Patent Description:
The skin, which is the largest organ of the body, serves to cover and protect the body. Factors such as allergies, irritants, genetic factors and skin conditions can result in irritation, clogging or inflammation of the skin, causing symptoms such as rashes, redness, swelling, burning or itching.

Common skin conditions include psoriasis, acne, dermatitis, rosacea and eczema.

Psoriasis is a skin disease affecting around <NUM> million people worldwide and causing medical, financial and human burden to psoriasis patients. The physical and psychological effects of psoriasis can be debilitating, with patients suffering from scaly red plaques and peeling on visible parts of the body. Psoriasis is caused by overly rapid division of skin cells, accompanied by painful inflammation.

Psoriasis vulgaris is an incurable chronic skin disease, characterized by recurring plaques. Even if the symptoms of the disease are reduced or cleared during treatment, they frequently reappear on another area of the skin.

The currently available options for treatment of psoriasis include phototherapy, administration of topical preparations containing corticosteroids, vitamin D analogues or retinoids; systemic drug administration; and Dead Sea climatotherapy. These treatment options have various degrees of efficacy and some undesired side effects.

Furthermore, Dead Sea climatotherapy requires the subject to be physically present in the region of the Dead Sea, thus involving loss of working days, travel expenses, board and lodging expenses.

Background art includes <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT> and <CIT>; <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>. <CIT> and <CIT>; <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT> and <CIT>; <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>. Non-patent background art includes:.

Aspects and embodiments of the invention are described in the specification herein below.

According to some embodiments, the multi-component regimen comprises administering an acidic composition to the subject.

According to some embodiments, the multi-component regimen comprises heating an area of skin of the subject.

According to some embodiments, the frequency at which the multi-component regimen is applied to a subject is four times per day, three times per day, twice a day, once a day, six times per week, five times per week, four times per week, three times per week, twice per week, once weekly, three times per month, twice per month, or once monthly.

According to some embodiments, the at least two components of the multi-component regimen are each applied substantially simultaneously, or subsequently, wherein the second component is applied substantially immediately after the first component.

According to some embodiments wherein three or more components of the multi-component regimen are applied, all components may be applied substantially simultaneously or subsequently, wherein each component is applied substantially immediately after the preceding component.

According to some embodiments wherein three or more components of the multi-component regimen are applied, two components may be applied substantially simultaneously and a third component applied substantially immediately after the preceding components.

According to some embodiments, two or more components of the multi-component regimen may be applied at any suitable interval. For example, a second component may be applied <NUM> minutes, <NUM> minutes, <NUM> minutes, <NUM> minutes, <NUM> minutes, one hour, two hours, three hours, four hours, six hours, eight hours, <NUM> hours or <NUM> hours after a first component.

According to some embodiments, two or more components of the multi-component regimen may each be applied on alternating days, wherein a first component is applied on days <NUM>, <NUM>, <NUM> etc., and a second component is applied on days <NUM>, <NUM>, <NUM>, etc..

The galenic microbial composition, comprises Proponibacterium freudenreichii shermanii, bacteria.

According to some embodiments of the multi-component regimen or the galenic microbial composition, the Propionibacterium shermanii are of the strain ATCC <NUM> / DSM <NUM> / CIP <NUM> / NCIMB <NUM> / CIRM-BIA1; NCTC <NUM>.

According to some embodiments of the multi-component regimen or the galenic microbial composition, the bacteria disclosed herein are living bacteria.

According to some embodiments of the multi-component regimen or the galenic microbial composition, the bacteria disclosed herein are non-living bacteria.

The galenic microbial composition disclosed herein comprises olive oil.

According to some embodiments, the bacteria are present in the galenic microbial composition in a concentration of from about <NUM>% (w/w) to about <NUM>% (w/w) of the total composition. In some preferred embodiments, the bacteria are present at a concentration of from about <NUM>% to about <NUM>% (w/w) of the total composition. In some embodiments, the bacteria are provided as a freeze-dried powder.

The present invention, provides a galenic microbial composition comprising Propionibacterium shermanii, olive oil, geranium oil, rose flower oil, and tocopherol. In some such embodiments, the galenic microbial composition comprises from about <NUM> to about <NUM>% (w/w) bacteria. In some such embodiments, the galenic microbial composition comprises from about <NUM> to about <NUM>% (w/w) olive oil, from about <NUM> to about <NUM>% (w/w) geranium oil, from about <NUM> to about <NUM>% (w/w) rose flower oil and from about <NUM> to about <NUM>% (w/w) tocopherol.

According to an exemplary embodiment, the galenic microbial composition consists essentially of <NUM>% (w/w) bacteria; <NUM>% (w/w) olive oil; <NUM> % (w/w) tocopherol; <NUM>% (w/w) geranium oil; and <NUM>% (w/w) rose flower oil.

According to some embodiments, the galenic microbial composition disclosed herein is a topical composition i.e. a composition suitable for topical administration. The composition for topical administration may be provided in the form of a solution, a suspension, an emulsion, a lotion, a cream, a liniment, a balm, an ointment, a gel, a foam, a patch, a plaster, a powder, a paste (including a fatty paste or a non-greasy paste), a paint, a poultice, a tincture, an emulgel (comprising an emulsion in a gel base), or the like, or any combination thereof.

