A method and system for testing qualified subjects for the soothing effect of cosmetics

Abstract

The present invention provides a method and system for testing subjects for qualified soothing efficacy of cosmetics, comprising: dividing subjects into a normal skin group and a sensitive skin group according to subjective and semi-subjective evaluation methods for cosmetic soothing efficacy testing; obtaining a skin index value for each subject, wherein the skin index value is selected from a hemoglobin concentration value, a heme concentration value, or a skin α value; performing data processing on the hemoglobin concentration value, the heme concentration value, or the skin α value according to a confusion matrix method to obtain a standard threshold value for screening subjects for qualified soothing efficacy by the hemoglobin concentration value, the heme concentration value, or the skin α value; selecting any of the above skin index values ​​as a detection index value, comparing the skin index value of each subject with the standard threshold value, and determining subjects with skin values ​​above the standard threshold value as having sensitive skin, i.e., qualified subjects for the soothing efficacy test. The testing method can quickly, objectively, and accurately screen qualified soothing efficacy subjects.

Description

Technical Field

[0001] The present invention relates to the field of cosmetic efficacy testing, and in particular to a method and system for testing subjects for qualified soothing efficacy of cosmetics. Background Art

[0002] In recent years, as the proportion of people with sensitive skin has gradually increased, the development of soothing cosmetics has also attracted much attention. Human efficacy testing, as an important scientific basis for evaluating the efficacy of cosmetics, requires the screening of qualified subjects with sensitive skin. At present, there are three main methods for evaluating sensitive skin: (1) Subjective evaluation: First, the respondents are asked to self-evaluate the sensitivity of their skin based on whether their skin is prone to subjective symptoms such as burning, stinging, itching and tightness when stimulated by triggering factors, and to determine whether they have sensitive skin. The triggering factors include physical factors (such as seasonal changes, temperature changes or sun exposure), chemical factors (such as cosmetics, cleaning products, disinfectants, irritating topical medications such as retinoic acid or environmental pollutants) or mental factors (such as anxiety or depression); (2) Semi-subjective evaluation: A stimulation test is used to determine whether the skin is sensitive, such as the lactic acid stinging test; (3) Objective evaluation: The severity of sensitive skin is reflected through non-invasive skin physiological indicators, such as transepidermal water loss rate, stratum corneum water content, skin pH, sebum, skin erythema index or local blood flow velocity and blood flow distribution histogram tests.

[0003] However, the current standards use subjective or semi-subjective methods to screen eligible people, which has poor repeatability. Irritation experiments are more likely to affect the body's tolerance, and sensitive skin may not necessarily be in a state of redness and need soothing. This results in low screening accuracy. In comparison, objective evaluation methods avoid possible errors caused by subjective evaluation. The "Chinese Expert Consensus on the Diagnosis and Treatment of Sensitive Skin" provides five quantitative evaluation indicators, but the clinical inclusion criteria for screening these commonly used indicators have not yet reached a unified standard. Setting the screening criteria too high may make it difficult to recruit qualified subjects, and setting the screening criteria too low may not be able to detect the actual effect of the product. How to quickly, accurately and reliably distinguish qualified subjects remains an urgent problem to be solved in the efficacy verification of soothing cosmetics.

[0004] CN114262729A discloses a method for testing the soothing effect of cosmetics and their raw materials. The method uses cells to replace human body tests. First, mouse macrophage cell lines are cultured in vitro, and the sample to be tested is added to the cells for testing. The cytotoxicity of the test sample is tested, and then a concentration without cytotoxicity is selected to perform a nitric oxide (NO) release inhibition test. The soothing effect of the sample is analyzed and evaluated by statistical means. The method is economical and fast, the test process is controllable, and the test system is standardized to avoid large result deviations caused by individual differences in the human body. However, cell experiments are far from the actual use scenarios of the human body and are only suitable for the screening of early raw materials. Moreover, due to the limitations of cell culture conditions, it is difficult to directly use finished cosmetic products / semi-finished products, so it is impossible to accurately evaluate the soothing effect on the human body.

[0005] CN114469948A provides a reusable skin redness modeling method for evaluating products' ability to improve skin irritability. This method uses methyl nicotinate to create a skin redness model. After the redness completely subsides, the skin is re-exposed to heat stimulation. This results in varying degrees of redness reappearing at the modeled site. The degree of redness is then used to characterize the differences in the product's ability to improve skin irritability. However, this modeling method cannot fully represent the actual population of sensitive skin that experiences redness, and this can introduce certain errors into cosmetic efficacy testing. Summary of the Invention

[0006] In view of this, the object of the present invention is to provide a method and system for testing subjects for soothing efficacy of cosmetics. The testing method can quickly, objectively and accurately screen out qualified subjects for soothing efficacy.

[0007] In a first aspect, the present invention provides a method for testing subjects for the soothing efficacy of cosmetics, comprising the following steps:

[0008] (1) The subjects were divided into normal skin group and sensitive skin group according to the subjective and semi-subjective evaluation methods of cosmetic soothing efficacy test;

[0009] (2) obtaining a skin index value for each subject, wherein the skin index value is selected from a hemoglobin concentration value, a heme concentration value, or a skin α value;

[0010] (3) performing data processing on the hemoglobin concentration value, heme concentration value, or skin α value described in step (2) according to a confusion matrix method, and obtaining a standard threshold value of the hemoglobin concentration value, a standard threshold value of the heme concentration value, or a standard threshold value of the skin α value;

[0011] (4) Select any one of the skin index values ​​in step (2) as the detection index value, compare the skin index value of each subject with the standard threshold value of the skin index value, and determine the subjects with skin values ​​higher than the standard threshold value as sensitive skin, i.e., qualified subjects for the soothing efficacy test, and determine the subjects with skin values ​​lower than the standard threshold value as normal skin.

[0012] Preferably, step (3) is specifically:

[0013] According to the confusion matrix calculation method, the hemoglobin concentration value, heme concentration value or skin a value described in step (2) are respectively processed to obtain the true positive rate and false positive rate of the hemoglobin concentration value, heme concentration value or skin a value at different thresholds, and the threshold value corresponding to the maximum difference between the true positive rate and the false positive rate in the hemoglobin concentration value, heme concentration value or skin a value is used as the standard threshold value to obtain the standard threshold value of the hemoglobin concentration value, the standard threshold value of the heme concentration value or the standard threshold value of the skin a value.

