 measurement in the test area and the basal value before treatment in the control group (P>0.05). There was no significant difference in the F4 measurement value between the non-skinbooster JC test group and the control group (P>0.05). There was no significant difference between the measurement of F4 and the basal value before use in the non-skinbooster treatment JC test group and the control sample group (P>0.05). Under the conditions of this study, the skin firmness of the test site of the subject was improved to a certain extent after 14 days of use of the JC test sample, which had a firming effect.
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F4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F4测量值与治疗前基础值比较降低,差异具有统计学意义(P<0.05);非水光针治疗JC测试样品组F4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F4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)。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紧实度均有一定程度改善,均具有紧致功效,且JC测试样品对测试部位皮肤紧实度改善效果与水光针治疗相当。 At the 28-day visit, the measurement value of skin F4 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<0.001). There was a statistically significant difference between the skin F4 measurement in the control group and the basal value before treatment (P<0.05), while there was no significant difference between the F4 measurement in the non-skinbooster JC test group and the control group (P>0.05). There was no significant difference between the measurement of F4 and the basal value before use in the non-skinbooster treatment JC test group and the control sample group (P>0.05). Under the conditions of this study, the skin firmness of the test site of the subjects was improved to a certain extent after 28 days of JC test sample treatment and 28 days after skin booster treatment, both of which had firming effects, and the improvement effect of JC test samples on the skin firmness of the test site was comparable to that of skin tightness treatment in the test area.
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F4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F4测量值与治疗前基础值比较降低,差异具有极显著性(P<0.001);非水光针治疗JC测试样品组F4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F4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)。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紧实度均有一定程度改善,均具有紧致功效,且JC测试样品对测试部位皮肤紧实度改善效果与水光针治疗相当。 At the 56th day visit, the measurement value of skin F4 in the test area of the subjects in the non-skin treatment JC test sample group was significantly lower than the basal value before use (P<0.001). Compared with the basic value before treatment, the measurement value of skin F4 in the control group was significantly lower than that before treatment (P<0.001), and there was no significant difference between the F4 measurement value in the non-skinbooster treatment JC test group and the control group (P>0.05). There was no significant difference between the measurement of F4 and the basal value before use in the non-skinbooster treatment JC test group and the control sample group (P>0.05). Under the conditions of this study, the skin firmness 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 improvement effect of JC test samples on the skin firmness of the test site was comparable to that of skin booster treatment.
研究者视觉评估 Investigator visual assessment
每次访视由同一研究者对各组受试者面部皮肤状态进行主观视觉评分。对皮肤细纹严重程度、皮肤粗糙程度、面部皮肤松弛、红斑、皮肤干燥及皮肤鳞屑的评分分数越低表示越轻微、分数越高表示越严重,0分表示无、1-3分为轻度、4-6分为中度、7-9分为重度;对皮肤弹性、紧致度及光泽度的评分分数越低表示越差、分数越高表示越好,1-3分为差、4-6分为一般、7-9分为好。 At each visit, the same investigator performed a subjective visual score on the facial skin status of the subjects in each group. The lower the score of fine lines, skin roughness, facial skin laxity, erythema, dry skin and skin scales, the lower the score, the more severe, 0 means none, 1-3 is mild, 4-6 is moderate, and 7-9 is severe. A lower score for skin elasticity, firmness, and radiance indicates a worse score, a higher score indicates a better score, a score of 1-3 is poor, a score of 4-6 is average, and a score of 7-9 is good.
