Evaluation method for eyebrow growth efficacy of eyebrow pencil

Abstract

The invention provides an eyebrow growth efficacy evaluation method of an eyebrow pencil, which can use an advanced digital light-emitting microscope and digital skin imaging integrated system, combines a VISIA-CR instrument, shoots close-up and clinical images, can observe and quantify the change of eyebrow growth, and adopts an AI hair identity tracking system; and individual hair follicle growth trajectory tracking across time points is realized. Meanwhile, in combination with the density score of a dermatologist, the product efficacy is evaluated objectively and semi-objectively in all directions, the actual effect of the eyebrow pencil on the human body is evaluated more effectively, and the accuracy and objectivity of evaluation are greatly improved. Compared with animal experiments, human body efficacy testing has great advantages, only a small amount of hair needs to be collected to be observed through a high-resolution imaging technology, and animals or human bodies are completely noninvasive and painless.

Description

TECHNICAL FIELD

[0001] The present application relates to a method for evaluating the effect of eyebrow pencil on eyebrow growth. BACKGROUND

[0002] In recent years, more and more consumers have begun to pay attention to the efficacy of cosmetics. Eyebrows, as one of the basic products of color cosmetics, play an important role in shaping facial expressions and aesthetics. However, due to factors such as environment, age, and personal living habits, many people face problems such as sparse, missing, and slow-growing eyebrows. Eyebrow pencils, as a commonly used makeup product, can not only beautify the facial curves of consumers, but also promote hair regeneration by nourishing the skin. Therefore, its quality and efficacy have also received widespread attention. Current domestic and foreign researches only target animal models: the back of the mouse is depilated with 8% sodium sulfide, with a depilation area of about 4cm 2 , 2min later, wipe off with a wet cloth to ensure that the local hair is completely removed. The next day after depilation, select smooth and undamaged mice in the depilation area and randomly divide them into distilled water control group, positive control group, and osm01, 02 sample groups, 8 mice in each group. Each group is directly applied to the depilation area, 0.2ml each time, once a day, for 23 consecutive days. Observe the color change of the mouse skin every day, and record the time of each mouse skin color change from pink to black, and the time of the skin from black to the hair growing out of the skin surface. Since sensory testing has individual differences and subjectivity, it is not possible to quantify the results, so the evaluation method using instruments is more important. SUMMARY

[0003] To make up for the shortcomings of the prior art, the purpose of the present application is to provide a method for evaluating the effect of eyebrow pencil on eyebrow growth, so as to objectively evaluate the effect of eyebrow pencil on eyebrow growth. To this end, the present application adopts the following technical solutions: The method for evaluating the effect of eyebrow pencil on eyebrow growth, characterized in that it comprises: (1) periodically testing the subjects; (2) statistically analyzing the test data: The data analysis includes analyzing the changes in eyebrow density and hair diameter. The higher the value of the eyebrow density, the denser the eyebrows; the higher the hair diameter change rate, the greater the change in the diameter of the eyebrows. The calculation formula of the hair diameter change rate is as follows: Hair shaft diameter change rate = (D X -D0) / D0*100% Where D X represents the hair shaft diameter on the Xth day, and D0 represents the hair shaft diameter before using the product; The hair diameter change rate in this algorithm is a direct indicator of the strength of hair follicle activity. This algorithm accurately measures this change, which is more sensitive than simply counting the hair follicle stage in reflecting the small changes in the growth state.

[0004] The mean, standard deviation, and normal distribution test of each parameter at each test time are calculated; wherein the normal distribution test is performed on the mean, and if the normality test asymptotic significance (two-tailed) value > the first threshold value, the mean is subject to normal distribution; Difference analysis is performed on the mean, and when both groups of data are subject to normal distribution, paired T test is used to analyze the difference between the two groups of data; when both groups of data are not subject to normal distribution, rank sum test is used to analyze the difference between the two groups of data; for rank data, pre- and post-comparison is adopted, and two related sample rank sum tests are used; the above statistical analysis is double-tailed test, and the significance level a = the second threshold value; (3) Result determination basis: if there is a significant difference between the eyebrow density and hair shaft diameter before using the product and the eyebrow density and hair shaft diameter after using the product, p < the third threshold value, it is determined that the eyebrow pencil has the effect of growing eyebrows during the test period, otherwise it is determined that the eyebrow pencil has no effect of growing eyebrows.