[0014] Among them, the minimum threshold among different thresholds is the minimum hemoglobin concentration value, heme concentration value or skin a value minus 1, the maximum threshold is the maximum hemoglobin concentration value, heme concentration value or skin a value plus 1, and all other thresholds are the average of the other two consecutively sorted hemoglobin concentration values, heme concentration values ​​or skin a values.

[0015] The true positive rate is the ratio of the number of people who were evaluated as having sensitive skin by subjective and semi-subjective evaluation in step (1) and were determined to have sensitive skin in step (4) to the number of people who were evaluated as having sensitive skin by subjective and semi-subjective evaluation in step (1).

[0016] The false positive rate is the ratio of the number of people whose skin was subjectively and semi-subjectively evaluated as normal in step (1) but was determined to be sensitive in step (4) to the number of people whose skin was subjectively and semi-subjectively evaluated as normal in step (1).

[0017] Preferably, the standard threshold value of the hemoglobin concentration value is 1.231.

[0018] Preferably, the standard threshold value of the hemoglobin concentration value is 276.15.

[0019] Preferably, the standard threshold value of the skin α value is 11.963.

[0020] Preferably, the skin index values ​​of the normal skin group and the sensitive skin group are obtained under an ambient temperature of 20° C. to 22° C., a humidity of 40% to 60%, and a skin area of ​​at least 3×3 cm.

[0021] In a second aspect, the present invention provides a testing system for subjects who are qualified for the soothing efficacy of cosmetics, comprising:

[0022] A classification module is used to classify the subjects into a normal skin group and a sensitive skin group based on the subjective and semi-subjective evaluation methods of the cosmetic soothing efficacy test;

[0023] A detection module, for obtaining a skin index value of each subject, wherein the skin index value is selected from a hemoglobin concentration value, a heme concentration value or a skin alpha value;

[0024] an analysis module for processing the hemoglobin concentration value, the hemoglobin concentration value, or the skin α value obtained by the detection module to obtain a standard threshold value of the hemoglobin concentration value, a standard threshold value of the hemoglobin concentration value, or a standard threshold value of the skin α value;

[0025] A comparison module, comprising a first comparison module, a second comparison module and a third comparison module;

[0026] The first comparison module is configured to compare the hemoglobin concentration value of each subject with the standard threshold value of the hemoglobin concentration value, and to determine subjects with hemoglobin concentration values ​​higher than the standard threshold value as having sensitive skin, i.e., qualified subjects for the soothing efficacy test, and subjects with hemoglobin concentration values ​​lower than the standard threshold value as having normal skin;

[0027] The second comparison module is configured to compare the hemoglobin concentration value of each subject with the standard threshold value of the hemoglobin concentration value, and to determine subjects with a hemoglobin concentration value higher than the standard threshold value as having sensitive skin, i.e., qualified subjects for the soothing efficacy test, and subjects with a hemoglobin concentration value lower than the standard threshold value as having normal skin;

[0028] The third comparison module is configured to compare the skin a-value of each subject with a standard threshold value of the skin a-value. Subjects with skin values ​​above the standard threshold value are determined to have sensitive skin, i.e., qualified subjects for the soothing efficacy test; and subjects with skin values ​​below the standard threshold value are determined to have normal skin.

[0029] The selection module is used to select any one of the first comparison module, the second comparison module and the third comparison module for comparison.

[0030] Preferably, the testing system also includes a statistical module for counting the number of people classified as normal skin and the number of people classified as sensitive skin in the classification module, and counting the number of people classified as sensitive skin by the classification module and determined as sensitive skin by the comparison module, as well as the number of people classified as normal skin by the classification module but determined as sensitive skin by the comparison module.

[0031] Preferably, the analysis module includes a calculation module, which is used to calculate the true positive rate and false positive rate of the hemoglobin concentration value, heme concentration value or skin a value obtained by the detection module at different thresholds, and obtain the difference between the true positive rate and the false positive rate at different thresholds.

[0032] Among them, the minimum threshold among different thresholds is the minimum hemoglobin concentration value, heme concentration value or skin a value minus 1, the maximum threshold is the maximum hemoglobin concentration value, heme concentration value or skin a value plus 1, and all other thresholds are the average of the other two consecutively sorted hemoglobin concentration values, heme concentration values ​​or skin a values.

[0033] Preferably, the analysis module also includes a judgment module, which is used to select the threshold corresponding to the maximum difference between the true positive rate and the false positive rate under different thresholds obtained by the calculation module as the standard threshold of the hemoglobin concentration value, the standard threshold of the hemoglobin concentration value or the standard threshold of the skin a value.

[0034] Preferably, the calculation module includes a true positive rate calculation module and a false positive rate calculation module.

[0035] The true positive rate calculation module is used to calculate the ratio of the number of people classified as having sensitive skin by the classification module and determined to have sensitive skin by the comparison module to the number of people classified as having sensitive skin in the classification module.

[0036] The false positive rate calculation module is used to calculate the ratio of the number of people classified as normal skin by the classification module but determined to be sensitive skin by the comparison module to the number of people classified as normal skin by the classification module.

[0037] In a third aspect, the present invention further provides an application of the test method or the test system in the soothing efficacy test of cosmetics.

