Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/185—Magnoliopsida (dicotyledons)
  • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
  • A61K36/258—Panax (ginseng)
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
  • A61K31/05—Phenols
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
  • A61K31/19—Carboxylic acids, e.g. valproic acid
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/88—Liliopsida (monocotyledons)
  • A61K36/886—Aloeaceae (Aloe family), e.g. aloe vera
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K41/00—Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
  • A61K41/0042—Photocleavage of drugs in vivo, e.g. cleavage of photolabile linkers in vivo by UV radiation for releasing the pharmacologically-active agent from the administered agent; photothrombosis or photoocclusion
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
  • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
  • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
  • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
  • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/08—Solutions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

• the present invention relates to treating pain and/or inflammation.
• the present invention relates to treating pain and/or inflammation associated with a dermatological method.
• the present invention also relates to a composition and photodermatological method for preventing and/or treating a skin or mucosal disease and/or condition.
• AK actinic keratosis
• Cryotherapy remains one of the most common treatments for AK, but has a number of limitations. There has even been uncertainty as to the duration one needs to freeze AKs to obtain maximal effect without excessive side effects. Common medical usage has recently demonstrated that a freeze of 6 to 20 seconds per lesion may be optimal. 1 However, this study did not look at long term efficacy of treatment. Most studies of efficacy in management of AKs use lesion count as the means of quantifying effect. This has its limitations. In a large Australian study 2 it was demonstrated that AKs can come and go of their own accord. Managing specific lesions might not lead to an overall improvement in actinic disease. While clinicians once focused on treating individual lesions, studies 2"4 suggest we should be increasingly managing the whole skin field rather than individual lesions.
• Treating one active AK may not assist any adjacent severely sun damaged skin. So treatments for field cancerization 4 have been more recently explored. Clinicians are moving away from lesion treatments in favour of treatments for the whole sun affected regions. Most commonly, the face, scalp, hands and forearms have been identified as regions in need of considering field treatment.
• IMIQ topical imiquimod 5
• 5FU topical 5-fluorouracil 6
• PDT photodynamic therapy 8
• Moloney 11 recently reported another RCT in which MAL and 5- aminolaevulinic acid (ALA) PDT were found to be both effective treatment options for AKs. MAL is significantly more expensive than ALA.
• AK kinasemiconductor kinase inhibitors
• topical administration of clotrimazole as taught in WO 96/33714, the publication of PCT/US96/05554, and topical application of a formulation containing 2-methyl-1-(2- methylpropyl)-1H-imidazo[4,5-c][1 ,5]naphthyridin-4-amine as taught in WO 2006/099275, the publication of PCT/US2006/008868.
• Perrett 12 recently studied the management of AKs in post transplant patients. Eight organ transplant recipients with epidermal dysplasia were recruited to an open-label intra-patient RCT.
• IMIQ imiquimod
• a preferred object is to treat pain and/or inflammation associated with a photodermatological method.
• Another preferred object is to provide a photodermatological method and composition for preventing or treating a skin or mucosal disease and/or condition.
• the present invention is broadly directed to treatment and prevention of pain and or inflammation.
• the treatment may be for acute inflammation and/or late phase response to a burn and/or other inflammatory stimuli.
• the invention may be applied to dermatology and particularly to photodermatology.
• a composition comprising menthol and ginseng treats and prevents pain and/or inflammation and treats skin and mucosal conditions and/or diseases.
• a composition comprising one or more alpha hydroxy acid may normalize and/or stabilize skin and thereby improve efficacy of a photodermatological method.
• novel photodermatological methods and compositions which prevent and/or treat a skin or mucosal disease or condition and which may then be associated with reduced pain and/or inflammation.
• the invention resides in a composition for treating pain and/or inflammation and/or for treating a skin or mucosal disease or condition, the composition comprising menthol and ginseng.
• composition according to the first aspect may comprise menthol at a concentration of 0.1 to 5 %.
• composition according to the first aspect may comprise menthol at a concentration of 0.25 to 2.0 %.