[0005] Further, the inclusion and exclusion criteria for screening subjects are: a. 18-60 years old, Asian healthy population, no eyebrow tattoo, no obvious skin lesions, scars on the face; b. Can cooperate well with the test, and can maintain the regularity of life during the study period; c. Agree not to use any cosmetics, drugs and health products that may affect the results during the trial period; And, do not have the following conditions: d. Using antihistamines within one week or immunosuppressants within one month; e. Within two months, the subject applied any anti-inflammatory drugs to the test site; f. The subject has not recovered from inflammatory skin diseases; g. Insulin-dependent diabetic patients; h. Patients with asthma or other chronic respiratory diseases who are receiving treatment; i. Received anti-cancer chemotherapy within 6 months; j. Patients with immunodeficiency or autoimmune diseases; l. Lactating or pregnant women; m. The test results are affected by the test site due to scarring, pigmentation, atrophy, fresh red macules or other imperfections; n. Participants in other clinical trials; o. Highly sensitive individuals.

[0006] Further, the test period is 58 days, and the test times are before product use, 14 days, 28 days and 56 days.

[0007] Further, the first threshold value is 0.050. The second threshold value is 0.05. The third threshold value is 0.05.

[0008] By using the method of the present application, the advanced digital light microscope and the integrated system of digital skin imaging are used in combination with the VISIA-CR instrument to shoot close-up and clinical images, the changes in eyebrow growth can be observed and quantified, and the AI hair identity tracking system is used: each hair is uniquely ID marked to realize the tracking of individual hair follicle growth trajectory across time points. At the same time, in combination with the density score of a dermatologist, the product efficacy is evaluated from objective and semi-objective all-around, the actual effect of eyebrow pencil on human body is more effectively evaluated, and the accuracy and objectivity of evaluation are greatly improved. Compared with animal experiments, human efficacy testing has great advantages, only a small amount of hair is collected for observation by high-resolution imaging technology, and the animal or human body is completely non-invasive and painless. DETAILED DESCRIPTION

[0009] The present application recruits a certain number of subjects, groups them, shaves their eyebrows, tests them with hair growth detection instruments, analyzes their eyebrow density, calculates the change rate of hair shaft diameter, and applies SPSS software for statistical analysis of data.

[0010] (I) Inclusion and exclusion criteria for screening subjects Inclusion criteria: a. 18-60 years old, Asian healthy population, no tattooed eyebrows, no obvious skin lesions, scars, etc. on the face; b. can cooperate well with the test, and can maintain the regularity of life during the study period; c. agree not to use any cosmetics, drugs and health products that may affect the results during the trial period; d. other corresponding inclusion criteria.

[0011] Exclusion criteria: a. subjects who have used antihistamines in the past week or immunosuppressants in the past month; b. subjects who have applied any anti-inflammatory drugs to the test site in the past two months; c. subjects with inflammatory skin diseases who have not clinically recovered; d. patients with insulin-dependent diabetes; e. patients with asthma or other chronic respiratory diseases who are receiving treatment; f. patients who have received anti-cancer chemotherapy in the past 6 months; g. patients with immune deficiency or autoimmune diseases; h. lactating or pregnant women; i. subjects whose skin test sites are affected by scars, pigments, atrophy, fresh red macules or other imperfections that affect the test results; j. subjects participating in other clinical trials; k. subjects with high physical sensitivity; l. subjects who are not willing to participate or cannot complete the specified content according to the requirements of the test.

[0012] (II) Test cycle determination: The test cycle is 58 days, and the test time is before product use, day 14, day 28 and day 56.

[0013] (III) Statistical analysis of test data The data analysis includes analysis of eyebrow density and hair diameter change rate. The greater the value of the eyebrow density, the thicker the eyebrows. The higher the hair diameter change rate, the greater the change in the diameter of the eyebrows. The formula for calculating the hair diameter change rate is as follows: Hair shaft diameter change rate = (D X -D0) / D0*100% Where D X represents the hair shaft diameter on day X, and D0 represents the hair shaft diameter before using the product.

[0014] The hair diameter change rate in the algorithm is a direct indicator of the strength of hair follicle activity. Accurate measurement of this change through the algorithm is more sensitive in reflecting the small changes in the growth state than simply counting the hair follicle stage.

[0015] The mean, standard deviation, and normal distribution test of each parameter at each time point are calculated.

[0016] The above mean is subjected to normal distribution test. If the progressive significance (two-sided) value of normality test is >0.050, the series data is subject to normal distribution.

[0017] The above mean is subjected to difference analysis. When both groups of data are normally distributed, paired T test is used to analyze the difference between the two groups of data. When both groups of data are not normally distributed, rank sum test is used to analyze the difference between the two groups of data. For ordinal data, before and after comparison is used, and two related sample rank sum test is used. The above statistical analysis is a two-tailed test, and the significance level a = 0.05.

[0018] (III) Result determination basis: If there is a significant difference between the eyebrow density and hair shaft diameter before and after using the product, p <0.05, it is determined that the eyebrow pencil has a hair growth effect in the test period, otherwise it is determined that the eyebrow pencil has no hair growth effect.