[0038] Compared with the prior art, the present invention has the following beneficial effects:

[0039] (1) The present invention selects hemoglobin concentration value, heme concentration value or skin a value as a quantifiable objective screening standard, which can quickly, objectively and accurately screen out qualified subjects with soothing efficacy;

[0040] (2) The present invention uses a confusion matrix model to calculate the standard threshold value of hemoglobin concentration value, heme concentration value or skin α value, which is used to replace the subjective and semi-subjective screening methods. The standard threshold value can effectively distinguish whether the subject has normal skin or sensitive skin;

[0041] (3) The subjects screened based on the standard threshold have a real condition of redness that needs soothing, which is more representative for clinical experimental research on the soothing effect of cosmetics. In addition, this single skin detection index can be used for measurement in both the subject screening and cosmetic efficacy verification stages, avoiding the tedious operations caused by subjective or semi-subjective screening of subjects in the existing technology, which is conducive to improving the compliance of subjects in human experiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Figure 1is the hemoglobin concentration distribution diagram of the subject in Example 1;

[0043] Figure 2 is the ROC curve diagram obtained in Example 1;

[0044] Figure 3 is the ROC curve diagram obtained in Example 3;

[0045] Figure 4 4 is the ROC curve diagram obtained in Example 4;

[0046] Figure 5 This is the ROC curve diagram obtained in Comparative Example 1. DETAILED DESCRIPTION

[0047] The following will clearly and completely describe the technical solutions of the present invention in conjunction with the embodiments of the present invention. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0048] The present invention has no particular limitation on the sources of all raw materials involved, and they can be purchased from the market or prepared according to conventional preparation methods well known to those skilled in the art.

[0049] The present invention provides a method for testing subjects for soothing efficacy of cosmetics, comprising the following steps:

[0050] (1) The subjects were divided into normal skin group and sensitive skin group according to the subjective and semi-subjective evaluation methods of cosmetic soothing efficacy test;

[0051] (2) obtaining a skin index value for each subject, wherein the skin index value is selected from a hemoglobin concentration value, a heme concentration value, or a skin α value;

[0052] (3) performing data processing on the hemoglobin concentration value, heme concentration value, or skin α value described in step (2) according to a confusion matrix method, and obtaining a standard threshold value of the hemoglobin concentration value, a standard threshold value of the heme concentration value, or a standard threshold value of the skin α value;

[0053] (4) Select any one of the skin index values ​​in step (2) as the detection index value, compare the skin index value of each subject with the standard threshold value of the skin index value, and determine the subjects with skin values ​​higher than the standard threshold value as sensitive skin, i.e., qualified subjects for the soothing efficacy test, and determine the subjects with skin values ​​lower than the standard threshold value as normal skin.

[0054] In the present invention, subjects are first preferably divided into a normal skin group and a sensitive skin group based on the subjective and semi-subjective evaluation method of soothing efficacy testing (lactic acid sting test). Specifically, those who self-reported having sensitive skin, or experiencing a sensitive or stressful state and requiring a soothing product, and who tested positive in the lactic acid sting test were classified as the sensitive skin group, while those who tested negative were classified as the normal skin group. In the present invention, the number of subjects in each of the normal skin group and the sensitive skin group is preferably no less than 150, and even no less than 200.

[0055] In the present invention, the subject is preferably between 18 and 45 years old (excluding pregnant and lactating women). In addition, the subject cannot have any of the following conditions:

[0056] (1) Those who used drugs that affected skin hemoglobin concentration or had surgery that affected skin hemoglobin concentration, skin hemoglobin, or skin a value in the past month;

[0057] (2) those who have used antihistamines in the past week or immunosuppressants in the past month;

[0058] (3) Those who used any anti-inflammatory drugs in the test area in the past two months;

[0059] (4) Subjects with clinically unresolved inflammatory skin diseases;

[0060] (5) Patients with insulin-dependent diabetes mellitus;

[0061] (6) Patients with asthma or other chronic respiratory diseases who are receiving treatment;

[0062] (7) Those who received anticancer chemotherapy within the past six months;

[0063] (8) Patients with immunodeficiency or autoimmune diseases;

[0064] (9) Lactating or pregnant women;

[0065] (10) Bilateral mastectomy and bilateral axillary lymph node resection;

[0066] (11) The judges of the test results may be affected by scars, pigmentation, atrophy, port-wine stains or other blemishes on the skin to be tested;

[0067] (12) Participating in other clinical trial researchers;

[0068] (13) Non-voluntary participants or those who are unable to complete the required content according to the experimental requirements.

[0069] In the present invention, the subject needs to meet the following requirements during the experiment:

[0070] (1) Oral or external use of other preparations claiming to affect skin hemoglobin concentration, skin hemoglobin, skin a value or similar claims is prohibited;

[0071] (2) The test site is prohibited from undergoing cosmetic surgery or other cosmetic procedures that may affect skin hemoglobin concentration, skin hemoglobin, or skin a value;

[0072] (3) The subjects should mainly engage in indoor activities and avoid long-term exposure to outdoor light.

[0073] According to the present invention, after subjects are classified according to subjective and semi-subjective (lactic acid sting test) evaluation methods, the skin index values ​​of each subject are measured. In the present invention, the skin index values ​​of the normal skin group and the sensitive skin group are preferably obtained under an ambient temperature of 20°C to 22°C and a humidity of 40% to 60%, and real-time dynamic monitoring is performed. In the present invention, the test conditions during the testing process should remain consistent, such as: tester, location, or instrument, etc.

[0074] In the present invention, the detection method can be carried out according to conventional methods well known to those skilled in the art. In the present invention, preferably, under the supervision of a tester, the subject cleans the face with clean water, rinses it clean, and then blots it dry with a dandruff-free absorbent paper towel. The subject sits quietly in a test environment with a temperature of 20°C to 22°C and a humidity of 40% to 60%. The subject cannot drink water or beverages. The cheekbone area is exposed, the subject remains relaxed, and contact with the cheekbone area is avoided. The present invention preferably uses the cheekbone area as the detection area, and the area of ​​the detection area is preferably at least 3cm×3cm. In the present invention, the subject's sitting time is at least 20 minutes, or even at least 30 minutes.

[0075] When the skin is exposed to external stimuli such as ultraviolet radiation and chemicals, it activates the capsaicin receptor (TRPV1) on the skin keratinocytes, causing calcium ion influx, producing inflammatory factors, and then triggering a series of reactions, including vasodilation, accelerated blood flow, etc., which increase the hemoglobin concentration on the face, especially in the cheekbone area. Subjective sensations include tingling, itching, fever, etc., and the appearance is redness or red blood streaks on the skin. In addition, because the redness of the skin also changes when exposed to external stimuli, the hemoglobin concentration or skin alpha value changes. Therefore, in the present invention, the skin index value is preferably selected from any one of the hemoglobin concentration value, the hemoglobin concentration value or the skin alpha value.

