COMPOSITIONS, DEVICES, SYSTEMS, KITS AND METHODS FOR THE TREATMENT OF A SKIN CONDITION

Abstract

A multi-component regimen for the treatment of a skin condition including administering at least two components of at least one galenic microbial composition, applying at least one acidic composition, applying at least one mineral salt composition, illuminating an area of the skin and heating an area of the skin. The regimen includes at least one of administering at least one galenic microbial composition and illuminating an area of the skin. Also provided is a galenic microbial composition including bacteria of the phylum Actinobacterium and a dermatologically compatible carrier. Further provided is a wearable cutaneous treatment device for the therapeutic illumination of mammalian skin when activated, to project light outwards from the inner surface to illuminate at least a portion the area of skin.

Claims

1. A multi-component regimen for the treatment of a skin condition in a subject in need thereof, the regimen comprising, in no particular order, at least two components selected from the group consisting of: administering at least one galenic microbial composition to the subject; applying at least one acidic composition to an area of skin of the subject; applying at least one mineral salt composition to an area of skin of the subject; illuminating an area of skin of the subject; and heating of an area of skin of the subject, wherein the regimen comprises at least one of administering at least one bacterial composition to the subject or illuminating an area of skin of the subject, thereby treating the skin condition, wherein said at least two components are carried out independently, sequentially, simultaneously or concomitantly, or in any combination thereof.

2. The multi-component regimen according to claim 1, wherein said administering of said at least one galenic microbial composition, said applying of said at least one acidic composition and applying of said at least one mineral composition are carried out independently, sequentially, simultaneously or concomitantly, or in a single composition.

3-7. (canceled)

8. The multi-component regimen according to claim 1, wherein said at least one galenic microbial composition comprises at least one biological ingredient selected from the group consisting of at least one microorganism, at least one substance produced by a microorganism, and any combination thereof.

9-11. (canceled)

12. A galenic microbial composition comprising bacteria of the phylum Actinobacterium and a dermatologically compatible carrier.

13-17. (canceled)

18. The multi-component regimen according to claim 1 or galenic microbial composition according to claim 12, wherein said galenic microbial composition comprises a carrier comprising an oily ingredient.

19-24. (canceled)

25. The multi-component regimen according to claim 1 or galenic microbial composition according to claim 12, wherein said galenic microbial composition further comprises a dermatologically compatible antioxidant.

26. (canceled)

27. The multi-component regimen according to claim 1 or galenic microbial composition according to claim 12, wherein said galenic microbial composition comprises a carrier selected from the group consisting of water and aloe vera leaf juice or a combination thereof.

28. The multi-component regimen according to claim 1 or galenic microbial composition according to claim 12, wherein said galenic microbial composition further comprises at least one excipient selected from the group consisting of a thickener, a preservative, a neutralizer, a humectant, an emulsifier, an occlusive, a coemulsifier, an antioxidant, a fragrance and any combination thereof.

29-36. (canceled)

37. The multi-component regimen according to claim 1, wherein said illuminating and/or heating of said area of the skin of a subject is accomplished using a wearable device suitable for the therapeutic illumination and/or heating of mammalian skin.

38. (canceled)

39. A wearable cutaneous-treatment device for the therapeutic illumination of mammalian skin, comprising: a support component having an inner surface, said support component dimensioned to cover an area of skin of a subject; at least one light source arranged on said inner surface, the light source or light sources constituting an illumination panel; and at least one attachment component for reversibly securing the device to a mammalian subject so that said inner surface faces an area of skin of the subject, said light source or sources configured, when activated, to project light outwards from said inner surface to illuminate at least a portion said area of skin.

40. The wearable cutaneous-treatment device according to claim 39, wherein the support component is contoured or flexible.

41-42. (canceled)

43. The multi-component regimen according to claim 1, or the wearable cutaneous-treatment device according to claim 39, wherein said illuminating of an area of skin is accomplished by a plurality of light sources, said plurality of light sources emitting at least two different wavelengths of light.

44. The multi-component regimen according to claim 1 or the wearable cutaneous-treatment device according to claim 39, wherein said illuminating of an area of skin is accomplished by a plurality of light sources, said plurality of light sources emitting a single wavelength of light.

45-47. (canceled)

48. The multi-component regimen according to claim 1 or the wearable cutaneous-treatment device according to claim 39, wherein said illumination and/or said device are configured to illuminate a first portion of an area of skin of the subject with light of a first wavelength and a second portion of an area of skin of the subject with light of a second wavelength.

49. The multi-component regimen according to claim 1, comprising a skin heating component or wearable device capable of heating mammalian skin, wherein said heating is accomplished by at least one heat source.

50. The multi-component regimen according to claim 49, wherein said wearable device further comprises at least one component selected from the group consisting of a heat sensor configured to monitor the temperature of said area of skin of the subject, a thermostatic control, and combinations thereof.

51-55. (canceled)

56. A system for the treatment of a skin condition, comprising at least two selected from the group consisting of at least one galenic microbial composition, at least one acidic composition, at least one mineral composition, at least one source of heat and at least one source of light, wherein the system comprises at least one galenic microbial composition or at least one source of light.

57. A kit for the treatment of a skin condition, comprising at least two selected from the group consisting of at least one galenic microbial composition, at least one acidic composition, at least one mineral composition, at least one source of heat and at least one source of light, wherein the kit comprises at least one galenic microbial composition or at least one source of light.

58-59. (canceled)

60. A galenic microbial composition consisting essentially of Propionibacterium shermanii bacteria, olive oil; tocopherol; geranium oil; and rose flower oil.

61. A method for the treatment of a skin condition comprising administration to a subject in need thereof the galenic microbial composition of claim 60.

62-63. (canceled)

Description

BRIEF DESCRIPTION OF THE FIGURES

[0201] Some embodiments of the invention are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some embodiments of the invention may be practiced. The figures are for the purpose of illustrative discussion and no attempt is made to show structural details of an embodiment in more detail than is necessary for a fundamental understanding of the invention. For the sake of clarity, some objects depicted in the figures are not to scale.