Non-limiting examples of excipients for a semi-solid dosage form include a base, an antimicrobial preservative, a humectant, an antioxidant, an emulsifier, a gelling agent, a penetration enhancer, a buffer and a fragrance.

Non-limiting examples of excipients for a gel formulation include carbomer (as a thickener), disodium EDTA (as a pH adjustment agent), glycerin (as a humectant), benzophenone-<NUM> (as a stabilizer), diazolidinyl urea and/or iodopropynyl butylcarbamate (as a preservative), PVP K-<NUM> and/or PVP/dimethylaminoethylmethacrylate copolymer, oleth-<NUM> (as a solubilizer), a fragrance, aminomethylpropanol (as a neutralizer) and water as solvent. Non-limiting examples of excipients for a cream include medium chain triglycerides (as an emollient/emulsifying agent/solvent), olelyl alcohol (as an emollient/emulsifying agent/penetration enhancer), propylene glycol (as a humectant/solvent), cetyl alcohol (as an emulsifier), stearyl alcohol (as a stiffening agent), glyceryl monostearate (as an emollient/emulsifier), sodium cotostearyl (as an emulsifier), benzyl alcohol (as a preservative), citric acid and/or sodium hydroxide (as a pH adjusting agent) and water as solvent.

Non-limiting examples of excipients for an ointment include sodium lauryl sulfate, propylene glycol, stearyl alcohol, white petrolatum, methyl hydroxybenzoate, propyl hydroxybenzoate, salicylic acid and water.

A base for an ointment may be an oleaginous base (comprising oleaginous materials such as water-insoluble hydrophobic oils and fats), an absorption base (water in oil emulsion, such as comprising a mixture of animal sterols with petrolatum), an emulsion base, a water-soluble base (generally comprising polyethylene glycols or one or more hydrocolloids) or a water removable base.

A non-limiting example of a base for a hydrophilic ointment (oil in water type emulsion base) comprises white petrolatum, stearyl alchol, propylene glycol, sodium lauryl sulphate and water.

A non-limiting example of a base for a cold cream (water in oil emulsion base) comprises white wax, cetyl esters wax, mineral oil, sodium borate and water.

A non-limiting example of a paste base comprises zinc oxide, starch, white petrolatum and salicylic acid.

The composition may be provided in a delivery form comprising a plaster, i.e. a solid or semi-solid mass which adheres to the skin, comprising, for example, cotton or muslin as a backing material.

The illuminating and/or heating of the area of the skin of a subject may be accomplished using a wearable cutaneous-treatment device suitable for the therapeutic illumination and/or heating of skin, such as mammalian skin (including human or non-human skin).

The wearable cutaneous-treatment device (also referred to herein as a 'wearable device') comprises:.

the light source or sources configured, when activated, to project light outwards from the inner surface to illuminate at least a portion of the area of skin of the subject.

According to some embodiments, the support component of the wearable device is contoured or flexible. The support component can be considered the body of the device, primarily serving to hold the single or multiple light sources in a desired manner.

In some embodiments, the support component is rigid but contoured to substantially follow the curves of a portion of a subject's body.

In some embodiments, the support component is flexible. In some exemplary such embodiments, the support component is or comprises a flexible woven cloth or plastic portion in which the plurality light sources are arranged.

In some embodiments, the support component is elastic. In some exemplary such embodiments, the support component is or comprises a flexible elasticized cloth or fabric portion in which the plurality light sources are arranged.

The device according to the teachings herein includes 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.

In some embodiments, the support component and the attachment component are distinct one from the other, e.g., attachment component comprises reversibly-connectable straps.

In some embodiments, the support component and the attachment component are substantially the same component.

According to some embodiments, the attachment components are elasticized.

Non-limiting examples of suitable attachments or elasticated components include ties, clips, straps, hook and loop fasteners (Velcro®) and the like, or combinations thereof.

According to some embodiments, the illuminating of an area of skin is accomplished by a single light source. According to some such embodiments, the single light source is monochromatic, configured to a single wavelength of light when activated. Any suitable monochromatic light source can be used, e.g., a LED or a laser.

According to some alternative embodiments, the single light source can be polychromatic, configured to emit a plurality of wavelengths of light when activated. Any suitable polychromatic light source can be used, e.g. a filtered tungsten lamp, a xenon lamp, a narrowband LED, an organic LED.

According to some embodiments, the illuminating of an area of skin is accomplished by a plurality of light sources arranged on the inner surface of the support component constituting an illumination panel.

According to some embodiments, a portion or each of the plurality of light sources is monochromatic. According to some such embodiments, the light sources emit light selected from the group consisting of infrared (IR), red, orange, yellow, green, indigo, violet, ultraviolet (UV) and any combination thereof.

In some embodiments, a portion or each of the plurality of light sources is polychromatic.

In some embodiments, the plurality of light sources comprises at least two light sources emitting light of different wavelengths one from the other.

