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(12) Patent Application Publication (10) Pub. No.: US 2012/0276182 A1 Baker, JR US 20120276.182A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2012/0276182 A1 Baker, JR. et al. (43) Pub. Date: Nov. 1, 2012 (54) METHODS OF TREATING FUNGAL, YEAST Publication Classification AND MOLD INFECTIONS (51) Int. C. Inventors: James R. Baker, JR. Ann Arbor, A6II 47/44 (2006.01) (75) A6II 3/53 (2006.01) MI (US); Mary R. Flack, Ann A638/12 (2006.01) Arbor, MI (US); Susan M. Ciotti, A63L/7048 (2006.01) Ann Arbor, MI (US); Joyce A. A 6LX 9/07 (2006.01) Sutcliffe, West Newton, MA (US) A63L/464 (2006.01) (73) Assignee: Nanobio Corporation A 6LX 3/5.375 (2006.01) B82Y5/00 (2011.01) (21) Appl. No.: 13/544,789 (52) U.S. C. ......... 424/405; 514/784: 514/785: 514/396; (22) Filed: Jul. 9, 2012 514/399; 514/274: 514/231.2: 514/3.6; 514/31; 977/700; 977/906 Related U.S. Application Data (63) Continuation of application No. 12/430,700, filed on (57) ABSTRACT Apr. 27, 2009, now Pat. No. 8,226,965. The present invention relates to methods for treating and (60) Provisional application No. 61/048.075, filed on Apr. completely curing fungal, yeast, and/or mold infections in 25, 2008, provisional application No. 61/129,962, human Subjects comprising topically administering to a filed on Aug. 1, 2008, provisional application No. human Subject in need thereof an antifungal nanoemulsion 61/115,879, filed on Nov. 18, 2008. composition. Patent Application Publication Nov. 1, 2012 Sheet 1 of 26 US 2012/0276182 A1 go as g 9. & as3 E2 O 8 ... C 92 .9 Es of a D -N4St So of OR oS2 O.s : C C 2 Cls -- Z. Cld g:2 w- . D Ut sma ... O SD- Cl2 g's55 O O) L Patent Application Publication Nov. 1, 2012 Sheet 2 of 26 US 2012/0276182 A1 uo|s|nueOueN:Z?un61 uÞISO?u,ÁIÐA||9C] Patent Application Publication Nov. 1, 2012 Sheet 3 of 26 US 2012/0276182 A1 *·**** ?ºff? * Á??ueqsisuoOeuesuo?s|nuuaoueN"9eun61-I 88: 3 & &$&&! ***************************{{?$3&&&#####$$3&&3&&3&&***** «&& **** ?*)(????????**?. i8::::3838 Patent Application Publication Nov. 1, 2012 Sheet 4 of 26 US 2012/0276182 A1 ************** uogovgousque?oøw.tzeun61 &&&&&&&& Patent Application Publication Nov. 1, 2012 Sheet 5 of 26 US 2012/0276182 A1 Patent Application Publication Nov. 1, 2012 Sheet 6 of 26 US 2012/0276182 A1 ????,wz?*****8?23. ##§§§§§?o~~~~~~~~~~~~~~~~~~~4.ºž **???????w?ºs???x**********??ggaez?)*******&****************3×4gººg»z?, ?*****9***???æg -orz §§§} ten peoeyeun Patent Application Publication Nov. 1, 2012 Sheet 8 of 26 US 2012/0276182 A1 euogsøgesauno?eoibo?ooÁINjouosqueduuoo;ºaumôia oe?uedpue(„z00-aNA)uorsinuaouen 838: 88: 8::::::: Patent Application Publication Nov. 1, 2012 Sheet 9 of 26 US 2012/0276182 A1 Patent Application Publication Nov. 1, 2012 Sheet 10 of 26 US 2012/0276182 A1 Patent Application Publication Nov. 1, 2012 Sheet 11 of 26 US 2012/0276182 A1 9?uosuo|s|nuuaoueN?o?oeduul'OLeun61 unuqnu'IgoÁl]]|qe?A Patent Application Publication Nov. 1, 2012 Sheet 12 of 26 US 2012/0276182 A1 Patent Application Publication Nov. 1, 2012 Sheet 13 of 26 US 2012/0276182 A1 Patent Application Publication Nov. 1, 2012 Sheet 14 of 26 US 2012/0276182 A1 SunOHvZ?euDISuenepeO is & is 8 x g :: * ueuunHo?u?KuêA||3C]uoIsInuuboueN.9||eun61 ess tuff it Patent Application Publication Nov. 1, 2012 Sheet 15 of 26 US 2012/0276182 A1 uoasocluo|s|nuaoueN?o?oe??E:7).?un61– sunoHVZ?eupIS6ldo?u,Kuan||eG Patent Application Publication Nov. 1, 2012 Sheet 17 of 26 US 2012/0276182 A1 Patent Application Publication US 2012/0276182 A1 sunouvzqesquuep?daupisau?wsu?a?ozeuoo?W?osla^aT'LLaun61-I '(GIIG)uo?eo||dde||eo!do!Jage Patent Application Publication Nov. 1, 2012 Sheet 19 of 26 US 2012/0276182 A1 '81,aun612 Patent Application Publication Nov. 1, 2012 Sheet 20 of 26 US 2012/0276182 A1 zuuoIzºg:eeuw6u?soqlejno zuuo£'C:eeuwalpp?W zuuoG’O:eeuwuauu! Patent Application Publication Nov. 1, 2012 Sheet 21 of 26 US 2012/0276182 A1 dogsurtoqþz?epaaotuðuupis Odogot?o?ëü?tä???äp Ápn?Suo?sn???qIeua?eI:Ozaun61-I upISuenepeoueuunHu? ?aaepeouetun?? Patent Application Publication Nov. 1, 2012 Sheet 22 of 26 US 2012/0276182 A1 g?z6+ 8388: 8: 88 SunoHVZ?eupISS?uuJep?d?J?AepeO ueuunHo?u?uo|sn?G|eJe?eT:LZ?un61 uo?sinuaoueN%9'00dOdeHºo??N%9’ ########&g ? 