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(12) Patent Application Publication (10) Pub. No.: US 2014/0287064 A1 Swenholt (43) Pub

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(12) Patent Application Publication (10) Pub. No.: US 2014/0287064 A1 Swenholt (43) Pub US 20140287O64A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2014/0287064 A1 SWenholt (43) Pub. Date: Sep. 25, 2014 (54) COMPOSITIONS FOR IMPROVING THE Publication Classification APPEARANCE AND/OR TREATING FUNGAL INFECTIONS OF NAILS, MUCUS (51) Int. Cl. MEMBRANES AND THE INTEGUMENT A633/20 (2006.01) A61E36/87 (2006.01) (71) Applicant: Karen G. Swenholt, Annandale, VA A6II 45/06 (2006.01) (US) A63L/05 (2006.01) A61E36/534 (2006.01) (72) Inventor: Karen G. Swenholt, Annandale, VA A61E36/63 (2006.01) (US) A61E36/53 (2006.01) (52) U.S. Cl. CPC ................. A61 K33/20 (2013.01); A61K 36/63 (21) Appl. No.: 14/120,510 (2013.01); A61 K36/87 (2013.01); A61K 36/53 (2013.01); A61 K3I/05 (2013.01); A61 K 36/534 (2013.01); A61K 45/06 (2013.01) (22) Filed: May 28, 2014 USPC .......................................................... 424/665 (57) ABSTRACT Related U.S. Application Data Fungal infections and other disease conditions of the integu (63) Continuation-in-part of application No. 13/507,871, ment can be effectively treated with compositions containing filed on Aug. 3, 2012, Continuation-in-part of applica oZonizable oils, plant extract oils and antimicrobials, when tion No. 12/587,495, filed on Oct. 7, 2009, Continu used in conjunction with Solutions containing sodium chlo ation-in-part of application No. 12/387,119, filed on rite. The compositions are particularly useful for treatment of Apr. 28, 2009, now abandoned. resistant fungal infections. US 2014/0287O64 A1 Sep. 25, 2014 COMPOSITIONS FOR IMPROVING THE inhibits the growth of a multitude of fungi known to cause APPEARANCE AND/OR TREATING FUNGAL onychomycosis (Phytother Res. 2003 Apr. 17 (4):376-9). INFECTIONS OF NAILS, MUCUS While camphor has little or no detectable anti-fungal activity, MEMBRANES AND THE INTEGUMENT a composition of 4% Menthol with 2% Camphor is signifi cantly more potent in its ability to kill toe nail fungus. It may 0001. This application claims priority from Provisional be that the camphor acts as a penetration agentallowing better Patent Application 61/573,008 filed Aug. 4, 2011 and from access of the menthol to the fungus under the toenail bed Provisional Patent Application 61/663,993 filed Feb. 22, (International Patent No. WO/2002/022115 to McKenzie, et 2012 This application claims priority from U.S. patent appli al., issued Mar. 21, 2002). However, when used in accord with cation Ser. No. 13/507,871, filed Aug. 3, 2012 and U.S. patent the teachings of this disclosure, the antimicrobial activity is application Ser. No. 12/587.495 filed Oct. 7, 2009. The con tents of each of these applications in incorporated in its enhanced. entirety. 0007 Thymol is known as a powerful antifungal. The essential oil of common thyme is made up of 20-55% thymol (Thymus Vulgaris. PDR for Herbal Medicine. Montvale, N.J.: BACKGROUND OF THE INVENTION Medical Economics Company. p. 1184). Thymol was used on 0002 The present invention relates generally to methods bandages before the advent of antibiotics. (Thyme. A Modern and compositions for the treatment of dermatological condi Herbal. Hypertext version of the 1931 edition. Accessed: tions in humans. It is particularly efficacious for treating Dec. 14, 2006). Thymol has also been shown to be effective infection-induced conditions of the integument and is par against the fungus that commonly infects toenails (Ram ticularly well adapted for us in treating fungal infections of sewak RS, et al. In vitro antagonistic activity of monoterpe the finger and toenails. nes and their mixtures against toe nail fungus pathogens. 0003 Damage to the integument is from many sources. Phytother Res. 2003 Apr. 17 (4):376-9) Many adverse conditions arise from exposure to infections of 0008. Third Planet Foods lists thymol as an antibacterial, various types. About 7-10% of Americans suffer from ony antimicrobial and antifungal agent. Thymol is also used as a chomycosis, a difficult to treat a fungal infection of the nail, disinfectant, and is a popular ingredient in mouthwash. Many particularly the toenail. More than 90 percent of cases are common medicines contain thymol. Medicines for acne, ath caused by one of two pathogens: Trichophyton rubrum or letes foot, and hemorrhoids contain thymol, as well as oint Trichophyton mentagrophytes, which is also primarily ments for chest congestion. Thymol is also a useful medica responsible for tinea pedis. Factors that have an important tion for treating hook worms and other parasites. The spread effect on the development of onychomycosis include increas of E. coli and Staphylococcus aureus bacteria can be inhibited ing age; genetic Susceptibility; and the presence of certain by the use of thymol. disease states such as diabetes, acquired immunodeficiency 0009. The use of sodium chlorite at lower pH in the pro syndrome, or peripheral arterial