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    • 专利摘要:
    A clinical test method utilising one or more facial image comprising: image capture & display, aesthetic feature selection, application of method of measurement. Test method can be useful for diagnostic, reference generation, in addition to the evaluation and/or optimisation of products and demonstrating overall product performance.
    公开号:SE1650868A1
    申请号:SE1650868
    申请日:2014-12-22
    公开日:2016-06-21
    发明作者:Jameson David
    申请人:Oriflame Cosmetics S A；
    IPC主号:
    专利说明:

    Ä A test method and assay for diagnosis and evaluation of clinical product performanceField of the Invention The present invention relates to a clinical diagnostic, predictive and productperforrnance method, tool and/ or system. In particular, the invention relates to a clinicaltest method to determine the performance of products and optionally to benchmarkthese products against performance of similar known products on the marketplace.Background to the Invention As we age certain physiological changes take place due to extrinsic (e.g. UV light,pollution, radiation, stress and other environmental factors) and intrinsic (e.g. geneticpredisposition, chronological aging etc.) factors that present themselves throughundesirable symptoms that can be resolved through the use of beauty and cosmeticproducts.
    The skin around the eye is thinner and more delicate than skin elsewhere on the body.As such, the eye can often show the first signs of fatigue, stress and aging. Fatigue,stress and aging may present as symptoms including but not limited to puffiness, darkcircles, fine lines and wrinkles. Skincare compositions can provide both short and longterm solutions to counter the effects and undesirable symptoms of aging, poor healthand extrinsic factors.
    Changes also occur to the eyelashes with age. Standard growth of an eyelash goesthrough four main phases: growth, resting, shedding and re-growth. As hair follicles agethis four phase process slows and may stop altogether leading to a thinning of theeyelashes and reduced fiallness and length. Greater definition and contrast of facialfeatures is understood to provide a younger looking appearance (C.E.R.I.E.S &Gettysburg, 2013). Fatigue and stress can also impact on the general appearance ofhealth and age of an individual. A more open looking eye is thought to improve andsupport a more refreshed, rested and overall younger appearance (Skinexigence &Helena Rubeinstein).
    Lack lustre eyelashes as a result of thinning, reduced fullness, length and curl cantherefore add to the increased appearance of aging of the eyes through reduceddefinition and perceived closing of the eye.
    Changes in eyelash condition and health may also occur due to other influencing factors other than age such as excessive scrubbing and/or rubbing of the eye, hereditary, 2 medical conditions, certain medications and/or treatments and other environmentalfactors.
    Age perception influences not only how an individual feels about themselves, impactingon general health, Well-being and confidence but is also said to impact socialinteractions, With perceived age influencing for example a persons rank, status, rights,responsibilities and professional development (C.E.R.I.E.S & Gettysburg, 2013).WithWomen Working longer hours and Working later in life the need to look professional andyounger looking has become increasingly important, With 36% of 55 to 64 year oldsagreeing that Wearing make-up makes them feel more professional and 69% agreeingthat it makes them feel more confident.
    Many options are available as a means to improve the appearance of fialler, longerlashes With more curl, lift and eye-opening capabilities. Make-up, including mascara,can offer Women a temporary yet more immediate solution to a younger-lookingappearance. Other cosmetic compositions applied to the eyelash, such as lash boostingserums provide nutrients, vitamins and active ingredients to improve the condition ofthe lashes for a more long term effect. False eyelashes and in more extreme caseseyelash transplants can provide longer lasting effects.
    In addition targeted skincare compositions can provide both short term and long termsolutions to a younger-looking appearance of the overall eye area.
    The economic downtum has influenced consumer spending habits resulting in demandsfor a better performance profile for products purchased. Claim substantiation hastherefore become increasingly important part of product development over the last tenyears (Hickey & Barton). This has lead to an ever increasing trend for productperformance in cosmetic, beauty and personal care goods and in-line With this trendthere have been developments in the cosmetics regulation (http ://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/guide_reg_claims_en.pdf) asa protective measure. This regulation sets out guidelines on making and substantiatingclaims.
    Most mascaras and other lash applied cosmetic products on the market claim to becapable of lifting, lengthening, curling and thickening the eyelashes and to providefuller lashes and an eye-opening effect. However, conventional performance testing ofsuch products relies on subj ective opinion-based consumer perception studies to demonstrate performance, Which has its draw backs. Skincare effectiveness or 80 90 3 performance is also often demonstrated through in vítro or subj ective opinion-basedconsumer perception studies.
    Consumer perception studies generally comprise of a panel of end-users for themarketed product. These end-users are provided with the test product and asked to usethe product for a period of time. Over this period of use the panellist subjectivelyassesses the test product. Each member of the panel is then asked to complete aquestionnaire, purposefully designed to capture the panels opinion as to whether theproduct does what it is intended for and how well the panel perceives the product tohave performed this task. All tests are performed under standard clinical researchprocedures as a blind trial and following the standards set out in the cosmeticsregulation 2013.
