WO2017093793A1

WO2017093793A1 - Skin inspection tool and method of improved assessment of skin lesions using a skin inspection tool

Info

Publication number: WO2017093793A1
Application number: PCT/IB2016/001698
Authority: WO
Inventors: Laurent Petit; Philippe Martel; Didier Zugaj; Anne-Sophie DUGARET
Original assignee: Galderma Research and Development SNC
Current assignee: Galderma Research and Development SNC
Priority date: 2015-11-30
Filing date: 2016-11-30
Publication date: 2017-06-08
Anticipated expiration: 2018-05-30
Also published as: EP3383253A1

Abstract

A skin inspection tool is described. The skin inspection tool utilizes a captured skin area image to identify and classify skin lesions, and displays the image with identified skin lesions on a user interface device, such as a tablet, mobile device, or computer and computer screen. The skin area image display is modifiable by user input. An improved skin lesion inspection method is also described. The systematic inspection method is described for optimizing assessment of inflammatory and non-inflammatory skin lesions. This general method takes into account a skin inspection tool and user input to optimize assessment of skin lesions.

Description

TITLE OF THE INVENTION

SKIN INSPECTION TOOL AND METHOD OF IMPROVED ASSESSMENT OF SKIN LESIONS USING A SKIN INSPECTION TOOL

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority from U.S. Provisional Patent Application No. 62/261,017, filed November 30, 2015, the disclosure of which is hereby incorporated by reference herein in its entirety.

FIELD OF THE INVENTION

[0002] The invention relates to improved skin lesion identification and severity assessment. In particular, the invention relates to a skin inspection tool and a system and a method for improved skin lesion assessment using a skin inspection tool.

BACKGROUND OF THE INVENTION

[0003] Variability in facial skin lesion counts over time for a given patient may result from either an actual modification in the number of lesions, or because of the lack of repeatability, such as the ability of the same observer to consistently achieve identical results across multiple evaluations.

[0004] On the other hand, existing automatic imaging technology, without the support of the clinician's eye, provides repeatable, but often inaccurate results. One of the main reasons may be that the technology is not able to discriminate between the different types of active skin lesions, such as inflammatory vs. non-inflammatory. For example, the existing automatic technology cannot differentiate between active acne lesions and post-acne sequelae, such as macules.

[0005] There is a need for skin lesion inspection technology that combines automatic imaging and a clinician's input to produce skin lesion assessments that have consistent and accurate results. Such skin inspection technology is described herein.

BRIEF SUMMARY OF THE INVENTION

[0006] In one general aspect, embodiments of the invention relate to a skin inspection tool for skin lesion identification on a skin area of a subject. The skin inspection tool comprises a processing program and a user interface device. In a preferred embodiment, the processing program is capable of processing a captured image, identifying skin lesions, and producing a processed image. The processing program can further determine a number and locations of the lesions. In another preferred embodiment, the user interface device is a tablet, a mobile device, or a computer and computer screen. The skin inspection tool is capable of receiving user input for modification of the processed image.

[0007] In another general aspect, embodiments of the invention relate to a method for improved skin lesion assessment on a skin area of a subject using a skin inspection tool and user input. The method comprises capturing an image of the skin area of the subject with an image capture device, processing the image with a processing program of the skin inspection tool to identify skin lesions and determine a number and locations of lesions to thereby produce a processed image, analyzing the processed image by a user on a user interface device, modifying the processed image by the user on the user interface device to obtain optimized number and optimized locations of lesions, and assessing a severity of skin lesions based on the optimized number and optimized locations of lesions. In a preferred embodiment, modifying the processed image comprises one or more of manually identifying additional skin lesions, removing erroneously identified skin lesions, and editing locations of identified skin lesions. In a further embodiment, modifying the processed image comprises classifying identified lesions by skin lesion type.

[0008] Other aspects, features and advantages of the invention will be apparent from the following disclosure, including the detailed description of the invention and its preferred embodiments and the appended claims.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0009] The foregoing summary, as well as the following detailed description of the invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there are shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown. In the drawings:

[0010] Fig. 1 is a diagram of the method for improved skin lesion assessment using a skin inspection tool in accordance with a preferred embodiment of the present invention.

[0011] Fig. 2 illustrates two modifications of a processed image by a user, according to one embodiment of the invention. [0012] Fig. 3 illustrates a modification of a processed image by a user, according to an alternate embodiment of the invention.

[0013] Fig. 4 illustrates a magnifier tool on the user interface device, according to an embodiment of the invention.

[0014] Fig. 5 is a graph showing the intra-investigator variability during a clinical evaluation of the use of a skin inspection tool, according to an embodiment of the invention.