• composition according to the first aspect may comprise menthol at a concentration of 0.4 to 0.6 %.
• composition according to the first aspect may comprise menthol at a concentration of 0.5%.
• the ginseng may be Panax ginseng
• the Panax ginseng may be fresh ginseng, white ginseng, red ginseng or sun ginseng.
• the ginseng may be present as an extract. According to the first aspect the ginseng may be at a concentration of
• the ginseng may be at a concentration of 2.5 to 7.5 %.
• the ginseng may be at a concentration of 4 to 6 %.
• the ginseng may be at a concentration of 5 %.
• composition may comprise one or more excipient.
• the one or more excipient may be polysorbate 20.
• composition may comprise one or more emollient.
• the one or more emollient may be paraffin and/or aloe vera.
• the composition may further comprise an agent which helps seal disrupted inter-epithelial surfaces.
• composition may further comprise a topical anaesthetic.
• composition may further comprise one or more anti-inflammatory, one or more anti-histamine and or one or more anti-prostaglandin.
• the anti-inflammatory may be an oral anti-inflammatory medication such as, fexofenidine, ceterizine or a non-steroidal anti-inflammatory drug (NSAID) such as, aspirin.
• NSAID non-steroidal anti-inflammatory drug
• the above anti-inflammatory may also have some action on the neurokinin (NK1) and acetylcholine (ACH) receptors.
• the anti-prostaglandin may be a non-steroidal anti-inflammatory such as aspirin, flunixin meglumine, dipyrone and phenylbutazone.
• composition may also comprise one or more medicament for blocking a prostanoid such as, a NSAID such as, aspirin.
• a prostanoid such as, a NSAID such as, aspirin.
• the ginseng may reduce a leukotriene.
• the leukotriene reduced may include leukotriene B4.
• composition may further comprise a sunscreen.
• the invention in a second aspect resides in a method for treating pain and/or inflammation and/or for treating a skin or mucosal disease or condition, the method including the step of applying the composition according to the first aspect to thereby treat the pain and/or inflammation.
• the invention resides in use of a composition according to the first aspect in the manufacture of a medicament for treatment of pain and/or inflammation and/or for the treatment of a skin or mucosal disease or condition.
• the pain and/or inflammation treated according to the first, second and/or third aspect may be acute inflammation and/or late phase response to a burn and/or other inflammatory stimuli.
• the pain and/or inflammation treated according to the first, second and/or third aspect may be associated with a photodermatological method.
• the skin disease and/ or skin condition treated may selected from the group consisting of: actinic keratosis (AK); skin cancer; a pre-cancerous growth; a condition resulting from pre-emptive and/or post-testing for an allergy; sunburn; a skin disease or condition resulting from a radiotherapy treatment; a skin disease or condition resulting from a tattoo; urticaria; eczema and other forms of dermatitis; or a burn.
• the mucosal disease or condition treated may be a cough; sinusitis; or post-chemotherapy bladder pain.
• composition may also be used to prepare skin for one or more procedure such as, PDT or a tattoo.
• the invention resides in a composition for treating a skin disease and/or a skin condition comprising one or more alpha hydroxy I acid (AHA).
• AHA alpha hydroxy I acid
• the one or more AHA may be selected from the group consisting of glycolic acid, lactic acid, citric acid, malic acid, tartaric acid and mandelic acid.
• the one or more AHA is at a concentration in the range of 2 to 20%.
• the one or more AHA is at a concentration in the range of 5 to 15 %. According to the fourth aspect the one or more AHA is at a concentration in the range of 8 to 12 %.
• the one or more AHA is at a concentration of 10 %.
• the one or more AHA is at a concentration of 5 %.
• the one or more AHA may be stabilised.
• the invention resides in a method for treating a skin disease or a skin condition including the step of applying a composition according to the fourth aspect to thereby treat the skin disease or skin condition.
• the invention resides in use of a composition according to the fourth aspect in the manufacture of a medicament for treatment of a skin disease or a skin condition.