    One such example of an at home skincare based consumer perception study invitesconsumers to purchase the product on offer and to use for a set period of time beforeassessing their progress. The consumer does this by comparing their skin conditionagainst a series of photos/picture as examples/ representative scale of the skin conditionprogressively worsening, having also assessed their skin before using the product todecide where they sit on the scale. After using the product the aim is to see animprovement or lessening of the skin condition compared to where the consumerstarted.
    Such testing, whether at home or under a more controlled clinical setting, is opinion-based, and thus subjective. In addition, most individuals tend to have a distorted view oftheir own appearance and the gravity of conditions presented, in extreme cases thismight result in Body Dysmorphic Disorder (BDD). This means that application of thetest varies considerably from individual to individual and outcomes vary depending onindividual interpretation leading to less dependable results.
    EPl298597 (L°Oreal) and EPll3470l (INFINITEFACE) provide for an analyticalmethod using a 3-D facial image designed to enable the consumer to virtually try outbeauty products in store for their potentially desirable aesthetic attributes and promoteconsumer/retail interaction. Such a method is not designed to measure the performanceof beauty products, but merely provides a virtual representation of certain features to theconsumer for a more inforrned purchasing choice.
    KR856l69 (Shiseido) describes an in-store mascara selecting method and system. This system comprises a mascara selection step, which is based on information ascertained 100 105 110 115 120 125 130 4 from the consumer on their eyelashes and the desired effect they Want to achieve. Sucha method does not comprise of an analytical method for perforrnance or objectivelydetermine the clinical effect of mascara or other cosmetic compositions; it merelyprovides a means for a consumer to make an informed purchasing decision as to Whatmascara Would best suit their needs.
    Previous attempts have been made to demonstrate the effectiveness of mascaraperformance utilising more objective means (Skinexigence & Helena Rubeinstein). TheSkineXigence/H. Rubenstein method sets forth a means to provide repeatable andconsistent result generation.
    The Rubinstein-Skinexigence method primarily utilises angle displacement between theaesthetic and anatomical angles to generate an angle value measured in degrees todemonstrate the curl of the eyelashes. In addition the opening of the eye is measuredindependently by means of a vertical line through the iris and taking the mean change indistance (cm) between the aesthetic and anatomical angle. The results describe that themean angle measurement of l2° corresponds to a 2mm increase in height. The means ofestablishing the angle displacement and distance height are limited due to the manualselection of the mean curvature of the eyelash and thus the aesthetic angle andextrapolated line generated. Such selection of the mean curvature of the eye isinaccurate and unclear and thus unlikely to provide a true indication of the eyelash curlor eye-opening capability. Subjectivity in an assessment method is likely to lead tofalse positive or false negative readouts. Such previous methods are limited in that themeasurements and results do not provide an accurate, true and realistic representation ofproduct performance.
    An objective clinical test method to demonstrate effectiveness of targeted or localisedskincare, mascaras and other beauty and cosmetic products Would therefore beadvantageous.
    As We age the eyes and surrounding area age and as such become prone to age-relateddisorders and/or conditions. Such conditions include but are not limited to, trichiasis,keratoconus, keratoglobus, glaucoma and localised inflammation of the eye. Suchconditions may also result from other environmental and genetic stimuli and thus maypresent themselves at any age.
    Trichasis is a condition characterised by the inWard projection of the eyelash(es). In more pronounced cases the eyelash can come into contact With the comea, scratching 135 140 145 150 155 160 165 5 and potentially damaging the eye as well as causing discomfort. There are severalcauses of misdirected eyelash growth. Entropion results from loss in norrnal elasticity ofthe eyelid and presents itself as an inward flip/fold of the eyelid. Blepharitis results fromeyelid infection and inflammation of the eyelids and lashes. Injury, surgical repair orcosmetic surgery of the eye area may cause the eyelid to become tom or injured; as aresult the position of the eyelashes may change and grow inward. Distichiasis is whenan extra row of eyelashes develops and grows inward, rubbing against the eye.Occasionally, an eyelash will simply grow or bend in the wrong direction (IdiopathicTrichasis).
    Keratoconus and Keratoglobus are degenerative disorders characterised by structuralchanges within the comea that cause it to thin and change shape. In Keratoconus the eyebecomes more conical in shape and in Keratoglobus the eye becomes more globular orspherical in shape. Both conditions cause distortion to vision and light sensitivity.Glaucoma is a multifactorial condition characterised by intraocular pressure-associatedoptic neuropathy and is the leading cause of blindness. Intraocular pressure fluctuationsmay result in fluctuations in the overall size and shape of the eye. Many diagnosticscurrently available involve practices which patients may find uncomfortable leading tochallenges in patient compliance, particularly with those who are squeamish abouthaving things close to their eyes.