表20. 不同访视时点研究者对受试者面部皮肤状态的视觉评估分数 Table20Visual assessment scores of the subject's facial skin status by the investigator at different visit time points
评估项 Assessment items
时间 Time
水光针治疗 Skinbooster treatment
对照样品组 Control sample set
非水光针治疗 Non-skinbooster treatment
JC测试样品组 JCtest sample set
P值 P-value
细纹严重程度 The severity of fine lines
D0
5.15
5.19
0.750
D7
5.12
5.16
0.764
D14
5.00
5.13
0.545
D28
5.00
5.13
0.545
D56
5.00
5.13
0.545
皮肤粗糙程度 Skin roughness
D0
4.73
4.78
0.669
D7
4.45
4.50
0.617
D14
4.36
4.44
0.561
D28
4.30
4.34
0.733
D56
4.30
4.31
0.887
面部皮肤松弛 Facial skin is loose
D0
4.73
4.75
0.797
D7
4.33
4.53
0.281
D14
3.97
4.22
0.167
D28
3.88
4.06
0.305
D56
3.91
4.06
0.430
红斑 erythema
D0
3.73
3.84
0.434
D7
3.24
3.59
0.036*
D14
2.85
3.06
0.088
D28
2.76
3.00
0.048*
D56
2.76
2.94
0.089
皮肤干燥 Dry skin
D0
3.97
4.16
0.190
D7
3.21
3.81
<0.001***
D14
3.21
3.06
0.267
D28
2.85
2.91
0.694
D56
2.85
2.88
0.805
皮肤鳞屑 Scaly skin
D0
3.82
3.69
0.342
D7
3.09
3.34
0.056
D14
2.94
2.88
0.639
D28
2.42
2.53
0.656
D56
2.52
2.34
0.178
皮肤弹性 Skin elasticity
D0
4.58
4.66
0.773
D7
4.88
4.88
0.878
D14
4.82
5.06
0.312
D28
4.82
5.28
0.082
D56
4.97
5.41
0.084
皮肤紧致度 Skin firmness
D0
4.73
4.75
0.739
D7
5.12
4.88
0.274
D14
5.09
5.00
0.613
D28
5.09
5.13
0.783
D56
5.21
5.25
0.564
皮肤光泽度 Skin radiance
D0
4.64
4.66
0.927
D7
5.12
4.81
0.111
D14
5.09
5.03
0.723
D28
5.00
5.34
0.046*
D56
5.09
5.50
0.013*
【小结】 【Summary】
统计结果表明: The statistical results show that:
在使用样品前,研究者对非水光针治疗JC测试样品组受试者面部皮肤细纹严重程度、皮肤粗糙程度、面部皮肤松弛、红斑、皮肤干燥、皮肤鳞屑、皮肤弹性、紧致度及光泽度的评估分数与水光针治疗对照样品组比较无明显差异(P>0.05)。 Before the use of the samples, there was no significant difference in the evaluation scores of the non-skinbooster treatment JC test group on the severity of facial skin fine lines, skin roughness, facial skin laxity, erythema, dry skin, skin scale, skin elasticity, firmness and gloss compared with the control sample group (P>0.05).
在第7天访视时,研究者对非水光针治疗JC测试样品组受试者面部皮肤红斑情况的评分高于水光针治疗对照样品组,差异具有统计学意义(P<0.05);研究者对非水光针治疗JC测试样品组受试者面部皮肤干燥情况的评分高于水光针治疗对照样品组,差异具有极显著性(P<0.001)。 At the 7th day visit, the investigator's score of facial skin erythema in the non-skinbooster treatment JC test group was higher than that in the control group, and the difference was statistically significant (P<0.05). The score of the investigators on the dryness of the facial skin of the subjects in the non-skinbooster treatment JC test group was higher than that in the control group, and the difference was extremely significant (P<0.001).
在第28天访视时,研究者对非水光针治疗JC测试样品组受试者面部皮肤红斑情况的评分高于水光针治疗对照样品组,差异具有统计学意义(P<0.05);研究者对非水光针治疗JC测试样品组受试者面部皮肤光泽度的评分高于水光针治疗对照样品组,差异具有统计学意义(P<0.05)。 At the 28th day visit, the investigator's score on facial skin erythema in the non-skinbooster JC test group was higher than that in the control group, and the difference was statistically significant (P<0.05). The investigator's score on the glossiness of the facial skin of the subjects in the non-skinbooster treatment JC test group was higher than that in the control group of the skinbooster treatment, and the difference was statistically significant (P<0.05).
在第56天访视时,研究者对非水光针治疗JC测试样品组受试者面部皮肤光泽度的评分高于水光针治疗对照样品组,差异具有统计学意义(P<0.05)。 At the 56th day visit, the investigator's score on the glossiness of the facial skin of the non-skinbooster JC test group was higher than that of the skinbooster control group, and the difference was statistically significant (P<0.05).