[0202] In the Figures:

[0203] FIG. 1A schematically illustrates, according to an exemplary embodiment, a wearable cutaneous-treatment device viewed towards an illumination panel;

[0204] FIG. 1B schematically illustrates, according to an exemplary embodiment, a wearable cutaneous-treatment device viewed towards an illumination panel near an exemplary part of a user's body;

[0205] FIG. 2 schematically illustrates, according to an exemplary embodiment, a close-up view of an illumination panel of a wearable cutaneous-treatment device;

[0206] FIG. 3 schematically illustrates, according to an exemplary embodiment, a side view of an illumination panel of a wearable cutaneous-treatment device;

[0207] FIG. 4 schematically illustrates, according to an exemplary embodiment, a close-up schematic view of an illumination panel of a wearable cutaneous-treatment device;

[0208] FIG. 5 schematically illustrates, according to an exemplary embodiment, a view of an illumination panel of a wearable cutaneous-treatment device comprising a plurality of light sources and a plurality of heating pads;

[0209] FIG. 6 schematically illustrates, according to an exemplary embodiment, a block diagram of a system for controlling the operation of a wearable cutaneous-treatment device;

[0210] FIG. 7 schematically illustrates, according to an exemplary embodiment, a block diagram of states and modes of operation of the system for controlling the operation of a wearable cutaneous-treatment device; and

[0211] FIGS. 8A and 8B schematically illustrates, according to an exemplary embodiment, a wearable cutaneous-treatment device formed as a sleeve.

DESCRIPTION OF SOME EMBODIMENTS OF THE INVENTION

[0212] Some embodiments of the invention relate to compositions, devices, systems, kits and methods for the treatment of skin conditions such as psoriasis.

[0213] Before explaining at least one embodiment in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth herein. The invention is capable of other embodiments or of being practiced or carried out in various ways. The phraseology and terminology employed herein are for descriptive purpose and should not be regarded as limiting.

[0214] The methods and treatment regimens according to the teachings herein can be performed using any suitable device or combination of devices. In some preferred embodiments, a method or treatment regimen according to the teachings herein is performed using a wearable cutaneous-treatment device for the therapeutic illumination of mammalian skin according to the teachings herein (also called a wearable device). The device is typically configured to be worn by a subject and, while being worn, to illuminate an area of skin of the subject, for example, an area of skin afflicted with a cutaneous condition. As discussed hereinbelow, in some embodiments the device is configured to heat the area of skin, alternatingly or concurrently with the illumination. In some embodiments, the device is configured to sense (e.g., measure, monitor) various parameters of the cutaneous condition. In some embodiments, the device is configured to be used in any setting, for example while performing activities indoors or outdoors for example while watching TV, reading, hiking and the like. According to one embodiment, the wearable device is portable, namely it may be carried by user to any desired place for usage. According to another embodiment, the wearable device is stationary, namely it is configured to stay in place, for example due to its size, or weight, or complexity of structure.

[0215] A wearable cutaneous-treatment device for the therapeutic illumination of mammalian skin according to the teachings herein comprises: [0216] a support component having an inner surface, the support component dimensioned to cover an area of skin of a mammalian subject (preferably a human subject); [0217] at least one light source arranged on the inner surface of the support component constituting an illumination panel; and [0218] at least one attachment component for reversibly securing the device to a mammalian subject so that the inner surface faces an area of skin of the subject,
wherein the light source or sources are configured, when activated, to project light outwards from the inner surface to illuminate at least a portion the area of skin of the mammalian subject.

[0219] A person having ordinary skill in the art is able, upon perusal of the description herein is able to manufacture a device according to the teachings herein without resorting to inventive activity using general common knowledge.

[0220] Referring now to the Figures, FIG. 1A schematically illustrates according to an exemplary embodiment, a wearable cutaneous-treatment device 10 viewed towards an illumination panel 12 thereof. Device 10 includes a support component 14 a somewhat flexible pad of multiple layers of woven polyester in which inner surface 16 are arranged 410 light sources (LEDs) 16 which constitutes illumination panel 12. Held inside support component 14 are the required wiring, power supply and controller required of device 10. For light sources 16, device 10 includes 310 UVB and/or NB-UVB LEDs, 20 red LEDs, 20 blue LEDs, 20 green LEDs, 20 white-light LEDs and 20 IR LEDs. The different types of LEDs are distributed homogeneously on illumination panel 12 so that all of an area of skin covered by device 10 when worn is illuminated in substantially the same fashion. As an attachment component, device 10 includes reversibly-closeable attachment straps 20. Device 10 is fashioned to be waterproof, that is to say, can be used when immersed in water, for example, in a shower or swimming pool.

[0221] In an alternative, otherwise-identical, embodiment, a device includes an illumination panel having 310 individual LEDS, a total of four different types of light sources of: 160 UVB and/or NB-UVB LEDs illuminating at a central wavelength of 311 nm, 50 red LEDs illuminating at a central wavelength of 633 nm, 50 blue LEDs illuminating at a central wavelength of 415 nm and 50 IR LEDs illuminating at a central wavelength of 830 nm. The different LEDs are distributed homogeneously on the illumination panel.

[0222] FIG. 1B schematically illustrates device 10 viewed towards illumination panel 12 near an exemplary part of a body of a subject, arm 22. As is understood from FIG. 1B, device 10 is secured to a part of the body of a subject by holding illumination panel 12 against the portion of skin to be treated, securing attachment straps 20 one to the other and then tightening straps 20 to immovably hold device 10 against the body of the subject. In FIG. 1B, support component 14, including inner surface 16 and an outer surface 24 are held inside a protective pouch 26. Pouch 26 protects support component 14 and illumination panel 12, for example, from dirt, dust, humidity and to prevent contact of illumination panel 12 with a topical composition applied on the treated area of a surface of a body of a user, and the like. At least part of pouch 26 that covers illumination panel 12 is sufficiently transparent to the light emitted by light sources 18 of illumination panel 12 so as not to negatively influence the results of the phototherapy treatment applied by illumination panel 12. Thus, pouch 26 is fashioned of any material known in the art that fulfills the aforementioned requirements, for example, is made of plastic sheeting and the like. Also seen in FIG. 1B is switch 28 which is functionally associated with the controller of device 10.

[0223] FIG. 1C schematically depicts the inside of support component 14 of device 10 in cross section parallel to illumination panel 12, showing a controller 30 with a memory 32 and a Bluetooth® transceiver 34, a power source 36 and switch 28 embedded inside support component 14. Switch 28 has three states: a first “off” state where none of the components of device 10 receive power and cannot operate, a “manual” state where all the LEDs are activated to illuminate for 15 minutes before shutting down and a “APP” state where controller 30 uses Bluetooth® transceiver 34 to establish and maintain wireless communication with a host (e.g., computer, tablet or smartphone) running control software for the device and, when wireless communication is maintained to receive commands such as to operate and cease to operate from the smartphone.