[0076] In the present invention, preferably, an ANTERA 3D imaging system is used to capture images of the subject's zygomatic area to detect the hemoglobin concentration; preferably, a Mexameter MX-18 instrument is used to measure the hemoglobin concentration of the subject's zygomatic area; preferably, a Colorimeter CL 400 or VISIA instrument is used to measure the skin a value of the subject's zygomatic area; more preferably, a VISIA-CR instrument is used to measure the skin a value of the subject's zygomatic area.

[0077] According to the present invention, it is preferred that the hemoglobin concentration value, the hemoglobin concentration value or the skin a value described in step (2) be processed according to the confusion matrix method to obtain the standard threshold value of the hemoglobin concentration value, the standard threshold value of the hemoglobin concentration value or the standard threshold value of the skin a value.

[0078] In the present invention, the standard threshold value of the hemoglobin concentration value is preferably 1.231, the standard threshold value of the hemoglobin concentration value is preferably 276.15, and the standard threshold value of the skin a value is preferably 11.963.

[0079] According to the present invention, the hemoglobin concentration value, heme concentration value or skin a value of each subject described in step (2) is preferably compared with the standard threshold value of the hemoglobin concentration value, the standard threshold value of the hemoglobin concentration value or the standard threshold value of the skin a value described in step (3). If the hemoglobin concentration value, heme concentration value or skin a value of the subject is higher than the corresponding standard threshold value, the subject has sensitive skin, that is, a qualified subject for the soothing efficacy test; otherwise, the subject with a value lower than the standard threshold value has normal skin.

[0080] The ROC curve (Receiver Operating Characteristic Curve), also known as the "receiver operating characteristic curve", was first used to distinguish between signals and noise in the field of radar signal detection. It has since been widely used to evaluate the effectiveness of the latest medical diagnostic methods in practical applications. In addition, in the field of statistical modeling, the ROC curve is often used to evaluate the accuracy of prediction models. In terms of working principle, the ROC curve is usually derived based on the confusion matrix. The confusion matrix is ​​based on the "binary classification (1 / 0)" model. It can mix all the results of the predicted situation and the actual performance in pairs, thereby deriving the following four situations: TP, FP, FN and TN. The interpretation of the indicators of the confusion matrix is ​​shown in Table 1 below:

[0081] Table 1

[0082]

[0083]

[0084] Based on this, the true positive rate (TPR), true negative rate (TNR), false positive rate (FPR), and false negative rate (FNR) of the model classification can be calculated. TPR is also called sensitivity, and TNR is also called specificity. The calculation formula is as follows:

[0085] TPR = TP / (TP + FN);

[0086] TN=TN / (TN+FP);

[0087] FPR = FP / (TN + FP);

[0088] FNR=FN / (TN+FP).

[0089] For the present invention, the skin index of each subject can be regarded as a soothing efficacy subject screening prediction model, and all subjects can be regarded as a collection of all soothing efficacy subject screening prediction models. On this basis, the "sensitive skin" and "normal skin" in each screening result can be used to replace the "P" and "N" in the confusion matrix respectively; at the same time, the "correct" and "wrong" of the judgment result can be used to replace the "T" and "F" in the confusion matrix respectively. The specific meanings of each indicator after model conversion are shown in Table 2 below:

[0090] Table 2

[0091]

[0092] By giving different thresholds to the classification model, the values ​​of TP, FP, FN and TN in the confusion matrix will change accordingly, and TPR, TNR, FPR and FNR will also change accordingly, so that the true positive rate and false positive rate under different thresholds can be obtained. In the present invention, the true positive rate is the ratio of the number of people who are subjectively and semi-subjectively evaluated as sensitive skin in step (1) and determined to be sensitive skin in step (4) to the number of people who are subjectively and semi-subjectively evaluated as sensitive skin in step (1). The false positive rate is the ratio of the number of people who are subjectively and semi-subjectively evaluated as normal skin in step (1) but determined to be sensitive skin in step (4) to the number of people who are subjectively and semi-subjectively evaluated as normal skin in step (1).

[0093] According to the change of the threshold, the ROC curve is drawn with FPR (false positive rate) and TRP (true positive rate) as the horizontal and vertical axes respectively. The minimum threshold is set to the minimum test value (test value is: hemoglobin concentration value, heme concentration value or skin a value) minus 1, and the maximum threshold is the maximum test value plus 1. All other thresholds are the average of the remaining two consecutive sorted test values. The Youden index is then used to determine the optimal threshold in the ROC curve. The Youden index, also known as the correct index, is the sum of sensitivity and specificity minus 1 (that is, the difference between the true positive rate and the false positive rate). The calculation formula is as follows:

[0094] Youden index = sensitivity + specificity – 1 = TPR + TNR-1 = TPR-FPR;

[0095] The Youden Index ranges from 0 to 1 and represents the ability to distinguish positives from negatives at the current threshold. A larger Youden Index indicates a higher probability of true positives and a lower probability of false positives, indicating better classification performance at that threshold.

[0096] At the same time, in order to determine the effect of the current classification model, the ROC curve model of SPSS (version 22.0) was used for analysis. In the present invention, the data of the normal skin group was defined as "negative", corresponding to a value of 0; the data of the sensitive skin group was defined as "positive", corresponding to a value of 1, and the area under the curve (AUC) was calculated. Assuming that there are n data in total, the coordinate points of the ROC curve are {(x1, y1)...(x n ,y n )}, then the AUC area calculation formula is as follows:

[0097] AUC area =

[0098]

[0099] The AUC area is usually around 0.5 to 1. The larger the value, the higher the classification accuracy of the classification model. The accuracy of the classification model is judged according to the following standards:

[0100] AUC = 1, perfect classification;

[0101] 0.85≤AUC≤0.95, the classification effect is very good;

[0102] 0.7≤AUC<0.85, classification effect is average;

[0103] 0.5<AUC<07, the classification effect is low;

[0104] AUC = 0.5, which is the same as random guessing (e.g., flipping a coin), and the model has no predictive value;

[0105] AUC < 0.5, which is worse than random guessing, but as long as you always go against the prediction, it is better than random guessing.

