CN115267161A - Test method and system for qualified subject with soothing effect of cosmetic - Google Patents
Test method and system for qualified subject with soothing effect of cosmetic Download PDFInfo
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Abstract
The invention provides a test method and a test system for qualified cosmetic soothing efficacy subjects, which comprise the following steps: dividing the subject into a normal skin group and a sensitive skin group according to subjective and semi-subjective evaluation methods of a cosmetic soothing efficacy test; obtaining a skin metric value for each subject, the skin metric value selected from a hemoglobin concentration value, or a skin a value; respectively carrying out data processing on the hemoglobin concentration value, the heme concentration value or the skin a value according to a confusion matrix method to respectively obtain a standard threshold value for screening the subjects with the relieving efficacy qualification through the hemoglobin concentration value, the heme concentration value or the skin a value; and selecting any one of the skin index values as a detection index value, comparing the skin index value of each subject with a standard threshold value, wherein the subject higher than the standard threshold value is sensitive skin, namely a qualified subject of the soothing efficacy test. The test method can quickly, objectively and accurately screen out qualified subjects with the relieving effect.
Description
Technical Field
The invention relates to the field of cosmetic efficacy testing, in particular to a testing method and system for a qualified subject with a soothing efficacy of a cosmetic.
Background
In recent years, with the increasing proportion of people with sensitive muscles, the development of soothing cosmetics is also receiving attention. As an important scientific basis for evaluating the efficacy of cosmetics, a human body efficacy test needs to screen out qualified sensitive skin subjects. Currently, there are three main methods for evaluating sensitive skin: (1) subjective evaluation: firstly, a person to be examined self-evaluates the sensitive condition of the skin according to whether the skin is easy to have subjective symptoms such as burning, stabbing pain, pruritus and tightness and the like when the person is stimulated by trigger factors, and the trigger factors comprise physical factors (such as alternate seasons, temperature change or solarization), chemical factors (such as irritative external medicines such as cosmetics, cleaning products, disinfection products, tretinoin and the like or environmental pollutants) or mental factors (such as anxiety or depression) and the like; (2) semi-subjective evaluation: adopting stimulation experiments to judge whether the skin is sensitive skin, such as lactic acid stabbing pain experiments; (3) objective evaluation: the severity of sensitive skin is reflected by non-invasive skin physiological indicators, such as by measurements of epidermal water loss rate, stratum corneum water content, skin pH, sebum, skin erythema index, or local blood flow velocity and distribution histograms.
However, in the existing standard, subjective or semi-subjective methods are adopted to screen qualified people, the repeatability is poor, the tolerance of a human body is easily influenced by a stimulation experiment, and sensitive skin is not always in a reddish state and needs to be relieved, so that the screening accuracy is low. Compared with the prior art, the objective evaluation method avoids possible errors caused by subjective evaluation, 5 quantitative evaluation indexes are provided in 'Chinese sensitive skin diagnosis and treatment expert consensus', but the clinical inclusion standards screened aiming at the common indexes still do not reach the unified standard so far, the recruitment of qualified subjects is difficult due to over-high setting of the screening standards, the actual effect of the product cannot be detected due to over-low setting of the screening standards, and how to quickly, accurately and reliably distinguish the qualified subjects is still a problem to be solved in the efficacy verification of the soothing cosmetics.
CN114262729A discloses a method for testing the soothing effect of cosmetics and raw materials thereof, which adopts a cell-substituted human body test, firstly culturing a mouse macrophage strain in vitro, adding a sample to be tested into cells for testing, testing the cytotoxicity of the sample, then selecting the concentration without cytotoxicity for carrying out a Nitric Oxide (NO) release inhibition test, and analyzing and evaluating the soothing effect of the sample by a statistical means. The method is economical and rapid, the testing process is controllable, the testing system is standardized, and large result deviation caused by individual difference of human bodies is avoided. However, the cell experiment is far different from the actual use scene of the human body, is only suitable for screening early raw materials, and is difficult to directly use finished products/semi-finished products of cosmetics due to the limitation of cell culture conditions, so that the relieving efficacy on the human body cannot be accurately evaluated.
CN114469948a provides a reusable skin redness model modeling method, and applies it to the evaluation of the product's ability to improve skin irritation. According to the method, after skin redness is modeled by using methyl nicotinate, thermal stimulation is carried out again after the skin redness is completely eliminated, the modeling part is reddened again to different degrees, and the difference of the capability of improving the skin irritability state of the product is represented according to the degree of the reddening. However, the model cannot completely replace the people who actually have sensitive muscles in redness, and certain error influence can exist on the detection of the efficacy of the cosmetics.
Disclosure of Invention
In view of the above, the present invention provides a method and a system for testing a subject with acceptable soothing effect. The test method can quickly, objectively and accurately screen out qualified subjects with the relieving effect.
In a first aspect, the present invention provides a method for testing a subject for acceptable cosmetic soothing efficacy, comprising the steps of:
(1) Dividing the subject into a normal skin group and a sensitive skin group according to subjective and semi-subjective evaluation methods of a cosmetic soothing efficacy test;
(2) Obtaining a skin metric value for each subject, the skin metric value selected from a hemoglobin concentration value, or a skin a value;
(3) Respectively carrying out data processing on the hemoglobin concentration value, the hemoglobin concentration value or the skin a value in the step (2) according to a confusion matrix method to respectively obtain a standard threshold of the hemoglobin concentration value, a standard threshold of the hemoglobin concentration value or a standard threshold of the skin a value;
(4) Selecting any one of the skin index values in the step (2) as a detection index value, comparing the skin index value of each subject with a standard threshold value of the skin index value, judging the subject higher than the standard threshold value as sensitive skin, namely a qualified subject of the relieving efficacy test, and judging the subject lower than the standard threshold value as normal skin.