[0015] Fig. 6 is a graph showing the inter- investigator variability during a clinical evaluation of the use of a skin inspection tool, according to an embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

[0016] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this invention pertains. Otherwise, certain terms used herein have the meanings as set in the specification. All patents, published patent applications and publications cited herein are incorporated by reference as if set forth fully herein. It must be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural reference unless the context clearly dictates otherwise.

[0017] It should also be understood that the terms "about," "approximately,"

"generally," "substantially" and like terms, used herein when referring to a dimension or characteristic of a component of the invention, indicate that the described

dimension/characteristic is not a strict boundary or parameter and does not exclude minor variations therefrom that are functionally the same or similar, as would be understood by one having ordinary skill in the art. At a minimum, such references that include a numerical parameter would include variations that, using mathematical and industrial principles accepted in the art (e.g., rounding, measurement or other systematic errors, manufacturing tolerances, etc.), would not vary the least significant digit.

[0018] As used herein, the term "skin lesion" is intended to encompass any type or classification of abnormal skin growth or appearance, specifically one that does not resemble the skin around it. Skin lesions can include inflammatory and non-inflammatory skin lesions, e.g. macules, papules, nodules, tumors, plaques, vesicles, bullae, pustules, wheals, burrows, comedones, cysts, telangiectasia, atrophic or hypertrophic scars, postinflammatory pigmented lesions, and age spots. Skin lesions can be caused by any skin disorder, including, but not limited to, e.g. acne, psoriasis, erythema, dermatitis, rosacea, and photo aging. [0019] For example, skin lesions can be rated by a clinician based on the 5 -point Investigator's Global Assessment (IGA) Scale, where a rating of 0 indicates clear skin; a rating of 1 indicates almost clear skin, i.e. having a few scattered skin lesions; a rating of 2 indicates mild skin, i.e., less than half of the half-face involved with more comedones, papules, and pustules; a rating of a 3 indicates moderate skin, i.e., more than half of the half-face involved with numerous comedones, papules, and pustules; a rating of 4 indicates severe, i.e., an entire half-face is involved and is covered with comedones, papules, and pustules and a few nodules and cysts; and a rating of 5 indicates very severe skin, i.e.

having a high number of skin lesions.

[0020] In view of the present disclosure, skin lesions can be identified on any skin area that is affected by skin lesions or that is prone to be affected by skin lesions. In a preferred embodiment, the skin area is a facial skin area of the subject. In further embodiments, the skin area can be located on one or more of the face, chest, back, shoulders, neck, and arms of the subject.

[0021] As used herein, the term "subject" means any animal, preferably a mammal, most preferably a human in need of the skin lesion assessment of the invention. Preferably, a subject is in need of, or has been the object of observation or experiment of, treatment or prevention of skin lesions. The skin area of the subject affected by skin lesions or that is prone to be affected by skin lesions can be treated by any treatment, prevention, or diagnostic methods known in the art.

[0022] As used herein, the term "user" means a human capable of operating the skin inspection tool. The user is preferably one of a clinician, doctor, nurse, or other healthcare professional performing an assessment of skin area of a subject.

[0023] As used herein, the term "instructions" when used in the context of a product includes a publication, a recording, a diagram or any other medium of expression which can be used to communicate the usefulness of the product for its designated use. The instructions can, for example, be affixed to or included within a container for the product, or can be displayed by the product itself.

[0024] It has been discovered in the invention that by using a skin inspection tool, such as a tool comprising a processing program and a user interface device, a user is able to obtain more consistent and more accurate assessments of the severity of skin lesions on a skin area of a subject. It has also been discovered that combining a skin inspection tool with user input, e.g. that of a clinician, improves assessment of the severity of skin lesions of a subject. For example, as described in more detail in the examples below, studies suggest that intra-investigator variability of multiple assessments of the same subject by the same and different investigators is reduced when combining a skin inspection tool of the invention and user input.

[0025] Accordingly, in one general aspect, embodiments of the invention relate to a skin inspection tool for skin lesion identification on a skin area of a subject affected by skin lesions or prone to be affected by skin lesions, comprising a processing program and a user interface device, wherein the processing program is capable of processing a captured image, identifying skin lesions, and producing a processed image, and wherein the skin inspection tool is capable of receiving user input via the user interface device for modifying the processed image. In a preferred embodiment, the skin inspection tool is further capable of determining a number and locations of the skin lesions present on the skin area of the subject.