• the invention resides in a method for preventing and/or treating a skin disease or skin condition including the steps of: treating an area of skin with a composition according to the first aspect; applying one or more photosensitizer to the area of skin; and exposing the area of skin to light to thereby prevent and/or treat the skin disease and or condition.
• the step of treating the area of skin with a composition according to the first aspect may be conducted prior to exposure to light, during exposure to light and/or after exposure to light.
• the method of the seventh aspect may also include a step of treating the area of skin with a composition according to the fourth aspect.
• the step of treating the area of skin with a composition according to the fourth aspect is conducted prior to exposing the area of skin to light.
• the one or more photosensitizer may be 5-aminolaevulinic acid.
• the light may comprise two or more wavelengths.
• the two or more light wavelengths may be blue light and red light.
• the method may also include the step of treating with one or more co-therapeut.
• the one or more co-therapeutic may be 5-fluorouracil and/or imiquinod.
• the method may also be combined with one or more physical treatment.
• the physical treatment may comprise cryotherapy and/or excision.
• the invention resides in a method for preventing and/or treating a skin disease or skin condition including the steps of: treating an area of skin with a composition according to the fourth aspect; applying one or more photosensitizer to the area of skin; and exposing the area of skin to light to thereby prevent and/or treat the skin disease and or condition.
• the method of the eighth aspect may also include a step of pre- treating the area of skin with a composition according to the first aspect.
• the method of the eighth aspect may also include a step of treating the area of skin with a composition according to the first aspect during the exposure step.
• the method of the eighth aspect may also include a step of post- treating the area of skin with a composition according to the first aspect.
• the one or more photosensitizer may be 5-aminolaevulinic acid.
• the light may comprise two or more wavelengths.
• the two or more light wavelengths may be blue light and red light.
• the method may also include the step of treating with one or more co-therapeut.
• the one or more co-therapeutic may be 5-fluorouracil and/or imiquinod.
• the method may also be combined with one or more physical treatment.
• the physical treatment may comprise cryotherapy and/or excision.
• the invention resides in a composition for treating a skin disease or a skin condition comprising an emollient, a topical anaesthetic and further comprising one or more further component selected from the group consisting of a pain reliever, an agent to help seal disrupted inter-epithelial surfaces and an agent to block noxious signalling from one or more receptor.
• the invention resides in a method for treating a skin disease or a skin condition including the step of applying a composition according to the eighth aspect.
• the invention resides in use of a composition according to the ninth aspect in the manufacture of a medicament for treatment of a skin disease or skin condition.
• the noxious signalling blocked may be noxious signalling from a receptor such as, the transient receptor potential vanilloid receptor 1.
• the invention resides in a composition comprising stabilized ALA.
• the invention resides in a method for treating a skin disease or a skin condition including the step of applying a composition according to the twelfth aspect.
• the invention resides in use of a composition according to the twelfth aspect in the manufacture of a medicament for treatment of a skin disease or skin condition.
• the invention resides in a method for treating a skin disease or a skin condition including the step of exposing an area of skin to be treated to light of two discrete and different wavelengths.
• the light may be blue light and red light.
• FIG. 1A is a flowchart showing a first embodiment of a method of the invention
• FIG. 1 B is a flowchart showing an additional step in the method shown in
• FIG. 1A A first figure.
• FIG. 1C is a flowchart showing a second embodiment of a method of the invention
• FIG. 1 D is a flowchart showing an additional step in the method shown in
• FIG. 1C
• FIG. 2A is a photo showing a right hand side of a subject's face at initial consult
• FIG. 2B is a photo showing a left hand side of a subject's face at initial consult
• FIG. 2C is a photo showing a front-on view of a subject's face at initial consult
• FIG. 2D is a photo showing a right hand side of a subject's face ten weeks after receiving a second treatment according to the method of the invention.
• FIG. 2E is a photo showing a left hand side of a subject's face ten weeks after receiving a second treatment according to the method of the invention.