Preferably, the first and second electrodes are formed of a metal, the step (3) is specifically as follows:
and (3) respectively carrying out data processing on the hemoglobin concentration value, the heme concentration value or the skin a value in the step (2) according to a confusion matrix calculation method to respectively obtain the true positive rate and the false positive rate of the hemoglobin concentration value, the heme concentration value or the skin a value under different threshold values, and respectively 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 a value by taking a corresponding threshold value of the hemoglobin concentration value, the heme concentration value or the skin a value when the difference value of the true positive rate and the false positive rate is maximum as a standard threshold value.
Wherein, the minimum threshold value in the different threshold values is the smallest hemoglobin concentration value, hemoglobin concentration value or skin a value minus 1, the maximum threshold value is the largest hemoglobin concentration value, hemoglobin concentration value or skin a value plus 1, and all other threshold values are the average value of the remaining two continuously ordered hemoglobin concentration values, hemoglobin concentration values or skin a values.
The true positive rate is the ratio of the number of people who are subjectively and semi-subjectively evaluated as sensitive skin in the step (1) and judged as sensitive skin in the step (4) to the number of people who are subjectively and semi-subjectively evaluated as sensitive skin in the step (1).
The false positive rate is the ratio of the number of people who subjectively and semi-subjectively evaluate to normal skin in the step (1) but judge to be sensitive skin in the step (4) to the number of people who subjectively and semi-subjectively evaluate to normal skin in the step (1).
Preferably, the standard threshold value for the hemoglobin concentration value is 1.231.
Preferably, the standard threshold value for the hemoglobin concentration value is 276.15.
Preferably, the standard threshold value for the skin a value is 11.963.
Preferably, the skin index values of the normal skin group and the sensitive skin group are obtained under the conditions that the ambient temperature is 20-22 ℃, the humidity is 40-60%, and the skin area is at least 3 x 3cm.
In a second aspect, the present invention provides a test system for a subject with acceptable cosmetic soothing efficacy, comprising:
the classification module is used for classifying the subjects into a normal skin group and a sensitive skin group according to subjective and semi-subjective evaluation methods of the cosmetic soothing efficacy test;
a detection module for obtaining a skin indicator value for each subject, the skin indicator value being selected from a hemoglobin concentration value, or a skin a value;
the analysis module is used for carrying out data processing on the hemoglobin concentration value, the heme concentration value or the skin a value obtained by the detection module to respectively obtain a standard threshold of the hemoglobin concentration value, a standard threshold of the heme concentration value or a standard threshold of the skin a value;
the comparison module comprises a first comparison module, a second comparison module and a third comparison module;
the first comparison module is used for comparing the hemoglobin concentration value of each subject with a standard threshold value of the hemoglobin concentration value, subjects higher than the standard threshold value are judged to be sensitive skin, namely qualified subjects of the soothing efficacy test, and subjects lower than the standard threshold value are judged to be normal skin;
the second comparison module is used for comparing the heme concentration value of each subject with a standard threshold of the heme concentration value, subjects higher than the standard threshold are judged to be sensitive skin, namely qualified subjects of the soothing efficacy test, and subjects lower than the standard threshold are judged to be normal skin;
the third comparison module is used for comparing the skin a value of each subject with a standard threshold value of the skin a value, subjects higher than the standard threshold value are judged to be sensitive skin, namely qualified subjects of the relieving efficacy test, and subjects lower than the standard threshold value are judged to be normal skin;
and the selection module is used for selecting any one of the first comparison module, the second comparison module and the third comparison module for comparison.
Preferably, the testing system further comprises a counting 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 judged as sensitive skin by the comparison module, and the number of people classified as normal skin by the classification module and judged as sensitive skin by the comparison module.
Preferably, the analysis module comprises a calculation module, and the calculation module is configured to calculate true positive rates and false positive rates of the hemoglobin concentration value, or the skin a value obtained by the detection module under different thresholds, and obtain true positive rates and false positive rates of the hemoglobin concentration value, or the skin a value under different thresholds.
Wherein, the minimum threshold value in the different threshold values is the smallest hemoglobin concentration value, hemoglobin concentration value or skin a value minus 1, the maximum threshold value is the largest hemoglobin concentration value, hemoglobin concentration value or skin a value plus 1, and all other threshold values are the average value of the remaining two continuously ordered hemoglobin concentration values, hemoglobin concentration values or skin a values.
Preferably, the analysis module further includes a judgment module, and the judgment module is configured to select, according to the difference between the true positive rate and the false positive rate obtained by the calculation module under different thresholds, a threshold corresponding to the largest difference as a standard threshold of the hemoglobin concentration value, or a standard threshold of the skin a value.
Preferably, the calculation module comprises a true positive rate calculation module and a false positive rate calculation module.
The true positive rate calculation module is used for calculating the ratio of the number of people classified as sensitive skin by the classification module and judged as sensitive skin by the comparison module to the number of people classified as sensitive skin by the classification module.
The false positive rate calculation module is used for calculating the ratio of the number of people who are classified as normal skin by the classification module and are judged as sensitive skin by the comparison module to the number of people who are classified as normal skin by the classification module.
In a third aspect, the invention also provides a use of the test method or the test system in a cosmetic soothing efficacy test.
