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(2006.01) Published: A61K9/08 ) ( (51) International Patent Classification: Published: A61K 31/05 (2006.01) A61P 1 7/02 (2006.01) — with international search report (Art. 21(3)) A61K9/08 (2006.01) A61P29/00 (2006.01) A61P 1 7/00 (2006.01) (21) International Application Number: PCT/AU20 19/05005 1 (22) International Filing Date: 24 January 2019 (24.01.2019) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 2018900226 24 January 2018 (24.01.2018) AU 62/621,225 24 January 2018 (24.01.2018) US 2018903600 25 September 2018 (25.09.2018) AU 62/736,052 25 September 2018 (25.09.2018) US (71) Applicant: BOTANIX PHARMACEUTICALS LTD [AU/AU]; 63 Aberdeen Street, Northbridge, Western Aus¬ tralia 6003 (AU). (72) Inventors: CALLAHAN, Matthew; One Kew Place, 150 Rouse Boulevard, Navy Yard Corporate Center, Philadel¬ phia, Pennsylvania 191 12 (US). THURN, Michael; 912 Kangaroobie Road, Kangaroobie, NSW 2800 (AU). (74) Agent: WRAYS PTY LTD; Level 7, 863 Hay Street, Perth, Western Australia 6000 (AU). (81) Designated States (unless otherwise indicated, for every kind of national protection available) : AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available) : ARIPO (BW, GH, GM, KE, LR, LS, MW, ML, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, Cl, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). (54) Title: CANNABINOID DOSING REGIME FOR DERMATITIS AND INFLAMMATORY SKIN CONDITIONS (57) Abstract: A treatment regime for use in the treatment or prevention of dermatitis and inflammatory skin conditions, said regime comprising the administration of: a) between 50 mg and 3000 mg of a topical liquid or gel composition comprising between 1% w/w and 15% w/w cannabinoid, wherein the cannabinoid is dissolved in the liquid or gel composition. Cannabinoid Dosing Regime for Dermatitis and Inflammatory Skin Conditions TECHNICAL FIELD [0001] A topical dosing regimen for the treatment or prevention of dermatitis and inflammatory skin conditions using cannabinoids. BACKGROUND ART [0002] Most mammalian skin, including human skin, comprises three layers: (i) an epidermis layer; (ii) a dermis layer; and (iii) a hypodermis layer. The epidermis itself is made up of two layers, the outer stratum corneum and the inner epidermal basal layer. [0003] The majority of skin conditions involve inflammation triggered by some insult to the skin. Keratinocytes respond quickly to environmental stimuli (e.g., UV radiation (UVR), allergens, irritants or physical damage) by producing a variety of inflammatory mediators, including cytokines (e.g., IL-I, TNF-alpha, and IL-6) and chemokines (e.g., IL-8). One of the most active inflammatory mediators is PGE-2 (Prostaglandin E2) and, of course, many topical dermatology drugs have been designed to lower levels of PGE-2. The fibroblasts in the dermis also produce PGE-2 along with a variety of chemokines, cytokines and matrix destroying enzymes such as collagenase (MMP-I). [0004] Eczema, also known as dermatitis, is a general term for many types of skin conditions that involve inflammation. Atopic dermatitis is the most common of the many types of eczema. Several other forms have very similar symptoms. Some of the diverse types of eczema are listed and briefly described below. [0005] Atopic dermatitis is a chronic skin disease wherein the skin becomes extremely itchy and inflamed, causing redness, swelling, cracking, weeping, crusting, and scaling. Atopic dermatitis most often affects infants and young children, but it can continue into adulthood or first show up later in life. Onset after age 30 is less common and often occurs after exposure of the skin to harsh conditions. In most cases, there are periods of time when the disease is worse, called exacerbations or flares, which are followed by periods when the skin improves or clears up entirely, called remissions. The cause of atopic dermatitis is unknown, but the disease seems to result from a combination of genetic and environmental factors. Atopic dermatitis is very common and affects males and females equally and accounts for 10 to 20 % of all referrals to dermatologists; more than 15 million people in the United States have symptoms of the disease. People who live in urban areas and in climates with low humidity seem to be at an increased risk for developing atopic dermatitis. [0006] Dermatitis is also an increasing problem in animals, particularly domestic animals such as pets (dogs, cats). Dogs, for the most part, tend