• FIG. 2F is a photo showing a front-on view of a subject's face ten weeks after receiving a second treatment according to the method of the invention
• FIGS. 2G and 2H are photos showing punch biopsy results of a subject treated according to the method of the invention.
• the invention relates, at least in part, to relief of pain and/or inflammation. Although it will be explained with reference to photodermatology, aspects of the present invention may be applied to the general treatment of pain and/or inflammation.
• a skin disease or condition includes damaged or unhealthy skin. Damaged skin includes skin damaged by the sun or other radiation as well as actinic keratosis. Treatment of a skin disease or condition includes pre- treatment of skin in preparation for a procedure such as, tattooing. A mucosal disease or condition includes damaged or unhealthy mucosa.
• a photosensitizer is a chemical compound that can be excited by light.
• the light may be of a specific wavelength. This light may be visible or near- infrared light.
• a photosensitizer includes a metabolic precursor which is converted to a photosensitizer after application to a subject.
• An emollient refers to a compound which softens skin.
• One or more emollient may be combined to form a moisturiser.
• the present inventors have advantageously found that a composition comprising menthol and ginseng may treat pain and/or inflammation and/or treat a skin or mucosal condition or disease.
• the composition may treat acute inflammation and/or late phase response to a burn and/or other inflammatory stimuli.
• the skin disease or condition treated may be actinic keratosis (AK); skin cancer; a pre-cancerous growth; a skin disease or condition resulting from pre-emptive or post testing for an allergy; sunburn; a skin disease or condition resulting from a radiotherapy treatment; a skin disease or condition resulting from a tattoo; urticaria; eczema and other forms of dermatitis; a burns.
• the mucosal disease or treatment may be a cough; sinusitis; and/or post-chemotherapy bladder pain.
• composition may also be used to prepare skin for one or more procedure such as, PDT or a tattoo.
• the menthol may be present in a concentration of 0.1 to 5 %.
• the menthol concentration may be 0.25 to 2.0 %.
• the menthol concentration may be 0.4 to 0.6 %.
• the menthol concentration may be 0.1, 0.2, 0.3, 0.4,
• menthol concentration 0.5%.
• the ginseng may be Panax ginseng (Asian ginseng) or Panax quinquefolius (American ginseng).
• the Panax ginseng may be fresh ginseng, white ginseng, red ginseng or sun ginseng.
• the ginseng is Panax ginseng.
• the ginseng may be present as an extract.
• the ginseng extract may be a commercially available extract.
• the ginseng extract may be present in a concentration of 1 to 10%.
• the ginseng extract may be present in a concentration of 2.5 to 7.5 %.
• the ginseng extract may be present in a concentration of 4 to 6 %.
• the concentration may be 1.0, 1.1 , 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1 ,
• the concentration of the ginseng extract is 5.0 %.
• the composition may comprise one or more emollient. Suitable emollients include paraffin and aloe vera.
• the composition may also comprise one or more pain reliever.
• the one or more pain reliever may include an agent that blocks noxious signalling from one or more receptor.
• the noxious signaling blocked may be noxious signaling from the transient receptor potential vanilloid receptor 1.
• the blocking may be specific to the transient receptor potential vanilloid receptor 1.
• the menthol blocks the transient receptor potential melastatin 8 (TRPM8) receptor.
• TRPM8 transient receptor potential melastatin 8
• composition may further comprise an agent which helps seal disrupted inter-epithelial surfaces.
• agent may be a ceremide compound such as lanoline, an oil base such as avocado oil or in paraffin.
• composition may further comprise a topical anaesthetic.
• composition may also comprise one or more anti-inflammatory, one or more anti-histamine and or one or more anti-prostaglandin.
• the anti-inflammatory may be an oral anti-inflammatory medication such as, fexofenidine, ceterizine or a non-steroidal anti-inflammatory drug (NSAID) such as, aspirin.
• NSAID non-steroidal anti-inflammatory drug
• the above anti-inflammatory may also have some action on the neurokinin (NK1) and acetylcholine (ACH) receptors.
