Method for evaluating degree of progress of alopecia
A novel alopecia evaluation method using hair-related indices and radar charts provides objective and accurate progression assessment, addressing subjectivity in existing methods and enabling early detection of treatment effects.
Patent Information
- Application Number
- JP2024063199
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2024-04-10
- Publication Date
- 2025-10-23
AI Technical Summary
Existing methods for evaluating the progression of alopecia, such as the Hamilton-Norwood classification and trichoscopy, are subjective and lack accuracy due to factors like evaluator variability and hair styling, making it difficult to objectively assess the condition.
An evaluation method using specific hair-related indices, including average diameter, terminal and vellus hair ratios, and hair follicle unit ratios, combined with a radar chart for objective and accurate progression assessment.
Enables more objective and accurate evaluation of alopecia progression, allowing for early detection of changes that may not be visible through appearance-based methods, thereby maintaining treatment motivation and facilitating effective treatment selection.
Smart Images
Figure 2025160581000001_ABST
Abstract
Description
[Technical Field]
[0001] The present invention relates to a technique for evaluating the progression of alopecia. [Background technology]
[0002] Conventionally, methods for assessing the progression of scalp hair loss (thinning hair) have been the Hamilton-Norwood classification (for male pattern hair loss) or the Sinclair scale (for female pattern hair loss) (e.g., Non-Patent Document 1). However, because these classifications are based on the appearance of the subject's head, there is a risk that the results will vary depending on the evaluator's subjectivity, and there may be cases where the results are not reproducible due to factors such as hairstyle.
[0003] In contrast, an objective evaluation method is trichoscopy (e.g., Non-Patent Document 2). In trichoscopy, hair is photographed with a dermatoscope, and the hair diameter and density are measured based on the image to evaluate the condition of the hair. [Prior art documents] [Non-patent literature]
[0004] [Non-Patent Document 1] Gupta M, Mysore V, “Classifications of Patterned Hair Loss: A Review”, J Cutan Aesthet Surg. 2016 Jan-Mar;9(1):3-12. doi: 10.4103 / 0974-2077.178536. [Non-patent document 2] "How to Use Trichoscopy for Hair Diseases - Focusing on Alopecia Areata," Internet (URL: https: / / www.lillymedical.jp / ja-jp / medical-education / dermatology / alopecia-areata / hair-diseases) Summary of the Invention [Problem to be solved by the invention]
[0005] However, research by the present inventors has revealed that, among the quantitative factors measured by trichoscopy, hair density does not necessarily correlate with the progression of alopecia, while hair diameter alone cannot explain the progression of alopecia. Therefore, it is difficult to accurately evaluate the progression of alopecia using general trichoscopy.
[0006] The present invention has been made in consideration of the above problems, and an object of the present invention is to evaluate the progression of alopecia more objectively and accurately than conventional techniques. [Means for solving the problem]
[0007] In order to solve the above problems, the present invention includes the following aspects. Section 1. An evaluation method for evaluating the progression of alopecia in a subject, comprising: acquiring an image including a predetermined measurement area of the subject's head; An index calculation step of calculating at least three indexes among the following indexes A to F related to the hair in the measurement area; Index A: The average diameter of the hairs with the top 1 to m diameters (m is a natural number equal to or greater than 1) Index B: The ratio of the number of terminal hairs having a diameter equal to or greater than the first predetermined value to the number of all hairs in the measurement area. Index C: The ratio of the number of vellus hairs having a diameter equal to or less than a second predetermined value to the number of all hairs in the measurement area. Index D: The ratio of the number of hair follicle units having one hair to the number of all hair follicle units in the measurement area Index E: The ratio of the number of hair follicle units having n (n is a natural number of 2 or more) hairs to the number of all hair follicle units in the measurement area Index F: The ratio of the number of hair follicle units having multiple hairs to the number of all hair follicle units in the measurement area a progress evaluation step of evaluating the progress based on the at least three indexes; An evaluation method comprising: Section 2. Item 2. The evaluation method according to item 1, wherein the indexes A to F are calculated in the index calculation step. Section 3. the subject is male; Item 1, an evaluation method characterized in that in the index calculation step, index A, at least one of indexes B and C, and at least one of indexes D and F are calculated. Section 4. the subject is female; Item 2. The evaluation method according to item 1, wherein the index calculation step calculates the index D and at least two of the indexes B, C, and F. Section 