受试者自我评估 Subject self-assessment
4.5.1 受试者对面部皮肤状态的主观评估 4.5.1 Subject's subjective assessment of the skin condition of the face
每次访视受试者对自身面部皮肤状态进行主观视觉评分。对面部细纹严重程度、皮肤粗糙程度、面部皮肤松弛、紧绷、泛红、干燥、瘙痒及脱皮情况的评分分数越低表示越轻微、分数越高表示越严重,0分表示无、1-3分为轻度、4-6分为中度、7-9分为重度;对皮肤弹性、紧致度及光泽度的评分分数越低表示越差、分数越高表示越好,1-3分为差、4-6分为一般、7-9分为好。 At each visit, subjects were subjectively visualized on their facial skin status. The lower the score for the severity of facial fine lines, skin roughness, facial skin laxity, tightness, redness, dryness, itching and peeling, the lower the score, the milder the score, the higher the score, the more severe, 0 means none, 1-3 is mild, 4-6 is moderate, and 7-9 is severe. A lower score for skin elasticity, firmness, and radiance indicates a worse score, a higher score indicates a better score, a score of 1-3 is poor, a score of 4-6 is average, and a score of 7-9 is good.
表21. 不同访视时点受试者对自身面部皮肤状态的自我评估分数 Table21Subjects' self-assessment scores on their own facial skin status at different visit time points
评估项 Assessment items
时间 Time
水光针治疗 Skinbooster treatment
对照样品组 Control sample set
非水光针治疗 Non-skinbooster treatment
JC测试样品组 JCtest sample set
P值 P-value
细纹严重程度 The severity of fine lines
D0
4.21
4.34
0.718
D7
3.30
3.63
0.248
D14
2.97
3.22
0.378
D28
2.82
3.03
0.615
D56
2.55
2.28
0.189
皮肤粗糙程度 Skin roughness
D0
4.30
4.81
0.094
D7
3.36
3.69
0.176
D14
3.06
3.34
0.226
D28
2.79
3.25
0.257
D56
2.48
2.44
0.601
面部皮肤松弛 Facial skin is loose
D0
4.82
4.69
0.846
D7
4.00
3.91
0.702
D14
3.39
3.38
0.543
D28
3.36
3.13
0.633
D56
2.97
2.44
0.095
皮肤紧绷 Tightness of the skin
D0
4.15
4.34
0.596
D7
2.76
3.16
0.322
D14
1.91
2.59
0.123
D28
1.91
2.25
0.634
D56
1.76
1.66
0.691
皮肤泛红 Redness of the skin
D0
2.94
3.75
0.065
D7
1.85
2.78
0.025*
D14
1.36
2.47
0.014*
D28
1.24
2.13
0.044*
D56
1.30
1.38
0.946
皮肤干燥 Dry skin
D0
5.00
4.72
0.842
D7
3.00
3.22
0.555
D14
2.33
2.84
0.216
D28
2.09
2.44
0.495
D56
1.88
1.72
0.633
皮肤瘙痒 Itchy skin
D0
2.03
3.06
0.076
D7
1.67
2.34
0.106
D14
1.27
1.94
0.072
D28
1.09
1.59
0.134
D56
1.06
1.09
0.881
皮肤脱皮 Peeling of the skin
D0
2.36
2.84
0.286
D7
1.42
2.00
0.086
D14
1.12
1.63
0.083
D28
1.15
1.41
0.233
D56
0.94
0.81
0.983
皮肤弹性 Skin elasticity
D0
4.30
4.06
0.238
D7
5.58
4.91
0.015*
D14
5.85
5.38
0.070
D28
6.03
5.63
0.282
D56
6.39
6.47
0.517
皮肤紧致度 Skin firmness
D0
3.94
3.75
0.502
D7
5.39
4.66
0.021*
D14
5.70
5.25
0.090
D28
5.85
5.59
0.430
D56
6.12
6.28
0.497
皮肤光泽度 Skin radiance
D0
3.85
3.56
0.302
D7
5.48
4.66
0.009**
D14
5.64
5.13
0.063
D28
5.88
5.41
0.155
D56
6.18
6.13
0.798
【小结】 【Summary】
统计结果表明: The statistical results show that:
在使用样品前,非水光针治疗JC测试样品组受试者对自身面部皮肤细纹严重程度、皮肤粗糙程度、面部皮肤松弛、紧绷、泛红、干燥、瘙痒、脱皮、皮肤弹性、紧致度及光泽度的评估分数与水光针治疗对照样品组比较无明显差异(P>0.05)。 There was no significant difference in the evaluation scores of the non-skinbooster JC test group on the severity of fine lines, skin roughness, facial skin laxity, tightness, redness, dryness, itching, peeling, skin elasticity, firmness and gloss compared with the control group (P>0.05).