    Inflammation of the eye area can arise due to many different factors, such as allergyirritation etc. The effects of which would be made apparent through a closing of the eye.The present invention may provide a quick, easy and convenient way to measure anddemonstrate clinical effectiveness/perforrnance of localised inflammatory products.Object of the Invention Whilst various diagnostics exist for all of the above conditions there is a continual needfor less invasive and remote means of diagnosis to enable early detection of changes inthe eye. Equally an easy, reproducible and inexpensive means for testing performanceof therapeutic compositions in certain eye-related conditions would be advantageous.The present invention sets out to provide a more objective means of evaluating productperformance and resolve the long-standing issue of clear performance measurement ofcosmetic, beauty and/or therapeutic products, and in particular of those products appliedto the eyelashes and/or surrounding eye area.
    Summary of the Invention 170 175 180 185 190 195 6 According to the present invention there is provided a method of analysing two imagesof an eye of a subject to deterrnine the change, between the two images, of the extent towhich the eye appears to be open, wherein the images are profile-view images of thesubject°s eye taken from the same Vantage point; wherein each image of the eye ischaracterised by an eyeball area bounded by a lower eyelid, an upper eyelid, and aneyeball periphery; and wherein the lower and upper eyelids comprise lower and upperlashes respectively, the method characterised by the steps of: for each image of the eye: plotting a lower target point proximate to the eyeball periphery and the lower eyelid; plotting an upper target point proximate to the eyeball periphery and the uppereyelid;drawing a measurement line through the lower target point and the upper target point; and calculating a value associated with the measurement line; comparing the degree of change in the value associated with the measurementline of the first image and the value associated with the measurement line of the secondimage; andinferring from the degree of change in the values associated with the measurement lines the change of the extent to which an eye appears to be open.Preferably the lower target point comprises the point of intersection between the lowereyelid and the eyeball periphery; the upper target point is plotted by: drawing a vertical line through the lower target point such that it intersects with theupper lid at the base of the upper lashes, and plotting the point of vertical lineintersection; plotting the point of upper/ lower lid intersection where the upper lid intersects with thelower lid; drawing an upper lid line through the point of vertical line intersection and the point ofupper/ lower lid intersection such that the upper lid line intersects with the eyeballperiphery; designating the point of intersection between the upper lid line and the eyeball peripheryas the upper target point; 200 205 210 215 220 225 230 7 and the measurement line is drawn between the lower target point and the upper target point following the outline of the eyeball periphery.
    In particular the upper target point may comprise the highest point on the upper lashes;the lower target point may comprise the lowest point on the lower lashes; and themeasurement line is a straight line drawn between the lower target point and the uppertarget point.
    The invention also provides a method of analysing two images of an eye of a subject todetermine the change, between the two images, of the extent to which the eye appears tobe open, wherein the images are profile-view images of the subject°s eye taken from thesame Vantage point; wherein each image of the eye is characterised by an eyeball areabounded by a lower eyelid, an upper eyelid, and an eyeball periphery; and wherein thelower and upper eyelids comprise lower and upper lashes respectively, the methodcharacterised by the steps of: for each image of the eye: plotting an upper/ lower lid point of intersection at the point of intersection of the uppereyelid and the lower eyelid; plotting a lower target point proximate to the eyeball periphery and the lower eyelid; plotting an upper target point proximate to the eyeball periphery and the upper eyelid; defining a triangle having apices respectively at each of said plotted points; measuring a characteristic area within said triangle, wherein the characteristic area isoptionally the white of the eye; comparing the degree of change in the magnitude of the characteristic area of the firstimage and the magnitude of the characteristic area of the second image; and inferring from the degree of magnitude change the extent to which an eye appears to beopen.
    Also provided is a method of deterrnining the change over time in the extent to which aneye of a subject appears to be open comprising the steps of: taking a first profile-view image of a subject at a first point in time; taking a second profile-view image of a subject at a second point in time; andperforming the method of any of claims l to 4 on said first and second images.
    The invention also provides a non-transitory computer readable medium carrying instructions thereon, which, when executed by a processor, cause the processor to carry 235 240 245 250 255 260 8 out any of the methods described above; an image analysis apparatus configured toperform any of the methods in Which the images are digital images.
    Also provided is an image capture and analysis system configured to perform a methodof deterrnining the change over time in the extent to Which an eye of a subject appears tobe open comprising an image capture device; and the image analysis apparatus definedabove.
    The present invention thus provides a clinical test method, apparatus and systemsinvolving one or more facial images. The method, apparatus and systems can alsoprovide for diagnostic and/or reference data generation purposes, and further optionallycomprises the evaluation and/or optimisation of products, Whereby the clinical testmethod comprises: (1) Image capture(2) Image analysis Advantages of the present invention include but are not limited to demonstratingproduct performance in an objective Way With reduced error and variability overstandard consumer perception studies currently available. In addition the presentinvention advantageously provides a means to compare and benchmark products againstcompetitor product offering to determine comparable activity. The present inventionalso enables a reduction in paper, staff1ng, contract research, travel and other studycosts, Which also advantageously reduces production costs as Well as reduces the carbonfoot print of such products tested by said clinical method and thus affords greatersustainability of the products.
    By comparison to the Rubinstein-Skinexigence method, the method(s) of the currentinvention provides for a more objective and easily repeatable method through the pixelselection rule that is applied as part of the Variant Methods (VM l,2 or 3) of the presentinvention and utilised in the image analysis step. The pixel selection rule of the presentinvention provides a means to remove subj ectivity between investigators on definingWhere the measurement is taken from and to.