5. Item 1, wherein m is 3. Section 6. Item 1, wherein n is 3. Section 7. The progress evaluation step includes: a score calculation step of scoring the at least three indicators; a chart generation step of generating a radar chart based on the scored indicators; Item 1. The evaluation method according to item 1, comprising: Section 8. An evaluation device for evaluating the progression of alopecia of a subject, an acquisition unit that acquires an image including a measurement region of the subject's head; An index calculation unit that calculates at least three of the following indexes A to F regarding the hair in the measurement area; Index A: The average diameter of the hairs with the top 1 to m diameters (m is a natural number equal to or greater than 1) Index B: The ratio of the number of terminal hairs having a diameter equal to or greater than the first predetermined value to the number of all hairs in the measurement area. Index C: The ratio of the number of vellus hairs having a diameter equal to or less than a second predetermined value to the number of all hairs in the measurement area. Index D: The ratio of the number of hair follicle units having one hair to the number of all hair follicle units in the measurement area Index E: The ratio of the number of hair follicle units having n (n is a natural number of 2 or more) hairs to the number of all hair follicle units in the measurement area Index F: The ratio of the number of hair follicle units having multiple hairs to the number of all hair follicle units in the measurement area an evaluation unit that evaluates the progress based on the at least three indexes; An evaluation device comprising: Section 9. An evaluation program for evaluating the progression of alopecia in a subject, acquiring an image including a predetermined measurement area of the subject's head; An index calculation step of calculating at least three indexes among the following indexes A to F related to the hair in the measurement area; Index A: The average diameter of the hairs with the top 1 to m diameters (m is a natural number equal to or greater than 1) Index B: The ratio of the number of terminal hairs having a diameter equal to or greater than the first predetermined value to the number of all hairs in the measurement area. Index C: The ratio of the number of vellus hairs having a diameter equal to or less than a second predetermined value to the number of all hairs in the measurement area. Index D: The ratio of the number of hair follicle units having one hair to the number of all hair follicle units in the measurement area Index E: The ratio of the number of hair follicle units having n (n is a natural number of 2 or more) hairs to the number of all hair follicle units in the measurement area Index F: The ratio of the number of hair follicle units having multiple hairs to the number of all hair follicle units in the measurement area a progress evaluation step of evaluating the progress based on the at least three indexes; An evaluation method characterized by causing a computer to execute the above. [Effects of the Invention]
[0008] According to the present invention, the progression of alopecia can be evaluated more objectively and accurately than with conventional techniques. [Brief explanation of the drawings]
[0009] [Figure 1] 1 is a block diagram showing a configuration of an evaluation system according to an embodiment of the present invention. [Figure 2] 1 is a flowchart showing a processing procedure of an evaluation method according to one embodiment of the present invention. [Figure 3] 1 is an example of an image captured by a camera. [Figure 4] 10 is an example of an enlarged image. [Figure 5] FIG. 10 is a diagram for explaining how to count the hairs in one hair follicle unit. [Figure 6] 10 is a flowchart showing a more specific processing procedure of the progress evaluation step. [Figure 7] This is an example of a radar chart. [Figure 8] This is another example of a radar chart. [Figure 9] This is yet another example of a radar chart. [Figure 10] 1 is a table showing detailed information for each clinical stage for male and female subjects. [Figure 11] FIG. 1 shows clinical head photographs, trichoscopic photographs (magnified images), and quantitative trichoscopic factors of male and female subjects. [Figure 12] 1 is a table showing the correlation between clinical stage group (HNC) and quantitative trichoscopy factors in male subjects. [Figure 13] 1 is a table showing the correlation between clinical stage groups (modified Sinclair scale) and quantitative trichoscopy factors in female subjects. [Figure 14] (A) is a table showing the strength of correlation between 12 trichoscopy factors and HNC, and (B) is a table showing a correlation matrix depicting the correlation between combinations of six trichoscopy factors. [Figure 15]This is an example of a clinical photograph of the entire head of a male subject, and a radar chart of HN C classification and indices A, B, and F. DETAILED DESCRIPTION OF THE INVENTION
[0010] Hereinafter, an embodiment of the present invention will be described with reference to the accompanying drawings. Note that the present invention is not limited to the following embodiment, and various modifications are possible without departing from the spirit of the present invention.