在第7天访视时,非水光针治疗JC测试样品组受试者对自身面部皮肤泛红情况的评估评分高于水光针治疗对照样品组,差异具有统计学意义(P<0.05);非水光针治疗JC测试样品组受试者对自身面部皮肤弹性及皮肤紧致度的评估评分低于水光针治疗对照样品组,差异具有统计学意义(P<0.05);非水光针治疗JC测试样品组受试者对自身面部皮肤光泽度的评估评分低于水光针治疗对照样品组,差异具有极显著性(P<0.001)。 At the 7th day visit, the evaluation score of facial skin redness in the non-skinbooster JC test group was higher than that in the control group, and the difference was statistically significant (P<0.05). The evaluation scores of facial skin elasticity and skin firmness in the non-skinbooster JC test group were lower than those in the control group, and the difference was statistically significant(P<0.05). The evaluation score of the non-skinbooster treatment JC test group was lower than that of the control group, and the difference was extremely significant (P<0.001).
在第14天访视时,非水光针治疗JC测试样品组受试者对自身面部皮肤泛红情况的评估评分高于水光针治疗对照样品组,差异具有统计学意义(P<0.05)。 At the 14th day visit, the evaluation score of facial skin redness in the non-skinbooster JC test group was higher than that in the control group, and the difference was statistically significant (P<0.05).
在第28天访视时,非水光针治疗JC测试样品组受试者对自身面部皮肤泛红情况的评估评分高于水光针治疗对照样品组,差异具有统计学意义(P<0.05)。 At the 28-day visit, the evaluation score of facial skin redness in the non-skinbooster JC test group was higher than that in the skinbooster control group, and the difference was statistically significant (P<0.05).
4.5.2 受试者使用样品后的主观感受和效果评价 4.5.2 Subjective feelings and effect evaluation of subjects after using samples
受试者使用测试样品后的感受和效果评价问卷选项采用5点法,即非常同意/非常满意、同意/满意、一般、不同意/不满意、非常不同意/非常不满意,分别赋予不同分值,“非常同意/非常满意”赋值5分、“同意/满意”赋值4分、“一般”赋值3分、“不同意/不满意”赋值2分、“非常不同意/非常不满意”赋值1分,受试者评价≥4分则视为认同该项测试问题。 The 5-point method was used to evaluate the feelings and effects of the test samples, i.e., strongly agree/strongly satisfied, agreed/satisfied, general, disagreed/dissatisfied, and strongly disagreed/strongly dissatisfied, and different scores were assigned, with 5 points assigned to "strongly agree/very satisfied", 4 points for "agree/satisfied", 3 points for "fair", 2 points for "disagree/dissatisfied", 1 point for "strongly disagree/very dissatisfied", and 4 points for the subject's evaluation ≥ were deemed to agree with the test question.
表22. 受试者使用测试样品后的主观感受和效果评价 Table22Subjective feelings and effect evaluation of subjects after using the test samples
序号 serial number
问题描述 Problem description
时间 Time
≥4分人数占比(%) ≥ 4 points (%)ofthe number of people
水光针治疗 Skinbooster treatment
对照样品组 Control sample set
非水光针治疗 Non-skinbooster treatment
JC测试样品组 JCtest sample set
1
使用过程中感觉精华和面霜样品易涂抹均匀 During application, it feels that the serum and cream samples are easy to apply evenly
D7
100.00
100.00
D14
100.00
100.00
D28
100.00
100.00
D56
100.00
96.88
2
使用过程中感觉三款样品易吸收 During use, I felt that the three samples were easily absorbed
D7
87.88
96.88
D14
93.94
96.88
D28
100.00
93.75
D56
100.00
96.88
3
使用后感觉三款样品不黏腻 After use, I feel that the three samples are not sticky
D7
84.85
87.50
D14
93.94
90.63
D28
93.94
90.63
D56
100.00
90.63
4
使用后感觉精华和面霜样品不搓泥 After use, feel that the serum and cream samples do not rub mud
D7
93.94
96.88
D14
96.97
100.00
D28
96.97
100.00
D56
100.00
96.88
5
使用后感觉精华和面霜样品不致痘 After use, the serum and cream samples are felt to be non-acne-free
D7
87.88
100.00
D14
96.97
100.00
D28
96.97
96.88
D56
100.00
90.63
6
三款样品连续使用后感觉面部皮肤更细腻、柔嫩 After continuous use of the three samples, the facial skin felt more delicate and soft
D7
84.85
87.50
D14
90.91
96.88
D28
96.97
93.75
D56
96.97
93.75
7
三款样品连续使用后感觉皮肤更水嫩平滑 After continuous use of all three samples, the skin felt more supple and smooth
D7
84.85
87.50
D14
93.94
90.63
D28
96.97