According to some embodiments, at least two of the different types of light sources emit light selected from the group consisting of visible light (i.e. light having a wavelength in the range of from about <NUM> to about <NUM> nanometers), ultraviolet (UV) light (i.e. light having a wavelength in the range of from about <NUM> to about <NUM> nanometers) and infrared (IR) light (i.e. light having a wavelength of from about <NUM> nanometers to about <NUM> millimeter), or any combination thereof.

According to some such embodiments, the visible light is selected from the group consisting of red, orange, yellow, green, blue, indigo or violet light, or a combination thereof. In some such embodiments, the combination provides white light.

According to some embodiments, the ultraviolet light is selected from the group consisting of ultraviolet A, ultraviolet B, ultraviolet C or any combination thereof.

According to some embodiments, the infrared light is selected from the group consisting of infrared A, infrared B, infrared C or any combination thereof.

According to some embodiments, wherein the wearable device comprises at least two different types of light sources, the light sources comprise sources of ultraviolet B, red light, blue light and infrared light.

According to some embodiments wherein the wearable device comprises a plurality of light sources, the light sources are arranged on the inner surface of the support component in a predefined geometric pattern, such as in a circular, triangular or quadratic pattern, a spiral or concentric circles. In some embodiments, the light sources are arranged so that each light that is not at the border of the geometric pattern has four closest neighbors, i.e., rectangular packing. In some embodiments, the light sources are arranged so that each light that is not at the border of the geometric pattern has six closest neighbors, i.e., hexagonal packing.

In some embodiments, the light sources are arranged in a series of rows and columns, such as, for example from <NUM> to <NUM> rows and from <NUM> to <NUM> columns. In one non-limiting examples, the light sources are arranged as <NUM> rows with <NUM> columns.

In some embodiments where the plurality of light sources comprises at least two different types of light sources, each type of light source emitting light different from the other types, the light sources are homogenously distributed on or within the inner surface of the support component so that, when all light sources are activated, the entire area of skin is illuminated with the same light.

Alternatively, in some embodiments where the plurality of light sources comprises at least two different types of light sources, each type of light source emitting light different from the other types, the light sources are heterogeneously distributed on or within the inner surface of the support component so that, when all light sources are activated, different portions of the area of skin are illuminated with different wavelengths of light. For example, in some such embodiments, light sources of a first type are localized in a first part of the inner surface of the support component and light sources of a second type are localized in a second part of the inner surface of the support component so that the device is configured to illuminate a first portion of an area of skin of the subject with light of a first wavelength emitted by the first type of light source and a second portion of an area of skin of the subject with light of a second wavelength emitted by the second type of light source.

In some embodiments, wherein the wearable device comprises light sources providing light of at least two different wavelengths, the wearable device is 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.

The illumination panel of device according to the teachings herein has any suitable number of light sources, typically any suitable number between <NUM> and <NUM> light sources.

In some embodiments, a device further comprises a power source sufficient to continuously power the light sources to project light for a period of time not less than <NUM> minutes. In preferred embodiments, the power source is a portable power source, e.g., batteries, so that a subject wearing the device is not forced to remain in a fixed location. In some such embodiments, the portable power source is rechargeable, e.g., comprises rechargeable batteries (e.g., LiION batteries). In some embodiments, such a rechargeable power source is rechargeable using a standard USB or micro USB connector. In some embodiments, the power source is not portable, e.g., the device is powered by the mains power supply.

In some embodiments of the multi-component regimen disclosed herein comprising a step of heating an area of skin of the subject, heating is provided by a device comprising at least one heat source. In some such embodiments, the device is a wearable device. In some such embodiments, the wearable device comprising at least one heat source is a separate device from the wearable device comprising at least one light source.

In some alternative embodiments, at least one light source and at least one heat source are provided in the same wearable device. In some such embodiments, the at least one light source generates sufficient radiant heat to act as at least one combined heat and light source.

In some embodiments, the heat source is configured to, when activated, heat the skin so as to increase the surface temperature of the skin of subject wearing the device to a desired maximum temperature. The maximum temperature is a temperature at which no damage is caused to the skin considering the duration for which the skin-heating component is activated.

The at least one heat source is any one or combination of at least two heat sources. In some embodiments, all heat sources are the same. In some embodiments, at least two heat sources are different.

In preferred embodiments, the heat source or sources are arranged on the inner surface of the support component.

Any suitable type of heat source may be used. In some embodiments, at least one heat source is an infrared heater that is to say, a component which radiates electromagnetic radiation having frequencies in the range of <NUM> to <NUM> in an intensity sufficient to heat the skin of a subject by radiative heat transfer.

In some embodiments, at least one heat source is a convection heater where a heating element (e.g., a fluid-containing pipe) is heated to heat air, which heated air heats the skin of a subject. In some such embodiments, a heat source comprises a fan to move heated air more efficiently towards a skin surface.

In some embodiments, power for powering the skin-heating component is provided by the same power source used to power the light sources of the device, as described above.

In some embodiments, a heat source is provided by a non-wearable device.

In some embodiments comprising a wearable device comprising at least one heat source, the device further comprises at least one component selected from the group consisting of a heat sensor configured to monitor the temperature of the area of skin of the subject, a thermostatic control, and combinations thereof.