[0011] (Overall composition) FIG. 1 is a block diagram showing the configuration of an evaluation system 1 according to one embodiment of the present invention. The evaluation system 1 is a system for evaluating the progression of alopecia in a subject, and is also referred to as a quantitative trichoscopy evaluation system. The evaluation system 1 includes a camera 2 and an evaluation device 3. In this embodiment, the subject is a patient suffering from scalp alopecia.
[0012] The camera 2 is a device that captures an image of an area including the measurement area on the subject's head, and may be, for example, a dermoscope camera (a magnifying glass camera).
[0013] The evaluation device 3 can be configured as a general-purpose computer, and includes, as its hardware configuration, a processor such as a CPU or GPU (not shown), a main memory device such as a DRAM or SRAM (not shown), and an auxiliary memory device 30 such as an HDD or SSD. The auxiliary memory device 30 stores the evaluation program P and the like.
[0014] The auxiliary storage device 30 may be external to the evaluation device 3. The evaluation device 3 may also be provided on the cloud.
[0015] The evaluation device 3 includes, as functional blocks, an acquisition unit 31, an image enlargement unit 32, an index calculation unit 33, a progress evaluation unit 34, and an output unit 35. Furthermore, the progress evaluation unit 34 includes a score calculation unit 341 and a chart generation unit 342. These functional blocks are realized by the processor of the evaluation device 3 reading an evaluation program P into a main storage device and executing it. The evaluation program P may be downloaded to the evaluation device 3 via a communication network such as the Internet, or may be recorded on a computer-readable non-transitory recording medium such as a CD-ROM or an SD card and installed on the evaluation device 3 via the recording medium.
[0016] (Evaluation method processing procedure) The function of the evaluation device 3 will be described with reference to Fig. 2. Fig. 2 is a flowchart showing the processing procedure of the evaluation method according to this embodiment. The evaluation method includes steps S1 to S7, and the above-mentioned functional blocks of the evaluation device 3 execute steps S3 to S7. That is, the evaluation program P causes the evaluation device 3 to execute steps S3 to S7.
[0017] In step S1, an image of an area including a predetermined measurement area on the subject's head is captured by camera 2. Fig. 3 shows an example of an image captured by camera 2, and the area surrounded by a solid rectangular frame is measurement area R. The position and size of measurement area R are not particularly limited as long as they are constant for each capture, but in this embodiment, it is a square measuring 5 mm long x 5 mm wide.
[0018] The image captured by the camera 2 may be a polarized image. Furthermore, to make it easier to identify the size in the image, ruled lines may be added to the image.
[0019] In step S2, the image captured by the camera 2 is transferred to the evaluation device 3. The method for transferring the image is not particularly limited, but the camera 2 may be connected to the evaluation device 3 by wire or wirelessly, and the image may be transmitted by wired or wireless communication. Alternatively, the image may be transferred to the evaluation device 3 via a recording medium such as an SD card or a USB memory.
[0020] In step S3 (acquisition step), the acquisition unit 31 of the evaluation device 3 acquires the image captured by the camera 2.
[0021] In step S4, the image enlargement unit 32 of the evaluation device 3 enlarges the measurement area R by image processing, as necessary. FIG. 4 is an enlarged image of the area surrounded by the dashed rectangular frame in FIG. 3. Note that if the measurement area R is displayed large enough or if the range of the image captured by the camera 2 coincides with the measurement area R, step S4 can be omitted. Alternatively, step S4 may be performed by the camera 2.
[0022] In step S5 (index calculation step), the index calculation unit 33 of the evaluation device 3 calculates at least three of the following indices A to F related to the hair within the measurement region R. Index A (maximum hair diameter): The average diameter of the hairs with the largest diameters (1 to m) (m is a natural number greater than or equal to 1) Index B (terminal hair rate): The ratio of the number of long terminal hairs with a diameter equal to or greater than the first predetermined value to the number of all hairs within the measurement area R Index C (vellus hair rate): The ratio of the number of short vellus hairs with a diameter of less than a second predetermined value to the number of all hairs within the measurement area R Index D: (Single hair-follicular unit rate) The ratio of the number of follicular units with one hair to the number of all follicular units within the measurement area R Index E: (n number of hairs-hair follicle unit rate) The ratio of the number of hair follicle units with n (n is a natural number of 2 or more) hairs to the number of all hair follicle units within the measurement area R Index F: (Multiple hair-follicular unit rate) The ratio of the number of follicular units with multiple hairs to the number of all follicular units within the measurement area R
[0023] Indicators A to C are indices related to hair thickness (hair diameter-related factors). Indicator A is calculated by measuring the diameter of all hairs present within the measurement area R, identifying hairs having diameters 1 to m, and averaging the diameters of those hairs. In this embodiment, m is 3, but is not particularly limited as long as it is a natural number of 1 or more.