[0026] According to an embodiment of the invention, the captured image is preferably a two-dimensional image. The captured image can comprise multiple images, for example superimposed to create one two-dimensional image. For example, a facial captured image can comprise a left facial side image, a right facial side image, and a frontal facial image, superimposed to create one complete two-dimensional facial image. The captured image can be acquired by any photographing image capture device, preferably a high-quality photographing device. For example, a facial captured image can be acquired using a VISIA- CR system by Canfield Scientific, Inc. (Parsippany, NJ; USA).

[0027] According to an embodiment of the invention, the captured image is processed by the processing program which produces a processed image. The image processing program can interpret the captured image to create one or more computed maps of the captured image, wherein the computed maps detect a number and locations of identified skin lesions. For example, the processing program can compute and create an inflammatory cartography based on a color captured image. The computed map and its corresponding data are comprised in the processed image.

[0028] According to an embodiment of the invention, the processed image can further comprise visual identifiers overlaid upon the captured image or the processed image at the locations of the identified skin lesions, thereby visually identifying to a user the locations of the identified skin lesions. The visual identifiers can be any shape, size, or color, as long as the identifiers are distinguishable from the portions of the captured or processed image which they are overlaid upon. Examples of circular visual identifiers are shown in Figs. 2 - 4. [0029] According to another embodiment of the invention, the user interface device displays the processed image. In some embodiments, the user interface device can also display the captured image before processing or an alternate version of the processed image, such as a cross-polarized version, a parallel-polarized version, or a magnified version. In some embodiments, the user interface device comprises a magnifier tool that is capable of displaying a section of the processed image as an alternate version of the processed image. An example of the magnifier tool is shown in Fig. 4, wherein the large circular magnifier tool shows a portion of the processed image in an alternate version. The user interface device can be any user device capable of displaying an image and receiving user input. For example, the user interface device can be a tablet, a mobile device, such as a mobile cell phone, or a computer and computer screen.

[0030] According to a preferred embodiment of the invention, the user interface device receives user input provided by the user of the skin inspection device. The user input can modify the processed image. For example, the user input can do one or more of the following actions to modify the processed image: identify additional skin lesions not identified by the processing program, identify the location of additional skin lesions, remove identified skin lesions erroneously identified by the processing program, and edit locations of skin lesions identified by the processing program. Locations of skin lesions can be edited, for example by moving a location or by increasing or decreasing the radius of a location. In a further embodiment, the user input can classify identified skin lesions according to a type of skin lesion. Types of skin lesions include, but are not limited to, inflammatory, non-inflammatory, macule, papule, nodule, tumor, plaque, vesicle, bullae, pustule, wheal, burrow, comedone, cyst, telangiectasia, atrophic or hypertrophic scars, postinflammatory pigmented lesions, and age spots. In yet another embodiment, the user modified processed image comprises skin lesion visual identifiers, as described above. Fig. 2 shows two examples of user input as applied to a processed image, the deletion of erroneously identified skin lesions and the classification of identified skin lesions. Fig. 2 also shows user modified processed images comprising visual identifiers of the skin lesions.

[0031] According to yet another embodiment of the invention, the skin inspection tool further comprises instructions.

[0032] In another general aspect, embodiments of the invention relate to a method for improved skin lesion assessment on a skin area of a subject affected by skin lesions or prone to be affected by skin lesions using a skin inspection tool and user input, comprising capturing an image of the skin area of the subject with an image capture device, processing the image with a processing program of the skin inspection tool to identify skin lesions and determine a number and locations of lesions, wherein the processing program produces a processed image, analyzing the processed image by a user on a user interface device, modifying the processed image by the user on the user interface device to optimize the number and the locations of lesions, and assessing a severity of skin lesions.

[0033] According to an embodiment of the invention, analyzing the processed image comprises reviewing the processed image displayed on the user interface device, including reviewing visual identifiers and a number of identified skin lesions, and reviewing the skin area of the subject. Analyzing the processed image can also comprise comparing the processed image to the skin area of the subject by simultaneously reviewing the skin area of the subject. In some embodiments, an alternate version of the processed image can be viewed, for example a cross-polarized image, a parallel polarized image, or a magnified image. Alternatively, a section of the image can be viewed as an alternate version, for example by using a magnifier tool.

[0034] According to a preferred embodiment, modifying the processed image comprises one or more of manually identifying additional skin lesions, removing erroneously identified skin lesions by the processing program, and editing locations of identified skin lesions by the processing program, in accordance with the simultaneous review of the skin area of the subject by the user. In a further embodiment, modifying the processed image comprises classifying identified lesions by skin lesion type, as described above. Fig. 3 is an example of modifying the processed image, wherein the image on the left is the unmodified processed image and the image on the right has been modified by manually identifying additional skin lesions and deleting identified skin lesions after simultaneous review by the user of the processed image and the skin area of the subject.