[0224] FIG. 2 schematically illustrates a close-up view of a portion of illumination panel 12 of an embodiment of a device according to the teachings herein, showing LEDs 18 arranged in columns and rows.

[0225] FIG. 3 schematically illustrates a side view of a portion of illumination panel 12 of device 10. Illumination panel 12 comprises a support sheet 38 and a plurality of light sources, LEDs 18 attached to support sheet 38. As noted above, illumination panel 28 is configured to be placed on a surface of a body of a user with light sources 18 facing the surface of the body. For example, illumination panel 12 is placed on an area of a skin where there is a cutaneous condition to be treated by illumination. An exemplary cutaneous condition that may be treated with illumination panel 12 of device 10 is a psoriasis skin lesion.

[0226] According to some embodiments, support sheet 38 may comprise a synthetic or natural cloth or fabric, a conductive or non-conductive polymer, or the like.

[0227] In some embodiments, the distance between the surface of an illumination panel of a device and a treated area of a surface of a body of a user is fixed, typically between 0 and 3 cm. A non-zero distance can be maintained in any suitable way, for example, pads of material (e.g., rolls of cloth, lengths of silicon rubber) arranged around the periphery of the illumination panel.

[0228] In some embodiments, the distance between the surface of an illumination panel and a treated area of a surface of a body of a user is adjustable, typically in the range of between 1 and 3 cm. The distance can be adjusted in any suitable way, for example, inflatable rolls of material (e.g., tubular balloons covered with an elastic-cloth) arranged around the periphery of the illumination panel. Such adjustable distance allows the user to adjust the distance of to illumination panel to the treated area of a body of the user to give rise to optimal treatment results.

[0229] In some embodiments, a support sheet such as support sheet 38 is rigid. In some embodiments, a support sheet such as support sheet 38 is flexible, for example made of fabric, nylon sheet and the like, thus allowing the illumination panel to bend to confirm to the shape of the surface of a body on which it is placed.

[0230] As noted above, light sources used in implementing a device according to the teachings herein may be any suitable light sources. In preferred embodiments, such as in device 10, the light sources are LEDs (light-emitting diodes) 18.

[0231] FIG. 4 schematically illustrates a close-up schematic view of part of an exemplary embodiment of illumination panel 12 of device 10 arranged in a specific geometric pattern. In some embodiments, all of the light sources are arranged in a regular array. In some embodiments, such as depicted in FIG. 4, the most common type of light sources (the 310 UVB and/or UVB-NB LEDs) are arranged in a regular 31×10 rectangular array) while the less common type of light sources are interspersed within the array. In FIG. 4 are seen part of three rows of light sources, row 40, row 42 and row 44. Rows 40 and 44 include only UVB or UV-NB light sources 18a while row 42 includes a red light source 18b, a blue light source 18c, a green light source 18d, an IR light source 18e and a white light source 18f.

[0232] In other embodiments the light sources such as LEDs are arranged in any other suitable pattern, for example, an illumination pattern that mimics irradiation by the sun in the area of the Dead Sea, which is believed by some to be optimal for the treatment of cutaneous conditions—a treatment type so-called Dead Sea climatotherapy.

[0233] Furthermore, depending on the embodiment, different wavelengths of light can be emitted from light sources that are configured to emit only one type of light, e.g., monochromatic light sources and/or from light sources that are polychromatic and emit multiple wavelengths of light, e.g. a light source that emits white light such as 18f in FIG. 4 or a light source that is configured to emit either red or blue or green or white light; or any combination thereof.

[0234] Light sources used in implementing a device according to the teachings herein are any type of suitable light source known in the art. According to one embodiment, the light sources comprise or are LEDs, as depicted in FIGS. 1-4. In such embodiments, any suitable type of LED may be used including suitable LEDS known in the art, for example but not limited to, LEDs that are based on AlGaN, AlGaP, GaAlAs, InGaN/GaN, AIN semiconductors, and the like, generating light within various light wavelength ranges.

[0235] It should be noted that an illumination panel of a device according to the teachings herein may be of any suitable size and/or dimensions and/or shape that are suitable for covering an area of a surface of a body of a subject to be treated. Thus, any size and/or any dimensions and/or any shape of the illumination panel are within the scope of the present subject matter. For example, in some embodiments and illumination panel is rectangular, circular, oval, and the like, at any size or dimensions. Further, any suitable number of light sources, including more than 1,000 light sources, is within the scope of the present subject matter, as the size, dimensions and shape of the illumination panel 10 may allow.

[0236] As noted above, in some embodiments a device according to the teachings herein comprises a skin heating component. In some embodiments, the skin heating component is at least partially found on the inner surface of the support component, the illumination panel. FIG. 5 schematically illustrates a view of an exemplary embodiment of an alternative illumination panel 46 of device 10 according to the teachings herein, comprising a plurality of light sources 18 and a plurality (fourteen) of individual heating pads 48 comprising a heat resistive material printed on a support sheet 38, wherein heating pads 48 emit heat upon passage of an electric current, which together constitute a skin heating component of device 10. In device 10, illumination panel 46 includes a support sheet 38 to which are attached light sources 18 and heating pads 48.

[0237] In some embodiments a device is configured to optionally function in a mode where only the heating component is activated to heat the skin surface and the light sources are not activated to illuminate the skin surface.

[0238] Additionally or alternatively, in some embodiments a device is configured to optionally function in a mode where only the light sources are activated to illuminate the skin surface and the heating component is not activated to heat the skin surface.

[0239] Additionally or alternatively, in some embodiments a device is configured to optionally function in a mode where both the light sources are activated to illuminate the skin surface and the heating component is activated to heat the skin surface.

[0240] In some embodiments there is no separate heating component and rather some or all of the light sources, when operated, produce sufficient heat to effectively function as a heating component of a device. In some such embodiments, a device further comprises a heat-dispersion mechanism (preferably associated with the illumination panel) configured to homogenously disperse the heat generated by the light sources throughout the illumination panel and over the treated area of a surface of a body of a subject. In some such embodiments, a device further comprises a heat-dispersion mechanism (preferably associated with the illumination panel) as a means for heating a treated area of a surface of a body of a subject.

[0241] In some embodiments, a device comprises a separate heating component (preferably associated with the illumination panel, such as heating pads 48 of device 52 in FIG. 5) and a heat dispersion mechanism as described immediately hereinabove, that may be operated separately or simultaneously for heating the treated area of a surface of a body of a subject.