Compared with the prior art, the invention has the beneficial effects that:
(1) The method selects the hemoglobin concentration value, the heme concentration value or the skin a value as quantifiable objective screening standards, and can quickly, objectively and accurately screen out qualified subjects with the relieving effect;
(2) The standard threshold of the hemoglobin concentration value, the heme concentration value or the skin a value is calculated by adopting a confusion matrix model to replace a subjective screening method and a semi-subjective screening method, and the standard threshold can be used for effectively distinguishing a subject as normal skin or sensitive skin;
(3) The subjects screened based on the standard threshold have real states that redness needs to be relieved, the relieving efficacy of the cosmetics for clinical experimental research is more representative, the single skin detection index can be adopted for measurement in the stages of subject screening and cosmetic efficacy verification, the complex operation brought by subjective or semi-subjective subject screening of the subjects in the prior art is avoided, and the compliance of the subjects in human body experiments is improved.
Drawings
FIG. 1 is a graph of the hemoglobin concentration profile of the subject of example 1;
FIG. 2 is a ROC plot obtained in example 1;
FIG. 3 is a ROC plot obtained in example 3;
FIG. 4 is a ROC plot obtained in example 4;
FIG. 5 is a ROC plot obtained in comparative example 1.
Detailed Description
The technical solutions of the present invention will be described clearly and completely with reference to the following embodiments of the present invention, and it should be understood that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without making any creative effort based on the embodiments in the present invention, belong to the protection scope of the present invention.
The present invention is not particularly limited in terms of the source of all raw materials involved, and may be obtained from commercial sources or prepared according to conventional preparation methods well known to those skilled in the art.
The invention provides a test method for qualified subjects with the soothing efficacy of cosmetics, which comprises the following steps:
(1) Dividing the subject into a normal skin group and a sensitive skin group according to subjective and semi-subjective evaluation methods of a cosmetic soothing efficacy test;
(2) Obtaining a skin metric value for each subject, the skin metric value selected from a hemoglobin concentration value, or a skin a value;
(3) Respectively carrying out data processing on the hemoglobin concentration value, the hemoglobin concentration value or the skin a value in the step (2) according to a confusion matrix method to respectively obtain a standard threshold of the hemoglobin concentration value, a standard threshold of the hemoglobin concentration value or a standard threshold of the skin a value;
(4) Selecting any one of the skin index values in the step (2) as a detection index value, comparing the skin index value of each subject with a standard threshold value of the skin index value, judging the subject higher than the standard threshold value as sensitive skin, namely a qualified subject for the relieving efficacy test, and judging the subject lower than the standard threshold value as normal skin.
In the invention, firstly, the subjects are preferably divided into a normal skin group and a sensitive skin group according to a subjective and semi-subjective evaluation method (lactic acid sting test) of a soothing efficacy test, namely, the subjects are self-reported to be sensitive muscles or products in a sensitive state and in a stress state which need the soothing efficacy, and the population which is positive by the lactic acid sting test is the sensitive skin group, otherwise, the subjects are 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 not less than 150, even not less than 200.
In the present invention, the subject is preferably between 18 and 45 years of age (excluding pregnant and lactating women). Additionally, the subject cannot have any of the following:
(1) An operator who has an influence on the hemoglobin concentration of the skin or the hemoglobin concentration, hemoglobin, or a value of a skin a in a month after the last month;
(2) Those who use antihistamines for nearly one week or immunosuppressants for nearly one month;
(3) Those who use any anti-inflammatory drug at the site of the test within approximately two months;
(4) The subject has a clinically unvulcanized inflammatory skin condition;
(5) Patients with insulin-dependent diabetes mellitus;
(6) Patients suffering from asthma or other chronic respiratory diseases undergoing therapy;
(7) Those who receive anti-cancer therapy within approximately six months;
(8) Patients with immunodeficiency or autoimmune disease;
(9) Lactating or pregnant women;
(10) Bilateral mastectomy and bilateral underarm lymph node resection;
(11) The judgment of the test result is influenced by scars, pigments, atrophy, port wine stains or other flaws on the skin to be tested;
(12) Participation in other clinical trial investigators;
(13) Non-volunteer participants or those who cannot complete the prescription according to the experimental requirements.
In the present invention, the subject needs to meet the following requirements during the experiment:
(1) Prohibiting oral or topical allegation of other agents that affect skin hemoglobin concentration, skin hemoglobin, skin a-value, or similar alleges;
(2) The subject site is prohibited from receiving cosmetic surgery or other cosmetic modalities that may affect skin hemoglobin concentration, skin hemoglobin, skin a value;
(3) The subject is mainly indoor activities and is prevented from being exposed to outdoor light for a long time.
According to the present invention, subjects are classified according to subjective and semi-subjective (lactic acid prick test) evaluation methods, and then skin index values of the subjects are detected. In the invention, the skin index values of the normal skin group and the sensitive skin group are preferably obtained under the conditions that the ambient temperature is 20-22 ℃ and the humidity is 40-60%, and real-time dynamic monitoring is carried out. In the present invention, the test conditions during the detection process should be consistent, such as: a tester, a site or an instrument, etc.
In the present invention, the detection method is performed according to conventional methods well known to those skilled in the art, and preferably under the management of a tester, the test subject cleans the face with clean water, washes the face clean, then sucks the face with a dry paper towel without crumbs, sits still in a test environment with the temperature of 20 ℃ to 22 ℃ and the humidity of 40% to 60%, cannot drink water and drinks, and has cheekbone exposed and kept relaxed to avoid contacting the cheekbone. In the present invention, the zygomatic bone site is preferably used as the detection site, and the area of the detection site is preferably at least 3cm × 3cm. In the present invention, the subject has a sedentary time of at least 20min, even at least 30min.