• NK1 neurokinin
• ACH acetylcholine
• the anti-prostaglandin may be a non-steroidal anti-inflammatory such as aspirin, flunixin meglumine, dipyrone and phenylbutazone.
• composition may also comprise one or more medicament for blocking a prostanoid such as, a NSAID such as, aspirin.
• a prostanoid such as, a NSAID such as, aspirin.
• the ginseng may reduce a leukotriene.
• the leukotriene reduced may be leukotriene B4.
• composition may further comprise a sunscreen.
• the sunscreen advantageously reduces ongoing activation of the one or more photosensitizer.
• the menthol and ginseng comprising composition may be used to treat any type of pain.
• the pain may be pain associated with light therapy, laser therapy, radiotherapy, burns, inflammation and/or mucosal inflammation.
• the present invention also provides methods and compositions for treating and/or prevention of a skin disease or skin condition. While the methods and compositions are explained with reference to photodynamic therapy (PDT), they are not constrained thereto.
• PDT photodynamic therapy
• a second composition for treating and/or prevention of a skin or mucosal disease or condition may comprise one or more alpha hydoxy acid (AHA).
• AHA is a compound that comprises a carboxylic acid substituted with a hydroxyl group on the adjacent carbon.
• the one or more AHA may be selected from the group consisting of glycolic acid, lactic acid, citric acid, malic acid, tartaric acid and mandelic acid.
• the one or more AHA has a small molecular size so that it is able to penetrate the top layer of the skin.
• the one or more AHA in the composition may be at a concentration in the range of 2 to 20%.
• the one or more AHA in the composition may be in a concentration range of 5 to 15 %.
• the one or more AHA in the composition may be in a concentration range of 8 to 12 %.
• the concentration may be 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 , 12, 13, 14, 15, 16, 17, 18, 19 or 20%.
• the one or more AHA in the composition is in a concentration of 10 %.
• the concentration of the one or more AHA may be in the range of 2 to 10 %.
• the concentration may be in the range of 4 to 6 %. In one embodiment the concentration is 5%.
• FIG. 1A shows one embodiment of a method 100 according to the invention.
• Method 100 includes a step 102 of treating an area of skin with the composition comprising one or more alpha hydroxy acid according to the invention.
• Method 100 also includes step 104 of applying one or more photosensitizer to the area of skin.
• step 106 the area of skin is exposed to light to thereby prevent and/or treat the skin disease and or condition.
• the treatment of the area of skin with a composition comprising one or more alpha hydroxyl amino acid may be for any suitable period.
• the period is sufficient for the integrity of the skin to be improved.
• the treatment may be for 1 day to 4 weeks.
• the treatment may be 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 14 days, 3 weeks or 4 weeks.
• Preferably the treatment is for 2 to 4 weeks.
• the treatment may be between one and five times a day or as needed.
• the treatment of the area of skin with a composition comprising one or more hydroxyl amino acid is a chemical treatment.
• the treatment may also include a physical treatment such as, exfoliation.
• the treatment may also include washing the area of skin.
• the washing may be with a ceramide.
• one of the significant advantages of the present invention is that exposure to the one or more AHA normalizes and stabilizes the skin, improving the skin integrity and the integrity of the lipid intracellular barrier.
• the normalized and stabilized skin is more receptive to PDT and thereby the efficacy of the PDT therapy is increased.
• the nerves are not as exposed which means less photosensitizer may be used because application is to a relatively smoother surface. Consequently, there is also less light scatter, better light penetration, less pain, better tolerance and higher compliance with the method of the invention.
• the one or more photosensitizer applied may be aminolevulinic acid (ALA) or methyl aminolevulinate (MAL), silicon phthalocyanine (Pc 4), m- tetrahydroxyphenylchlorin (mTHPC), mono-L-aspartyl chlorin e6 (NPe6), Photofrin, Visudyne and/or LS 11.
• ALA aminolevulinic acid
• MAL methyl aminolevulinate
• Pc 4 silicon phthalocyanine
• mTHPC m- tetrahydroxyphenylchlorin
• NPe6 mono-L-aspartyl chlorin e6
• Photofrin Visudyne and/or LS 11
• the one or more photosensitizer is ALA.