[0106] The present invention also provides a testing system for qualified subjects of the soothing effect of cosmetics, comprising:

[0107] A classification module is used to classify the subjects into a normal skin group and a sensitive skin group based on the subjective and semi-subjective evaluation methods of the cosmetic soothing efficacy test;

[0108] A detection module, for obtaining a skin index value of each subject, wherein the skin index value is selected from a hemoglobin concentration value, a heme concentration value or a skin alpha value;

[0109] an analysis module for processing the hemoglobin concentration value, the hemoglobin concentration value, or the skin α value obtained by the detection module to obtain a standard threshold value of the hemoglobin concentration value, a standard threshold value of the hemoglobin concentration value, or a standard threshold value of the skin α value;

[0110] A comparison module, comprising a first comparison module, a second comparison module and a third comparison module;

[0111] The first comparison module is configured to compare the hemoglobin concentration value of each subject with the standard threshold value of the hemoglobin concentration value, and to determine subjects with hemoglobin concentration values ​​higher than the standard threshold value as having sensitive skin, i.e., qualified subjects for the soothing efficacy test, and subjects with hemoglobin concentration values ​​lower than the standard threshold value as having normal skin;

[0112] The second comparison module is configured to compare the hemoglobin concentration value of each subject with the standard threshold value of the hemoglobin concentration value, and to determine subjects with a hemoglobin concentration value higher than the standard threshold value as having sensitive skin, i.e., qualified subjects for the soothing efficacy test, and subjects with a hemoglobin concentration value lower than the standard threshold value as having normal skin;

[0113] The third comparison module is configured to compare the skin a-value of each subject with a standard threshold value of the skin a-value. Subjects with skin values ​​above the standard threshold value are determined to have sensitive skin, i.e., qualified subjects for the soothing efficacy test; and subjects with skin values ​​below the standard threshold value are determined to have normal skin.

[0114] The selection module is used to select any one of the first comparison module, the second comparison module and the third comparison module for comparison.

[0115] In the present invention, the testing system preferably also includes a statistical module for counting the number of people classified as normal skin and the number of people classified as sensitive skin in the classification module, and counting the number of people classified as sensitive skin by the classification module and determined as sensitive skin by the comparison module, as well as the number of people classified as normal skin by the classification module but determined as sensitive skin by the comparison module.

[0116] In the present invention, the analysis module includes a calculation module, which is used to calculate the true positive rate and false positive rate of the hemoglobin concentration value, heme concentration value or skin a value obtained by the detection module at different thresholds, and obtain the difference between the true positive rate and the false positive rate at different thresholds.

[0117] Among them, the minimum threshold among different thresholds is the minimum hemoglobin concentration value, heme concentration value or skin a value minus 1, the maximum threshold is the maximum hemoglobin concentration value, heme concentration value or skin a value plus 1, and all other thresholds are the average of the other two consecutively sorted hemoglobin concentration values, heme concentration values ​​or skin a values.

[0118] In the present invention, the analysis module also includes a judgment module, which is used to select the threshold corresponding to the maximum difference between the true positive rate and the false positive rate under different thresholds obtained by the calculation module as the standard threshold of the hemoglobin concentration value, the standard threshold of the hemoglobin concentration value or the standard threshold of the skin a value.

[0119] Preferably, the calculation module includes a true positive rate calculation module and a false positive rate calculation module.

[0120] The true positive rate calculation module is used to calculate the ratio of the number of people classified as having sensitive skin by the classification module and determined to have sensitive skin by the comparison module to the number of people classified as having sensitive skin in the classification module.

[0121] The false positive rate calculation module is used to calculate the ratio of the number of people classified as normal skin by the classification module but determined to be sensitive skin by the comparison module to the number of people classified as normal skin by the classification module.

[0122] The present invention also provides an application of the above-mentioned test method or test system in testing the efficacy of soothing cosmetics. The present invention has no special restrictions on the method of testing the efficacy of soothing cosmetics, and it can be done according to conventional methods familiar to those skilled in the art. In the present invention, preferably, under the supervision of a tester, the subject cleans the face with clean water, rinses it clean, and then dry it with a dandruff-free absorbent dry towel. The subject sits quietly in a test environment with a temperature of 20°C to 22°C and a humidity of 40% to 60%. The subject cannot drink water or beverages. The cheekbone area is exposed, the subject remains relaxed, and avoids contact with the cheekbone area. The initial value of the subject's corresponding skin index value is recorded. The present invention preferably uses the cheekbone area as the detection area, and the area of ​​the detection area is preferably at least 3 cm × 3 cm. In the present invention, the subject's sitting time is at least 20 minutes, or even at least 30 minutes.

[0123] According to the present invention, after completing the detection of the initial values ​​of the corresponding skin index values, the sample is applied to the subject. In the present invention, the test sample (i.e., soothing cosmetic) is preferably applied at a concentration of (2.0±0.1) mg / cm 2A single application of the desired amount is performed, and quantitative sampling is performed using a syringe, pipette, or equivalent. The sample is evenly applied to the subject's cheekbone using a latex fingertip, and the actual amount of sample applied is recorded. In the present invention, the interval between measurement time points is preferably no less than 0.5 hours. Multiple measurement points can be set according to the needs of soothing cosmetic evaluation. The total test duration is preferably no more than 8 hours, and the long-term test period is preferably no more than 28 days.

[0124] In the present invention, SPSS 22.0 software is preferably used to perform statistical descriptions of the measured skin index values, including quantity, mean, standard deviation, minimum value, median value, and maximum value. If the test data is normally distributed, the T test method is preferably used for statistical analysis; if the test data is non-normally distributed, the rank sum test method is preferably used for statistical analysis.

[0125] In the present invention, the statistical method preferably adopts a two-tailed test, and the test level α=0.05.

[0126] Calculate the average value of the difference between the initial value of the skin index value of the test sample application side and the control side and the measured value at other measurement time points, see formula (1) and formula (2);

[0127]

[0128] Where:

[0129] -The average value of the difference in skin index values ​​on the sample application side;

[0130] -The average value of the skin index values ​​on the sample application side before the sample is used;

[0131] -The average value of the skin index values ​​on the sample application side at different measurement time points after sample use;

[0132]

[0133] Where:

[0134] -The average value of the difference in skin index values ​​on the control side;

[0135] -The average value of the skin index values ​​on the control side before sample use;

[0136] -The average value of the skin index values ​​on the control side at different measurement time points after sample use.