When skin is subjected to external stimulation such as ultraviolet irradiation and chemical substances, capsaicin receptor (TRPV 1) on skin keratinocytes is activated, calcium ion inflow is caused, inflammatory factors are generated, a series of reactions including vasodilatation, blood flow speed acceleration and the like are further caused, the hemoglobin concentration of the face, particularly cheekbone parts, is increased, the face is subjectively experienced as stabbing pain, pruritus, fever and the like, and the appearance is manifested as reddening or red blood streak and the like of the skin. In addition, the skin redness may also change when exposed to external stimuli, resulting in a change in the hemoglobin concentration or the skin a value. Therefore, in the present invention, the skin index value is preferably selected from any one of a hemoglobin concentration value, or a skin a value.
In the present invention, the number of hemoglobin concentration is preferably detected by taking images of the zygomatic bone region of the subject using an ANTERA 3D imaging system; the hemoglobin concentration value of the zygomatic site of the subject is preferably measured using a Mexameter MX-18 instrument, the skin a value of the zygomatic site of the subject is preferably measured using a Colorimeter CL 400 or VISIA instrument, and the skin a value of the zygomatic site of the subject is more preferably measured using a VISIA-CR instrument. .
According to the present invention, it is preferable that the hemoglobin concentration value, or the skin a value in step (2) is subjected to data processing according to a confusion matrix method to obtain a standard threshold value of the hemoglobin concentration value, or a standard threshold value of the skin a value, respectively.
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.
According to the present invention, it is preferable that the hemoglobin concentration value, the hemoglobin concentration value or the skin a value of each subject described in step (2) is 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), and if the hemoglobin concentration value, the hemoglobin concentration value or the skin a value of the subject is higher than the corresponding standard threshold value, the subject is sensitive skin, i.e., a qualified subject for the soothing efficacy test, whereas a subject lower than the standard threshold value is normal skin.
The ROC Curve (Receiver Operating Characteristic Curve) is also called as a Receiver Operating Characteristic Curve, and is firstly applied to distinguishing signals and noises in the field of radar signal detection, and then widely applied to evaluating the effectiveness of the latest medical diagnosis method in practical application. Furthermore, in the field of statistical modeling, ROC curves are also often used to evaluate the accuracy of predictive models. In working principle, the ROC curve is usually obtained based on a confusion matrix, which is based on a "binary (1/0)" model, and can be mixed two by two for all results of the predicted case and the actual performance, so as to obtain the following 4 cases: TP, FP, FN and TN. The confusion matrix is defined in the following table 1:
TABLE 1
Accordingly, the True Positive Rate (TPR, true Positive Rate), the True Negative Rate (TNR, true Negative Rate), the False Positive Rate (FPR, false Positive Rate) and the False Negative Rate (FNR, false Negative Rate) of the model classification can be calculated, wherein the TPR is also called sensitivity, and the TNR is also called specificity, and the calculation formula is as follows:
TPR=TP/(TP+FN);
TN=TN/(TN+FP);
FPR=FP/(TN+FP);
FNR=FN/(TN+FP)。
for the present invention, the skin index of each subject can be regarded as a screening and prediction model of the subjects with the effect of relieving, and the whole subjects can be regarded as a set of the screening and prediction models of all the subjects with the effect of relieving, on the basis, the sensitive skin and the normal skin in each screening result can be used to respectively replace the P and the N in the confusion matrix; meanwhile, the 'correct' and 'wrong' of the judgment result are used for replacing 'T' and 'F' in the confusion matrix respectively, and the specific meanings of each index after model conversion are shown in the following table 2:
TABLE 2
By giving different thresholds to the classification model, values of TP, FP, FN and TN in the confusion matrix are changed, and TPR, TNR, FPR and FNR are also changed, so that the true positive rate and the false positive rate under different thresholds can be obtained. In the present invention, the true positive rate is a ratio of the number of persons who are subjectively and semi-subjectively evaluated as sensitive skin in step (1) and who are judged as sensitive skin in step (4) to the number of persons 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 judged to be sensitive skin in the step (4) and the number of people who are judged to be normal skin in the step (1) through subjective and semi-subjective evaluation.
According to the variation of the threshold values, an ROC curve is drawn by taking FPR (false positive rate) and TRP (true positive rate) as the horizontal axis and the vertical axis respectively, the minimum threshold value is set to be the minimum test value (the test value is: hemoglobin concentration value, hemoglobin concentration value or skin a value) minus 1, the maximum threshold value is the maximum test value plus 1, and all other threshold values are the average value of the other two continuously sequenced test values. The optimal threshold in the ROC curve is then determined by the johnsen index. The jotan index, also called correct index, is the sum of sensitivity and specificity minus 1 (i.e. the difference between true positive rate and false positive rate), and is calculated as follows:
york index = sensitivity + specificity-1= -tpr + tnr-1= -tpr-FPR;
the jotan index has a value ranging from 0 to 1 and represents the ability to discriminate between positive and negative within the current threshold. The larger the york index is, the higher the probability of occurrence of true positives and the lower the probability of false positives are, indicating the better classification performance at the threshold.