disease. All of the disease duction of chlorine dioxide for disinfecting inanimate object, conditions of the integument are exacerbated when other including fruits and vegetables is known. Sodium chlorite is disease conditions such as diabetes are present. For example, used for industrial applications such as controlling microbial it is reported that up to one third of diabetics develop nail contamination in industrial cooling systems and towers. It is fungus. In the presence of any disease affecting circulation an oxidizer. Since it can destroy natural color matter without there is slowing of healing, particularly in the feet. The com attacking the fibers themselves, it is used as a bleaching agent positions of the invention were first developed to treat such on textiles. When added to an acid base, it forms chlorine infections, but are also useful for treating many other condi dioxide which is used in most municipal water Supplies. tions of the integument such as acne and other skin blemishes Sodium chlorite, particularly when acidified, is currently that arise from pressure, stress or infection. being used as an ingredient in personal care products such as 0004 Hoofs of horses and claws of dogs and cats contain facial cleansing lotions, acne creams, mouthwash, toothpaste keratin and are hard like human nails. Animals, particularly and contact lens preparations for its antimicrobial action and mammals can benefit from these treatments against dermato as a preservative. Ballinger has taught its use in generating logical infections and infections of hoofs and claws. chlorine dioxide for processing chickens. (U.S. Pat. No. 0005 Feet exposed to a warm, dark, moist environment 7.854,651) However, at pH ranges used in the methods of the can get infected. Some people may already be genetically invention under room temperature conditions the composi predisposed to onychomycosis. For those who are suscep tions are useful in treatment of the conditions as described tible, the condition is highly contagious. The best way to herein. avoid onychomycosis is to keep feet clean and dry, washing 0010. It has previously been reported that ozonized olive them at least once a day and drying the toes well. Shoes and oil can be used as an antifungal. Without relying on any Socks should be changed daily and should also be kept dry. particular theory, it is believed probable that ozonization of The application of the compositions of the invention, particu the oils as used in the invention results in production of larly those lacking the usual fungicides, can be used as a peroxide, which has fungicidal/bacteriocidal properties. means of preventing infection of the feet. The use of the “Ozonated plant and vegetable extracts have been Sodium chlorite containing compositions in accord with the researched in various countries, notably Cuba and Russia, teachings disclosed herein can provide soothing and effective where original research has been published for the last 40 treatment of or prophylaxis against the conditions arising in years on the effects of ozonated sunflower and olive oils. Use at-risk individuals. of these oZonated oils offers good antimicrobial activity, 0006. It has long been known that menthol, when applied show no tendency to resultin micro-biological resistance, and to the nail can act as an antimicrobial used to combat infec show no harm to the patient or operator. When vegetable oils, tions that cause damage to the nails and other structures of the which consist fundamentally of triglycerides are oZonised, integument. It is now also known that menthol specifically oZonides, aldehydes, and peroxides are formed. Diaz US 2014/0287O64 A1 Sep. 25, 2014 reviewed past research from Cuba and Russia that showed the pH, not including oxidizing agents such as Sodium these products are related with the observed biological effect hypochlorite, or adding buffers, antioxidants and other stabi of these oils. lizers. While there are other chlorite salts that may be used, 0011. In the pharmaceutical industry, ozonated olive and Such as but not limited to potassium, calcium, magnesium and Sunflower oils are recognized. The cosmetic industry lists other salts both organic and inorganic. Stabilizers commonly oZonated olive, Sunflower, jojoba and caster oils in the Inter used in the pharmaceutical and cosmetic arts can be used in national Cosmetic Ingredient Dictionary and Handbook. the compositions of the invention. For example, Sodium “Ozonated olive oil must be kept refrigerated and is costly to bicarbonate can be used as a stabilizing agent as can lemon oil produce because of the methods used to create it. It is believed and or other citrus oils including grapefruit oil which can also that the introduction of sodium chlorite as described herein be used as preservatives. When sodium chlorite is used in (which is a potent oxidizer) to oils such as olive oil results in accord with the instructions in this application, formation of benefits similar to or exceeding the benefits of the ozonation chlorine dioxide was not noted.
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