[0019] The present application researches the hair growth effect detection technology of eyebrow pencil by means of hair growth analysis management system Molemax HD+Trichoscan and VISIA-CR, and through the optimization of pre-brow processing and instrument parameters. The hair growth analysis management system integrates polarizing lens, LED ring light, resolution ≥5μm, and magnification 30 times. VISIA-CR is a standard light source shooting, and the front face is shot. The two instruments are combined, the real-time image is superimposed, the shooting angle is consistent, and the effect before and after using the product is more accurately compared.

[0020] During the test, the hair growth detection instrument is used to take three images of the shaved eyebrow part and analyze the hair density value, and the deviation rate RSD of the hair density value is less than 10%, so as to ensure the reliability of the experiment.

[0021] The experimental procedure specifically includes the following steps: One to two days before the test, eligible subjects did not use any products except for normal cleansing. During the test, subjects cleaned their faces and dried their skin with a dry facial tissue, and sat quietly for 30 minutes in a laboratory at a temperature of 21±1℃ and 50±10% RH. Laboratory technicians randomly assigned subjects to groups: the experimental group used an eyebrow pencil containing eyebrow-growing ingredients, while the control group did not use the product. Facial image acquisition using VISIA-CR; Dermatologists visually assess eyebrow density based on the images and score the density. Laboratory technicians used 3D positioning stickers to locate and remove the eyebrows on both sides of the subject, with a residual length of <1mm; Laboratory technicians used a dermoscope to capture local images of the areas to be removed on both sides; The Trichoscan software was used to analyze eyebrow density and calculate the rate of change in hair shaft diameter.

[0022] The above embodiments are only used to illustrate the present invention and are not intended to limit the present invention. Those skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, all equivalent technical solutions also fall within the scope of the present invention, and the patent protection scope of the present invention should be determined by the claims.

Claims

1. A method for evaluating the eyebrow-growth efficacy of an eyebrow pencil, characterized in that, include: (1) Periodic testing of the subjects; (2) Perform statistical analysis on the test data: Data analysis includes analyzing the rate of change in eyebrow density and hair diameter. The formula for calculating the rate of change in hair diameter is as follows: Hair shaft diameter change rate = (D X -D0) / D0*100% Where D X D0 represents the diameter of the hair shaft on day X, and D0 represents the diameter of the hair shaft before using the product. Calculate the mean, standard deviation, and normality test for each parameter at each test time; wherein, a normality test is performed on the mean, and if the asymptotic significance (two-tailed) value of the normality test is greater than the first threshold, then it follows a normal distribution; A difference analysis was performed on the means. When both sets of data were normally distributed, a paired T-test was used to analyze the difference between the two sets of data. When the two sets of data were not normally distributed, a rank-sum test was used to analyze the difference between the two sets of data. For ordinal data, a two-sample rank-sum test was used for comparison before and after. All the above statistical analyses were two-tailed tests, and the significance level α was equal to the second threshold. (3) Result judgment criteria: If there are significant differences between the eyebrow density and hair shaft diameter before and after using the product, and p < the third threshold, then the eyebrow pencil is considered to have the effect of growing eyebrows during the test period; otherwise, the eyebrow pencil is considered not to have the effect of growing eyebrows.

2. The method for evaluating the eyebrow-growth efficacy of the eyebrow pencil as described in claim 1, characterized in that, Criteria for inclusion and exclusion of participants: a. 18-60 years old, healthy Asian individuals, without eyebrow tattoos, and with no obvious skin damage or scars on their face; b. Able to cooperate well with the test subjects and maintain a regular lifestyle during the research period; c. During the trial period, you agree not to use any cosmetics, medicines, or health products that may affect the results; Furthermore, it does not have the following characteristics: d. Those who have used antihistamines within the past week or immunosuppressants within the past month; e. Those who have used any anti-inflammatory drugs on the test site within the past two months; f. Subjects with clinically unhealed inflammatory skin diseases; g. Patients with insulin-dependent diabetes mellitus; h. Patients with asthma or other chronic respiratory diseases who are currently receiving treatment; i. Those who have received anti-cancer chemotherapy within the past 6 months; j. Patients with immunodeficiency or autoimmune diseases; 1. Breastfeeding or pregnant women; m. Judges whose test results are affected by scars, pigmentation, atrophy, port-wine stains or other blemishes at the skin test site; n. Participants in other clinical trials; o. Individuals with highly sensitive constitutions.

3. The method for evaluating the eyebrow-growth efficacy of the eyebrow pencil as described in claim 1, characterized in that, The testing period was 58 days, with testing times at the beginning, 14th, 28th, and 56th days of product use.

4. The method for evaluating the eyebrow-growth efficacy of the eyebrow pencil as described in claim 1, characterized in that, The first threshold is 0.

050.

5. The method for evaluating the eyebrow-growth efficacy of the eyebrow pencil as described in claim 1, characterized in that, The second threshold is 0.

05.

6. The method for evaluating the eyebrow-growth efficacy of the eyebrow pencil as described in claim 1, characterized in that, The third threshold is 0.05.