90.63
D56
96.97
96.88
8
三款样品连续使用后感觉毛孔有缩小 After continuous use of the three samples, the pores were felt to be reduced
D7
75.76
68.75
D14
87.88
81.25
D28
84.85
84.38
D56
93.94
90.63
9
三款样品连续使用后感觉面部皮肤干纹、细纹减少 After continuous use of the three samples, dry lines and fine lines on the facial skin were reduced
D7
75.76
71.88
D14
90.91
87.50
D28
90.91
84.38
D56
90.91
96.88
10
三款样品连续使用后感觉样品温和无刺激 After continuous use of the three samples, the samples felt mild and non-irritating
D7
90.91
100.00
D14
100.00
100.00
D28
100.00
100.00
D56
100.00
100.00
11
三款样品连续使用后感觉样品具有皮肤舒缓效果 After continuous use, the three samples felt that the samples had a soothing effect on the skin
D7
84.85
96.88
D14
96.97
84.38
D28
96.97
96.88
D56
93.94
100.00
12
三款样品连续使用后感觉皮肤更饱满透亮 After continuous use, the skin of the three samples felt plumper and translucent
D7
81.82
81.25
D14
93.94
90.63
D28
87.88
90.63
D56
93.94
96.88
13
三款样品使用后皮肤无不适 There was no skin discomfort in the three samples after use
D7
96.97
100.00
D14
96.97
100.00
D28
100.00
100.00
D56
100.00
100.00
14
三款样品使用后效果显著,能明显感觉到皮肤整体状态变化 After the use of the three samples, the effect was remarkable, and the overall state of the skin could be clearly noticed
D7
90.91
90.63
D14
96.97
93.75
D28
93.94
90.63
D56
96.97
96.88
15
对该样品的整体满意度 Overall satisfaction with the sample
D56
81.82
100.00
结论 conclusion
本项研究通过招募66名年龄30-55岁的亚洲健康女性受试者,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。在治疗前/使用前、第7天、第14天、第28天及第56天,分别经仪器测量两组测试区域皮肤角质层含水量、经表皮水分流失、光泽度、粗糙度、皱纹、皮肤弹性及紧致度,并结合研究者视觉评估及受试者自我评估进行综合评价。 In this study, 66 healthy Asian female subjects aged 30-55 years were randomly divided into a control group and a non-skinbooster JC test group. Before treatment/before use, on the 7th, 14th, 28th and 56th days, the water content of the stratum corneum, transepidermal water loss, glossiness, roughness, wrinkles, skin elasticity and firmness of the skin in the two groups of test areas were measured by instruments, and the comprehensive evaluation was carried out in combination with the investigator's visual assessment and the subject's self-assessment.
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 Under the conditions of this study, JC test samples were used for 7 days and 7 days after skin booster treatment on the skin of the subject's test site
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。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。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。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。 It has moisturizing effect, and the moisturizing effect of skin booster treatment on the test site of the subject is better than that of JC test samples. The JC test samples were used for 14 days and 14 days after the skin booster treatment had moisturizing effect on the skin of the test site, and the moisturizing effect of the skin of the skin of the test site was better than that of the JC test sample. The JC test samples were used for 28 days and 28 days after skin booster treatment, and the moisturizing effect of the JC test samples on the skin of the test area was comparable to that of the skin of the test area. The JC test samples were used for 56 days and 56 days after skin booster treatment, and the moisturizing effect of JC test samples on the skin of the test area was comparable to that of skin booster treatment.
在该研究条件下,JC测试样品使用7天、14天、28天及56天,对受试者测试部位皮肤 Under the study conditions, JC test samples were used for 7 days, 14 days, 28 days, and 56 days on the skin of the test site
屏障功能具有修护功效。 The barrier function has a restorative effect.