[0024] Index B is calculated by counting the number of terminal hairs whose diameter is equal to or greater than a first predetermined value, then counting the number of all hairs present within the measurement area R, and finding the quotient. In this embodiment, the first predetermined value is 60 μm, but is not particularly limited as long as the diameter is such that it is determined to be a terminal hair.
[0025] The index C is calculated by counting the number of soft hairs whose diameter is equal to or smaller than a second predetermined value, then counting the number of all hairs present in the measurement area R, and finding the quotient. In this embodiment, the second predetermined value is 30 μm, but is not particularly limited as long as the diameter is determined to be soft hair.
[0026] Indicators D to F are indices related to the number of hairs (hair count-related factors). Indicator D is calculated by counting the number of hair follicle units having one hair, then counting the number of all hair follicle units present in the measurement area R, and finding the quotient. Indicator E is calculated by counting the number of hair follicle units having n hairs, then counting the number of all hair follicle units present in the measurement area R, and finding the quotient. In this embodiment, n is 3, but is not particularly limited as long as it is a natural number of 2 or greater. Indicator F is calculated by counting the number of hair follicle units having multiple (two or more) hairs, then counting the number of all hair follicle units present in the measurement area R, and finding the quotient.
[0027] The method for counting hairs in one hair follicle unit will be explained with reference to Figure 5. When multiple hairs grow close to each other, as in hair follicle unit M1, the number of adjacent hairs is the number of hairs in one hair follicle unit. Even when multiple hairs are not close to each other, as in hair follicle unit M2, if the distance between them is equal to or less than a reference value (e.g., 20 μm), those hairs are considered to be in one hair follicle unit. Furthermore, when a single hair grows with no other hairs within the reference value, as in hair follicle unit M3, that single hair is considered to form one hair follicle unit.
[0028] In this embodiment, the index calculation unit 33 calculates all of the indices A to F. In addition, the indices B to F are calculated as percentages (%). The numerical value of each index may be measured by a person while viewing the image, or may be measured automatically by image processing.
[0029] Next, in step S6 (progression evaluation step), the progress evaluation unit 34 of the evaluation device 3 evaluates the progress of alopecia based on at least three of the indices A to F. In the present embodiment, the progress evaluation unit 34 evaluates the progress of alopecia based on all of the indices A to F.
[0030] 6 is a flowchart showing a more specific processing procedure of step S6. Step S6 includes steps S61 to S62.
[0031] In step S61 (score calculation step), the score calculation unit 341 scores the indices A to F. Specifically, if the subject is male, the score calculation unit 341 scores based on the following Table 1, and if the subject is female, the score calculation unit 341 scores based on the following Table 2.
[0032] [Table 1]
[0033] [Table 2]
[0034] For example, suppose the subject is a male and the indices A to F are the following values: Index A: 65μm Indicator B: 35% Index C: 33% Index D: 30% Index E: 23% Index F: 70%
[0035] In this case, the indicators A to F are scored as follows: Indicator A: 1 point Indicator B: 2 points Indicator C: 3 points Index D: 4 points Index E: 5 points Index F: 7 points
[0036] In step S62 (chart generation step), the chart generation unit 342 generates a radar chart based on the scored indices. Fig. 7 is an example of a radar chart.
[0037] This completes step S6, and the process then proceeds to step S7 shown in Fig. 2. In step S7, the output unit 35 of the evaluation device 3 outputs the evaluation result of the degree of progression. The manner of output is not particularly limited, and for example, a radar chart may be displayed on a display (not shown) of the evaluation device 3, or the radar chart may be printed. By visualizing the scores of each index using the radar chart, the evaluator and the subject can objectively and accurately grasp the degree of progression of alopecia based on the radar chart.
[0038] The above-mentioned indices A to F are indices for accurately evaluating the degree of progression of alopecia in men and women, but the inventors of the present application have, as a result of intensive research, discovered the following changes in the indices. It has been discovered that in the evaluation of male pattern baldness, indices A to C are particularly effective in the early stages of the disease, and that it is preferable to also add indices D to F as the disease progresses. It has been discovered that in the evaluation of female pattern baldness, index D is particularly effective in the early stages of the disease, and that it is preferable to also add indices B, C, and F as the disease progresses. In other words, of the indices A to F, if the subject is male, in step S5, index A, one of indices B and C, and at least one of indices D and F may be calculated, and if the subject is female, index D and at least two of indices B, C, and F may be calculated.