[0137] To further illustrate the present invention, the following examples are provided for detailed description. The sources of the experimental raw materials used in the following examples of the present invention are not particularly limited and can be purchased from the market or prepared according to conventional preparation methods well known to those skilled in the art.

[0138] Example 1

[0139] This embodiment provides a method for testing subjects for the soothing efficacy of cosmetics, comprising the following steps:

[0140] (1) 224 people with sensitive skin who met the subjective and semi-subjective evaluation criteria were included. The inclusion criteria were people who self-reported as having sensitive skin or were in a sensitive state, needed soothing products in a stressful state, and had a positive lactic acid sting test, and 225 people with normal skin;

[0141] (2) The ANTERA 3D imaging system was used to capture images of the zygomatic region of the sensitive skin group and the normal skin group, and the hemoglobin concentration values ​​of the sensitive skin group and the normal skin group were recorded respectively. The test values ​​are shown in Table 1 below. The test values ​​were plotted, as shown in Table 1 below. Figure 1 As shown, it can be seen that the hemoglobin concentration values ​​of sensitive skin people (experimental group) and normal skin people (control group) form an effective distinction category:

[0142] Table 3

[0143]

[0144]

[0145]

[0146]

[0147]

[0148]

[0149]

[0150]

[0151]

[0152] (3) performing data processing on the hemoglobin concentration value obtained in step (2) according to the calculation method of the confusion matrix to obtain the true positive rate and false positive rate under different thresholds;

[0153] The minimum threshold value among the different threshold values ​​is the minimum hemoglobin concentration value minus 1, the maximum threshold value is the maximum hemoglobin concentration value plus 1, and all other threshold values ​​are the average of two consecutively ranked hemoglobin concentration values ​​between the minimum hemoglobin concentration value and the maximum hemoglobin concentration value;

[0154] The true positive rate is the ratio of the number of people who subjectively and semi-subjectively evaluated their skin as sensitive and were judged to have sensitive skin to the number of people who subjectively and semi-subjectively evaluated their skin as sensitive;

[0155] The false-negative rate is the ratio of the number of people who subjectively and semi-subjectively evaluated their skin as normal but were judged to have sensitive skin to the number of people who subjectively and semi-subjectively evaluated their skin as normal;

[0156] The results are shown in Table 4 below. It can be seen that the standard threshold is 1.231, the corresponding true positive rate is 0.866, the false positive rate is 0.044, and the Youden index is 0.822. The ROC curve is drawn for the data in Table 4 as follows Figure 2 As shown in the figure, after calculation, the AUC area is 0.968 (>0.95), indicating that the classification effect is very good:

[0157] Table 4

[0158]

[0159]

[0160]

[0161]

[0162]

[0163]

[0164]

[0165]

[0166]

[0167]

[0168]

[0169]

[0170] (4) Screen subjects whose hemoglobin concentration values ​​are higher than the standard threshold value of hemoglobin concentration value (1.231) as qualified subjects for the soothing effect of cosmetics.

[0171] Example 2

[0172] In this example, more than 30 subjects whose hemoglobin concentrations were higher than the standard threshold (1.231) were recruited as the experimental group, and more than 30 subjects whose hemoglobin concentrations were lower than the standard threshold (1.231) were recruited as the control group to conduct a clinical trial on the efficacy of soothing cosmetics.

[0173] The experimental method is as follows:

[0174] The test environment temperature is 20℃~22℃, and the humidity is 40%~60%, and real-time dynamic monitoring is performed. The test conditions should remain consistent during the test, such as testers, locations, instruments, etc.

[0175] The test sites of the experimental instrument are: zygomatic area;

[0176] Under the supervision of the test personnel, the subjects in the experimental group and the control group washed their faces with clean water, rinsed them clean, and then dried them with a lint-free paper towel. They sat quietly in a standard test environment for at least 20 minutes, without drinking water or beverages, with their cheekbones exposed, and kept relaxed, avoiding contact with the cheekbones. Then, the hemoglobin concentration values ​​of the subjects in the experimental group and the control group were recorded before using the soothing mask. After recording, the subjects in the experimental group and the control group tried the same commercially available soothing mask (such as: Xiao Mihu Vitamin B5 Soothing Mask), and the hemoglobin concentration values ​​were tested 0.5 hours later. The results are shown in Tables 5-6 below. Table 5 shows the hemoglobin concentration value data of the subjects in each group before and after using the soothing mask. Table 6 shows the results of the analysis of the data in Table 5. It can be seen that the experimental group can have a significant improvement effect, while the control group has no significant improvement effect. This shows that the selection of 1.231 as the standard threshold value for hemoglobin concentration value can more quickly detect the efficacy of soothing cosmetics for screening qualified subjects with soothing efficacy. The threshold setting is relatively reasonable:

[0177] Table 5

[0178]

[0179]

[0180]

[0181] Table 6

[0182]

[0183] Example 3

[0184] This embodiment provides a method for testing subjects for the soothing efficacy of cosmetics, comprising the following steps:

[0185] (1) 209 people with sensitive skin who met the subjective and semi-subjective evaluation criteria were included. The inclusion criteria were people who self-reported as having sensitive skin or were in a sensitive state, needed soothing products in a stressful state, and had a positive lactic acid sting test, and 207 people with normal skin;

[0186] (2) The hemoglobin concentration values ​​at the zygomatic bone of the sensitive skin group and the normal skin group were measured using a Mexameter MX-18 instrument. The test values ​​are shown in Table 7 below.