[0242] In some embodiments, a device according to the teachings herein further comprises at least one sensor. In such embodiments, the at least one sensor is configured to monitor the condition of a treated area of a surface of a body of a user, for example in order to monitor the condition of the treated area prior the treatment in order to allow application of a type of treatment that is suitable for the condition of the area to be treated. The at least one sensor may be used also for monitoring the condition of the treated area during or after treatment in order to aid in the assessment of the results and progress of the treatment.

[0243] Any type of sensor known in the art that is suitable for monitoring the condition of a treated area of a surface of a body of a user is under the scope of the present subject matter. Examples of such a sensor include, but not limited to: at least one heat sensor (also called temperature sensor), configured to monitor the temperature of the treated area during treatment, for example in order to prevent overheating of the treated area, as discussed above. The at least one sensor may be attached to the illumination panel (e.g., to a support sheet that is part of the illumination panel) or is physically separate from the illumination panel, or any combination thereof.

[0244] The present subject matter further provides a system for controlling the operation of a wearable cutaneous-treatment device. FIG. 6 schematically illustrates, according to an exemplary embodiment, a block diagram of a system 50 for controlling the operation of an embodiment of wearable cutaneous-treatment device 52 having an illumination panel 46 as described with reference to FIG. 5. Device 52 is substantially similar to device 10 described above.

[0245] System 50 comprises a controller 30. Controller 30 is communicationally connected to illumination panel 46 and is configured to control the operation of the light sources (not depicted in FIG. 6) thereof as well as to control the operation of heating pads 48 constituting the heating component of device 52, as well as to receive data from at least one sensor, for example a light board temperature sensor 54 configured to determine the temperature of illumination panel 46, and a skin temperature sensor 56, configured to determine the temperature of an area of a surface of a body of a user that is treated with device 52.

[0246] System 50 further comprise a control panel 58 with a display 60 (e.g., LCD or LED display) communicationally-connected to controller 30 configured to display data regarding the operation of device 52, such as data received from at least one of sensors 54 and 56, and the like. In some embodiments, a display is a component of a device, for example display 58 of device 52. In some alternate embodiments, a display is a display of a remote device (e.g., a smartphone) in communication with a controller of a device.

[0247] Control panel 58 of system 50 further comprises a keyboard 62 as an input component connected to controller 30 to input user commands and data for operating device 52. In some alternate embodiments, an input component is an input component of a remote device (e.g., a smartphone) in communication with a controller of a device. Drivers 64 provide power to the light sources.

[0248] System 50 further comprises a memory 32 communicationally connected to controller 30. Memory 32 is configured to store, for example, predetermined treatment profiles, i.e., predetermined patterns (protocols) of illumination and/or heating of an area of a surface of a body of a subject. A treatment profile may comprise illumination/heating duration parameters, intensity parameters of the illumination/heating, changing patterns of wavelength and/or temperatures and/or duration of illumination/heating in each type of light/temperature, frequency of pulsation of light irradiation and/or heating, and the like. A treatment profile may also comprise information about the type of cutaneous condition that the treatment profile is suitable to treat.

[0249] System 50 further comprise a host 60 communicationally connected to controller 30. Host 60 is a computing device, for example, but not limited to, a computer, a smartphone, a mobile phone, a tablet, and the like. According to one embodiment, host 60 is configured to operate and/or store software, for example computer programs or smartphone applications, for the operation of device 52. In some embodiments, host 60 is configured to display data received by at least one of sensors 54 and 56, or data provided by a user, as described hereinafter. Alternately or additionally, in some embodiments a host is configured to process images. According to a further embodiment, a host is configured to collect data, analyzed the collected data and export data relating to treatment regimes.

[0250] System 50 is configured to automatically shut down when there is a need for system 50 to shut down, for example, when a treatment has been ended, when device 52 is overheated, the when safety of the user is at risk, and the like.

[0251] System 50 further comprises a power source 36, as described above, for example a battery, electrically connected to the components of the system 50 for supplying electrical power for their operation.

[0252] In some embodiments, a system of a device further comprises a user manual, detailing instructions for use, troubleshooting and any other information needed for safe and efficient operation of the wearable device and the system.

[0253] The various components of system 50 are communicationally connected by any type of communication connection known in the art, for example but not limited to, wired communication like a cable with USB plugs, unwired communication like Bluetooth®, Wifi, and the like. In FIG. 6, system 50 comprises a Bluetooth® transceiver 34 functionally associated with controller 30 that enables communication between the controller 30 and other components of system 50, for example host 66.

[0254] As noted above, treatment of a skin surface of a subject with a device according to the teachings typically comprises a treatment profile which includes a light and/or heat treatment of a cutaneous condition. The illumination pattern, namely the wavelengths and doses and duration of illumination, of the light emitted from various light sources, as well as the heating pattern, may be controlled, either manually or automatically. A treatment profile may be provided, based for example on updated results of research conducted in the area of treatment of cutaneous conditions with light and heat. A specific treatment profile may be based on various parameters, for example, but not limited to, skin type, physician's recommended treatment, age, gender, type of cutaneous condition, severity of the cutaneous condition, and the like.

[0255] In some embodiments, a system is configured to provide various types of treatment profile, as well as create new treatment profiles based, for example on data about a user and/or a cutaneous condition provided to the system, or data based on scientific research on cutaneous conditions treatment provided to the system. The system is capable of allowing the creation of treatment profiles comprising a wide range of spectral light exposure, various types of heating treatments, various treatment duration times, various pulsating of illumination types, and any combination thereof. Furthermore, the operation of a device and of a system may be conducted in accordance with established safety procedures and regulations.

[0256] Controller 30 of system 50 is communicationally connected to the illumination panel 46, and is configured to control the operation of illumination panel 46, including illuminating, heating or concurrently illuminating and heating of an area of a surface of a body of a subject.

[0257] In some embodiments, controller 30 controls the operation of illumination panel 46 using predetermined treatment profiles, which are stored in memory 32 that is communicationally connected to controller 30. In addition, controller 30 is communicationally-connected to host 66, for example a computer, a smartphone, a mobile phone, a tablet, and the like. A user may use host 66 to operate controller 30, which in turn activates a treatment profile according to the choice of the user.

[0258] In some embodiments, a device according to the teachings herein may be activated manually. In other words, a user may select a predetermined treatment profile manually, for example by using keyboard 62 which is physically associated with device 52 or by using host 66, for example by using a keyboard of a computer or a touch-screen of a smartphone or a tablet.