• the ALA may be stabilized.
• the novel stabilized form of ALA provided by the present invention has an improved shelf life of three months and thereby has many advantages over single use bottles such as, ability to evenly distribute the ALA on the area of skin, ability to use any remainder on subsequent subject and decreased cost.
• the ability to evenly distribute the ALA on the skin also means that lower intensity light may be used in PDT and also that decreased pain is encountered. Further advantages such as better tolerance and increased patient compliance flow from these significant advantages of the invention.
• the exposure to light may comprise exposure to two or more discrete wavelengths of light.
• the two or more wavelengths comprise blue light and red light.
• the exposure is to blue light and then to red light.
• the exposure to blue light may be for between 2 and 20 minutes.
• the exposure may be for 5 to 15 minutes.
• the exposure may be for between 8 and 12 minutes.
• the exposure to blue light may be for 2, 3, 4, 5, 6, 7, 8 , 9,
• the exposure to blue light is for 10 minutes.
• the exposure to red light may be for between 5 and 30 minutes.
• the exposure to red light may be for between 15 and 25 minutes.
• the exposure to red light may be for between 18 and 22 minutes.
• the exposure to red light may be for ⁇ , 6, 7, 8, 9, 10, 11 , 12, 13, 14, 15, 16, 17, 18, 19, 20, 21 , 22, 23, 24, 25, 26, 27, 28, 29 or 30 minutes.
• the exposure to red light is for 20 minutes.
• discrete wavelength is meant exposure to light of only or substantially only of a wavelength or a range of wavelengths. For example, exposure to sunlight or white light is not exposure to discrete light and is instead exposure to a wide spectrum of light.
• the blue light may have a wavelength between 450 and 495 nm.
• the wavelength may be between 460 and 490 nm.
• the wavelength may be between 460 and 480 nm.
• the wavelength may be 450, 451 , 452, 453, 454, 455, 456, 457, 458, 459, 450, 451 , 452, 453, 454, 455, 456, 457, 458, 459, 460, 461 , 462, 463, 464, 465, 466, 467, 468, 469, 470, 471 , 472, 473, 474, 475, 476, 477, 478, 479, 480, 481 , 482, 483, 484, 485, 486, 487, 488, 489, 490, 491 , 492, 493, 494 or 495 nm.
• the wavelength is 470 nm.
• the red light may have a wavelength between 620 and 750 nm.
• the wavelength may be between 630 and 700 nm.
• the wavelength may be between 635 and 645 nm.
• the wavelength may be 620, 621 , 622, 623, 624, 625, 626, 627, 628, 629, 630, 631 , 632, 633, 634, 635, 636, 637, 638, 639, 640, 641 , 642, 643, 644, 645, 646, 647, 648, 649, 650, 651 , 652, 653, 654, 655, 656, 657, 658, 659, 660, 661 , 662, 663, 664, 665, 666, 667, 668, 669, 670, 675, 680, 685, 690, 695, 700, 705, 710, 715, 720, 725, 730, 735, 740, 745 or 750 nm.
• the wavelength is 640nm.
• the exposure to light may activate the photosensitizer. Accordingly, the light wavelength and/or exposure time may be selected to activate the photosensitizer. A person of skill in the art may alter the light wavelength and/or exposure time to suit a particular photosensitizer.
• the exposure to light may also include exposure to laser light and or intense pulsed light (IPL).
• the method 100 may also be combined with one or more physical treatment.
• the physical treatment may be a physical intervention on the area of skin such as, a surgical method, an excision or cryotherapy.
• the present inventors hypothesize that there is no medical or pharmacological interaction between the AHA's and the one or more photosensitizer.
• their combined use has synergistically led to advantages such as less pain, better tolerance and increased compliance.
• FIG. 1 B shows another embodiment of the method 100 of the invention comprising the step 108 of post-treating the area of skin.