[0187] Table 7

[0188]

[0189]

[0190]

[0191]

[0192]

[0193]

[0194]

[0195]

[0196]

[0197] (3) performing data processing on the hemoglobin concentration value obtained in step (2) according to the calculation method of the confusion matrix to obtain the true positive rate and false positive rate under different thresholds;

[0198] The minimum threshold among the different thresholds is the minimum hemoglobin concentration value minus 1, the maximum threshold is the maximum hemoglobin concentration value plus 1, and all other thresholds are the average of two consecutive sorted hemoglobin concentration values ​​between the minimum hemoglobin concentration value and the maximum hemoglobin concentration value;

[0199] The true positive rate is the ratio of the number of people who subjectively and semi-subjectively evaluated their skin as sensitive and were judged to have sensitive skin to the number of people who subjectively and semi-subjectively evaluated their skin as sensitive;

[0200] The false-positive rate is the ratio of the number of people who subjectively and semi-subjectively evaluated their skin as normal but were judged to have sensitive skin to the number of people who subjectively and semi-subjectively evaluated their skin as normal;

[0201] The results are shown in Table 8 below. It can be seen that the standard threshold is 276.165, the corresponding true positive rate is 0.726, the false positive rate is 0.024, and the Youden index is 0.702. The ROC curve is drawn for the data in Table 8 as follows Figure 4 As shown in the figure, after calculation, the AUC area is 0.925 (>0.85), which shows that the classification effect is very good;

[0202] Table 8

[0203]

[0204]

[0205]

[0206]

[0207]

[0208]

[0209]

[0210]

[0211]

[0212]

[0213]

[0214]

[0215] (4) Screen subjects whose hemoglobin concentration values ​​are higher than the standard threshold of hemoglobin concentration value (276.165) as qualified subjects for the soothing effect of cosmetics.

[0216] Example 4

[0217] This embodiment provides a method for testing subjects for the soothing efficacy of cosmetics, comprising the following steps:

[0218] (1) 165 people with sensitive skin who met the subjective and semi-subjective evaluation criteria were included. The inclusion criteria were people who self-reported as having sensitive skin or were in a sensitive state, needed soothing products in a stressful state, and had a positive lactic acid sting test, and 165 people with normal skin;

[0219] (2) The skin a value of the zygomatic area of ​​the sensitive skin group and the normal skin group was measured using the VISIA-CR instrument. The test values ​​are shown in Table 9 below.

[0220] Table 9

[0221]

[0222]

[0223]

[0224]

[0225]

[0226]

[0227]

[0228] (3) processing the skin a value obtained in step (2) according to the calculation method of the confusion matrix to obtain the true positive rate and false positive rate under different thresholds;

[0229] The minimum threshold among the different thresholds is the smallest skin a value minus 1, the maximum threshold is the largest skin a value plus 1, and all other thresholds are the average of two consecutive sorted skin a values ​​between the smallest skin a value and the largest skin a value;

[0230] The true positive rate is the ratio of the number of people who subjectively and semi-subjectively evaluated their skin as sensitive and were judged to have sensitive skin to the number of people who subjectively and semi-subjectively evaluated their skin as sensitive;

[0231] The false-positive rate is the ratio of the number of people who subjectively and semi-subjectively evaluated their skin as normal but were judged to have sensitive skin to the number of people who subjectively and semi-subjectively evaluated their skin as normal;

[0232] The results are shown in Table 10 below. It can be seen that the standard threshold is 11.963, the corresponding true positive rate is 0.927, the false positive rate is 0.218, and the Youden index is 0.709. The ROC curve is drawn for the data in Table 9 as follows Figure 5 As shown in the figure, after calculation, the AUC area is 0.922 (>0.85), indicating that the classification effect is very good;

[0233] Table 10

[0234]

[0235]

[0236]

[0237]

[0238]

[0239]

[0240]

[0241]

[0242]

[0243]

[0244]

[0245]

[0246] (4) Screen subjects whose skin a-value is higher than the standard threshold of skin a-value (11.963) as qualified subjects for the soothing effect of cosmetics.

[0247] Comparative Example 1

[0248] This comparative example provides a method for testing qualified subjects for the soothing effect of cosmetics, comprising the following steps:

[0249] (1) 201 people with sensitive skin who met the subjective and semi-subjective evaluation criteria were included. The inclusion criteria were people who self-reported as having sensitive skin or were in a sensitive state, needed soothing products in a stressful state, and had a positive lactic acid sting test, and 201 people with normal skin;

[0250] (2) The water content of the stratum corneum of the zygomatic region of the sensitive skin group and the normal skin group was measured using a Cornemeter CM825 instrument. The test values ​​are shown in Table 11 below.

[0251] Table 11

[0252]

[0253]

[0254]

[0255]

[0256]

[0257]

[0258]

[0259]

[0260] (3) performing data processing on the water content of the skin stratum corneum obtained in step (2) according to the calculation method of the confusion matrix to obtain the true positive rate and false positive rate under different thresholds;

[0261] The minimum threshold value among the different threshold values ​​is the minimum skin stratum corneum water content minus 1, the maximum threshold value is the maximum skin stratum corneum water content plus 1, and all other threshold values ​​are the average values ​​of the two consecutively ranked skin stratum corneum water contents between the minimum skin stratum corneum water content and the maximum skin stratum corneum water content;

[0262] The true positive rate is the ratio of the number of people who subjectively and semi-subjectively evaluated their skin as sensitive and were judged to have sensitive skin to the number of people who subjectively and semi-subjectively evaluated their skin as sensitive;

[0263] The false-positive rate is the ratio of the number of people who subjectively and semi-subjectively evaluated their skin as normal but were judged to have sensitive skin to the number of people who subjectively and semi-subjectively evaluated their skin as normal;

[0264] The results are shown in Table 8 below. It can be seen that the standard threshold is 80.515, the corresponding true positive rate is 0.279, the false positive rate is 0.229, and the Youden index is 0.05. The ROC curve is drawn for the data in Table 9 as follows Figure 5 As shown, after calculation, the AUC area is 0.503, which shows that the classification effect is very general, the same as following random guessing (for example, flipping a coin), which means that the model that selects water content as a screening indicator for sensitive skin has no predictive value.

[0265] Table 12

[0266]

[0267]

[0268]

[0269]

[0270]

[0271]

[0272]

[0273]

[0274]

[0275]

[0276]

[0277]

[0278]

[0279] The above description of the disclosed embodiments will enable one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be readily apparent to one skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention is not limited to the embodiments shown herein but is to be construed in the widest manner consistent with the principles and novel features disclosed herein.