[0259] Once a treatment profile is selected it may be activated, and as a result the illumination panel illuminates, or heats, or concurrently both illuminates and heats an area to be treated according to the chosen treatment profile.

[0260] In some embodiments, a system associated with a device according to the teachings herein is configured to store and run software that is configured to diagnose the situation of a cutaneous condition of a subject, by analyzing data provided, for example, by a user, a professional person like a physician, and the like. Any type of data analysis that is performed by the software is under the scope of the present subject matter. Any type of data known in the art is under the scope of the present subject matter. Examples of data include, but not limited to, text, images and the like. For example, text data may be answers to a questionnaire regarding a user and the condition of a cutaneous condition to be treated, images of hair, eyes and the like. Any type of image known in the art is under the scope of the present subject matter. Furthermore, the image may be of any subject known in the art that may be used during analysis for the determination of the situation of a cutaneous condition of a user. Image data may be images of a cutaneous condition to be treated. Data that are provided to the software may be stored in a memory for future usage, for example for monitoring the progress of treatment of a user, research analysis of the data, and the like.

[0261] The software is configured to analyze the data and accordingly provide a treatment profile for treating a cutaneous condition. According to one embodiment, the software may either choose a predetermined treatment profile, or design a new treatment profile, that corresponds to the diagnosis and is expected to yield optimal treatment results. According to an additional embodiment, the software is configured to be updated with results of research in the area of treatment of cutaneous conditions, based for example on the most updated research, so it may activate the most updated treatment profiles, for the benefit of the user. According to some embodiments, the software may be stored in, an operated by, a host such as host 66, namely a computer, a smartphone, a mobile phone, a tablet, and the like.

[0262] For example, the software may diagnose the cutaneous condition of a user according to the Fitzpatrick skin type classification scale, and provide a treatment profile suitable for the type of cutaneous condition that was diagnosed. Table 1 summarizes some UVB light treatment profiles that are suitable for different types of cutaneous conditions according to the Fitzpatrick skin type classification scale.

TABLE-US-00001 TABLE 1 Skin Start dose 2.sup.nd dose 3rd dose 4.sup.th dose subsequent Type [mJ/cm.sup.2] [mJ/cm.sup.2] [mJ/cm.sup.2] [mJ/cm.sup.2] increments I 100 140 180 220 20% of previous dose II 120 170 220 270 20% of previous dose III 150 210 270 330 20% of previous dose IV 200 280 360 440 20% of previous dose V 300 420 540 600 20% of previous dose VI 500 700 900 1100 20% of previous dose * Maximum single dose 5000 mJ/cm.sup.2

[0263] FIG. 7 schematically illustrates, according to an exemplary embodiment, a block diagram 68 of states and modes of operation of the system for controlling the operation of a device 52 provided with a system 50 as depicted in FIG. 6.

[0264] In Off Mode 70, device 52 is connected to power source 36 and power source 36 is charged to a sufficient level. Device 52 is not connected to host 66 and illumination panel 46 is not functioning.

[0265] For operation, in 72 a user uses a switch to activate device 52. The switch used is optionally a dedicated switch and/or a switch implemented via keyboard 62 of control panel 58. In some embodiments, immediately after device is activated 72 a user selects either Manual Mode 74 or APP Mode 76. In some embodiments, during activation either Manual Mode 74 or APP Mode 76 is selected, e.g., a switch is a three-state switch (Off/Manual/App) especially a three-state toggle switch.

[0266] In Manual Mode 74, a user may select, via keyboard 62 and display 60 of control panel 58, to revert 78 to Off Mode 70 or to select a desired treatment profile, namely determine for example illumination intensity and treatment duration. During Manual Mode 72, Bluetooth® transceiver 34 is disabled. After user-selection of operational parameters, it is confirmed that device 52 is placed on a treatment area of the body of the subject, and a “StartTreatment” option is selected using control panel 58. The initial activation of the light sources of illumination panel 46 may be done gradually, and only after the skin temperature sensor 56 show that illumination panel 46 is positioned over the skin. Skin temperature sensor 56 measure initial skin temperature should be in the range of substantially 28-34° C. If the measured skin temperature is below this range, the operation of the light sources of illumination panel 46 is stopped.

[0267] In APP Mode 76, a user may select to revert 78 to Off Mode 70, but ordinarily Bluetooth® transceiver 34 is activated and waits for establishing communication with host 66. After communication is established, software, for example an application, stored for example on host 66, is activated and controls the operation of device 52. This may be achieved for example by initiation of communication between host 66 and controller 30 of device 52. Once communication has been established, a treatment profile is set. Periodically, for example every three seconds, device 52 sends a status message to host 66. This periodic message is used for information purpose for a user, or stored in log. The operation of device 52—for example, control of electric current supplied to the light sources, control of illumination panel temperature and skin temperature, timing and any safety issues, is done by controller 30.

[0268] During both Manual Mode 74 and App Mode 76, a Continuous Built in Test Unit 80 of controller 30 monitors various parameters that relate to the operation of device 52. If Test Unit 80 detects an exceptional parameter, device 52 is automatically changed to Preservation Mode 82, optionally while activating an alarm and/or reporting the reason for entering Preservation Mode 82 on display 60 of control panel 58.

[0269] In Preservation Mode 82, illumination panel 46 is not powered and not functioning, but communication between device 52 and host 66 is maintained (if in APP Mode). Device 52 may enter into Preservation State 76 in case at least one of the following situations occurs: [0270] skin temperature sensor 56 measures a temperature higher than a predetermined
upper threshold, for example substantially 45° C.; [0271] skin temperature sensor 56 measure a temperature lower than a predetermined lower threshold, for example substantially 26° C., a situation showing that illumination panel 46 may not positioned correctly on the skin and that there is a danger of the subject looking at the light sources so it is important to shut-off illumination panel 46; [0272] light board temperature sensor 54 measures a temperature higher than a predetermined threshold, for example a temperature that may harm illumination panel 46 and/or the user; [0273] the electrical current (e.g., in Amperes) to the light sources is above a predetermined threshold, in order to avoid damage to the light sources.

[0274] In FIGS. 8A and 8B an additional embodiment of a wearable cutaneous-treatment device 84 according to the teachings herein is depicted. In FIG. 8A looking at an illumination panel 80 of device 84 and in FIG. 8B at device 84 from the front.