In some embodiments, such a heat sensor is similar or identical in operation to a noncontact infrared medical thermometer. Typically, such a heat sensor is activated to monitor the surface temperature of an area of skin to be treated.

Additionally or alternatively to a heat sensor as described above, in some embodiments a device includes a thermostat being operatively connected to a heat sensor to measure, for example, skin temperature.

In some embodiments, determination by the heat sensor and/or thermostat that the surface temperature of skin to be treated is below a predetermined lower threshold leads to activation of at least some of the skin heating component to heat the skin. In some embodiments, determination by the heat sensor and/or thermostat that the surface temperature of skin to be treated is above a predetermined intermediate threshold leads to deactivation of at least some of the skin heating component to reduce the rate or extent of heating of the skin. In some embodiments, determination by the heat sensor and/or thermostat that the surface temperature of skin to be treated is above a predetermined upper threshold leads to deactivation of the skin heating component to stop heating of the skin. In some embodiments, activation and/or deactivation of a heat source as a result of determination of skin temperature by the heat sensor or thermostat is by a controller, see below.

In some embodiments, determination by the heat sensor of a temperature below a certain predetermined threshold indicates that the treatment surface is not directed towards the skin, in some such embodiments such determination prevents activation of the light sources. For example, in some embodiments, a temperature below <NUM> indicates that the treatment surface is not directed at the skin so light sources are not activated or deactivated if already activated.

In some embodiments, a device according to the teachings herein further comprises at least one composition application element, configured to provide a predetermined environment to the treated area of a surface of a body of a user during treatment, namely during illumination and/or heating, by application of at least one composition to the surface. For example, the application element or elements, may apply a galenic microbial composition, an acidic composition, a mineral composition or combinations thereof. For example, the application element may apply a composition that renders the treated area acidic. The composition may be in any form known in the art that is suitable for application on the body surface of a subject, for example but not limited to, balm, liquid, gel, spray and the like. The composition application element may be in any form known in the art that renders the composition application element suitable for storage of the composition and application of the composition on the treated area. For example, the composition application element may comprise a container, configured to store the composition; and a composition applicator, configured to apply the composition on the treated area, for example a sprayer, a nozzle, and the like. Another example of a composition application element is a composition-releasing fabric or cloth optionally impregnated or suffused with a composition for application. Said fabric or cloth may be configured as a plaster, comprising a first adhesive site configured to adhere to the skin of a subject, and in some embodiments, a second adhesive side configured to adhere to a protective pouch of the device, see below with referenced to <FIG>. Such a composition-releasing release plaster is configured to contain a composition for being applied on the skin of a subject, and release the composition through the first surface once adhered to the skin of the user during use of the device. In some preferred embodiments, the composition is an acidic topical composition, configured to render the treated area of the skin of the subject acidic.

In some embodiments, a device according to the teachings herein comprises a controller for controlling activation and deactivation of other components of the device. Although any suitable controller may be used in implementing such embodiments (e.g., an on-switch with timer that activates the light sources for a predetermined duration), a preferred controller is a computer controller configured with hardware and/or software to accept input from other components of the device or from a user and to output commands to other components of the device or information to a user.

In some such embodiments, the controller is functionally associated with the light sources and is configured to activate or deactivate some or all of the light sources based on predetermined criteria. For example, in some embodiments, the controller is configured to automatically deactivate the light sources a predetermined time after activation of the light sources.

In some such embodiments, the controller is functionally associated with a heating component and is configured to activate or deactivate some or all of the skin heating component based on predetermined criteria.

In some such embodiments, the controller is functionally associated with a heating component and a heat sensor and/or thermostat and is configured to activate or deactivate some or all of the skin heating component based at least in part on input from the heat sensor and/or thermostat.

In some embodiments, the controller comprises a memory. Any suitable memory can be used, such as memory known in the art of computing such as flash memory.

In some embodiments, the controller comprises a memory for storing results received from a heat sensor and/or thermostat.

In some embodiments, the controller comprises a memory for storing one or more treatment profiles as described hereinbelow, and the controller is configured to access a stored treatment profile and then activate and deactivate other components of the device in accordance with the accessed treatment profile.

In some embodiments, the controller comprises a memory that stores one or more treatment profiles, each treatment profile being a specific protocol during which other components of the device, specifically the light sources and, if present, heating component are activated and deactivated according to a predetermined schedule for the duration of the protocol. In some embodiments, the protocol includes activating or deactivating one or more components of the device on receiving some specific reading from a thermostat, heat sensor or similar component.

In some embodiments, the device includes a user interface allowing a human user to input commands to the controller and to receive information from the controller. For example, in some embodiments, the controller is configured to output readings of made by a thermostat, heat sensor or similar component through the user interface. For example, in some embodiments, the controller is configured to accept commands from the user interface, for example, to receive and store a treatment profile input from the user interface.

In some embodiments, a user interface may be used to input to the controller a treatment profile for immediate activation. Any suitable user interface may be used for implementing a device according to the teachings herein.

