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(12) Patent Application Publication (10) Pub. No.: US 2009/0269380 A1 Baker, JR

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(12) Patent Application Publication (10) Pub. No.: US 2009/0269380 A1 Baker, JR US 20090269380A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2009/0269380 A1 Baker, JR. et al. (43) Pub. Date: Oct. 29, 2009 (54) METHODS OF TREATING FUNGAL YEAST (22) Filed: Apr. 27, 2009 AND MOLD INFECTIONS Related U.S. Application Data (75) Inventors: James R. Baker, JR. Ann Arbor, (60) Provisional application No. 61/048,075, filed on Apr. MI (US); Mary R. Flack, Ann 25, 2008, provisional application No. 61/129,962, Arbor, MI (US); Susan M. Ciotti, filed on Aug. 1, 2008, provisional application No. Ann Arbor, MI (US); Joyce A. 61/115,879, filed on Nov. 18, 2008. Sutcliffe, West Newton, MA (US) Publication Classification Correspondence Address: (51) Int. Cl. FOLEY AND LARDNER LLP AOIN 25/00 (2006.01) SUTESOO (52) U.S. Cl. ........................................................ 424/405 3OOOK STREET NW (57) ABSTRACT WASHINGTON, DC 20007 (US) The present invention relates to methods for treating and completely curing fungal, yeast, and/or mold infections in (73) Assignee: Nanobio Corporation human Subjects comprising topically administering to a human Subject in need thereof an antifungal nanoemulsion (21) Appl. No.: 12/430,700 composition. Patent Application Publication Oct. 29, 2009 Sheet 1 of 26 US 2009/0269380 A1 u?XISO?u,Ku?A||3C] uo|s|nuuÐOueN.IeInô Patent Application Publication Oct. 29, 2009 Sheet 3 of 26 US 2009/0269380 A1 ;· Fire ?uffir E .1:1±”?öjiäö?öjö-elozeuopeu?i - *x*j*******************(~~~r ufi or--------------------------------------~--~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~&No. ufrical Patent Application Publication Oct. 29, 2009 Sheet 4 of 26 US 2009/0269380 A1 uO??0\/JOUusque?.00W *********ggæskæog. Patent Application Publication Oct. 29, 2009 Sheet 6 of 26 US 2009/0269380 A1 ??Mou9||eNueau?Tp??0???eunu??u???seguuou?06ue?O:9?un61– (queussessyo?u?ºu?ueId) toi aftiet) i.ec.) ex paioaiei Patent Application Publication Oct. 29, 2009 Sheet 7 of 26 US 2009/0269380 A1 eeuwp??0æJJVu??seauoade???os?sÁIeuvuu?u??u|| (queuussassyo?u?auu?ueId) 3 i3Seguidi afuiet.) Lean) :/?un61– ELLule: EY p3xy Patent Application Publication Oct. 29, 2009 Sheet 8 of 26 US 2009/0269380 A1 euo?sa?ex,aunoleo?6olooÁIN?ouosqueduuoºo:8ºun61-I oe?uºdpue(„Z00-£IN„)uo?sinuaoueN -8. --------------------------- ------- -3- ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- eley end leobooo/W Patent Application Publication Oct. 29, 2009 Sheet 9 of 26 US 2009/0269380 A1 Patent Application Publication Oct. 29, 2009 Sheet 10 of 26 US 2009/0269380 A1 penu??uOO’6?un61– Patent Application Publication Oct. 29, 2009 Sheet 12 of 26 US 2009/0269380 A1 ?.0||C?? S?JOds Patent Application Publication Oct. 29, 2009 Sheet 13 of 26 US 2009/0269380 A1 ZLeInfi!-- Patent Application Publication Oct. 29, 2009 Sheet 14 of 26 US 2009/0269380 A1 ueuunHO?u,KuÐA||3C]uo|s|nuu?OueN:£|?un61– SunOH?7Z?eu?XISJÐAepeO Patent Application Publication Oct. 29, 2009 Sheet 15 of 26 US 2009/0269380 A1 KuÐA??aqleuuedAu3A||3C]Ieuuep?dE - MM 0099 009 000€E ©009Z(º 000z& !,9 009900‰?i Patent Application Publication Oct. 29, 2009 Sheet 16 of 26 US 2009/0269380 A1 C#X00-8NEX00-£IN -?–oose- ?0?Ê {005?) ?002 {0.05T {000T 00$ Patent Application Publication Oct. 29, 2009 Sheet 17 of 26 US 2009/0269380 A1 oHg+uue-,3/3n? Patent Application Publication Oct. 29, 2009 Sheet 18 of 26 US 2009/0269380 A1 sunouvzqesquuep?deupisau?ºwsu?ejozeuoo?Wgosla^eºT‘ZI,?un61-I *(c11a)uo?eo?iddeIeo!do)d???e Patent Application Publication Oct. 29, 2009 Sheet 19 of 26 US 2009/0269380 A1 sunouyzjesquuuapupisau?