1. Field of the Invention
The present invention relates to the field of topical preparations in forms such as ointment or spray which accelerate the healing of thermal injury, ultraviolet injury or radiation induced burns to the skin of humans, other mammals and other living creatures.
2. Description of the Prior Art
Skin is the primary protective barrier for humans. Healthy skin is a major factor in overall health. Skin can be injured by mechanical disruption (e.g., cuts and scrapes), by internal mechanisms (e.g., infiltrative disease) or by absorption of energy (e.g., heat, ultraviolet, and ionizing radiation). This study focuses on the acceleration of the healing of skin injuries caused by the absorption of various forms of energy: heat, ultraviolet and ionizing radiation.
Heat causes thermal skin injury. Burns are classified as first, second or third degree by the extent of the injury.
Degree Characteristics
                1 Affects only the outer layer of the skin. Symptoms: pain, redness, and swelling. (sunburn, thermal injury)        2 Affects both the outer and underlying layer of skin. Symptoms: pain, redness, swelling, and blistering.        3 Extends into deeper tissues.         Symptoms: White or blackened, charred skin that may be numb.        
First- and second-degree burns are a common first aid problem. They cause pain, redness and swelling; progressing to blistering in many cases. The discomfort during healing is the primary morbidity of thermal injury. Extensive wounds and third degree burns require expert medical intervention. Burn injury is usually independent of skin type.
Ultraviolet light causes sunburn. Not all skin is equally resistant to ultraviolet injury. A common skin phenotype classification is based on the likelihood of the skin to burn or tan.
TypeSkin ColorCharacteristics1WhiteAlways burns, never tan2WhiteUsually burns, tans less than average3WhiteSometimes mild burn, tans more than average4WhiteRarely burns, tans more than average5BrownRarely burns, tans profusely6BlackNever burns, deeply pigmented
White skin is at greater risk of ultraviolet light injury. Ultraviolet radiation injury causes pain, redness and swelling, i.e. inflammation. The discomfort during healing is the primary morbidity of sunburn.
Sunscreens, protective clothing and limiting exposure are the traditional methods to protect skin from ultraviolet induced injury. Dietary intake of carotenoids or other photoprotective compounds can increase protection of skin against injury by ultraviolet or ionizing radiation.
Skin exposed to the high energy photons in ionizing radiation develops burns not unlike severe sunburn. Radiation-induced erythema is a comorbidity of radiation treatment in oncology.
Topical therapy is the first line therapy for minor burns, whether heat, ultraviolet or radiation induced. Anesthetics in the topical formulations mask the pain of burns while the skin heals itself.
Humans have used plants and plant extracts as topical medications to treat various conditions from the dawn of remembered history. The use of mosses, muds and plants are well known in the “fable and folklore” pharmacopeia. George Washington Carver recognized the medicinal value of the tomato in the early 20th century. The classical treatment for burns is the plant or an extract of Aloe vera. A review of individual studies and meta analyses reveals few positive results or little objective evidence for any positive effect, and notably, some negative effects of Aloe vera extracts on various burn injuries. Other plant derived polyphenols and extracts have been evaluated topically with mixed results. Synthetic medications, such as topical corticosteroids are effective in acute radiation dermatitis although there may be substantial side effects.