Meanwhile, in order to determine the effect of the current classification model, an ROC curve model of SPSS (version 22.0) is used for analysis, in the invention, the data of the normal skin group is defined as negative, and the corresponding numerical value is 0; defining the data of the sensitive state skin group as positive, corresponding to a value of 1, calculating the Area of AUC (AUC) Under the Curve, and assuming that n data are in total, the coordinate point of the ROC Curve is { (x) 1 ,y 1 )…(x n ,y n ) And the calculation formula of the AUC area is as follows:
AUC area =
The AUC area is usually about 0.5-1, the classification accuracy of the classification model is higher if the numerical value is larger, and the accuracy of the classification model is judged according to the following criteria:
AUC =1, perfect classification;
AUC is more than or equal to 0.85 and less than or equal to 0.95, and the classification effect is good;
AUC is more than or equal to 0.7 and less than 0.85, and the classification effect is general;
AUC is more than 0.5 and less than 07, and the classification effect is low;
AUC =0.5, the follower guessed the same (e.g. missing copper plate), the model was not predictive;
AUC <0.5 is worse than random guessing, but better than random guessing as long as always doing against the prediction.
The invention also provides a test system for a subject with acceptable cosmetic soothing efficacy, comprising:
the classification module is used for classifying the subjects into a normal skin group and a sensitive skin group according to subjective and semi-subjective evaluation methods of the cosmetic soothing efficacy test;
a detection module for obtaining a skin indicator value for each subject, the skin indicator value being selected from a hemoglobin concentration value, or a skin a value;
the analysis module is used for carrying out data processing on the hemoglobin concentration value, the heme concentration value or the skin a value obtained by the detection module to respectively obtain a standard threshold of the hemoglobin concentration value, a standard threshold of the heme concentration value or a standard threshold of the skin a value;
the comparison module comprises a first comparison module, a second comparison module and a third comparison module;
the first comparison module is used for comparing the hemoglobin concentration value of each subject with a standard threshold value of the hemoglobin concentration value, the subjects higher than the standard threshold value are judged to be sensitive skin, namely qualified subjects of the relieving efficacy test, and the subjects lower than the standard threshold value are judged to be normal skin;
the second comparison module is used for comparing the heme concentration value of each subject with a standard threshold of the heme concentration value, subjects higher than the standard threshold are judged to be sensitive skin, namely qualified subjects of the relieving efficacy test, and subjects lower than the standard threshold are judged to be normal skin;
the third comparison module is used for comparing the skin a value of each subject with a standard threshold value of the skin a value, subjects higher than the standard threshold value are judged to be sensitive skin, namely qualified subjects for the soothing efficacy test, and subjects lower than the standard threshold value are judged to be normal skin;
and the selection module is used for selecting any one of the first comparison module, the second comparison module and the third comparison module for comparison.
In the present invention, the testing system preferably further includes a counting 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 judged as sensitive skin by the comparison module, and the number of people classified as normal skin by the classification module and judged as sensitive skin by the comparison module.
In the invention, the analysis module comprises a calculation module, and the calculation module is used for calculating the true positive rate and the false positive rate of the hemoglobin concentration value, the hemoglobin concentration value or the skin a value obtained by the detection module under different thresholds, and obtaining the difference value of the true positive rate and the false positive rate under different thresholds.
Wherein, the minimum threshold value in the different threshold values is the smallest hemoglobin concentration value, hemoglobin concentration value or skin a value minus 1, the maximum threshold value is the largest hemoglobin concentration value, hemoglobin concentration value or skin a value plus 1, and all other threshold values are the average value of the remaining two continuously ordered hemoglobin concentration values, hemoglobin concentration values or skin a values.
In the present invention, the analysis module further includes a determination module, and the determination module is configured to select, according to the difference between the true positive rate and the false positive rate obtained by the calculation module under different thresholds, a threshold corresponding to the largest difference as a standard threshold of the hemoglobin concentration value, or a standard threshold of the skin a value.
Preferably, the calculation module comprises a true positive rate calculation module and a false positive rate calculation module.
The true positive rate calculation module is used for calculating the ratio of the number of people classified as sensitive skin by the classification module and judged as sensitive skin by the comparison module to the number of people classified as sensitive skin by the classification module.
The false positive rate calculation module is used for calculating the ratio of the number of people who are classified as normal skin by the classification module and are judged as sensitive skin by the comparison module to the number of people who are classified as normal skin by the classification module.
The invention also provides application of the test method or the test system in testing the efficacy of the soothing cosmetics. The method for the efficacy test of the soothing cosmetics according to the present invention is not particularly limited, and may be performed according to a conventional method well known to those skilled in the art. Preferably, under the management of testers, a testee cleans the face by using clean water, the testee is flushed and then is sucked dry by using a non-scrap water-absorbing dry paper towel, the testee sits still in a test environment with the temperature of 20-22 ℃ and the humidity of 40-60%, water and beverages cannot be drunk, cheekbone parts are exposed, the cheekbone parts are kept relaxed, the cheekbone parts are prevented from being contacted, and the initial value of the corresponding skin index value of the testee is recorded. In the present invention, the zygomatic bone site is preferably used as the detection site, and the area of the detection site is preferably at least 3cm × 3cm. In the present invention, the subject has a sedentary time of at least 20min, even at least 30min.
According to the invention, the sample is applied to the subject after the detection of the initial value of the corresponding skin index has been completed. In the present invention, it is preferred that the test sample (i.e., soothing cosmetic) is (2.0. + -. 0.1) mg/cm 2 The dosage of the preparation is applied for a single time, quantitative sampling is carried out through a syringe, a pipettor or the like, a latex finger cot is used for uniformly coating the sample in the cheekbone part of a subject, and the actual sample application amount is recorded. In the invention, the set measuring time point interval is preferably not less than 0.5h, a plurality of measuring points can be set according to the evaluation requirement of the soothing cosmetics, the total testing time period is preferably not more than 8h, and the long-term testing period is preferably not more than 28 days.
In the present invention, SPSS 22.0 software is preferably used to statistically describe the measured skin index values, including number, mean, standard deviation, minimum, median, maximum, and the like. If the test data is normal distribution, preferably adopting a T test method to carry out statistical analysis; if the test data is non-normal distribution, then statistical analysis is preferably performed using a rank sum test.