• the post-treatment may be treatment with the composition comprising menthol and ginseng according to the invention.
• the composition may also comprise any of the further components of the composition identified herein.
• the post-treatment may further include avoidance of direct and indirect sunlight.
• the post-treatment blocks sensory nociceptors, reestablishes epithelial integrity by the emollient properties as well as by the use of an agent to help seal disrupted inter-epithelial surfaces and thereby reduces pain and reduces transepidermal water loss.
• the post-treatment composition may be combined with one or more co-therapeutic.
• the one or more co-therapeutic may comprise imiquimod and/or 5-fluorouracil.
• Imiquimod or AldaraTM is 1-(2-methylpropyl)-1H-imidazo[4,5- c]quinolin-4-amine and has a molecular formula Of CuHi 6 N 4 and a molecular weight of 240.3.
• Imiquimod may be applied topically to the area of skin after and/or as part of post-treatment.
• 5-fluorouracil may be applied as EfudixTM. 5-fluorouracil may be applied topically to the area of skin after and/or as part of post-treatment.
• the invention also provides a second method 200 for preventing and/or treating a skin disease or condition, shown in FIG. 1C, which includes a step 202 of treating an area of skin with the composition comprising menthol and ginseng described above.
• the composition may also comprise any of the further components of the composition identified herein.
• Method 200 also includes step 204 in which one or more photosensitizer is also be applied to the area of skin.
• step 206 the area of skin is exposed to light to thereby prevent and/or treat the skin disease and or condition.
• Step 202 may be conducted prior to exposure to light, during exposure to light and/or after exposure to light.
• FIG. 1 D shows an additional step 208 in which the area of skin is treated with the composition comprising one or more AHA described above.
• step 208 is conducted prior to step 206 in which the area of skin is exposed to light.
• the one or more photosensitizer applied in method 200 may be aminolevulinic acid (ALA) or methyl aminolevulinate
• MAL silicon phthalocyanine
• Pc 4 silicon phthalocyanine
• mTHPC m-tetrahydroxyphenylchlorin
• NPe6 mono-L-aspartyl chlorin e6
• Photofrin Visudyne and/or LS11.
• the one or more photosensitizer is ALA.
• the ALA may be stabilized.
• the exposure to light in method 200 may be as described with reference to method 100.
• the method 200 may also be combined with one or more physical treatment.
• the physical treatment may be a physical intervention on the area of skin such as, a surgical method, an excision or cryotherapy.
• Method 200 may also include avoidance of direct and indirect sunlight post-treatment.
• the compounds referred to herein may be applied as a pharmaceutically acceptable salt thereof.
• compositions of the invention may comprise an effective amount of one or more relevant compounds, or a pharmaceutically-acceptable salt thereof, and a pharmaceutically acceptable carrier, diluent and/or excipient.
• the excipient may be present in a concentration of 0.1 to 5.0 %.
• the excipient may be present in a concentration of 1.0 to 3.0 %.
• the excipient may be present in a concentration of 1.5 to 2.5 %.
• the excipient may be present in a concentration of 0.1 , 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1,
• the excipient is present in an amount of 2.0 %.
• the excipient is polysorbate 20.
• compositions of the invention may comprise an effective amount of a solvent.
• the solvent is water. Dosage form and rates for pharmaceutical use and compositions are readily determinable by a person of skill in the art.
• Dosage forms include tablets, dispersions, suspensions, injections, solutions, syrups, troches, capsules, suppositories, aerosols, transdermal patches, creams, gels and the like. These dosage forms may also include injecting or implanting devices designed specifically for, or modified to, controlled release of the pharmaceutical composition. Controlled release of the therapeutic agent may be effected by coating the same, for example, with hydrophobic polymers including acrylic resins, waxes, higher aliphatic alcohols, polyactic and polyglycolic acids and certain cellulose derivates such as hydroxypropylmethyl cellulose. In addition, the controlled release may be affected by using other polymer matrices, liposomes and/or microspheres.
• compositions of this invention may also be incorporated into the compositions of this invention.