    It has also been advantageously found that the method could be utilised in diagnosis ofcertain disease states and/or conditions associated With the eye. Such age-relateddisorders and/or conditions include but are not limited to, trichiasis, keratoconus,keratoglobus, glaucoma and localised inflammation of the eye, as Well as the result of environmental and genetic stimuli. 265 270 275 280 285 290 295 Brief Description of the Drawings The accompanying drawings, figures and diagrams incorporated in the specification, inconjunction with the description, serve to explain the features, advantages and otherobjects of the present invention, in which: Figure 1: Illustrates the general structure of the eye and eyelid showing the iris (thepigmented part); the comea (a clear dome over the iris); the pupil (the black circularopening in the iris that lets light in); the sclera (the white part).
    Figure 2: Provides a flow diagram illustrating a method of deterrnining and optimisingand evaluating products in accordance with the invention.
    Figure 3: Demonstrates variant measurements (VM) applied in accordance with theinvention. A is the Base Method, B is Method Variant l, C is Method Variant 2 and Dis Method Variant 3. The figure shows measurements taken before product application(untreated) and after product application using the claimed Base method in conjunctionwith the one or more method variant (VM) l, 2 or 3 singularly, sequentially or inparalell.
    Figure 4: Shows significant and reproducible product performance compared tountreated control. Statistically significant product performance on lash length, curl, liftand overall eye opening capabilities* = P value <0.05 Figure 5: Shows pixel selection as part of the clinical test method. Demonstrates thepixel selection process, as part of the variant methods applied. Pl = lash point.
    Figure 6: Validation of methodology : Figure shows comparison of benchmark product(A), positive control (B), negative control (C) and untreated (D). * = p value of SOMOÖ considered to be statisticallv significant.
    Detailed Description of the Drawings The current invention comprises of clinical test method whereby an image(s) is capturedbefore and after product application and various points of assessment are selected andmeasured to demonstrate effectiveness of the product applied.
    It is understood that the figures and descriptions of the present invention have beensimplified to illustrate elements that are relevant for a clear understanding of the presentinvention. The present invention comprises a plurality of elements and features (Fig 2),which are outlined in conjunction with figures, examples and data as described.
    Facial images of panellists (n=4) were captured (l) and the resulting image generated is then displayed on a display device (~S2). Investigations performed under the present 300 305 310 315 320 325 1 0 invention utilised the apparatus and analysis software Image Pro Plus that can bepurchased from Media Cybemetics; however, there are many standard apparatus andsoftware packages that exist, any of which could be utilised in conjunction with thepresent invention. The aesthetic feature of interest is then selected (~S3a.), in particularwhere the aesthetic feature is the eye and surrounding areas. On selection of theaesthetic feature, method may further optionally comprise an additional step (~S3b.),whereby product is optionally applied to the aesthetic feature. For diagnostic purposesand/or untreated controls, (~S3b) is omitted. Image analysis (2) then takes placestarting with the intersection point (p) being established (~S4) and the alto line (Ll) andbase line (L2) are articulated outward from the point of intersection (~S5). A referenceline (Rl) is drawn vertically through the mid reference point (r) which runs parallel tothe intersection point (p), from Ll downwards through the base line (L2) of the aestheticfeature (~S6). In accordance with the invention, one or more method variants, asdescribed in the examples, are then applied (~S7) singularly, sequentially or in parallel,which utilises a pixel selection method as further described in the examples (f1g 5).Measurements are taken with the output deterrnined (~S 8) and represented as anumerical value (OP). Measurements taken from untreated (baseline value) are thencompared to measurements obtained after product application (~S3b), or measurementstaken from one product is compared to one or more other products, as represented bythe mathematical formula below: (~S3a + VM(1,2,3)) = ÛP1 (~S3b + VM(1,2,3)) = ÛPQ; ÛPQ - ÛP1 =dR1 ÛPQ - ÛPQ = dRggl) During comparison (~S9.) product application maybe compared againstuntreated data obtained or compared to other test products under analysis. The fianctiondR represents the difference in response obtained; dR1 represents comparative responseto control, dRgül) represents intra-comparative responses between products. As part ofthe comparison step standard statistical analysis is applied to establish the significanceof results obtained. From comparative data, products can be selected on the basis of defined parameters set by study led/obj ective. 330 335 340 345 350 355 360 11 Examples, below, are provided to explain additional detail as to some of the aspects ofthe present inVention and is hereby understood to not limit the scope of the presentinVention.
    Example 1 In accordance to the inVention the Variable aspect of the method may optionallycomprise of a length of curVe of the eye Visible under the lash line measurement (VM1).Upper (L1) and base (L2) lines are articulated outward from the point (p) of intersection(~S5). A reference line (Rl) is drawn Vertically through the mid reference point (r)which runs parallel to the intersection point (p), from L1 downwards through the baseline (L2) of the aesthetic feature (~S6). The curVed line (T1) is then drawn between thelines (L1) and (L2), along a curVed feature, for example the comea. The output (OP) isdefined by T1.