In the present invention, the statistical methods all preferably use a two-tailed test, with test level α =0.05.
Respectively calculating the average value of the difference values between the initial values of the skin index values of the smearing side and the control side of the test sample and the measurement values of other measurement time points, and obtaining a formula (1) and a formula (2);
in the formula:
-average value of skin index values at different measurement time points on the side of sample application after sample application;
in the formula:
To further illustrate the present invention, the following examples are provided for illustration. The sources of the experimental raw materials used in the following examples of the present invention are not particularly limited, and they may be purchased from the market or prepared according to conventional preparation methods well known to those skilled in the art.
Example 1
This example provides a method for testing a subject for acceptable cosmetic soothing efficacy, comprising the steps of:
(1) The method comprises the following steps of taking 224 sensitive muscle groups meeting subjective and semi-subjective evaluation, wherein the inclusion criteria of the groups are self-declared sensitive muscles or sensitive states, products with the effect of relieving are needed in stress states, and the groups are evaluated to be positive through a lactic acid stabbing pain test, and 225 normal skin groups;
(2) The method comprises the following steps of enabling an ANTERA 3D imaging system to shoot zygomatic bone position images of a sensitive muscle group and a normal muscle group, respectively recording hemoglobin concentration values of the sensitive muscle group and the normal skin group, drawing the test values as shown in the following table 1, and as shown in fig. 1, observing that the hemoglobin concentration values of the sensitive muscle group (experimental group) and the normal skin group (control group) form an effective distinguishing range:
TABLE 3
(3) Processing data according to a calculation method of a confusion matrix aiming at the hemoglobin concentration value obtained in the step (2) to obtain true positive rate and false positive rate under different threshold values;
the hemoglobin concentration value with the minimum threshold value of different threshold values is minus 1, the hemoglobin concentration value with the maximum threshold value is plus 1, and all other threshold values are the average values of two continuously ordered hemoglobin concentration values between the hemoglobin concentration value with the minimum threshold value and the hemoglobin concentration value with the maximum threshold value;
the true positive rate is the ratio of the number of people who subjectively and semi-subjectively evaluate as sensitive skin and judge as sensitive skin to the number of people who subjectively and semi-subjectively evaluate as sensitive skin;
the false-yin rate is the ratio of the number of people who subjectively and semi-subjectively evaluate normal skin but judge as sensitive skin to the number of people who subjectively and semi-subjectively evaluate normal skin;
the results are shown in table 4 below, where it can be seen that the standard threshold is 1.231, corresponding to a true positive rate of 0.866, a false positive rate of 0.044, and a john index of 0.822. An ROC curve is plotted against the data in table 4, and as shown in fig. 2 below, the area of AUC obtained by calculation is 0.968 (> 0.95), indicating that the classification effect is good:
TABLE 4
(4) Subjects having a hemoglobin concentration value higher than the standard threshold value of hemoglobin concentration value (1.231) were screened as cosmetic soothing efficacy-eligible subjects.
Example 2
In this example, 30 or more subjects having a hemoglobin concentration value higher than the standard threshold value (1.231) were recruited as an experimental group, and 30 or more subjects having a hemoglobin concentration value lower than the standard threshold value (1.231) were recruited as a control group, and clinical experiments on the efficacy of soothing cosmetics were performed.
The experimental method is as follows:
testing the environmental temperature: 20 ℃ to 22 ℃, humidity: 40% -60%, and real-time dynamic monitoring is carried out. The test conditions during the test should be consistent, such as: testers, sites, instruments, etc.;
the detection part of the experimental instrument is as follows: the zygomatic region;
under the management of testers, the testees in each group of the experimental group and the testees in the control group respectively use clean water to clean the face, after the face is washed clean, the testees are dried by using a dry paper towel which absorbs water by using a chipless paper towel, and the testees sit still for at least 20min in a standard testing environment, cannot drink water and drinks, expose cheekbones, keep relaxed and avoid contacting the cheekbones. Then recording the hemoglobin concentration value of each group of subjects in the experimental group and the control group before using the soothing mask; after recording, the subjects in the experimental group and the control group respectively try the same commercially available soothing mask (such as a small vague vitamin B5 soothing mask) after 0.5h, and the hemoglobin concentration value is detected, the results are shown in the following tables 5-6, the table 5 shows the hemoglobin concentration value data before and after the subjects use the soothing mask, the table 6 shows the results of analyzing the data in the table 5, it can be seen that the experimental group can have significant improvement effect, the control group has no significant improvement effect, which indicates that 1.231 is selected as the standard threshold of the hemoglobin concentration value, and the subjects with qualified screening of soothing effect can more quickly detect the efficacy of soothing cosmetics, and the threshold is set reasonably:
TABLE 5
TABLE 6
Example 3
This example provides a method for testing a subject for acceptable cosmetic soothing efficacy, comprising the steps of:
(1) 209 sensitive muscle groups meeting subjective and semi-subjective evaluation are included, wherein the inclusion criteria of the groups are the groups which are self-declared as sensitive muscles or sensitive states, need a product with a relieving effect in a stress state and are evaluated to be positive through a lactic acid stabbing pain test, and 207 normal skin groups;
(2) The values of the concentration of hemoglobin in the zygomatic sites of the sensitive muscle population and the normal muscle population were measured using a Mexameter MX-18 instrument, as shown in Table 7 below,
TABLE 7
(3) Processing data according to a calculation method of a confusion matrix aiming at the heme concentration value obtained in the step (2) to obtain true positive rate and false positive rate under different threshold values;
the minimum threshold of 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 values of two continuously ordered hemoglobin concentration values between the minimum hemoglobin concentration value and the maximum hemoglobin concentration value;
the true positive rate is the ratio of the number of people who subjectively and semi-subjectively evaluate the skin to be sensitive and judge the skin to be sensitive to the number of people who subjectively and semi-subjectively evaluate the skin to be sensitive;
the false positive rate is the ratio of the number of people who subjectively and semi-subjectively evaluate to normal skin but judge to be sensitive skin to the number of people who subjectively and semi-subjectively evaluate to normal skin;
the results are shown in table 8 below, where it can be seen that the standard threshold is 276.165, corresponding to a true positive rate of 0.726, a false positive rate of 0.024, and a near-denying index of 0.702. An ROC curve is drawn for the data of the table 8, as shown in the following fig. 4, and the area of AUC obtained by calculation is 0.925 (> 0.85), which indicates that the classification effect is good;
TABLE 8
(4) Screening subjects having a hemoglobin concentration value above the hemoglobin concentration value standard threshold (276.165) for eligibility for cosmetic soothing efficacy.