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,JC测 Under the conditions of this study, the skin gloss of the test site of the subject improved to a certain extent 7 days after the treatment with skin boosters, and the JC test was measured
试样品使用7天后受试者测试部位皮肤光泽度无明显改善,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;水光针治疗后14天和JC测试样品使用14天对受试者测试部位皮肤光泽度有一定程度改善,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;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改善效果与水光针治疗相当;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改善效果与水光针治疗相当。 After 7 days of use, there was no significant improvement in the skin gloss of the test site, and the effect of skin booster treatment on the skin gloss of the test site was better than that of the JC test sample. After 14 days of skin booster treatment and 14 days of use of JC test samples, the skin gloss of the test site of the subjects was improved to a certain extent, and the effect of skin skin gloss improvement on the test site of the subjects was better than that of the JC test samples. 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 improvement effect of JC test samples on the skin gloss of the test site was comparable to that of skin booster treatment. The skin radiance of the test site was improved to a certain extent after 56 days of use of the JC test sample and 56 days after the skin booster treatment, and the improvement effect of the JC test sample on the skin radiance of the test site was comparable to that of the skin booster treatment.
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,水 Under the conditions of this study, the JC test samples were used for 7 days and the skin roughness of the test site of the subjects was improved to a certain extent, with water
光针治疗后7天受试者测试部位皮肤粗糙度无明显改善,JC测试样品对受试者测试部位皮肤粗糙度改善效果优于水光针治疗;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,水光针治疗后14天受试者测试部位皮肤粗糙度无明显改善,JC测试样品对受试者测试部位皮肤粗糙度改善效果优于水光针治疗;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,水光针治疗后28天受试者测试部位皮肤粗糙度无明显改善,JC测试样品对受试者测试部位皮肤粗糙度改善效果优于水光针治疗;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,水光针治疗后56天受试者测试部位皮肤粗糙度无明显改善,JC测试样品对受试者测试部位皮肤粗糙度改善效果优于水光针治疗。 There was no significant improvement in the skin roughness of the test site of the subjects 7 days after the photoacupuncture treatment, and the improvement effect of the JC test samples on the skin roughness of the test site was better than that of the skin skin roughness treatment of the subjects. 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, and there was no significant improvement in the skin roughness of the test site of the subjects after 14 days of skin booster treatment, and the improvement effect of the JC test samples on the skin roughness of the test site of the subjects was better than that of the skin booster treatment. The skin roughness of the test site of the subjects was improved to a certain extent after 28 days of use of the JC test samples, and there was no significant improvement in the skin roughness of the test site of the subjects 28 days after the treatment of skin booster treatment, and the improvement effect of the JC test samples on the skin roughness of the test site of the subjects was better than that of the skin skin patch treatment of the subject with skin booster treatment. The skin roughness of the test site of the subjects was improved to a certain extent after 56 days of use of the JC test samples, and there was no significant improvement in the skin roughness of the test site after 56 days of skin booster treatment, and the improvement effect of the JC test samples on the skin roughness of the test site of the subjects was better than that of the skin skin injection treatment.
5.5在该研究条件下,非水光针治疗JC测试样品组受试者使用测试样品28天及56天,角质层含水量测试值与使用前基础值比较显著升高、光泽度测量值与使用前基础值比较显著升高、粗糙度评估参数测量值与使用前基础值比较显著降低。由此提示,JC测试样品对测试部位皮肤具有滋养功效。 5.5 Under the conditions of this study, the test value of stratum corneum moisture content was significantly higher than that before use, the measured value of gloss was significantly higher than the basic value before use, and the measured value of roughness evaluation parameters was significantly lower than that before use of the basic value after 28 days and 56 days in the non-skin injection-treated JC test sample group. This suggests that the JC test sample has a nourishing effect on the skin at the test site.