    Example 2 In accordance to the inVention the Variable aspect of the method may optionallycomprise of a minimum to maximum measurement (VMg). Upper (Ll) and base (L2)lines are articulated outward from the point (p) of intersection (~S5). A reference line(Rl) is drawn Vertically through the mid reference point (r) which runs parallel to theintersection point (p), from L1 downwards through the base line (L2) of the aestheticfeature (~S6). A connecting line (d) joins L1 and L2 highlighting the minimum andmaximum points. The output (OP) is defined by (d).
    Example 3 In accordance to the inVention the Variable aspect of the method may optionallycomprise of an area under the Line (AUL) measurement (VMg). Upper (L1) and base(L2) lines are articulated outward from the point (p) of intersection (~S5). A referenceline (Rl) is drawn Vertically through the mid reference point (r) which runs parallel tothe intersection point (p), from L1 downwards through the base line (L2) of the aestheticfeature (~S6). The area (A) within the confines of L1 and L2 is then defined andmeasured resulting in an output (OP). The area between L1 and L2 can be defined by aplurality of elements including but not limit to the white of the eye (as shown in fig 2),the pupil, iris, comea, or any other Visible outer portion of the eye structure or any combination of these elements.
    Example 4 365 370 375 380 385 390 12 To effectively perform the variant methods l, 2 and 3, in addition to the standardmethodology as described, the lash is differentiated from background “noise° using apixel selection process.
    With the aid of image software, the image is refocused (Fig 5). By zooming in on theimage but maintaining clear differentiation of Where the end-point of the lash exists (Fig5). Against the background, it is then possible from this view to select the pixels thatdefine Where the point and outer line of the lash exists. Such pixel selection enables amore accurate representation of the measurements taken in the test method used.Measurements can then be expressed as an output value in the format of pixel count (fig4), and statistically shown to be significantly different before and after productapplication (fig 4). Manual selection and characterisation of pixel colour forinclusion/exclusion from measurement parameters is performed in accordance tostandard protocols and technical information available from the apparatus/softwaresupplier, in this instance Media Cybemetics. This selection process is of particularimportance to VM; as defining the lash from the background noise is a key aspect to enable accurate measurements.
    Example 5The set-up of the imaging device ensures that the images are reproducible. Additional images are taken to account for and minimise the less common errors during capturesuch as the panellist blinking, looking up, down or to the sides, as Well as tilting thehead. These checks are performed, as a rule, immediately after image capture andretakes are performed if necessary. These images are then rechecked by the responsibleperson trained in the analysis, and any images comprising of these types of errors arediscarded. Commonly, it is the case that all repeats are okay, and images are simplypicked on the basis of one before and one after treatment.
    Panellists sit on the same chair for both before and after images, placing their chin in achin rest to assist in positioning. Specific points of reference are highlighted for thepanellist to look at during the image capture.
    The panellists are told that there Will be a countdoWn “3, 2, l” after Which the imageWill be captured. They can blink during and up to the end of this countdoWn and thenthey have to keep their eyes open (fixated on the reference point) once the countdoWn is complete. The image is captured instantaneously at this point. 395 400 405 410 415 420 425 13 The more powerful the image capture device, the sharper the image will be, leading toincreased clarity and better defined edges which enables more accurate pixel selectionand measurement. For the purpose of analysis, selection of an appropriate image capturedevice provides for reduced variability upon selection of the desirable points on theimage.
    Example 6 The current invention has utility in assessing effectiveness of lash based products forcertain desirable attributes. Depending on the desirable attributes under evaluation anappropriate variant method (1, 2 or 3) is selected.
    The clinical test method as described and illustrated (Fig 2) is performed with theomission of (~S3b) to generate baseline data, which enables the assessment ofvariability in measurements. Product is then applied to one eye of the panellist, as perstandard protocols in clinical assessment and the clinical test method is performed againwith the inclusion of (~S3b) utilising one or more of the method variants as described.Effectiveness of lash based products is usually achieved through a combination of boththe composition and the device used to apply the composition, such as an applicator,brush or comb etc. To be able to assess the impact of either the device or forrnulation, orany combination of both, on the overall performance of the product as a whole apositive and negative control must first be established. A number of applicator andcomposition combinations were trialled using the method of the current inventionagainst a benchmark. The benchmark taken in this case was Helena Rubinstein, LashQueen Mascara, Fatal Blacks Waterproof a gold standard product for lash length, curl,lift and overall eye-opening capability.
    The assessment is performed immediately after product application and, optionally, atvarious time points following application of the product under assessment. The outputs(OP) are then recorded as numerical values and statistical analysis performed.Performance is shown as the mean percentage change in length of curve visible underthe lash line, relative to the baseline measurement, where statistical significance is takento be a p value of 0.05 or below.