Example 4
This example provides a method for testing a subject for acceptable cosmetic soothing efficacy, comprising the steps of:
(1) 165 sensitive muscle groups meeting subjective and semi-subjective evaluation are included, wherein the inclusion standard of the groups is the groups which are self-declared to be sensitive muscles or are in a sensitive state, need a relaxing effect product in a stress state and are evaluated to be positive through a lactic acid stabbing pain test, and 165 normal skin groups are included;
(2) The VISIA-CR instrument was used to measure the skin a values of the zygomatic sites of the sensitive muscle population and the normal muscle population, as shown in table 9 below,
TABLE 9
(3) Processing data according to a calculation method of a confusion matrix aiming at the skin a value obtained in the step (2) to obtain true positive rate and false positive rate under different threshold values;
the minimum threshold value in the different threshold values is the smallest skin a value minus 1, the maximum threshold value is the largest skin a value plus 1, and all other threshold values are the average values of two continuously ordered skin a values between the smallest skin a value and the largest skin a value;
the true positive rate is the ratio of the number of people who subjectively and semi-subjectively evaluate as sensitive skin and judge as sensitive skin to the number of people who subjectively and semi-subjectively evaluate as sensitive skin;
the false positive rate is the ratio of the number of people who subjectively and semi-subjectively evaluate to normal skin but judge to be sensitive skin to the number of people who subjectively and semi-subjectively evaluate to normal skin;
the results are shown in table 10 below, where the standard threshold is 11.963, corresponding to a true positive rate of 0.927, a false positive rate of 0.218, and a near exponential of 0.709. An ROC curve is plotted against the data in table 9, and as shown in fig. 5 below, the area of AUC obtained by calculation is 0.922 (> 0.85), indicating that the classification effect is good;
watch 10
(4) Screening the subjects with skin a value higher than the standard threshold for skin a value (11.963) as qualified subjects for cosmetic soothing efficacy.
Comparative example 1
The present comparative example provides a method for testing a subject for acceptable cosmetic soothing efficacy, comprising the steps of:
(1) The method comprises the following steps of (1) including 201 sensitive muscle groups meeting subjective and semi-subjective evaluation, wherein the population inclusion standard is a population which is self-declared to be sensitive muscle or is in a sensitive state and needs a product with a relieving effect in a stress state and is evaluated to be positive through a lactic acid stabbing pain test, and 201 normal skin groups;
(2) The moisture content of the stratum corneum of the cheekbone sites of the sensitive muscle population and the normal muscle population was measured using a Cornemeter CM825 instrument, and the values were as shown in table 11 below,
TABLE 11
(3) Processing data according to a calculation method of a confusion matrix aiming at the water content of the skin stratum corneum obtained in the step (2) to obtain true positive rate and false positive rate under different threshold values;
the minimum threshold value in 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 two continuous sequences of skin stratum corneum water contents between the minimum skin stratum corneum water content and the maximum skin stratum corneum water content;
the true positive rate is the ratio of the number of people who subjectively and semi-subjectively evaluate as sensitive skin and judge as sensitive skin to the number of people who subjectively and semi-subjectively evaluate as sensitive skin;
the false positive rate is the ratio of the number of people who subjectively and semi-subjectively evaluate to normal skin but judge to be sensitive skin to the number of people who subjectively and semi-subjectively evaluate to normal skin;
the results are shown in table 8 below, where it can be seen that the standard threshold is 80.515, corresponding to a true positive rate of 0.279, a false positive rate of 0.229, and a near-denudation index of 0.05. An ROC curve was plotted against the data of table 9, as shown in fig. 5 below, and the calculated AUC area was 0.503, indicating that the classification effect was very general, as guessed by the follower (e.g., missing copper plate), indicating that the model selecting moisture content as the screening index for skin in sensitive state had no predictive value.
TABLE 12
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
Claims (10)
1. A method for testing a subject for acceptable soothing efficacy of a cosmetic, comprising the steps of:
(1) Dividing the subject into a normal skin group and a sensitive skin group according to subjective and semi-subjective evaluation methods of a cosmetic soothing efficacy test;
(2) Obtaining a skin metric value for each subject, the skin metric value selected from a hemoglobin concentration value, or a skin a value;
(3) Respectively carrying out data processing on the hemoglobin concentration value, the hemoglobin concentration value or the skin a value in the step (2) according to a confusion matrix method to respectively obtain a standard threshold of the hemoglobin concentration value, a standard threshold of the hemoglobin concentration value or a standard threshold of the skin a value;
(4) Selecting any one of the skin index values in the step (2) as a detection index value, comparing the skin index value of each subject with a standard threshold value of the skin index value, judging the subject higher than the standard threshold value as sensitive skin, namely a qualified subject for the relieving efficacy test, and judging the subject lower than the standard threshold value as normal skin.