[0039] Fig. 8 is an example of a radar chart when indices A to C are used. Fig. 9(A) is an example of a radar chart when indices B to D are used, and Fig. 9(B) is an example of a radar chart when indices B, C, and E are used. By narrowing down the number of indices to three in this way, it is possible to reduce the load of calculating the indices in step S5 while ensuring the objectivity and accuracy of the evaluation.
[0040] (Summary) As described above, in the evaluation method according to this embodiment, at least three hair-related indices A to F are calculated from a photograph of the subject's head, and the progression of alopecia is evaluated based on these indices. The indices A to F correlate with the progression of alopecia, and research by the inventors of the present application has revealed that indices A to C are particularly useful for evaluating the early stage of male pattern baldness, and index D is particularly useful for evaluating the early stage of female pattern baldness. Therefore, it is possible to evaluate the progression of alopecia more objectively and accurately than conventional methods.
[0041] Furthermore, the evaluation method according to the present embodiment is useful for determining the effectiveness of alopecia treatment because it changes the numerical value or score of the index even when the change in progression is so small that it cannot be detected by evaluation methods based on appearance, such as the Hamilton-Norwood classification. Therefore, alopecia patients can maintain their motivation to continue treatment even if they cannot sense any changes in appearance. [Example]
[0042] Hereinafter, Example 1 of the present invention will be described, but the present invention is not limited to the following example.
[0043] [Research Contents] (subject) This study was a two-year retrospective observational study of 126 Japanese subjects with androgenetic alopecia (MAGA) (baldness on the vertex) and 57 Japanese subjects with female pattern hair loss (FPHL) (baldness on the frontal and vertex). Subjects were screened by a dermatologist, and the Hamilton-Norwood Classification (HNC), commonly used in dermatological clinical practice, was used to assess the degree of hair loss in MAGA. For FPHL, the original Sinclair scale (Stages 1-5) was used to classify hair loss. The modified Sinclair scale (a-Sinclair), which divides Sinclair scale 1-3 into five stages (I-V) to suit Japanese female subjects, visually assessed the width of the central parting. All subjects underwent physical examinations and blood tests to rule out serious systemic diseases and hair loss disorders other than MAGA or FPHL. Subjects receiving DHT inhibitors (oral finasteride or dutasteride) or other AGA treatments for more than 3 months were excluded.
[0044] (Measurement of trichoscopy values) For MAGA, the measurement point was set at the center of the whorl. For FPHL, the measurement point was set 15 cm from the center of the glabella on a vertical line drawn from the center of the glabella to the top of the head. Images of each subject's entire head and close-up photographs of each measurement point were taken using a dermatoscope (Casio DZ-D100, Japan). Hair details were observed, measured, and counted using image management software (D'z image Viewer, Casio, Japan).
[0045] (Analyzed factors) Nine quantitative trichoscopy factors (QTFs) were analyzed, six of which are indicators A to F in the present invention. Hair density: Total hair count (THC) per 5x5mm grid Hair diameter-related factors: maximum hair diameter (index A, Max D), terminal hair rate (index B, TH%), vellus hair rate (index C, VH%), intermediate hair rate (IH%) Max D: To predict the ability to produce thick hairs, index A calculated the average diameter of the three thickest hairs in that area. TH% (Index B): Terminal hairs (TH) are defined as having a diameter >60 μm and a length >2 mm. VH% (Indicator C): The definition of vellus hair (VH) is a diameter <30 μm. IH%: Intermediate hair (IH) is defined as having a diameter between VH and TH. Hair count-related factors: the ratio of the number of follicular units with one hair to the total number of follicular units (index D, 1FU%), the ratio of the number of follicular units with two hairs to the total number of follicular units (2FU%), the ratio of the number of follicular units with three hairs to the total number of follicular units (index E, 3FU%), and the ratio of the number of follicular units with multiple hairs to the total number of follicular units (index F, MFU%). Note that if multiple hairs are spaced 20 μm or less apart, they are considered to be in the same follicular unit (FU).