In some embodiments, a user interface is a graphic-user interface implemented on a display panel, for example, a display screen such as known in the art of smartphones. Accordingly, in some embodiments, a device further comprises display panel in communication with the controller, the display panel configured to display data received from the sensor and/or to receive instructions from a user.

In some embodiments, a user interface comprises a hardware portion that comprises a transmitter (e.g., a radiofrequency transmitter (e.g., Bluetooth®), infrared transmitter) that is physically associated with the controller, and a software portion that is configured to run on a remote device (e.g., a remote control or smartphone of a user). When in use, a user uses the remote device to input commands / receive information which are wirelessly transmitted to and received by the controller via the hardware portion.

In some embodiments a device comprises an alarm, in some preferred embodiments, functionally associated with a processor of the device. Such an alarm is configured to provide an alarm signal relating to the operation of the device and/or of the processor. For example, such an alarm may start when a treatment has been ended, for example in situations when a treatment profile is set for a predetermined duration of time; or when the treatment is stopped prematurely, and the like. Any type of alarm is under the scope of the present subject matter, for example but not limited to, a sound alarm like a buzzer, a visual alarm like a blinking light, an alarm signal sent to the host, and the like.

According to some embodiments, the multi-component regimen disclosed herein is for treating a skin condition selected from the group consisting of psoriasis, vitiligo, eczema, acne, dermatitis, lupus, tinea, versicolor, rosacea, actinic keratosis, leukoderma, herpes simplex virus, lupus, a bacterial, viral, fungal or mycobacterial skin infection, a phyto skin infection, a wound, a diabetes-induced skin condition, a skin rash, a pressure sore, a bed sore, a burn, athlete's foot, diaper rash, itching, chafing, or any combination thereof.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. In case of conflict, the specification, including definitions, will take precedence.

As used herein, the term "cutaneous condition" relates to any condition that affects the organ system that encloses the body, including skin, hair, nails, and related muscles and glands. Examples of a cutaneous condition typically include, but are not limited to, medical conditions and cosmetic conditions that are associated with medical conditions. Examples of medical conditions include but are not limited to, psoriasis, vitiligo, eczema, acne, dermatitis, seborrheic dermatitis, atopic dermatitis, actinic keratosis, Urticaria, scleroderma, tinea versicolor, leukoderma and the like. For the sake of simplicity, the term "cutaneous condition" has been used herein interchangeably with the term "skin condition".

As used herein, the term "treating" includes ameliorating, mitigating, and reducing the instances of a disease or condition, or the symptoms of a disease or condition. In some embodiments, the treating refers to medical treatment i.e. treatment relating to the health of the subject. In some embodiments, the treating refers to cosmetic treatment i.e. treatment relating to aesthetic, non-medical aspects of a skin condition.

As used herein, the term "administering" includes any mode of administration, such as oral, subcutaneous, sublingual, transmucosal, parenteral, intravenous, intra-arterial, buccal, sublingual, topical, vaginal, rectal, ophthalmic, otic, nasal, inhaled, intramuscular, intraosseous, intrathecal, and transdermal, or combinations thereof. "Administering" can also include providing a different compound that when ingested or delivered as above will necessarily transform into the compound that is desired to be administered, this type of "different compound" is often being referred to as a "Prodrug". "Administering" can also include prescribing or filling a prescription for a dosage form comprising a particular compound. "Administering" can also include providing directions to carry out a method involving a particular compound or a dosage form comprising the compound or compounds.

As used herein, the term "therapeutically effective amount" means the amount of an active substance that, when administered to a subject for treating a disease, disorder, or other undesirable medical condition, is sufficient to have a beneficial effect with respect to that disease, disorder, or condition. The therapeutically effective amount will vary depending on the chemical identity and formulation form of the active substance, the disease or condition and its severity, and the age, weight, and other relevant characteristics of the patient to be treated. Determining the therapeutically effective amount of a given active substance is within the ordinary skill of the art and typically requires no more than routine experimentation.

As used herein, the terms "comprising", "including", "having" and grammatical variants thereof are to be taken as specifying the stated features, integers, steps or components but do not preclude the addition of one or more additional features, integers, steps, components or groups thereof. These terms encompass the terms "consisting of" and "consisting essentially of".

As used herein, the indefinite articles "a" and "an" mean "at least one" or "one or more" unless the context clearly dictates otherwise.

As used herein, when a numerical value is preceded by the term "about", the term "about" is intended to indicate +/-<NUM>% of that value.

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.

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.

A wearable cutaneous-treatment device for the therapeutic illumination of mammalian skin according to the teachings herein comprises:.

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.

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.

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

In an alternative, otherwise-identical, embodiment, a device includes an illumination panel having <NUM> individual LEDS, a total of four different types of light sources of: <NUM> UVB and/or NB-UVB LEDs illuminating at a central wavelength of <NUM>, <NUM> red LEDs illuminating at a central wavelength of <NUM>, <NUM> blue LEDs illuminating at a central wavelength of <NUM> and <NUM> IR LEDs illuminating at a central wavelength of <NUM>. The different LEDs are distributed homogeneously on the illumination panel.