• the pharmaceutical composition comprises a pharmaceutically-acceptable excipient or an acceptable excipient.
• pharmaceutically-acceptable excipient is meant a solid or liquid filler, diluent or encapsulating substance that may be safely used.
• carriers well known in the art may be used. These carriers or excipients may be selected from a group including sugars, starches, cellulose and its derivates, malt, gelatine, talc, calcium sulphate, vegetable oils, synthetic oils, polyols, alginic acid, phosphate buffered solutions, emulsifiers, isotonic saline, and pyrogen-free water.
• any suitable route of administration may be employed for providing a human or non-human patient with the pharmaceutical composition of the invention.
• oral, rectal, parenteral, sublingual, buccal, intravenous, intraarticular, intra-muscular, intra-dermal, subcutaneous, inhalational, intraocular, intraperitoneal, intracerebroventricular, transdermal, topical and the like may be employed.
• the pharmaceutical composition is applied topically.
• the composition of the invention may be atomized, nebulised or instilled.
• compositions of the present invention suitable for administration may be presented in discrete units such as vials, capsules, sachets or tablets each containing a predetermined amount of one or more pharmaceutically active compounds of the invention, as a powder or granules or as a solution or a suspension in an aqueous liquid, a nonaqueous liquid, an oil-in-water emulsion or a water-in-oil emulsion or as a solution or suspension in a cream or gel.
• Such compositions may be prepared by any of method of pharmacy but all methods include the step of bringing into association one or more pharmaceutically active compounds of the invention with the carrier which constitutes one or more necessary ingredients.
• compositions are prepared by uniformly and intimately admixing the agents of the invention with liquid carriers or finely divided solid carriers or both, and then, if necessary, shaping the product in to the desired presentation.
• the active compounds of the compositions of this invention may be present in an amount sufficient to prevent, inhibit or ameliorate a disease or condition. Suitable dosages of the compounds and the pharmaceutical compositions containing such may be readily determined by those skilled in the art. So that the invention may be readily understood and put into practical effect, the following non-limiting Examples are provided
• EXAMPLE 1 A composition comprising 2.00% polysorbate 20, 0.50 % liquid menthol 0.50, 5.00 % panax ginseng (hydroglyceric) extract was prepared in water to 100%.
• FIGS. 2A-2C shows a subject at initial consult with obvious AKs and skin abnormalities.
• FIGS. 2D-2F show the subject 10 weeks after receiving two PDT treatments according to the invention and show much improved skin clarity, stability and normality.
• Example 1 The composition of Example 1 was applied to the skin of the treatment area ten (10) minutes prior to treatment with photodynamic therapy. Care was taken to avoid mucosal membrane contact.
• FIG. 2G and 2H shows punch biopsy results for residual suspicious lesions for the subject.
• the subject had squamous-cell carcinoma (SCC) in situ below the right eye as well as above the left eye, well differentiated SCC below the left eye and a superficially invasive well differentiated SCC near the left ear.
• SCC squamous-cell carcinoma
• Example 1 During and following PDT treatment the composition of Example 1 was applied to the area of skin treated. Acute pain was reduced by approximately 90% during PDT treatment and reduced by approximately 80% when used 1 and 2 days post-PDT treatment.
• the present invention has improved efficiency and reduced pain as compared to other methods and compositions.
• the present invention advantageously reduces cancers and related pre-cancerous lesions within the field or area around prior cancers or lesions.
• the present invention provides a holistic process of skin stabilization and normalisation followed by a precise, two-wavelength PDT, which may be followed by post-treatment modalities. This novel approach is especially promising for treating the 'field' or broad area impacted by skin cancers, with the expectation of reducing or eliminating future recurrence.

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• 2010
  • 2010-05-10 EP EP10771913.0A patent/EP2429559A4/de not_active Withdrawn
  • 2010-05-10 WO PCT/AU2010/000539 patent/WO2010127411A1/en active Application Filing
  • 2010-05-10 AU AU2010244983A patent/AU2010244983B2/en not_active Ceased

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