[0275] In device 84, a support component and attachment component are the same component 86, a flexible sleeve made of an elasticized cloth, shaped and dimension to fit over the knee of a human subject.

[0276] The entire inner surface of device 84 constitutes illumination panel 88, in which a plurality of light sources (LEDs, depicted as dots in FIG. 8A) is arranged.

[0277] Helping to maintain the shape of device 84 is a bendable rib 90 of polyethylene that also functions to protect the knee of a wearer from impact.

[0278] A control unit 92 including a controller, memory, power source and also a Bluetooth® transceiver to transmit information and receive commands from software that is loaded on the smartphone or a remote control of the user is attached to the bottom of the device on an encircling band 94.

Examples of Compositions for Use in the Methods Disclosed Herein

I. Exemplary Compositions

Materials:

[0279] P. shermanii bacteria (Propinobacterium 50) were obtained as a freeze-dried bacterial powder from Biena, Canada.

[0280] Olive oil (Olea europaea Fruit Oil) was obtained from Sophim, France (CAS No. 8001-25-0).

[0281] Tocopherol was obtained from Phyto Active Plant Extracts, Israel (CAS No. 59029) Geranium oil (Pelargonium graveolens oil) was obtained from Phyto Active Plant Extracts, Israel (CAS No. 8000462)

[0282] Rose flower oil (Rosa damascena extract) was obtained from Phyto Active Plant Extracts, Israel (CAS No. 8007010).

Example 1: Bacterial Composition a (Test Composition)

Bacteria:

[0283] 6.7% (w/w) P. shermanii (1×10.sup.6 CCFU, 0.005-2 g freeze-dried mix powder)

Carrier:

[0284] 92.8% (w/w) olive oil;

[0285] 0.5% (w/w) tocopherol;

[0286] 0.01% (w/w) geranium oil; and

[0287] 0.005% (w/w) rose flower oil.

[0288] All carrier ingredients were added to a mixing container and mixed for 5 minutes. The mixture was divided into 90 ml portions and filled into bottles. The bacterial powder was added to each bottle. The bottles were sealed and labelled.

Example 2: Bacterial Composition B

Bacteria:

[0289] Brevibacterium sp.; Propionibacteria acnes; and Micrococcus luteus (1×10.sup.6 CCFU,

[0290] 0.5-1 g freeze-dried mix powder)

Carrier:

[0291] 50% (w/w) olive oil;

[0292] 33.3% (w/w) shea butter;

[0293] 16.7% (w/w) beeswax.

[0294] All carrier ingredients were added to a mixing container and mixed while melting by heating. The temperature of the mixture was adjusted to 45° C. or less. The bacterial powder was added and mixed.

Example 3: Bacterial Composition C

Bacteria:

[0295] P. shermanii (1×10.sup.6 CCFU, 0.005-2 g freeze-dried mix powder)

Carrier:

[0296] 50% (w/w) olive oil;

[0297] 33.3% (w/w) shea butter;

[0298] 16.7% (w/w) beeswax.

[0299] All carrier ingredients were added to a mixing container and mixed while melting by heating to a temperature of about 65° C. The temperature of the mixture was then adjusted to 45° C. or less. The bacterial powder was added and mixed.

Example 4: Bacterial Composition D

Bacteria:

[0300] Brevibacterium sp.; Propionibacteria acnes; and Micrococcus luteus (1×10.sup.6 CCFU,

[0301] 0.5-1 g freeze-dried mix powder)

Carrier:

[0302] 50% (w/w) olive oil;

[0303] 12.5% (w/w) pomegranate oil;

[0304] 37.5% (w/w) rosehip oil.

[0305] All carrier ingredients were added to a mixing container and mixed. The bacterial powder was added and mixed.

Example 5: Bacterial Composition E

Bacteria:

[0306] 6% P. shermanii (1×10.sup.6 CCFU, 0.005-2 g freeze-dried mix powder)

Carrier:

[0307] 72% (w/w) Aloe barbadensis leaf juice with water;

[0308] 2% (w/w) sclerotium gum;

[0309] 0.2% (w/w) salicylic acid or citric acid;

[0310] 1.1% (w/w) sodium gluconate;

[0311] 5% (w//w) saccharide isomerate and/or cetearyl wheat straw;

[0312] 5% (w/w) glucoside and/or cetearyl;

[0313] 3% (w/w) coconut oil;

[0314] 2% (w/w) cetyl alcohol;

[0315] 3% (w/w) Olea europaea fruit oil;

[0316] 0.55 (w/w) tocopherol;

[0317] 0.1% (w/w) Lavendula angustifolia;

[0318] 0.1% (w/w) Rosa damscena extract.

[0319] Water and Aloe barbadensis leaf juice were mixed in a mixing container and heated to 60° C.

[0320] Sclerotium gum, salicylic acid/citric acid, sodium gluconate and saccharide isomerate/cetearyl wheat straw were added to the mixing container and mixed for a further 5 minutes.

[0321] In a second mixing container, glucosides/cetearyl, coconut oil, cetyl alcohol and olea Europaea fruit oil were mixed and heated to 60° C.

[0322] The mixtures in the two mixing containers were slowly combined and mixed for 30 minutes while cooling.

[0323] When the combined mixture reached a temperature of less than 40° C., the bacteria, tocopherol, Lavedula angustifolia and Rosa damascena extract were added and the final mixture further cooled to 25° C.

[0324] pH and viscosity were measured and adjusted, and pH adjusted, if necessary, to about 4.5.

Example 6: Acidic Composition

[0325] 0.1-0.3 mM citric acid in water.

[0326] Citric acid was diluted in water and the pH checked to ensure that a value of less than about 7 was attained.

Example 7: Mineral Composition

[0327] 30% (w/w) Dead Sea minerals in water.

Mineral composition:

[0328] 31-35% magnesium chloride

[0329] 24-26% potassium chloride

[0330] 4-8% sodium chloride

[0331] 0.4-0.6% calcium chloride

[0332] 0.3-0.6% bromide

[0333] 0.05-0.2% sulfate

[0334] Water of crystallization, typically 34-38%

[0335] The minerals were combined with water and mixed at ambient temperature.

II. Clinical Study Using Bacterial Composition A

Materials and Methods

Subjects

[0336] 16 otherwise healthy male and female subjects, between the ages of 18-65, suffering from psoriasis vulgaris as diagnosed by a qualified dermatologist and having Phototype I-IV on Fitzpatrick scale were recruited.