ºwsu?3Iozeuoo?IN?osla^3T'8||3.Infi? '(GIIG)uo?eo||ddeIeo!do?da??e ensses foE Sri Patent Application Publication Oct. 29, 2009 Sheet 20 of 26 US 2009/0269380 A1 zuuoZZºg:eeuw6u?soqu??nO zuuo£'º:eeuweIpp?W „uoG’O:eeuwuauu! Patent Application Publication Oct. 29, 2009 Sheet 21 of 26 US 2009/0269380 A1 ERHOO?HEINNI** ERHOOETCICIIIN…………..><!-----….(……. :u?uO??eu?u00uOO No.= Ápn?Suo?sn???CIIeua?e"?:OZ?un61-I u?XISJÐAepeOueUunHu? ?Iduues J3AepeoueuunH Patent Application Publication Oct. 29, 2009 Sheet 22 of 26 US 2009/0269380 A1 SunOH?7Z?eu?XISS?uuJep?dEJ?AepeO ueuunHO?u,uO?Sn???C]|ed??eT:LZ?un61– Patent Application Publication Oct. 29, 2009 Sheet 24 of 26 US 2009/0269380 A1 Oau?=Go'sinouºpueoau?:6u?sopGIG (GIE:%szo)slujeqt)|- |–)| |-(GO:%s(o)s(ulea—|--|— OGZ OOZ OG|| 09 enSSI) ueuf 100 fin Patent Application Publication ueuf 100 firl Patent Application Publication Oct. 29, 2009 Sheet 26 of 26 US 2009/0269380 A1 X00-EN%9'0gouo?e0||ddwyeuO U2, (O 108 for US 2009/0269380 A1 Oct. 29, 2009 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 contact with contaminated items such as hairbrushes or 0001. This application claims priority of U.S. Provisional through the use of the same toilet seat as an infected indi Patent Application No. 61/048,075, filed on Apr. 25, 2008: vidual. Tinea spreads readily, as those infected are contagious U.S. Provisional Patent Application No. 61/129,962, filed on even before they show symptoms of the disease. Participants Aug. 1, 2008; and U.S. Provisional Patent Application No. in contact sports Such as wrestling have a risk of contracting 61/115,879, filed on Nov. 18, 2008. The contents of these applications are incorporated herein by reference in their the fungal infection through skin-to-skin contact. entirety. 0006 Tinea is mildly contagious. Tinea is also a common 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 0002 The present invention relates to methods for treat “ringworm”) from these animals as humans are in close con ing, killing, and/or inhibiting the growth of fungal, yeast, and tact with them. Tinea can also be caught from other humans, mold pathogens in human Subjects comprising topically both by direct contact and by prolonged contact with flakes of administering to a human Subject in need thereofa nanoemul shed skin (from sharing clothes or from house dust, for sion composition having antifungal, anti-yeast, and/or anti instance). mold properties. The present invention also relates to meth 0007. The best known sign of tinea in people is the appear ods for treating, preventing, and/or completely curing fungal, ance of one or more red raised itchy patches with defined yeast, and/or mold infections in human Subjects comprising edges, not unlike the herald rash of Pityriasis rosea. These topically administering to a human Subject in need thereof a patches are often lighter in the center, taking on the appear nanoemulsion composition having antifungal, anti-yeast, ance of a ring with hyperpigmentation around the circumfer and/or anti-mold properties. ence caused by an increase in melanin. If the infected area involves the scalp or beard area, then bald patches may BACKGROUND OF THE INVENTION become evident. The affected area may become itchy for 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. Notably, Microsporum spp. mostly infect the hair inflammation. A second type of tinea pedis is called the moc and skin. Microsporum canis is the principal cause of ring casin tinea pedis and is characterized by chronic plantar worm in dogs and cats and a Zoophilic fungal species causing erythema with slight scaling to diffuse hyperkeratosis that can sporadic dermatophytosis in humans, especially tinea capitis be asymptomatic or pruritic. Other types include inflamma in children with cats and dogs. tory/vesicular and ulcerative tinea pedis.
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