[0035] According to another embodiment of the invention, assessing a severity of skin lesions comprises reviewing the user modified processed image and rating the skin area of the subject according to a clinician rating scale for severity of skin lesions. For example, rating the severity with the 5-point Investigator's Global Assessment (IGA) Scale.

[0036] Fig. 1 is a diagram of one embodiment of the method for improved skin lesion assessment on a skin area of a subject. Specifically, in the diagram of Fig. 1, a facial image of the subject is captured with a photographing device, the processing program of the skin inspection tool creates a processed image comprising a computed map, the processed image comprising visual identifiers of locations of skin lesions is displayed on the user interface device of the skin inspection tool, the user analyzes and modifies the processed image in order to make an assessment of the severity of skin lesions on the skin area of the subject.

[0037] According to yet another embodiment of the invention, the method for improved skin lesion assessment can be performed one or more of before, during, and after a clinical trial of a skin treatment method.

[0038] This invention will be better understood by reference to the non-limiting examples that follow, but those skilled in the art will readily appreciate that the examples are only illustrative of the invention as described more fully in the claims which follow thereafter.

EMBODIMENTS

[0039] Embodiment 1 is a skin inspection tool for skin lesion identification on a skin area of a subject affected by skin lesions or prone to be affected by skin lesions, comprising a processing program and a user interface device, wherein the processing program is capable of processing a captured image, identifying skin lesions, and producing a processed image, and wherein the skin inspection tool is capable of receiving user input via the user interface device for modifying the processed image.

[0040] Embodiment 2 is the skin inspection tool according to embodiment 1, being further capable of determining a number and locations of the skin lesions present on the skin area of the subject.

[0041] Embodiment 3 is the skin inspection tool according to any one of embodiments 1-2, wherein the user interface device is selected from the group consisting of a tablet, a mobile device, and a computer and computer screen.

[0042] Embodiment 4 is the skin inspection tool according to any one of embodiments 1-3, wherein the user interface device comprises a magnifier tool that is capable of displaying a section of the processed image as an alternate version of the processed image.

[0043] Embodiment 5 is the skin inspection tool according to any one of embodiments 1-4, wherein the captured image is a two-dimensional image.

[0044] Embodiment 6 is the skin inspection tool according to embodiment 5, wherein the two-dimensional image is composed of multiple images.

[0045] Embodiment 7 is the skin inspection tool according to any one of embodiments 1-6, wherein the processed image comprises at least one visual identifier at a location of an identified skin lesion. [0046] Embodiment 8 is a method for improved skin lesion assessment on a skin area of a subject using a skin inspection tool and user input, the method comprising: a) capturing an image of the skin area of the subject with an image capture device; b) processing the image with a processing program of the skin inspection tool to identify skin lesions and determine a number and locations of lesions to thereby produce a processed image; c) analyzing the processed image by a user on a user interface device of the skin inspection tool; d) modifying the processed image by the user on the user interface device to obtain optimized number and optimized locations of lesions; and e) assessing a severity of skin lesions based on the optimized number and optimized locations of lesions.

[0047] Embodiment 9 is the method according to embodiment 8, wherein the step of modifying the processed image comprises one or more of manually identifying additional skin lesions, removing erroneously identified skin lesions, and editing locations of identified skin lesions.

[0048] Embodiment 10 is the method according to embodiment 8, wherein the step of modifying the processed image comprises classifying identified skin lesions by skin lesion type.

[0049] Embodiment 1 1 is the method according to any one of embodiments 8-10, wherein the user interface device is selected from the group consisting of a tablet, a mobile device, and a computer and computer screen.

[0050] Embodiment 12 is the method of according to any one of embodiments 8-1 1 , wherein the skin lesion is selected from the group consisting of non-inflammatory skin lesions, inflammatory skin lesions, macules, papules, nodules, tumors, plaques, vesicles, bullae, pustules, wheals, burrows, comedones, cysts, telangiectasia, atrophic scars, hypertrophic scars, post-inflammatory pigmented lesions, and age spots.

Example 1

[0051] Five investigators reviewed fourteen subjects twice a day (morning and afternoon) using two methods of evaluation: (1) a visual clinical evaluation as typically performed by a clinician, and (2) a clinical evaluation using the skin inspection tool (SIT).

[0052] Male and female subjects aged at least 16 years old included in the study had a medical diagnosis of mild to severe acne, according to the IGA scale. Subjects were instructed to shave the test area 24 hours prior to the study, and not to wear any jewelry or cosmetics on the test area on the day of the study. Subjects were also instructed not to manipulate any acne lesions on the test area at least 24 hours prior to the study. [0053] Table 1 shows the inflammatory acne lesion count by each investigator, using the SIT and without the SIT for all subjects, each for morning and afternoon counts.