The following published articles have addressed the subject matter of treatment of burns and various remedies that are known or have been considered in the prior art.    1. McMillan T J, Leatherman E, Ridley A, Shorrocks J, Tobi S E, Whiteside J R Cellular effects of long wavelength UV light (UVA) in mammalian cells. J Pharm Pharmacol 60(8): 969-76, 2008.    2. Fitzpatrick T B. The validity and practicality of sun reaction types I through VI. Arch Dermatol (1988) 124: 869-871.    3. Fitzpatrick T B. (1986) Ultraviolet-induced pigmentary changes: Benefits and hazards. Curr Probl Derm 15:25-38.    4. Stahl W, Sies H. Carotenoids and flavonoids contribute to nutritional protection against skin damage from sunlight. Mol Biotechnol. 37(1):26-30, 2007.    5. Stahl W, Heinrich U, Aust O, Tronnier H, Sies H. Lycopene-rich products and dietary photoprotection Photochem Photobiol Sci. 5(2):238-42, 2006.    6. Aust O, Stahl W, Sies H, Tronnier H, Heinrich U. Supplementation with tomato-based products increases lycopene, phytofluene, and phytoene levels in human serum and protects against UV-light-induced erythema. Int J Vitam Nutr Res. 75(1):54-60, 2005.    7. Stahl W, Heinrich U, Wiseman S, Eichler O, Sies H, Tronnier H. Dietary tomato paste protects against ultraviolet light-induced erythema in humans. J. Nutr. 131(5):1449-51, 2001.    8. Césarini J P, Michel L, Maurette J M, Adhoute H, Bejot M. Immediate effects of UV radiation on the skin: modification by an antioxidant complex containing carotenoids. Photodermatol Photoimmunol Photomed. 19(4):182-9, 2003.    9. Heinrich U, Gärtner C, Wiebusch M, Eichler O, Sies H, Tronnier H, Stahl W. Supplementation with beta-carotene or a similar amount of mixed carotenoids protects humans from UV-induced erythema. J Nutr. 133(1):98-101, 2003.    10. Greul A K, Grundmann J U, Heinrich F, Pfitzner I, Bernhardt J, Ambach A, Biesaiski H K, Goilnick H. Photoprotection of UV-irradiated human skin: an antioxidative combination of vitamins E and C, carotenoids, selenium and proanthocyanidins. Skin Pharmacol Appl Skin Physiol. 15(5):307-15, 2002.    11. Stahl W, Sies H. Carotenoids and protection against solar UV radiation. Skin Pharmacol Appl Skin Physiol. 15(5):291-6, 2002.    12. Sies H, Stahl W. Non-nutritive bioactive constituents of plants: lycopene, lutein and zeaxanthin. Int J Vitam Nutr Res. 73(2):95-100, 2003.    13. Dinkova-Kostova A T. Phytochemicals as protectors against ultraviolet radiation: versatility of effects and mechanisms. Planta Med. 74(13):1548-59, 2008.    14. Weiss J F, Landauer M R Protection against ionizing radiation by antioxidant nutrients and phytochemicais. Toxicology 189(1-2):1-20, 2003.    15. Maenthaisong R, Chaiyakunapruk N, Niruntraporn S, Kongkaew C. The efficacy of aloe vera used for burn wound healing: a systematic review. Burns 33(6):713-8, 2007.    16. Vogler B K, Ernst E. Aloe vera: a systematic review of its clinical effectiveness. Br J Gen Pract. 49(447):823-8, 1999.    17. Richardson J, Smith J E, McIntyre M, Thomas R, Pilkington K. Aloe vera for preventing radiation-induced skin reactions: a systematic literature review. Clin Oncol (R Coll Radiol). 17(6):478-84, 2005.    18. Kaufman T, Kalderon N, Ullmann Y, Berger J. Aloe vera gel hindered wound healing of experimental second-degree burns: a quantitative controlled study. J Burn Care Rehabil. 9(2): 156-9, 1998.    19. Reuter J, Jocher A, Stump J, Grossjohann B, Franke G, Schempp C M. Investigation of the anti-inflammatory potential of Aloe vera gel (97.5%) in the ultraviolet erythema test. Skin Pharmacol Physiol. 21(2):106-10, 2008.    20. Boström A, Lindman H, Swartling C, Berne B, Bergh J. Potent corticosteroid cream (mometasone furoate) significantly reduces acute radiation dermatitis: results from a double-blind, randomized study. Radiother Oncol. 59(3):257-65, 2001.    21. Mnich C D, Hoek K S, Virkki L V, Farkas A, Dudli C, Laine E, Urosevic M, Dummer R. Green tea extract reduces induction of p53 and apoptosis in UVB-irradiated human skin independent of transcriptional controls. Exp Dermatol. 18(1):69-77, 2009.    22. Lincz L F, Gupta S A, Wratten C R, Kilmurray J, Nash S, Seldon VI, O'Brien P C, Bell K J, Denham J W. Thrombin generation as a predictor of radiotherapy induced skin erythema. Radiother Oncol. 90(1):136-40, 2009.    23. Carver, G W How to Grow the Tomato and 115 Ways to Prepare It For the Table. Tuskegee Institute Press, Bulletin 36, 1936.