to remain in the cutaneous stage of the atopic disease. Similarly to humans, atopic dermatitis (AD) in dogs is becoming increasingly common. [0007] Contact eczema is a localized reaction that includes redness, itching, and burning where the skin has come into contact with an allergen (an allergy-causing substance) or with an irritant such as an acid, a detergent (soap, bodywash), or other chemical. [0008] Allergic contact eczema is a red, itchy, weepy reaction where the skin has come into contact with a substance that the immune system recognizes as foreign, such as poison ivy or certain preservatives in creams and lotions. [0009] Seborrheic eczema is a form of skin inflammation of unknown cause but which is associated with a certain type of yeast that lives on the skin. Seborrheic eczema presents as yellowish, oily, scaly patches of skin on the scalp, face, and occasionally other parts of the body (called cradle cap in infants). [0010] Nummular eczema is coin-shaped patches of irritated skin-most commonly on the arms, back, buttocks, and lower legs-that may be crusted, scaling, and extremely itchy. [001 1] Neurodermatitis is scaly patches of skin on the head, lower legs, wrists, or forearms caused by a localized itch (such as an insect bite) that becomes intensely irritated when scratched. [0012] Stasis dermatitis is a skin irritation on the lower legs, generally related to circulatory problems. [0013] Dyshidrotic eczema is irritation of the skin on the palms of hands and soles of the feet characterized by clear, deep blisters that itch and burn. [0014] Radiation therapy can have some unpleasant side effects which include inflammation of the skin and radiation dermatitis. Specific side effects of radiotherapy, both acute and chronic, depend on the part of the body being treated as well as the dose given. In general, the first change is a reddening of the skin, resembling sunburn. In many patients this is all that is experienced. However, in most patients the burn can be severe and in many cases equivalent to second degree burns. Like sunburn, the involved area is often sensitive and even painful to the touch. In addition, the overlying skin may break down and the area may remain open until several days to weeks after the course of radiation is completed. Once the course of radiotherapy is completed, the redness will gradually go away and any open areas normally will heal. However, the skin in this area will most likely develop features of aged skin including pronounced wrinkling, skin thinning, stiffness and/or dryness, as well as possible pigmentation changes. [0015] Most of the current treatment options for radiation dermatitis involve the use of emollients or aloe gels in an attempt to keep the skin moisturized. However, although moisturization helps the skin from drying out, it does not reduce the pain or redness, which are caused by inflammation. [0016] Rosacea is a vascular, inflammatory skin disorder that affects approximately 5% of the population and is characterized by frequent periods of facial redness or flushing caused by over- active capillaries. Over time, this chronic state of skin inflammation gives rise to a variety of rosacea symptoms. Rosacea is sometimes characterized mistakenly as adult-acne because patients present with a reddened face and acne-like symptoms. However, individuals affected with this skin disease also may have persistent redness with accompanying pain and itching in areas such as the forehead, chin, nose, ears, chest and back. As the disease progresses, small blood vessels and tiny pimples (called papules or pustules) begin to appear on and around the reddened area. In severe cases rosacea can affect the eyes (ocular rosacea) and cause disfigurement of the nose (rhynophyma). In addition to the physical symptoms associated with rosacea, patients also suffer significant psychological and social problems if left untreated. The main form of rosacea is erythrotelangiectatic rosacea (also known as erythematotelangiectatic rosacea or vascular rosacea). [0017] Four rosacea subtypes exist, and a patient may have more than one subtype: i) Erythrotelangiectatic rosacea exhibits permanent redness (erythema) with a tendency to flush and blush easily. It is also common to have small, widened blood vessels visible near the surface of the skin (telangiectasias) and possibly intense burning, stinging, or itching. People with this type often have sensitive skin.
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