Table 1: Inflammatory lesion count by investigator

[0054] Table 2 shows the mean values of the inflammatory lesion count of table 1, and the standard deviations between investigators.

Mean 17.61

with SIT

3.90

std

(22.15%)

Mean 16.38

without SIT

3.09

std

(18.86%)

Table 2: STD between investigators on mean values [0055] Intra-investigator variability, i.e. variability within the lesion counts of each investigator, was calculated for counts with and without SIT for each investigator using formula 1 , where a smaller 1 -ICC indicates less variability.

σ error

1 - ICC

& error K * &subj

Formula 1

[0056] Table 3 shows the values for 1-ICC for each investigator, for counts of inflammatory acne lesions with and without use of the SIT.

Table 3: inflammatory acne lesion 1-ICC for each investigator

[0057] As shown in Fig. 5, the use of SIT to count acne lesions significantly decreased intra-investigator variability during the study for counts of inflammatory acne lesions.

[0058] Inter-investigator variability, i.e. variability between the counts of different investigators, was calculated for counts with and without SIT using formula 2. σ error ² + ¹ Κ " ' * σ ^v exp ²

ICC

2 * ( ^uT error ² 4 '- ⁱ K^V ' * ( ^uT exp ²

Formula 2

[0059] Table 4 shows the values for ICC between investigators for counts of inflammatory acne lesions with and without use of the SIT.

Table 4: inflammatory acne lesion ICC between investigators

[0060] As shown in Fig. 6, the use of SIT to count inflammatory acne lesions did not significantly change the inter-investigator variability, as compared to counts of acne lesions without the SIT.

[0061] Accordingly, the study showed significant improvement of intra-investigator variability of counts of inflammatory acne lesions. The study also showed good correlation between investigators, for counts with and without the SIT.

[0062] It will be appreciated by those skilled in the art that changes could be made to the embodiment described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiment disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the present disclosure.

Claims

CLAIMS I/We claim:

1. A skin inspection tool for skin lesion identification on a skin area of a subject

affected by skin lesions or prone to be affected by skin lesions, comprising a processing program and a user interface device, wherein the processing program is capable of processing a captured image, identifying skin lesions, and producing a processed image, and wherein the skin inspection tool is capable of receiving user input via the user interface device for modifying the processed image.

2. The skin inspection tool according to claim 1 , being further capable of determining a number and locations of the skin lesions present on the skin area of the subject.

3. The skin inspection tool according to any one of claims 1-2, wherein the user

interface device is selected from the group consisting of a tablet, a mobile device, and a computer and computer screen.

4. The skin inspection tool according to any one of claims 1-3, wherein the user

interface device comprises a magnifier tool that is capable of displaying a section of the processed image as an alternate version of the processed image.

5. The skin inspection tool according to any one of claims 1-4, wherein the captured image is a two-dimensional image.

6. The skin inspection tool according to claim 5, wherein the two-dimensional image is composed of multiple images.

7. The skin inspection tool according to any one of claims 1-6, wherein the processed image comprises at least one visual identifier at a location of an identified skin lesion.

8. A method for improved skin lesion assessment on a skin area of a subject using a skin inspection tool and user input, the method comprising:

a. capturing an image of the skin area of the subject with an image capture device;

b. processing the image with a processing program of the skin inspection tool to identify skin lesions and determine a number and locations of lesions to thereby produce a processed image;

c. analyzing the processed image by a user on a user interface device of the skin inspection tool; d. modifying the processed image by the user on the user interface device to obtain optimized number and optimized locations of lesions; and e. assessing a severity of skin lesions based on the optimized number and optimized locations of lesions.

9. The method according to claim 8, wherein the step of modifying the processed image comprises one or more of manually identifying additional skin lesions, removing erroneously identified skin lesions, and editing locations of identified skin lesions.

10. The method according to claim 8, wherein the step of modifying the processed image comprises classifying identified skin lesions by skin lesion type.

11. The method according to any one of claims 8-10, wherein the user interface device is selected from the group consisting of a tablet, a mobile device, and a computer and computer screen.

12. The method of according to any one of claims 8-1 1 , wherein the skin lesion is

selected from the group consisting of non-inflammatory skin lesions, inflammatory skin lesions, macules, papules, nodules, tumors, plaques, vesicles, bullae, pustules, wheals, burrows, comedones, cysts, telangiectasia, atrophic scars, hypertrophic scars, post-inflammatory pigmented lesions, and age spots.