The following 13 patents and published patent applications are also relevant prior art:    1. United States Published Patent Application No. 2002/0183248 to Michael J. Oldham et al. on Dec. 5, 2002 for “Method Of Using Lectins For Prevention And Treatment Of Skin Diseases And Disorders” (hereafter the “Oldham Published Patent Application”);    2. U.S. Pat. No. 6,623,769 issued to Raluca Lorant et al. on Sep. 23, 2003 for “Administration Of Lycopene For Combating Skin/Mucous Membrane Damage” (hereafter the “Lorant Patent”);    3. U.S. Pat. No. 6,780,444 issued to Alma Reza on Aug. 24, 2004 for “Method Of Making Cosmetic, Pharmaceutical, And Dermatological Compositions And Compositions Made According To The Method” (hereafter the “Reza Patent”);    4. U.S. Pat. No. 6,953,574 issued to Constantin Vladimirovich Sobol et al. and assigned to Technology Commercialization, Inc. on Oct. 11, 2005 for “Method For Producing A Fermented Hydrolyzed Medium Containing Microorganisms” (hereafter the “Sobol Patent”);    5. United States Published Patent Application No. 2005/0266018 to Benson K. Boreyko et al. on Dec. 1, 2005 for “Nutraceutical Compositions With Mangosteen” (hereafter the “Boreyko Published Patent Application”);    6. United States Published Patent Application No. 2006/0013782 to Harish Mahalingam et al. on Jan. 19, 2006 for “Use Of Active Extracts To Improve The Appearance Of Skin. Lips, Hair And/Or Nails” (hereafter the “Mahalingam Published Patent Application”);    7. United States Published Patent Application No. 2006/0105059 to Thomas James McArthur on May 18, 2006 for “Fruit And/Or Vegetable Derived Composition” (hereafter the “'0105059 McArthur Published Patent Application”);    8. U.S. Pat. No. 7,048,943 issued to Yeckezkel Barenholz et al. and assigned to Yissum Research Development Company of the Hebrew University of Jerusalem on May 23, 2006 for “Carotenoid-Loaded Liposomes” (hereafter the “Barenholz Patent”);    9. U.S. Pat. No. 7,189,419 issued to Harish Mahalingam et al. and assigned to Avon Products, Inc. on Mar. 13, 2007 for “Use Of Active Extracts To Lighten Skin, Lips, Hair, And/Or Nails” (hereafter the “Mahalingam Patent”);    10. United States Published Patent Application No. 2007/0202197 to Thomas James McArthur on Aug. 30, 2007 for “Pawpaw And/Or Peach Derived Composition” (hereafter the “'0202197 McArthur Published Patent Application”);    11. United States Published Patent Application No. 2007/0286916 to Stig Bengmark on Dec. 13, 2007 for “Synbiotic Use” (hereafter the “Bengmark Published Patent Application”);    12. European Patent No. 1,122,796 issued to Gustave Giradiere on Aug. 7, 1968 for “Composition For Making A Coating On Human Tissue” (hereafter the “Giradiere European Patent”);    13. Patent Abstract of Japan No. 2000229828 issued to Uehara Shizuka et al. and assigned to Kose Corp on Aug. 22, 2000 for “Skin Bleaching Lotion” (hereafter the “Shizuka Patent Abstract of Japan”).
The Oldham Published Patent Application discloses a method of using lecithin for prevention and treatment of skin diseases and disorders. The inventor believed that lecithin could be administered in a variety of forms for the delivery to dermal surfaces, either topically or subcutaneously.
The Lorant Patent deals with treating cosmetic effects of aging by administering topically compositions which include lycopene. The patent teaches “A method for treating an individual having cutaneous signs of aging caused by expression of proteases in the extracellular matrix comprising administering to said individual an amount of lycopene effective to substantially inhibit the expression of said proteases in the extracellular matrix of said individual.”
The Reza Patent discloses the concept of a skin treatment which includes a mixture of a base which consists of liquid extract from a mixture of tomatoes and apples once a spontaneous chemical reaction is initiated by the mixture of the two crushed plants is completed. Specifically, the patent discloses: “A method for manufacturing a composition comprising crushing tomatoes and apples, mixing the crushed tomatoes and apples together in a weight ratio of tomatoes to apples between 0.8 and 1.25 to produce a mixture (M), allowing the mixture (M) to stand for about twenty-four hours, and filtering the mixture (M) after the standing for about twenty-four hours to produce a filtered liquid as the composition.”
The Sobol Patent discloses manufacturing a skin treatment by a method of fermenting vegetable hydrolysate to create a therapeutically effective preparation. This includes various chemical combinations to treat scars, wrinkles and healing of burns. The patent discloses the following method:
“A method for producing a fermented hydrolyzed medium containing non-pathogenic microorganisms and products of their metabolism comprising the steps of:                a) providing at least one solid food ingredient reduced to small pieces;        b) providing at least one biocompatible liquid ingredient containing at least one non-pathogenic microorganism;        c) mixing said solid food ingredient with said biocompatible liquid ingredient thereby obtaining a mixture in proportions of about 10-90% liquid to about 70-75% solid food by weight;        d) adding a sugar by mixing the sugar into the mixture at about 0.1-30% by weight; and        e) fermenting the mixture at 10-58 degrees C. until acidity reaches at least about 300 degrees Terner; whereby obtaining high acidity medium with high concentration of microorganisms and products of their metabolism.”        