[0046] (Statistical analysis used) The statistical significance of differences in the nine QTFs (described above) for each clinical disease duration was assessed using Spearman's rank correlation coefficient. Subsequently, the Mann-Whitney U test was used to compare the values of selected trichoscopy factors between clinical disease durations, clinical stage groups, and young, middle-aged, and elderly age groups. All statistical values were considered statistically significant with a p value of <0.05.
[0047] [result] (overview) The mean age of male subjects was 53.0 years (range: 28-86 years), with the majority being 40-59 years old (58.7%). Female subjects were 51.9 years old (range: 22-81 years), with the majority being 40-59 years old (57.9%). Male subjects were most commonly HNC III (30.2%), while female subjects were most commonly a-Sinclair III (35.1%). Detailed information on each clinical stage is shown in Figure 10. Figure 10(A) shows the overall characteristics of male subjects, and Figure 10(B) shows the overall characteristics of female subjects.
[0048] (Correlation between clinical stage and QTF) Figure 11(A) shows typical clinical and trichoscopy photographs of the head and a graph of QTF scores for each clinical stage in male subjects. Figure 11(B) shows typical clinical and trichoscopy photographs of the head and a graph of QTF scores for each clinical stage in female subjects. Furthermore, as shown in Figures 12 and 13, Spearman's rank correlation coefficients were calculated between the clinical stage groups and the nine QTFs. Figure 12 shows the correlation between the clinical stage groups and quantitative trichoscopy factors in male subjects, and Figure 13 shows the correlation between the clinical stage groups and quantitative trichoscopy factors in female subjects. To facilitate identification of which category the nine QTFs belong to, they are color-coded into three categories: hair diameter-related factors (green), hair count per follicular unit-related factors (blue), and hair density-related factors (yellow). Factors with absolute correlation coefficients (rs values) greater than 0.2 and statistical significance (p<0.05) are indicated in the same color. As can be seen from the ALL (overall view) of each table, VH% (index B), TH% (index C), 1FU% (index D), and MFU% (index F) had a particularly strong correlation with clinical stage in both males and females. Max D (index A) was also correlated in female subjects, but showed a stronger correlation with clinical stage in male subjects, and 3FU% (index E) was also correlated in male subjects, but showed a stronger correlation with clinical stage in female subjects.
[0049] From the above, it was found that indicators A, B, C, D, and F are particularly useful for evaluating MAGA, and indicators B to F are particularly useful for evaluating FPHL. [Example]
[0050] Hereinafter, a second embodiment of the present invention will be described, but the present invention is not limited to the following second embodiment.
[0051] (subject) In this study, 33 subjects (27-69 years old, mean age 50.7 years, SD ±10.5) were selected from 88 MAGA patients who visited Tokyo Midtown Dermatology and Plastic Surgery Clinic Noage between March 2021 and December 2022, excluding the following: those with serious systemic illnesses or hair loss disorders other than MAGA, those who had been taking DHT inhibitors (oral finasteride or dutasteride) for less than six months, and those receiving other MAGA treatments. At the start of this study, subjects who had already been taking DHT inhibitors for six months or more were instructed to continue the DHT inhibitors during and after treatment for up to nine months.
[0052] (Treatment Protocol) Microinjection of SHED-CM into the affected area was performed using a 34G four-pronged needle (Quantron; ASTI Corporation) at 0.1 mL per site at 1 cm intervals into the deep dermis. A total of 4.5 mL was administered six times at monthly intervals.
[0053] (Results Measurement) The hair condition of the subjects was evaluated by taking clinical and trichoscopic photographs of the entire head before treatment (T0), and 3 months (T3), 6 months (T6), and 9 months (T9) after the initial treatment. The progression of the HN C classification was evaluated for all subjects before and after treatment. Trichoscopic images were taken using the same dermatoscope as in Example 1, with a 5 x 5 mm image set at the center of the whorl. Detailed findings of the hair were measured using the same image management software as in Example 1.
[0054] (Analysis of Trichoscopy Factors) In addition to the nine factors (9 QTF) in Example 1, the following three factors were added to analyze quantitative trichoscopy factors. Total Follicular Units (TFU) Difference between maximum and minimum hair diameter (M-MD) Percentage of follicular units with 2 or 3 hairs (FFU%)
[0055] (Method for evaluating therapeutic effects using quantitative trichoscopy factors) A multiple regression analysis was performed using the 12 trichoscopy factors, and the treatment effects were evaluated based on the results. Mean values and standard errors were used for quantitative variables, and relative frequencies and mean differences (percentages) were used for categorical variables. The strength of correlation between HN C and each trichoscopy factor was analyzed using Spearman's rank correlation coefficient. Differences in Max D, VH%, MFU%, and THC between T0 and T3, T6, and T9 for each subject were confirmed for significance using the Wilcoxon signed-rank test. Mean differences between T0 and T3, T6, and T9 were tested using the Mann-Whitney U test. Significant differences between categorical variables were analyzed using Fisher's exact test. A P value of less than 0.05 was considered statistically significant.