    The positive control was deterrnined to comprise of a standard in-house mascaracomposition combined with GEKA 311164 bowling Brush. The negative control wasdeterrnined to be a standard in-house composition combined with a GEKA 311164 Helix brush. Untreated controls were performed in parallel to confirm that the method is 430 435 440 445 450 455 14 reproducible and that the changes observed were due to product performance and notintrinsic alterations that naturally occur in the eyelashes over time (Fig 6).
    Results demonstrate that a mean change in measurement (using VM1) relative tobaseline in the range of 23 - 28% provides optimal performance in lash, curling, liftingto provide a wider more open eye look.
    Use of alternative measurement (VM 2 or 3) is anticipated to demonstrate a meanchange relative to baseline that would provide a range of values where optimalperformance can be demonstrated.
    Example 7 The current invention has utility in assessing effectiveness of both topical compositionsintended for localised application in and around the eye area, such as, but not limited to,cosmetic compositions intended to alleviate and/or prevent the signs of eye relatedaging.
    The clinical test method as described and illustrated (Fig 2) is performed with theomission of (~S3b) to generate baseline data, which enables the assessment ofvariability in measurements. Facial images of panellists (n=x) were captured (l) and theresulting image generated is then displayed on a display device (~S2). The clinical testmethod is then performed again, and this time product is applied to one eye of thepanellist (~S3b), as per standard protocols in clinical assessment and analysis utilisingvariant method 3.
    The assessment is performed immediately after product application and, optionally, atvarious time points following application of the product under assessment. The outputs(OP) are then recorded as numerical values and statistical analysis performed.Performance is shown as the mean percentage change in area of the eye visible underthe lash line, relative to the baseline measurement, where statistical significance is takento be a p value of 0.05 or below.
    Readouts derived from the described method provide an indication of skincareeffectiveness in tightening, f1rming and wrinkle reduction.
    Example 8 The current invention could feasibly be utilised to generate data that would be useful indiagnosis of select conditions associated with the eye.
    The clinical test method as described and illustrated (Fig 2) is performed with the omission of (~S3b) in entirety. Facial images of the “control group” (n=x) were 460 465 470 475 480 485 490 captured (l) and the resulting image generated is then displayed on a display device(~S2). The clinical test method is then performed again, and this time facial images ofthe “patient” group (n=x) were captured (l) and the resulting image generated is thendisplayed on a display device (~S2).
    The following assessment is performed utilising variant method 3 and the outputs (OP)are recorded as numerical values and statistical analysis performed. Control conditionsare demonstrated as the mean area of the eye visible under the lash line, where statisticalsignificance is taken to be a p value of 0.05 or below. The “onset differential” is thentaken to be the mean percentage change in area visible under the lash line in the diseasestate, relative to control conditions, where statistical significance is taken to be a p valueof 0.05 or below.
    A database can be generated comprising of the range of acceptable fluctuations withinmeasurements for control conditions as well as the percentage change measurement(s)that indicate the onset of a disease state as reference samples. Patients can then besubsequently tested and a value generated from the variant method, which can then becompared to the reference samples within the database. Comparison will provide anindication of whether said patient is presenting symptoms of the disease state.
    Example 9 The clinical method can feasibly be used to generate data useful in the assessment ofproduct effectiveness in trials.
    The clinical test method as described and illustrated (Fig 2) is performed with theomission of (~S3b) to generate baseline data, which enables the assessment ofvariability in measurements. Facial images of panellists (n=x) were captured (l) and theresulting image generated is then displayed on a display device (~S2). The clinical testmethod is then performed again, and this time product is applied to one eye of thepanellist (~S3b), as per standard protocols in clinical assessment and analysis utilisingvariant method 3.
    The assessment is performed immediately after product application and, optionally, atvarious time points following application of the product under assessment. The outputs(OP) are then recorded as numerical values and statistical analysis performed.Performance is shown as the mean percentage change in area of the eye visible underthe lash line, relative to the baseline measurement, where statistical significance is taken to be a p value of 0.05 or below. 495 500 16 Readouts derived from the described method provide an indication of producteffectiveness in relation to reduction of localised inflammation, sWelling and or Waterretention.
    Example 10 Below is provided a typical composition that could be evaluated using the presentinvention as described by Way of example, Which is intended for illustrative purposes and is hereby understood not to limit the scope of the present invention.
    Table 1: Typical mascara composition Material % Wt AQUA CI 77499 STEARIC ACID ORYZA SATIVA CERA HYDROGENATED CETYL OLIVE ESTERS GLUCAMINE BUTYLENE GLYCOL COPERNICIA CERIFERA CERA HELIANTHUS ANNUUS SEED CERA ACACIA SENEGAL GUM PVP CYCLOPENTASILOXANE PVP/EICO SENE COPOLYMER SILICA CYCLOHEXASILOXANE CERA ALBA SYNTHETIC WAX SHOREA ROBUSTA RESIN 505 510 515 17 IMIDAZOLIDINYL UREA DIMETHICONE RHUS VERNICIFLUA PEEL CERA HYDROXYETHYLCELLULOSE METHYLPARABEN DISODIUM EDTA HYDROGENATED MYRISTYL OLIVE ESTERS LECITHIN CETEARETH-ZO PANTHENOL TOCOPHERYL ACETATE PROPYLPARABEN PHENOXYETHANOL BHT PEG-l 2 DIMETHICONE ETHYLPARAB EN Utilising such methods as described in the examples, product performance can beassessed, represented by objective statistically significant means (Fig 4; fig 6).