2. The test method according to claim 1, wherein the step (3) is specifically:
respectively carrying out data processing on the hemoglobin concentration value, the heme concentration value or the skin a value in the step (2) according to a confusion matrix calculation method to respectively obtain the true positive rate and the false positive rate of the hemoglobin concentration value, the heme concentration value or the skin a value under different threshold values, and respectively 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 a value by taking a corresponding threshold value of the hemoglobin concentration value, the heme concentration value or the skin a value when the difference value of the true positive rate and the false positive rate is maximum as a standard threshold value;
wherein, the minimum threshold value in the different threshold values is the smallest hemoglobin concentration value, hemoglobin concentration value or skin a value minus 1, the maximum threshold value is the largest hemoglobin concentration value, hemoglobin concentration value or skin a value plus 1, and all other threshold values are the average value of the remaining two continuously ordered hemoglobin concentration values, hemoglobin concentration values or skin a values;
the true positive rate is the ratio of the number of people who are subjectively and semi-subjectively evaluated as sensitive skin in the step (1) and judged as sensitive skin in the step (4) to the number of people who are subjectively and semi-subjectively evaluated as sensitive skin in the step (1);
the false positive rate is the ratio of the number of people who subjectively and semi-subjectively evaluate to normal skin in the step (1) but judge to be sensitive skin in the step (4) to the number of people who subjectively and semi-subjectively evaluate to normal skin in the step (1).
3. The test method according to claim 1, wherein 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 for the skin a value is 11.963.
4. The test method according to claim 1, wherein the skin index values of the normal skin group and the sensitive skin group are obtained at an ambient temperature of 20 ℃ to 22 ℃, a humidity of 40% to 60%, and a skin area of at least 3 x 3cm.
5. A system for testing a subject for acceptable cosmetic soothing efficacy, comprising:
the classification module is used for classifying the subjects into a normal skin group and a sensitive skin group according to subjective and semi-subjective evaluation methods of the cosmetic soothing efficacy test;
a detection module for obtaining a skin indicator value for each subject, the skin indicator value being selected from a hemoglobin concentration value, or a skin a value;
the analysis module is used for carrying out data processing on the hemoglobin concentration value, the heme concentration value or the skin a value obtained by the detection module to respectively obtain a standard threshold of the hemoglobin concentration value, a standard threshold of the heme concentration value or a standard threshold of the skin a value;
the comparison module comprises a first comparison module, a second comparison module and a third comparison module;
the first comparison module is used for comparing the hemoglobin concentration value of each subject with a standard threshold value of the hemoglobin concentration value, subjects higher than the standard threshold value are judged to be sensitive skin, namely qualified subjects of the soothing efficacy test, and subjects lower than the standard threshold value are judged to be normal skin;
the second comparison module is used for comparing the heme concentration value of each subject with a standard threshold of the heme concentration value, subjects higher than the standard threshold are judged to be sensitive skin, namely qualified subjects of the soothing efficacy test, and subjects lower than the standard threshold are judged to be normal skin;
the third comparison module is used for comparing the skin a value of each subject with a standard threshold value of the skin a value, subjects higher than the standard threshold value are judged to be sensitive skin, namely qualified subjects of the relieving efficacy test, and subjects lower than the standard threshold value are judged to be normal skin;
and the selection module is used for selecting any one of the first comparison module, the second comparison module and the third comparison module for comparison.
6. The system according to claim 5, further comprising a counting 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 and determined as sensitive skin by the comparison module and the number of people classified as normal skin and determined as sensitive skin by the comparison module.
7. The test system of claim 5, wherein the analysis module comprises a calculation module, and the calculation module is configured to calculate a true positive rate and a false positive rate of the hemoglobin concentration value, or the skin a value obtained by the detection module at different thresholds, and obtain a true positive rate and a false positive rate difference at different thresholds;
wherein, the minimum threshold value in the different threshold values is the smallest hemoglobin concentration value, hemoglobin concentration value or skin a value minus 1, the maximum threshold value is the largest hemoglobin concentration value, hemoglobin concentration value or skin a value plus 1, and all other threshold values are the average value of the remaining two continuously ordered hemoglobin concentration values, hemoglobin concentration values or skin a values.
8. The test system of claim 7, wherein the analysis module further comprises a determination module, and the determination module is configured to select a threshold corresponding to the largest difference as a standard threshold of the hemoglobin concentration value, or a standard threshold of the skin a value according to the true positive rate and the false positive rate differences obtained by the calculation module at different thresholds;
the standard threshold value of the hemoglobin concentration value is 1.231;
the standard threshold value of the heme concentration value is 276.15;
the standard threshold for the skin a value is 11.963.
9. The test system of claim 7, wherein the calculation module comprises a true positive rate calculation module and a false positive rate calculation module;
the true positive rate calculation module is used for calculating the ratio of the number of people classified as sensitive skin by the classification module and judged as sensitive skin by the comparison module to the number of people classified as sensitive skin by the classification module;
the false positive rate calculation module is used for calculating the ratio of the number of people classified as normal skin by the classification module and judged as sensitive skin by the comparison module to the number of people classified as normal skin by the classification module.
10. Use of the test method of any one of claims 1 to 4 or the test system of any one of claims 5 to 9 in a cosmetic soothing efficacy test.
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