<FIG> schematically illustrates device <NUM> viewed towards illumination panel <NUM> near an exemplary part of a body of a subject, arm <NUM>. As is understood from <FIG>, device <NUM> is secured to a part of the body of a subject by holding illumination panel <NUM> against the portion of skin to be treated, securing attachment straps <NUM> one to the other and then tightening straps <NUM> to immovably hold device <NUM> against the body of the subject. In <FIG>, support component <NUM>, including inner surface <NUM> and an outer surface <NUM> are held inside a protective pouch <NUM>. Pouch <NUM> protects support component <NUM> and illumination panel <NUM>, for example, from dirt, dust, humidity and to prevent contact of illumination panel <NUM> 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 <NUM> that covers illumination panel <NUM> is sufficiently transparent to the light emitted by light sources <NUM> of illumination panel <NUM> so as not to negatively influence the results of the phototherapy treatment applied by illumination panel <NUM>. Thus, pouch <NUM> 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> is switch <NUM> which is functionally associated with the controller of device <NUM>.

<FIG> schematically depicts the inside of support component <NUM> of device <NUM> in cross section parallel to illumination panel <NUM>, showing a controller <NUM> with a memory <NUM> and a Bluetooth® transceiver <NUM>, a power source <NUM> and switch <NUM> embedded inside support component <NUM>. Switch <NUM> has three states: a first "off" state where none of the components of device <NUM> receive power and cannot operate, a "manual" state where all the LEDs are activated to illuminate for <NUM> minutes before shutting down and a "APP" state where controller <NUM> uses Bluetooth® transceiver <NUM> 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.

<FIG> schematically illustrates a close-up view of a portion of illumination panel <NUM> of an embodiment of a device according to the teachings herein, showing LEDs <NUM> arranged in columns and rows.

<FIG> schematically illustrates a side view of a portion of illumination panel <NUM> of device <NUM>. Illumination panel <NUM> comprises a support sheet <NUM> and a plurality of light sources, LEDs <NUM> attached to support sheet <NUM>. As noted above, illumination panel <NUM> is configured to be placed on a surface of a body of a user with light sources <NUM> facing the surface of the body. For example, illumination panel <NUM> 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 <NUM> of device <NUM> is a psoriasis skin lesion.

According to some embodiments, support sheet <NUM> may comprise a synthetic or natural cloth or fabric, a conductive or non-conductive polymer, or the like.

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 <NUM> and <NUM>. 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.

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 <NUM> and <NUM>. 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 te illumination panel to the treated area of a body of the user to give rise to optimal treatment results.

In some embodiments, a support sheet such as support sheet <NUM> is rigid. In some embodiments, a support sheet such as support sheet <NUM> 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.

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 <NUM>, the light sources are LEDs (light-emitting diodes) <NUM>.

<FIG> schematically illustrates a close-up schematic view of part of an exemplary embodiment of illumination panel <NUM> of device <NUM> 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>, the most common type of light sources (the <NUM> UVB and/or UVB-NB LEDs) are arranged in a regular <NUM> x <NUM> rectangular array) while the less common type of light sources are interspersed within the array. In <FIG> are seen part of three rows of light sources, row <NUM>, row <NUM> and row <NUM>. Rows <NUM> and <NUM> include only UVB or UV-NB light sources 18a while row <NUM> 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.

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.

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> or a light source that is configured to emiteither red or blue or green or white light; or any combination thereof.

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 <FIG>. 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.

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 <NUM>,<NUM> light sources, is within the scope of the present subject matter, as the size, dimensions and shape of the illumination panel <NUM> may allow.

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> schematically illustrates a view of an exemplary embodiment of an alternative illumination panel <NUM> of device <NUM> according to the teachings herein, comprising a plurality of light sources <NUM> and a plurality (fourteen) of individual heating pads <NUM> comprising a heat resistive material printed on a support sheet <NUM>, wherein heating pads <NUM> emit heat upon passage of an electric current, which together constitute a skin heating component of device <NUM>. In device <NUM>, illumination panel <NUM> includes a support sheet <NUM> to which are attached light sources <NUM> and heating pads <NUM>.

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.

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.

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.

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.

In some embodiments, a device comprises a separate heating component (preferably associated with the illumination panel, such as heating pads <NUM> of device <NUM> in <FIG>) 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.

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.

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 panle) or is physically separate from the illumination panel, or any combination thereof.

The present subject matter further provides a system for controlling the operation of a wearable cutaneous-treatment device. <FIG> schematically illustrates, according to an exemplary embodiment, a block diagram of a system <NUM> for controlling the operation of an embodiment of wearable cutaneous-treatment device <NUM> having an illumination panel <NUM> as described with reference to <FIG>. Device <NUM> is substantially similar to device <NUM> described above.

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

System <NUM> further comprise a control panel <NUM> with a display <NUM> (e.g., LCD or LED display) communicationally-connected to controller <NUM> configured to display data regarding the operation of device <NUM>, such as data received from at least one of sensors <NUM> and <NUM>, and the like. In some embodiments, a display is a component of a device, for example display <NUM> of device <NUM>. 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.

Control panel <NUM> of system <NUM> further comprises a keyboard <NUM> as an input component connected to controller <NUM> to input user commands and data for operating device <NUM>. 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 <NUM> provide power to the light sources.