[0337] Pregnant or breastfeeding women; women planning a pregnancy during the study period; subjects having a history of drug or sun hypersensitivity, recurrent dermatological diseases or recent sunburn; subjects who used topical or systemic treatment during the weeks preceding the study, which were considered liable to interfere with the assessment of the tolerance of the test products; subjects enrolled in another study during the study period; and subjects considered by the investigator to be unlikely to be compliant to the protocol were excluded.

Methods

[0338] The purpose of the study was to investigate skin tolerance and efficacy of the test composition in the treatment of psoriasis.

[0339] The study was conducted in accordance with the guidelines for Good Clinical Practice defined by the ICH Topic E6 “Notes for Guidance and Good Clinical Practice” (CPMP/ICH/135/95), the Helsinki Declaration (1964, WMA) and its successive updates.

[0340] The scope of tests was compliant with Regulation of the European Parliament and of the Council (EC) No. 1223/2009 of 30 Nov. 2009 on cosmetic products; Cosmetics Europe—The Personal Care Association Guidelines “Product Test Guidelines for the Assessment of Human Skin Compatibility 1997”; and Cosmetics Europe—The Personal Care Association Guidelines for the Evaluation of the Efficacy of Cosmetic Products 2008.

[0341] Information regarding the study was provided orally and in writing to each participating subject and a written consent form was signed by each subject prior to commencement of the study.

[0342] Each subject was initially provided with a bottle comprising 90 ml of the test composition. The subject was instructed to shake the bottle well and then to apply the test composition to skin areas in which psoriasis was present morning and evening a daily over a period of 16 consecutive weeks. The subject was instructed to record the number of applications amount of composition used in a daily log, together with a record of any other medications taken on that day.

[0343] Skin condition was assessed by a technician prior to commencement of the study, weekly during the study and after 112 days of use. During each weekly visit, the skin areas under investigation were photographed.

a. Physical Indicators of Skin Condition

[0344] Skin condition was further assessed by a dermatologist, before and after application of the product, using a 4 point structured scale to identify specified physical signs of skin reaction, including redness, swelling, dryness, etc., where 0 indicates absence of the physical sign of psoriasis, 1 indicates mild occurrence, 2 indicates moderate occurrence and 3 indicates severe occurrence.

b. Functional Signs of Skin Condition

[0345] The subjects were instructed to record functional signs of skin reaction, including burning sensation, tightness, etc., according to the 4 point structured scale as described above. Functional signs were further recorded by a clinical investigator during the monthly visit of each patient.

c. Dermatology Life Quality Index (DLQI)

[0346] At the beginning and end of the study (weeks 0 and 16), subjects were further required to fill out a 10 question Dermatology Life Quality Index (DLQI) questionnaire, used to measure the impact of skin diseases on the quality of life of the affected subjects and the DLQI score was calculated.

[0347] The scoring of each question was as follows:

TABLE-US-00002 Response Score Very much Score 3 A lot Score 2 A little Score 1 Not at all Score 0 Not relevant Question unanswered Question 7 Score 3

[0348] The DLQI was calculated by summing the score for each question, resulting in a maximum score of 30 and a minimum score of 0. A higher score is indicative of a greater degree of impairment of quality of life.

d. Psoriasis Area Severity Index (PASI)

[0349] Severity of psoriasis was determined by a dermatologist, according to the Psoriasis Area Severity Index (PASI). The body of each subject was considered to comprise four sections: head (10% of a subject's skin); arms (20%); trunk (30%); and legs (40%). Each section was first scored separately and the scores then combined into a final PASI score. For each section, the percentage of skin involved was estimated and then transformed into a grade from 0 to 6, according to the following:

0: 0% of skin;
1: <10% of skin;
2: 10-29% of skin;
3: 30-49% of skin;
4: 50-69% of skin;
5: 70-89% of skin;
6: 90-100% of skin.

[0350] For each section, the severity was estimated by three clinical signs (erythema, induration and desquamation), with severity parameters on a scale of 0 to 4, where 0 indicates no signs and 4 indicates maximum signs. The sum of all three clinical signs was calculated for the skin of each section of the body, multiplied by the percentage of skin involved for that area, and multiplied by the weight of the area score for that section (0.1 for head; 0.2 for arms; 0.3 for trunk; and 0.4 for legs).

Test Schedule

[0351] Day 0: The test area was examined by a dermatologist and PASI scores determined. The test area was photographed.

[0352] Weekly (weeks 1-3, 5-7, 9-11 and 13-15): The subjects reported to the study center without having applied any product to the test area. The test area was examined by a technician and photographed. The subjects were instructed to apply the product later in the day after the examination and as usual on the same evening.

[0353] Monthly (weeks 4, 8, 12 and 16): The subjects reported to the study center without having applied any product to the test area. The test area was examined by a dermatologist and photographed. PASI scores were determined.

Statistical Analysis

[0354] The results were statistically analyzed using the STATISTICA 13® analytics software package (TIBCO Software Inc., USA).

[0355] Paired sample t-test or two-sided Wilcoxon signed rank sum tests were used to assess differences in results. The level of significance was sent as p<0.05.

Post-Study Follow Up

[0356] Follow-up was conducted over a 6 month period following completion of the study. Subjects were required to continue the daily log of and to visit the test center on a monthly basis, at which time photo documentation of the condition of the skin area tested was obtained by technicians.

Results

[0357] a. Dermatology Life Quality Index (DLQI) at Weeks 0 and 16.

TABLE-US-00003 TABLE 2 Subject's DLQI scores DLQI scores no. (W 0) Meaning of DLQI Scores (W 16) Meaning of DLQI Scores 1. 12 very large effect on subject's life 2 small effect on subject's life 2. 2 small effect on subject's life 4 small effect on subject's life 3. 13 very large effect on subject's life 5 small effect on subject's life 4. 19 very large effect on subject's life 10 moderate effect on subject's life 5. 1 no effect at all on subject's life 0 no effect at all on subject's life 6. 6 moderate effect on subject's life 6 moderate effect on subject's life 7. 6 moderate effect on subject's life 2 small effect on subject's life 8. 9 moderate effect on subject's life 2 small effect on subject's life 9. 3 small effect on subject's life 3 small effect on subject's life 10. 19 very large effect on subject's life 17 very large effect on subject's life 11. 16 very large effect on subject's life 0 no effect at all on subject's life 12. 12 very large effect on subject's life 8 moderate effect on subject's life 13. 3 small effect on subject's life 7 moderate effect on subject's life 14. 9 moderate effect on subject's life Subject was included 4 weeks later 15. 1 no effect at all on subject's life Subject was included 4 weeks later 16. 7 moderate effect on subject's life Subject was included 8 weeks later

[0358] As seen in Table 1, the test product provided an improvement in the quality of life in 7 out of 13 patients.

b. Psoriasis Assessment Severity Index (PASI) at Weeks 4, 8, 12 and 16.