    “Beauty Product” is taken to include natural and/or artificial hair f1laments such as falseeyelashes and extensions; as Well as brushes, combs, applicators and delivery devicesfor the application of cosmetic and/or topical compositions.
    The term “Cosmetic products” is taken to include but not limit to mascaras,conditioning agents, primers, serums and any other cosmetic compositions applied tothe eyelash, eyelash root, eyelid, eyeball, under eye, eyebroW and surrounding area,Which are intended to impart advantageous properties such as lengthening, lifting, eye-opening, curling and/or thickening, as Well as f1rming, tightening, brightening, reducepuffiness etc.
    “Product performance” may include, but is not limited to testing the performance,efficacy and/or effectiveness of beauty products, particularly beauty productscomprising natural and/or artificial hair filaments such as false eyelashes andextensions; cosmetic products including but not limited to mascaras, conditioning agents, primers, serums and any other cosmetic formulations applied to the eyelash, 520 525 530 535 540 545 550 18 eyelash root, eyelid, eyeball, under eye, eyebrow and surrounding area, which areintended to impart advantageous properties such as lengthening, eye-opening, curlingand/or thickening as well as firming, tightening, toning, lifting, brightening, reducepuffiness etc. Also included is product perforrnance of therapeutic (medicinal orveterinary) products intended for use on the eyelash, eyelash root, eyelid, eyeball,eyebrow and the surrounding area of the eye. Product perforrnance testing of suchmedical products may be useful to assess effectiveness of products in the treatment ofvarious eye conditions including but not limited to trichiasis, keratoconus, keratoglobus,glaucoma and/or localised inflammation of the surrounding eye area (e. g. upper and/orlower eyelid, under eye and eyebrow).
    “Diagnostic tool” may include use of the method, systems and apparatus to diagnose apre-existing condition associated with the aesthetic feature or to predict the likelihood ofdeveloping a condition associated with the aesthetic feature, in particular a conditionassociated with the eye or surrounding area. Such conditions include but are not limitedto trichiasis, keratoconus, keratoglobus, glaucoma and/or localised inflammation of theeye area (e.g. upper and/or lower eyelid, under eye and eyebrow).
    “Reference sample(s)” includes but does not limit to the use of the method to generateuntreated control data as a means of reference to compare and evaluate productperforrnance; generation of consumer/patient records, generation of database comprisingreadout information optionally with additional consumer/patient information that can beused to tailor products to consumer/patient or predict incidence or occurrence of acondition or inclusion in population subgroup.
    “Database” is taken to comprise of, but not limit to, the following elements: (i)collection of data/ information, such as consumer/patient records, reference samples,and/or readout information and (ii) a means of categorising, organising and retrievingsaid collection in a systematic way.
    “Disorder” is taken to include but not limit to conditions, particularly of the skin and/oreyelashes, brought about by an imbalance of the normal processes or a disease statethereof. Examples of conditions of interest within the scope of the present inventioninclude but are not limited to trichiasis, keratoconus, keratoglobus, glaucoma and/orlocalised inflammation of the eye area (e.g. upper and/or lower eyelid, under eye and eyebrow). 555 560 565 570 575 1 9“Panellist(s)” is taken to include but not limit to individuals taking part in, and underassessment With respect to effectiveness and product performance of a beauty orcosmetic nature.
    “Patient(s)” is taken to include but not limit to individual(s) presenting With thecondition of interest, Which includes but not limited to the following: trichiasis,keratoconus, keratoglobus, glaucoma and/or localised inflammation of the eye area (e. g.upper and/or lower eyelid, under eye and eyebroW).
    “Control Group” is taken to include but not limit to healthy individual(s) selected as perstandard clinical research protocols to meet the criteria set by the study. Suchindividuals provide a “reference sample” to compare against the “patient(s)” group toestablish onset of disease state or conditions.
    “Onset differential” is taken to include but not limit to the potential for an individual or“patient” to be presenting the symptoms associated With the condition of interest, andthus the likelihood that the patient requires treatment and/or further more invasivediagnosis.
    The Words “comprises/comprising” and the Words “having/including” When used hereinWith reference to the present invention are used to specify the presence of statedfeatures, integers, steps or components but does not preclude the presence or addition ofone or more other features, integers, steps, components or groups thereof.
    It is appreciated that certain features of the invention, Which are, for clarity, described inthe context of separate embodiments, may also be provided in combination in a singleembodiment. Conversely, various features of the invention Which are, for brevity,described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination.