System <NUM> further comprises a memory <NUM> communicationally connected to controller <NUM>. Memory <NUM> 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.

System <NUM> further comprise a host <NUM> communicationally connected to controller <NUM>. Host <NUM> 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 <NUM> is configured to operate and/or store software, for example computer programs or smartphone applications, for the operation of device <NUM>. In some embodiments, host <NUM> is configured to display data received by at least one of sensors <NUM> and <NUM>, 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.

System <NUM> is configured to automatically shut down when there is a need for system <NUM> to shut down, for example, when a treatment has been ended, when device <NUM> is overheated, the when safety of the user is at risk, and the like.

System <NUM> further comprises a power source <NUM>, as described above, for example a battery, electrically connected to the components of the system <NUM> for supplying electrical power for their operation.

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.

The various components of system <NUM> 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>, system <NUM> comprises a Bluetooth® transceiver <NUM> functionally associated with controller <NUM> that enables communication between the controller <NUM> and other components of system <NUM>, for example host <NUM>.

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.

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.

Controller <NUM> of system <NUM> is communicationally connected to the illumination panel <NUM>, and is configured to control the operation of illumination panel <NUM>, including illuminating, heating or concurrently illuminating and heating of an area of a surface of a body of a subject.

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

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 <NUM> which is physically associated with device <NUM> or by using host <NUM>, for example by using a keyboard of a computer or a touch-screen of a smartphone or a tablet.

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.

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.

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 <NUM>, namely a computer, a smartphone, a mobile phone, a tablet, and the like.

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 <NUM> summarizes some UVB light treatment profiles that are suitable for different types of cutaneous conditions according to the Fitzpatrick skin type classification scale.

<FIG> schematically illustrates, according to an exemplary embodiment, a block diagram <NUM> of states and modes of operation of the system for controlling the operation of a device <NUM> provided with a system <NUM> as depicted in <FIG>.

In Off Mode <NUM>, device <NUM> is connected to power source <NUM> and power source <NUM> is charged to a sufficient level. Device <NUM> is not connected to host <NUM> and illumination panel <NUM> is not functioning.

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

In Manual Mode <NUM>, a user may select, via keyboard <NUM> and display <NUM> of control panel <NUM>, to revert <NUM> to Off Mode <NUM> or to select a desired treatment profile, namely determine for example illumination intensity and treatment duration. During Manual Mode <NUM>, Bluetooth® transceiver <NUM> is disabled. After user-selection of operational parameters, it is confirmed that device <NUM> is placed on a treatment area of the body of the subject, and a "StartTreatment" option is selected using control panel <NUM>. The initial activation of the light sources of illumination panel <NUM> may be done gradually, and only after the skin temperature sensor <NUM> show that illumination panel <NUM> is positioned over the skin. Skin temperature sensor <NUM> measure initial skin temperature should be in the range of substantially <NUM>-<NUM>. If the measured skin temperature is below this range, the operation of the light sources of illumination panel <NUM> is stopped.

In APP Mode <NUM>, a user may select to revert <NUM> to Off Mode <NUM>, but ordinarily Bluetooth® transceiver <NUM> is activated and waits for establishing communication with host <NUM>. After communication is established, software, for example an application, stored for example on host <NUM>, is activated and controls the operation of device <NUM>. This may be achieved for example by initiation of communication between host <NUM> and controller <NUM> of device <NUM>. Once communication has been established, a treatment profile is set. Periodically, for example every three seconds, device <NUM> sends a status message to host <NUM>. This periodic message is used for information purpose for a user, or stored in log. The operation of device <NUM> - 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 <NUM>.

During both Manual Mode <NUM> and App Mode <NUM>, a Continuous Built in Test Unit <NUM> of controller <NUM> monitors various parameters that relate to the operation of device <NUM>. If Test Unit <NUM> detects an exceptional parameter, device <NUM> is automatically changed to Preservation Mode <NUM>, optionally while activating an alarm and/or reporting the reason for entering Preservation Mode <NUM> on display <NUM> of control panel <NUM>.

In Preservation Mode <NUM>, illumination panel <NUM> is not powered and not functioning, but communication between device <NUM> and host <NUM> is maintained (if in APP Mode). Device <NUM> may enter into Preservation State <NUM> in case at least one of the following situations occurs:.

In <FIG> an additional embodiment of a wearable cutaneous-treatment device <NUM> according to the teachings herein is depicted. In <FIG> looking at an illumination panel <NUM> of device <NUM> and in <FIG> at device <NUM> from the front.

In device <NUM>, a support component and attachment component are the same component <NUM>, a flexible sleeve made of an elasticized cloth, shaped and dimension to fit over the knee of a human subject.

The entire inner surface of device <NUM> constitutes illumination panel <NUM>, in which a plurality of light sources (LEDs, depicted as dots in <FIG>) is arranged.

Helping to maintain the shape of device <NUM> is a bendable rib <NUM> of polyethylene that also functions to protect the knee of a wearer from impact.