[0056] (result) 1) Correlation between HN C and quantitative trichoscopy factors: 88 subjects were classified by HN C, and the correlation with trichoscopy factors was examined. Only six factors—Max D, M-MD, VH%, TH%, 1FU%, and MFU%—had absolute rs values of 0.51 or greater and p<0.05 (Figure 14(A)). Next, similar combinations were eliminated from the correlation matrix of these six factors (Figure 14(B)), and multiple regression analysis was performed. The final multiple regression analysis model was determined to be a combination of three factors: Max D, VH%, and MFU%. Therefore, this combination of three factors was named the three quantitative trichoscopy factors (3QTF). However, the results of this analysis indicated that the correlation between HN C and hair density (THC), which has been frequently used in previous hair measurements, was weaker than that of Max D, VH%, and MFU%.
[0057] 2) 3QTF scoring system: Next, we used boxplots to examine the distribution of Max D, VH%, and MFU% at T0, T3, T6, and T9, and divided the interquartile range into seven equal parts to create a score table for these three factors. The actual measured values of Max D, VH%, and MFU% were converted into the score table, and the individual scores for the actual measured values (3QTF-av) were called 3QTF-is, and the sum of the individual scores was called 3QTF-ts. Furthermore, multiple regression analysis of these results revealed that 3QTF-is and 3QTF-ts showed a high correlation with HN C at T0.
[0058] 3) Evaluation of improvement rate by SHED-CM using 3QTF: For 33 subjects selected by screening, the mean and mean difference of the actual measured values showed statistically significant improvement in Max D, VH%, and MFU% at T3, T6, and T9 compared to T0. For individual subjects, the improvement rate for HN C was 33.3%, while the improvement rate for 3QTF-ts was 75.8%. There were no cases in which HN C worsened at T9, but 9.1% of cases showed a decline in 3QTF-ts. From the above, 3QTF-ts is considered to be a more sensitive evaluation system than HN C.
[0059] 4) Predictors of SHED-CM effect: To predict 3QTF-ts at T9, we performed multiple regression analysis of 3QTF-av, 3QTF-is, and 3QYF-ts at T0, T3, and T6. The model with the highest corrected multiple correlation early on was 3QTF-is at T0. The regression equation for this model (the equation for predicting 3QRF-t at T9 from 3QTF-is at T0) is: T9 3QTF-ts=8.87+0.41*[Max D]+1.27*[VH%]+0.03*[MFU%] It was.
[0060] These findings suggest that 3QTF-ts and 3QTF-is are important and useful indicators for predicting the therapeutic effect of SHED-CM.
[0061] (Case presentation) We show how quantitative trichoscopy factors (QTF) can be applied to individual patient hair diagnosis.
[0062] Figure 15 shows a case of a 54-year-old male with HN C II (non-severe group) who received SHED-CM in combination with a DHT inhibitor. Clinical cranial photographs (upper left) showed no change between baseline and 9 months. Furthermore, HN C was II at T0 and II at T9 (lower left, graph on the right), showing no improvement. However, trichoscopy photographs of the crown of the head (middle left) showed visual improvement, and the 3QTF-ts increased from 13 at T0 to 20 at T9 (lower left, graph on the right). Furthermore, the radar graph (triangle in the lower left) showed that the triangle formed by the 3QTF scores of Max D, VH%, and MFU% changed from a small, irregular shape at T0 to a large, well-balanced shape at T9.
[0063] As such, even if a treatment is effective, there may be cases where the HNC classification shows no change. However, the present invention allows patients and therapists to visually grasp the treatment effect. This has the advantage that patients can easily maintain their motivation to continue treatment, and therapists can proceed with treatment while checking the effectiveness. Furthermore, if a treatment is not effective, the option to switch to another treatment early is thought to have psychological and economic benefits for both patients and therapists.