    权利要求:
    Claims (11)
    [1] 1. l. A method of analysing two images of an eye of a subject to determine the change,between the two images, of the extent to which the eye appears to be open, wherein theimages are profile-view images of the subject°s eye taken from the same Vantage point;wherein each image of the eye is characterised by an eyeball area bounded by a lowereyelid, an upper eyelid, and an eyeball periphery; and wherein the lower and uppereyelids comprise lower and upper lashes respectively, the method characterised by thesteps of:for each image of the eye: plotting a lower target point proximate to the eyeball periphery and the lowereyelid; plotting an upper target point proximate to the eyeball periphery and the uppereyelid; drawing a measurement line through the lower target point and the upper targetpoint; and calculating a Value associated with the measurement line; comparing the degree of change in the Value associated with the measurementline of the first image and the value associated with the measurement line of the secondimage; and inferring from the degree of change in the values associated with the measurement lines the change of the extent to which an eye appears to be open.
    [2] 2. The method of claim l, wherein: the lower target point comprises the point of intersection between the lowereyelid and the eyeball periphery; the upper target point is plotted by: drawing a Vertical line through the lower target point such that it intersects withthe upper lid at the base of the upper lashes, and plotting the point of Vertical lineintersection; plotting the point of upper/ lower lid intersection where the upper lid intersects with the lower lid; 610 615 620 625 630 635 640 21 drawing an upper lid line through the point of Vertical line intersection and thepoint of upper/ lower lid intersection such that the upper lid line intersects with theeyeball periphery; designating the point of intersection between the upper lid line and the eyeballperiphery as the upper target point; further wherein the measurement line is drawn between the lower target point and the upper target point following the outline of the eyeball periphery.
    [3] 3. The method of claim 1, whereinthe upper target point comprises the highest point on the upper lashes;the lower target point comprises the lowest point on the lower lashes; andwherein the measurement line is a straight line drawn between the lower target point and the upper target point.
    [4] 4. A method of analysing two images of an eye of a subject to determine the change,between the two images, of the extent to which the eye appears to be open, wherein theimages are profile-view images of the subject°s eye taken from the same Vantage point;wherein each image of the eye is characterised by an eyeball area bounded by a lowereyelid, an upper eyelid, and an eyeball periphery; and wherein the lower and uppereyelids comprise lower and upper lashes respectively, the method characterised by thesteps of:for each image of the eye: plotting an upper/ lower lid point of intersection at the point of intersection of theupper eyelid and the lower eyelid; plotting a lower target point proximate to the eyeball periphery and the lowereyelid; plotting an upper target point proximate to the eyeball periphery and the uppereyelid; def1ning a triangle having apices respectively at each of said plotted points; measuring a characteristic area within said triangle, wherein the characteristicarea is optionally the white of the eye; comparing the degree of change in the magnitude of the characteristic area of the first image and the magnitude of the characteristic area of the second image; and 645 650 655 660 665 670 22 inferring from the degree of magnitude change the extent to Which an eye appears to be open.
    [5] 5. A method of deterrnining the change over time in the extent to Which an eye of asubject appears to be open comprising the steps of: taking a first profile-view image of a subject at a first point in time; taking a second profile-view image of a subject at a second point in time; and performing the method of any of claims l to 4 on said first and second images.
    [6] 6. A method as claimed in any preceding claim for the diagnosis of disease states and/or conditions associated With the eye.
    [7] 7. A method as claimed in claim 6 Wherein the disease states or conditions are selectedfrom trichiasis, keratoconus, keratoglobus, glaucoma and localised inflammation of the eye, as Well as the results of environmental and genetic stimuli.
    [8] 8. A method as claimed in any of claims l to 5 for the assessment of cosmetic compositions Which may be applied to the eyelash.
    [9] 9. A non-transitory computer readable medium carrying instructions thereon, Which,When executed by a processor, cause the processor to carry out the method of any of claims 1-8.
    [10] 10. l0.An image analysis apparatus conf1gured to perform the method of any of claims l-4 or 6 to 8 Wherein the images are digital images.
    [11] 11. ll.An image capture and analysis system configured to perform the method of claim 5comprising:an image capture device; and the image analysis apparatus of claiml0.
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    同族专利:
    公开号 | 公开日
    WO2015097183A3|2015-08-27|
    WO2015097183A2|2015-07-02|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    DE112010005290T5|2010-02-22|2012-12-27|Toyota Jidosha K.K.|Image processing apparatus and fatigue judging apparatus|
    JP5907710B2|2011-12-05|2016-04-26|長谷部　由紀夫|Eyelash analysis method and analysis apparatus|US10952519B1|2020-07-16|2021-03-23|Elyse Enterprises LLC|Virtual hub for three-step process for mimicking plastic surgery results|
    US11160497B1|2020-07-16|2021-11-02|Elyse Enterprises LLC|Software configuration for virtual skincare assessment and virtual cues|
    法律状态:
    2019-08-20| NAV| Patent application has lapsed|
    优先权:
    申请号 | 申请日 | 专利标题
    GB201322913A|GB201322913D0|2013-12-23|2013-12-23|A test method and assay for diagnosis and evaluation of clinical product performance|
    IES20130393|2013-12-23|
    PCT/EP2014/079070|WO2015097183A2|2013-12-23|2014-12-22|A test method and assay for diagnosis and evaluation of clinical product performance|
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