A control unit <NUM> 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 <NUM>.

shermanii bacteria (Propinobacterium <NUM>) were obtained as a freeze-dried bacterial powder from Biena, Canada.

<NUM>% (w/w) P. shermanii (1x10<NUM> CCFU, <NUM>-<NUM> freeze-dried mix powder).

All carrier ingredients were added to a mixing container and mixed for <NUM> minutes. The mixture was divided into <NUM> portions and filled into bottles. The bacterial powder was added to each bottle. The bottles were sealed and labelled.

Brevibacterium sp. ; Propionibacteriaacnes; and Micrococcus luteus (1x10<NUM> CCFU, <NUM>-<NUM> freeze-dried mix powder).

All carrier ingredients were added to a mixing container and mixed while melting by heating. The temperature of the mixture was adjusted to <NUM> or less. The bacterial powder was added and mixed.

shermanii (1x10<NUM> CCFU, <NUM>-<NUM> freeze-dried mix powder).

All carrier ingredients were added to a mixing container and mixed while melting by heating to a temperature of about <NUM>. The temperature of the mixture was then adjusted to <NUM> or less. The bacterial powder was added and mixed.

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

shermanii (1x10<NUM> CCFU, <NUM>-<NUM> freeze-dried mix powder).

Water and aloe Barbadensis leaf juice were mixed in a mixing container and heated to <NUM>.

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 <NUM> minutes.

In a second mixing container, glucosides/cetearyl, coconut oil, cetyl alcohol and olea Eruopaea fruit oil were mixed and heated to <NUM>.

The mixtures in the two mixing containers were slowly combined and mixed for <NUM> minutes while cooling.

When the combined mixture reached a temperature of less than <NUM>, the bacteria, tocopherol, Lavedula Angustifolia and Rosa damascena extract were added and the final mixture further cooled to <NUM>.

pH and viscosity were measured and adjusted, and pH adjusted, if necessary, to about <NUM>.

Citric acid was diluted in water and the pH checked to ensure that a value of less than about <NUM> was attained.

<NUM>% (w/w) Dead Sea minerals in water.

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

<NUM> otherwise healthy male and female subjects, between the ages of <NUM> - <NUM>, suffering from psoriasis vulgaris as diagnosed by a qualified dermatologist and having Phototype I - IV on Fitzpatrick scale were recruited.

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.

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

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/<NUM>/<NUM>), the Helsinki Declaration (<NUM>, WMA) and its successive updates.

The scope of tests was compliant with Regulation of the European Parliament and of the Council <CIT> on cosmetic products; Cosmetics Europe - The Personal Care Association Guidelines "<NPL>.

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.

Each subject was initially provided with a bottle comprising <NUM> 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 <NUM> 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.

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

Skin condition was further assessed by a dermatologist, before and after application of the product, using a <NUM> point structured scale to identify specified physical signs of skin reaction, including redness, swelling, dryness, etc., where <NUM> indicates absence of the physical sign of psoriasis, <NUM> indicates mild occurrence, <NUM> indicates moderate occurrence and <NUM> indicates severe occurrence.

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

At the beginning and end of the study (weeks <NUM> and <NUM>), subjects were further required to fill out a <NUM> 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.

The scoring of each question was as follows:
<IMG>.

The DLQI was calculated by summing the score for each question, resulting in a maximum score of <NUM> and a minimum score of <NUM>. A higher score is indicative of a greater degree of impairment of quality of life.

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 (<NUM>% of a subject's skin); arms (<NUM>%); trunk (<NUM>%); and legs (<NUM>%). 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 <NUM> to <NUM>, according to the following:.

For each section, the severity was estimated by three clinical signs (erythema, induration and desquamation), with severity parameters on a scale of <NUM> to <NUM>, where <NUM> indicates no signs and <NUM> 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 (<NUM> for head; <NUM> for arms; <NUM> for trunk; and <NUM> for legs).

Day <NUM>: The test area was examined by a dermatologist and PASI scores determined. The test area was photographed.

Weekly (weeks <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM> and <NUM>-<NUM>): 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.

Monthly (weeks <NUM>, <NUM>, <NUM> and <NUM>): 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.

The results were statistically analyzed using the STATISTICA <NUM>® analytics software package (TIBCO Software Inc.

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<<NUM>.

Follow-up was conducted over a <NUM> 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.

As seen in Table <NUM>, the test product provided an improvement in the quality of life in <NUM> out of <NUM> patients.

As seen in Tables <NUM>, <NUM>, <NUM> and <NUM> the test product significantly decreased the PASI score after <NUM>, <NUM>, <NUM> and <NUM> weeks, respectively, indicating an improvement in the skin condition. The results are further summarized in Table <NUM>.

Claim 1:
A multi-component regimen for use in the treatment of a skin disorder in a subject in need thereof, the regimen comprising the following two components:
i) topically administering at least one galenic microbial composition to an area of skin of the subject, the at least one galenic microbial composition consisting essentially of Propionibacterium freudenreichii subsp. shermanii bacteria, olive oil, tocopherol, geranium oil, and rose flower oil, and
ii) illuminating the area of skin of the subject,
wherein said components of the regimen are carried out sequentially, simultaneously or concomitantly.