5.6在该研究条件下,JC测试样品使用7天和水光针治疗后7天受试者测试部位皮肤皱纹长度、面积及体积均有一定程度改善,均具有抗皱功效,JC测试样品对测试部位皮肤抗皱功效与水光针治疗相当;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皱纹长度、面积及体积均有一定程度改善,均具有抗皱功效,JC测试样品对测试部位皮肤抗皱功效与水光针治疗相当;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皱纹长度、面积及体积均有一定程度改善,均具有抗皱功效,JC测试样品对测试部位皮肤抗皱功效与水光针治疗相当;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皱纹长度、面积及体积均有一定程度改善,均具有抗皱功效,JC测试样品对测试部位皮肤抗皱功效与水光针治疗相当。 5.6 Under the conditions of this study, the length, area and volume of skin wrinkles in the test area of the subjects were improved to a certain extent after 7 days of use of JC test samples and 7 days after skin booster treatment, and all of them had anti-wrinkle effects, and the anti-wrinkle effect of JC test samples on the skin of the test site was comparable to that of skin booster treatment. The length, area and volume of skin wrinkles in the test area of the subjects were improved to a certain extent after 14 days of use of JC test samples and 14 days after skin booster treatment, and all of them had anti-wrinkle effects, and the anti-wrinkle effect of JC test samples on the skin at the test site was comparable to that of skin booster treatment. The length, area and volume of skin wrinkles in the test area of the subjects were improved to a certain extent after 28 days of JC test and 28 days after skin booster treatment, and all of them had anti-wrinkle effects, and the anti-wrinkle effect of JC test samples on the skin of the test site was comparable to that of skin booster treatment. The length, area and volume of skin wrinkles in the test area of the subjects were improved to a certain extent after 56 days of use of JC test samples and 56 days after skin booster treatment, and all of them had anti-wrinkle effects, and the anti-wrinkle effect of JC test samples on the skin at the test site was comparable to that of skin booster treatment.
5.7 在该研究条件下,JC测试样品使用7天和水光针治疗后7天受试者测试部位皮肤弹性均有一定程度改善,JC测试样品对受试者皮肤弹性改善效果优于水光针治疗;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弹性均有一定程度改善,JC测试样品对受试者测试部位皮肤弹性改善效果与水光针治疗相当;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弹性均有一定程度改善,JC测试样品对受试者皮肤弹性改善效果优于水光针治疗;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弹性均有一定程度改善,JC测试样品对受试者皮肤弹性改善效果优于水光针治疗。 5.7 Under the conditions of this study, the skin elasticity of the test site of the subjects was improved to a certain extent after 7 days of use of JC test samples and 7 days after skin booster treatment, and the improvement effect of JC test samples on the skin elasticity of subjects was better than that of skin booster treatment. The skin elasticity of the test site of the subjects was improved to a certain extent after 14 days of use of the JC test samples and 14 days after the treatment of skin boosters, and the improvement effect of the JC test samples on the skin elasticity of the test sites was comparable to that of the skin elasticity treatment of the subjects. The skin elasticity of the test site was improved to a certain extent after 28 days of use of JC test samples and 28 days after skin booster treatment, and the improvement effect of JC test samples on skin elasticity of subjects was better than that of skin booster treatment. The skin elasticity of the test site was improved to a certain extent after 56 days of use of JC test samples and 56 days after skin booster treatment, and the improvement effect of JC test samples on skin elasticity of subjects was better than that of skin booster treatment.
5.8在该研究条件下,水光针治疗后7天受试者测试部位皮肤紧实度有一定程度改善,具有紧致功效;JC测试样品使用14天受试者测试部位皮肤紧实度有一定程度改善,具有紧致功效;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紧实度均有一定程度改善,均具有紧致功效,JC测试样品对测试部位皮肤紧实度改善效果与水光针治疗相当;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紧实度均有一定程度改善,均具有紧致功效,JC测试样品对测试部位皮肤紧实度改善效果与水光针治疗相当。 5.8 Under the conditions of this study, the skin firmness of the test site of the subject was improved to a certain extent 7 days after the treatment with skin boosters, which had a tightening effect; The skin firmness of the test site of the subject was improved to a certain extent after 14 days of use of the JC test sample, which had a tightening effect. The skin firmness of the test site was improved to a certain extent after 28 days of use of the JC test samples and 28 days after the skin booster treatment, and both had firming effects, and the improvement effect of the JC test samples on the skin firmness of the test site was comparable to that of the skin tightness treatment of the skin booster treatment. The skin firmness of the test site was improved to a certain extent after 56 days of use of the JC test samples and 56 days after the skin booster treatment, and both had firming effects, and the improvement effect of the JC test samples on the skin firmness of the test site was comparable to that of the skin tightness treatment of the skin booster treatment.