Claims

1. A method for testing qualified subjects for the soothing effect of cosmetics, characterized in that: The steps include: (1) The subjects were divided into normal skin group and sensitive skin group according to the subjective and semi-subjective evaluation methods of cosmetic soothing efficacy test; (2) obtaining a skin index value for each subject, wherein the skin index value is selected from a hemoglobin concentration value, a heme concentration value, or a skin α value; (3) performing data processing on the hemoglobin concentration value, heme concentration value or skin a value described in step (2) according to the confusion matrix calculation method, respectively obtaining the true positive rate and false positive rate of the hemoglobin concentration value, heme concentration value or skin a value at different thresholds, respectively, taking the threshold value corresponding to the maximum difference between the true positive rate and the false positive rate in the hemoglobin concentration value, heme concentration value or skin a value as the standard threshold value, respectively obtaining the standard threshold value of the hemoglobin concentration value, the standard threshold value of the heme concentration value or the standard threshold value of the skin a value; Among them, the minimum threshold value among different thresholds is the minimum hemoglobin concentration value, hemoglobin concentration value or skin a value minus 1, the maximum threshold value is the maximum hemoglobin concentration value, hemoglobin concentration value or skin a value plus 1, and all other threshold values ​​are the average of the remaining two consecutively sorted hemoglobin concentration values, hemoglobin concentration values ​​or skin a values; The true positive rate is the ratio of the number of people who were subjectively and semi-subjectively evaluated as having sensitive skin in step (1) and were determined to have sensitive skin in step (4) to the number of people who were subjectively and semi-subjectively evaluated as having sensitive skin in step (1); The false positive rate is the ratio of the number of people whose skin was subjectively and semi-subjectively evaluated as normal in step (1) but was determined to be sensitive in step (4) to the number of people whose skin was subjectively and semi-subjectively evaluated as normal in step (1); (4) selecting any one of the skin index values ​​in step (2) as the detection index value, comparing the skin index value of each subject with the standard threshold value of the skin index value, determining the subject with a skin index value higher than the standard threshold value as having sensitive skin, i.e., a qualified subject for the soothing efficacy test, and determining the subject with a skin index value lower than the standard threshold value as having normal skin; The standard threshold value of the hemoglobin concentration value is 1.231; The standard threshold value of the hemoglobin concentration value is 276.15; The standard threshold value of the skin α value is 11.

963.

2. The testing method according to claim 1, wherein: The skin index values ​​of the normal skin group and the sensitive skin group were obtained under an ambient temperature of 20° C. to 22° C., a humidity of 40% to 60%, and a skin area of ​​at least 3×3 cm.

3. A testing system for qualified subjects of cosmetic soothing efficacy, characterized in that: include: A classification module is used to classify the subjects into a normal skin group and a sensitive skin group based on the subjective and semi-subjective evaluation methods of the cosmetic soothing efficacy test; A detection module, for obtaining a skin index value of each subject, wherein the skin index value is selected from a hemoglobin concentration value, a heme concentration value or a skin alpha value; an analysis module for performing data processing on the hemoglobin concentration value, heme concentration value, or skin α-value obtained by the detection module to obtain a standard threshold value for the hemoglobin concentration value, a standard threshold value for the heme concentration value, or a standard threshold value for the skin α-value; the analysis module includes a calculation module for calculating the true positive rate and false positive rate of the hemoglobin concentration value, heme concentration value, or skin α-value obtained by the detection module at different thresholds, and obtaining the difference between the true positive rate and the false positive rate at different thresholds; Among them, the minimum threshold value among different thresholds is the minimum hemoglobin concentration value, hemoglobin concentration value or skin a value minus 1, the maximum threshold value is the maximum hemoglobin concentration value, hemoglobin concentration value or skin a value plus 1, and all other threshold values ​​are the average of the remaining two consecutively sorted hemoglobin concentration values, hemoglobin concentration values ​​or skin a values; The analysis module further includes a judgment module, which is configured to select, based on the difference between the true positive rate and the false positive rate under different thresholds obtained by the calculation module, a threshold corresponding to the maximum difference as a standard threshold for hemoglobin concentration, a standard threshold for hemoglobin concentration, or a standard threshold for skin alpha value; The standard threshold value of the hemoglobin concentration value is 1.231; The standard threshold value of the hemoglobin concentration value is 276.15; The standard threshold of the skin a value is 11.963; The calculation module includes a true positive rate calculation module and a false positive rate calculation module; The true positive rate calculation module is used to calculate the ratio of the number of people classified as having sensitive skin by the classification module and determined to have sensitive skin by the comparison module to the number of people classified as having sensitive skin by the classification module; The false positive rate calculation module is used to calculate the ratio of the number of people classified as normal skin by the classification module but determined as sensitive skin by the comparison module to the number of people classified as normal skin by the classification module; A comparison module, comprising a first comparison module, a second comparison module and a third comparison module; The first comparison module is configured to compare the hemoglobin concentration value of each subject with the standard threshold value of the hemoglobin concentration value, and to determine subjects with hemoglobin concentration values ​​higher than the standard threshold value as having sensitive skin, i.e., qualified subjects for the soothing efficacy test, and subjects with hemoglobin concentration values ​​lower than the standard threshold value as having normal skin; The second comparison module is configured to compare the hemoglobin concentration value of each subject with the standard threshold value of the hemoglobin concentration value, and to determine subjects with a hemoglobin concentration value higher than the standard threshold value as having sensitive skin, i.e., qualified subjects for the soothing efficacy test, and subjects with a hemoglobin concentration value lower than the standard threshold value as having normal skin; The third comparison module is configured to compare the skin a-value of each subject with a standard threshold value of the skin a-value. Subjects with skin values ​​above the standard threshold value are determined to have sensitive skin, i.e., qualified subjects for the soothing efficacy test; and subjects with skin values ​​below the standard threshold value are determined to have normal skin. The selection module is used to select any one of the first comparison module, the second comparison module and the third comparison module for comparison.

4. The test system according to claim 3, characterized in that: It also includes a statistical module for counting the number of people classified as normal skin and the number of people classified as sensitive skin in the classification module, and counting the number of people classified as sensitive skin by the classification module and determined as sensitive skin by the comparison module, as well as the number of people classified as normal skin by the classification module but determined as sensitive skin by the comparison module.

5. Use of the test method according to claim 1 or 2 or the test system according to claim 3 or 4 in testing the soothing effect of cosmetics.

Images