88: 8:::::::: 88 Patent Application Publication Nov. 1, 2012 Sheet 23 of 26 US 2012/0276182 A1 ønssil?eurapidau??,uo?sinuaoueNgoquodsueu1:zzaun612 ;*,**,***** K: sm ess tie. frt Patent Application Publication Nov. 1, 2012 Sheet 24 of 26 US 2012/0276182 A1 s: 888; i.e. f is fit Patent Application Publication Nov. 1, 2012 Sheet 25 of 26 US 2012/0276182 A1 tire fift is Patent Application Publication Nov. 1, 2012 Sheet 26 of 26 US 2012/0276182 A1 sunouºzstuuuedu?ulina(Odo)uo?sinuaoueN.gzºdnôl uo?eo?idde-isod US 2012/0276.182 A1 Nov. 1, 2012 METHODS OF TREATING FUNGAL YEAST another term for dermatophyte infections of the nail. Second AND MOLD INFECTIONS ary bacterial infections may develop from the fungal infec tion. CROSS-REFERENCE TO RELATED 0005 Tinea is very common, especially among children, APPLICATIONS and may be spread by skin-to-skin contact, as well as via 0001. This application is a continuation of U.S. patent contact with contaminated items such as hairbrushes or application Ser. No. 12/430,700, filed Apr. 27, 2009, which through the use of the same toilet seat as an infected indi claims priority of U.S. Provisional Patent Application No. vidual. Tinea spreads readily, as those infected are contagious 61/048,075, filed on Apr. 25, 2008; U.S. Provisional Patent even before they show symptoms of the disease. Participants Application No. 61/129,962, filed on Aug. 1, 2008; and U.S. in contact sports Such as wrestling have a risk of contracting Provisional Patent Application No. 61/115,879, filed on Nov. the fungal infection through skin-to-skin contact. 18, 2008. The contents of these applications are incorporated 0006 Tinea is mildly contagious. Tinea is also a common herein by reference in their entirety. infection in domestic animals, especially farm animals, dogs and cats and even Small pets like hamsters or guinea pigs. FIELD OF INVENTION Humans can contract tinea (also commonly referred to as “ringworm”) from these animals as humans are in close con 0002 The present invention relates to methods for treat tact with them. Tinea can also be caught from other humans, ing, killing, and/or inhibiting the growth of fungal, yeast, and both by direct contact and by prolonged contact with flakes of mold pathogens in human Subjects comprising topically shed skin (from sharing clothes or from house dust, for administering to a human Subject in need thereofa nanoemul instance). sion composition having antifungal, anti-yeast, and/or anti 0007. The best known sign of tinea in people is the appear mold properties. The present invention also relates to meth ance of one or more red raised itchy patches with defined ods for treating, preventing, and/or completely curing fungal, edges, not unlike the herald rash of Pityriasis rosea. These yeast, and/or mold infections in human Subjects comprising patches are often lighter in the center, taking on the appear topically administering to a human Subject in need thereof a ance of a ring with hyperpigmentation around the circumfer nanoemulsion composition having antifungal, anti-yeast, ence caused by an increase in melanin. If the infected area and/or anti-mold properties. involves the scalp or beard area, then bald patches may become evident. The affected area may become itchy for BACKGROUND OF THE INVENTION periods of time. A. Fungal/Yeast/Mold Infections 0008. Sometimes a tinea infection may cause skin lesions 0003) Fungi cause a wide variety of diseases in humans. in a part of the body that is remote from the actual infection. While some fungi cause infections limited to the outermost Such lesions are called “dermatophytids'. The lesions them layers of the skin and hair (Superficial mycoses), other fungi selves are fungus-free, and normally disappear upon treat cause cutaneous mycoses by penetrating to the keratinized ment of the actual infection. The most common example is an layers of the skin, hair and nails and triggering pathologic eruption in the hands resulting from a fungus infection of the changes in the host. Subcutaneous mycoses cause infections feet. Dermatophytids are essentially a generalized allergic in the dermis, Subcutaneous tissues, muscle and fascia and are reaction to the fungus. often chronic. Systemic mycoses originate primarily in the 0009. Thus, fungi and yeast such as Microsporum species, lung and may cause secondary infections in other organ sys Trichophyton species, Epidermophyton species, and Candida tems in the body. Patients with immune system deficiencies species can cause persistent and difficult to treat infections. are often prone to opportunistic mycoses. 00.10 Examples of Microsporum species include M. canis 0004 Dermatophytes, including Trichophyton rubrum and M. gypseum. Microsporum is one of the several fungal and Trichophyton mentagrophytes, are responsible for fungal genera that cause dermatophytosis. Dermatophytosis is a infections of the skin or Dermatophytoses (dermatophytose). general term used to define the infection in hair, skin or nails Tinea pedis is a skin infection that most often manifests due to any dermatophyte species. Similar to other dermato between the toes, causing scaling, flaking and itching of the phytes, Microsporum has the ability to degrade keratin and affected skin. Blisters and cracked skin may also occur, lead thus can reside on skin and its appendages and remains non ing to exposed raw tissue, erythema, pain, Swelling and invasive.
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