TABLE-US-00004 TABLE 3 Subject's Before After 4 weeks Difference no. (W 0) (W 4) (W 4 − W 0) Variation % 1. 4.81 3.80 −1.01 −21 2. 1.00 0.61 −0.39 −39 3. 2.00 2.00 0.00 0 4. 3.41 1.80 −1.61 −47 5. 1.80 1.61 −0.19 −11 6. 1.80 0.61 −1.19 −66 7. 3.41 3.80 0.39 11 8. 4.81 1.40 −3.41 −71 9. 1.80 1.00 −0.80 −44 10. 1.80 1.71 −0.09 −5 11. 1.21 0.81 −0.40 −33 12. 4.50 3.41 −1.09 −24 13. 2.21 2.21 0.00 0 14. 0.31 0.31 0.00 0 15. 0.21 0.21 0.00 0 16. 3.00 1.80 −1.20 −40 Mean 2.38 1.69 −0.69 Min 0.21 0.21 −3.41 Max 4.81 3.80 0.39 SD 1.47 1.16 0.93 Median 1.90 1.66 −0.40 Δ % −29% % subjects with positive effect  69%

TABLE-US-00005 TABLE 4 Subject's Before After 8 weeks Difference no. (W 0) (W 8) (W 8 − W 0) Variation % 1. 4.81* no assessment 2. 1.00 0.61 −0.39 −39 3. 2.00 1.61 −0.39 −20 4. 3.41 1.21 −2.20 −55 5. 1.80 1.80 0.00 0 6. 1.80 2.00 0.20 11 7. 3.41 3.21 −0.20 −6 8. 4.81 1.40 −3.41 −71 9. 1.80 1.00 −0.80 −44 10. 1.80 2.80 1.00 56 11. 1.21 0.81 −0.40 −33 12. 4.50 2.21 −2.29 −51 13. 2.21 1.40 −0.81 −37 14. 0.31 0.11 −0.20 −65 15. 0.21 0.11 −0.10 −48 16. 3.00 1.80 −1.20 −40 Mean 2.22 1.47 −0.75 Min 0.21 0.11 −3.41 Max 4.81 3.21 1.00 SD 1.37 0.89 1.12 Median 1.80 1.40 −0.39 Δ % −34% % subjects with positive effect  80%

TABLE-US-00006 TABLE 5 Subject's Before After 12 weeks Difference no. (W 0) (W 12) (W 12 − W 0) Variation % 1. 4.81 7.20 2.39 50 2. 1.00 0.61 −0.39 −39 3. 2.00 1.21 −0.79 −40 4. 3.41 2.21 −1.20 −35 5. 1.80 0.61 −1.19 −65 6. 1.80 0.31 −1.49 −83 7. 3.41 3.60 0.19 6 8. 4.81 1.80 −3.01 −63 9. 1.80 1.21 −0.59 −33 10. 1.80* no assessment 11. 1.21 0.00 −1.21 −100 12. 4.50 2.21 −2.29 −51 13. 2.21 1.40 −0.81 −37 14. 0.31 0.31 0.00 0 15. 0.21 0.11 −0.10 −48 16. subject was included 8 weeks later Mean 2.38 1.63 −0.75 Min 0.21 0.00 −3.01 Max 4.81 7.20 2.39 SD 1.57 1.89 1.26 Median 1.90 1.21 −0.80 Δ % −32% % subjects with positive effect  79% indicates data missing or illegible when filed

TABLE-US-00007 TABLE 6 Subject's Before After 16 weeks Difference no. (W 0) (W 12) (W 16 − W 0) Variation % 1. 4.81 6.00 1.19  25 2. 1.00 0.61 −0.39 −39 3. 2.00 1.21 −0.79 −40 4. 3.41 1.80 −1.61 −47 5. 1.80 0.61 −1.19 −66 6. 1.80 0.31 −1.49 −83 7. 3.41 3.60 0.19  6 8. 4.81 1.80 −3.01 −63 9. 1.80 0.31 −1.49 −83 10. (1.80) (9.50)* (7.70)*  (428)* 11. 1.21 0.00 −1.21 −100  12. 4.50 3.10 −1.40 −31 13. 2.21 1.80 −0.41 −19 14. subject was included 4 weeks later 15. subject was included 4 weeks later 16. subject was included 8 weeks later Mean 2.73 1.76 −0.97 Min 1.00 0.00 −3.01 Max 4.81 6.00 1.19 SD 1.40 1.74 1.05 Median 2.11 1.51 −1.20 Δ % −35% % subjects with positive effect  83%

TABLE-US-00008 TABLE 7 PASI score Signi- Kinetics (Mean ± SD) p-value Test type ficance Before (W 0) 2.38 ± 1.47* 4.sup.th week (W 4) 1.69 ± 1.16* 8.sup.th week (W 8) 1.47 ± 0.89* 12.sup.th week (W 12)  1.63 ± 1.89** 16.sup.th week (W 16)  1.76 ± 1.74*** PASI score change −0.69 ± 0.93*  0.0047* Wilcoxon Yes (W 4 − W 0) PASI score change −0.75 ± 1.12*  0.0222* T-test Yes (W 8 − W 0) PASI score change −0.75 ± 1.26** 0.0439** T-test Yes (W 12 − W 0) PASI score change  −0.97 ± 1.05*** 0.0085*** T-test Yes (W 16 − W 0) Legend: *the result was calculated for 16 subjects **the result was calculated for 15 subjects ***the result was calculated for 13 subjects

[0359] As seen in Tables 2, 3, 4 and 5 the test product significantly decreased the PASI score after 4, 8, 12 and 16 weeks, respectively, indicating an improvement in the skin condition. The results are further summarized in Table 6.

SUMMARY AND CONCLUSIONS

[0360] The test product was found to be well tolerated in the majority of subjects (13 out of 16). No indications of intolerance (such as irritation, burning sensation, redness or itching) were seen in these subjects, and the product did not cause skin dryness in the area of application. A significant improvement was seen with use of the test product, as determined by DLQI and PASI values.