The Boreyko Published Patent Application teaches the general concept of nutraceutical compositions including various fruits and vegetables for a variety of conditions including skin ailments.
The Mahalingam Published Patent Application discloses using various fruits and vegetables to improve the aesthetic appearance of the skin.
The McArthur Published Patent Application discloses a process for treating a fruit or a vegetable to arrive at a composition which is believed to help provide benefits to the skin. The process includes:                “A process for making a composition suitable for topical application comprising the steps of a) heating at least one fruit and/or vegetable pulp to up to a temperature in the range of about 40° C. to 100° C.; b) mixing between 1 and 40% w/w of a mild base with the heated fruit and/or vegetable pulp. There is also provided a fruit and/or vegetable derived composition suitable for topical application prepared by the above process. There is further provided a fruit and/or vegetable derived composition comprising at least one fruit and/or vegetable-derived pulp and a mild base, said composition having a pH in the range of about 7.5 to about 9.5.”        
The Barenholz Patent discloses treatment of skin ailments that have come from UV radiation and other types of harmful radiation. The concept is to encapsulate within liposomes substantially water-immiscible carotenoids.
The Mahalingam Patent discloses active extracts to lighten skin, lips, hair and/or nails. The extracts include Butea frondosa, Naringi crenulata and Stenoloma chusana. These three are added to additional extracts as set forth in Column 3 Line 54 which are Azadirachata indica, Glycyrrhiza glabra linn., Morinda citrifolia, tomato glycolipid, or any combinations thereof, can reduce melanin pigmentation of hair, skin, lips and/or nails.
The patent alleges:                “Lightening of hair, skin, lips and/or nails, as used in the present invention, means one or more of the following benefits is achieved. These benefits include bleaching hyper-pigmented hair, skin, lips, and/or nails; reducing age spots; evening or optimizing skin discoloration; improving the appearance of dark circles under the eyes; treating melasma, cholasma, freckles, after-burn scars, and post-injury hyperpigmentation; bleaching hair on the scalp, legs, face and other areas where bleaching and color reduction are desired; and bleaching nail stains.”        
The McArthur Published Patent Application has the following disclosure:                “Typically, a composition of the present invention is topically applied to an animal, preferably a human, for the treatment or prophylaxis of all epidermal disorders including psoriasis, eczema, insect bites, general epidermal irritation and redness including Rosaceae and itchiness, alopecia, circulatory disorders affecting the epidermis, sunburn, windsurf and first, second and third degree burns, healing of sores, wounds and skin infections, skin cancers including sunspots, skin melanomas, and also alleviates some gum diseases and mouth ulcers and other gum and mouth dermatological disorders. Also typically, the composition of the present invention can be topically applied to arthritic joints to alleviate pain and swelling associated with all forms of arthritis as well as general joint and muscle aches and pains. Also typically, the composition of the present invention is applied as a general pain reliever. It can also be typically applied to prevent sunburn.”        
The Bengmark Published Patent Application discloses a formulation which includes one antioxidant, vitamin, mineral, amino acid, peptide or protein and also includes various fruits and vegetables for use to treat burns of the skin. Specifically, the patent has the following claim:                “A method for manufacturing a formulation for the prevention or treatment of stress-induced inflammatory disorder comprising providing Pediococcus pentosaceus 16:1 (LMG P-20608), Leuconostoc mesenteroides 23-77:1 (LMG P-20607), Lactobacillus paracasei subsp paracasei F-19 (LMG P-17086), and Lactobacillus plantarum 2362 (LMG P-20606) wherein the bacterial strains are in an amount of at least 1011 CFU/ml of each of the bacteria and at least four different fibres.”        
The Giradiere European Patent Application discloses the treatment of irritated, blotchy and sunburned skin by using products including tomato juice. The patent application claims:                “A composition for making a coating on human tissue so as to apply thereto an active substance, the composition comprising the active substance, a first solution of a water-soluble alginate and a second solution of an appropriate metal salt which is capable of coagulating the alginate, such that when the solutions are separately applied to the tissue the alginate is coagulated to make the coating.”        
The Japanese Patent Application discloses a skin bleaching lotion which contains tomato juice as an active ingredient. The applications claims that the content of tomato extract is preferably 0.00005-5 wt % as a solid content.
While the above prior art has extensively discussed the general concept of utilizing a tomato or portions of a tomato or products derived from a tomato to help treat the skin, none of these formulations appear to have been effective and are primarily of a theoretical nature.
There is a significant need for an improved topical lotion and/or spray to help relieve the pain and heal burns on the skin of both humans, mammals and other animals which do not have some of the negative side effects of prior art compositions as discussed above.