[0064] [Summary of Examples] As described above, the present invention has found that when the index score after the treatment of alopecia is not significantly changed compared with before treatment, it can be used as a guide for selecting other treatment at that time, and is useful for treatment selection.In addition, the present invention has found that by investigating which index is not improved, it can select (next) treatment, and is useful for selecting treatment that is suitable for individual.In addition, the present invention has found that by investigating which index improves new treatment, it can clarify the difference with existing treatment, and is useful for developing new treatment. [Explanation of symbols]
[0065] 1. Rating System 2 Cameras 3 Evaluation equipment 30 Auxiliary storage 31 Acquisition Department 32 Image enlargement section 33 Indicator calculation section 34 Progress Assessment Section 341 Score Calculation Unit 342 Chart Generation Unit 35 Output section P Evaluation Program R measurement area
Claims
1. An evaluation method for evaluating the progression of alopecia in a subject, comprising: acquiring an image including a predetermined measurement area of the subject's head; An index calculation step of calculating at least three indexes among the following indexes A to F regarding the hair in the measurement area; Index A: Average diameter of hairs having the top 1 to m diameters (m is a natural number of 1 or more) Index B: The ratio of the number of terminal hairs having a diameter equal to or greater than a first predetermined value to the number of all hairs in the measurement area Index C: The ratio of the number of vellus hairs having a diameter equal to or less than a second predetermined value to the number of all hairs in the measurement area. Index D: Ratio of the number of hair follicle units having one hair to the number of all hair follicle units in the measurement area Index E: The ratio of the number of hair follicle units having n (n is a natural number of 2 or more) hairs to the number of all hair follicle units in the measurement area Index F: The ratio of the number of hair follicle units having multiple hairs to the number of all hair follicle units in the measurement area a progress evaluation step of evaluating the progress based on the at least three indexes; An evaluation method comprising:
2. 2. The evaluation method according to claim 1, wherein the indexes A to F are calculated in the index calculation step.
3. the subject is male; 2. The evaluation method according to claim 1, wherein said index calculation step calculates said index A, at least one of said indexes B and C, and at least one of said indexes D and F.
4. the subject is female; 2. The evaluation method according to claim 1, wherein said index calculation step calculates said index D and at least two of indexes B, C, and F.
5. 2. The evaluation method according to claim 1, wherein m is 3.
6. 2. The evaluation method according to claim 1, wherein n is 3.
7. The progress evaluation step includes: a score calculation step of scoring the at least three indicators; a chart generation step of generating a radar chart based on the scored indicators; The evaluation method according to claim 1 , comprising:
8. An evaluation device for evaluating the progression of alopecia of a subject, an acquisition unit that acquires an image including a measurement region of the subject's head; an index calculation unit that calculates at least three of the following indexes A to F regarding hair in the measurement area; Index A: Average diameter of hairs having the top 1 to m diameters (m is a natural number of 1 or more) Index B: The ratio of the number of terminal hairs having a diameter equal to or greater than a first predetermined value to the number of all hairs in the measurement area Index C: The ratio of the number of vellus hairs having a diameter equal to or less than a second predetermined value to the number of all hairs in the measurement area. Index D: Ratio of the number of hair follicle units having one hair to the number of all hair follicle units in the measurement area Index E: The ratio of the number of hair follicle units having n (n is a natural number of 2 or more) hairs to the number of all hair follicle units in the measurement area Index F: The ratio of the number of hair follicle units having multiple hairs to the number of all hair follicle units in the measurement area an evaluation unit that evaluates the progress level based on the at least three indexes; An evaluation device comprising:
9. An evaluation program for evaluating the progression of alopecia in a subject, acquiring an image including a predetermined measurement area of the subject's head; An index calculation step of calculating at least three indexes among the following indexes A to F regarding the hair in the measurement area; Index A: Average diameter of hairs having the top 1 to m diameters (m is a natural number of 1 or more) Index B: The ratio of the number of terminal hairs having a diameter equal to or greater than a first predetermined value to the number of all hairs in the measurement area Index C: The ratio of the number of vellus hairs having a diameter equal to or less than a second predetermined value to the number of all hairs in the measurement area. Index D: Ratio of the number of hair follicle units having one hair to the number of all hair follicle units in the measurement area Index E: The ratio of the number of hair follicle units having n (n is a natural number of 2 or more) hairs to the number of all hair follicle units in the measurement area Index F: The ratio of the number of hair follicle units having multiple hairs to the number of all hair follicle units in the measurement area a progress evaluation step of evaluating the progress based on the at least three indexes; An evaluation method characterized by causing a computer to execute the above.