US 2008022O103A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2008/0220103 A1 Birnbaum et al. (43) Pub. Date: Sep. 11, 2008 (54) METHOD FOR Publication Classification TREATING/CONTROLLING/KILLING FUNG (51) Int. Cl. AND BACTERIA ON LIVING ANIMALS A636/00 (2006.01) A 6LX 36/899 (2006.01) (76) Inventors: Jay Birnbaum, Montville, NJ (US); A636/534 (2006.01) Thomas Blake, Budd Lake, NJ A6IR 36/6 (2006.01) (US); Mahmoud Ghannoum, A636/736 (2006.01) Hudson, OH (US); Steven A63L/045 (2006.01) Vallespir, Park Ridge, NJ (US) A63L/05 (2006.01) A63L/35 (2006.01) Correspondence Address: A63L/II (2006.01) SONNENSCHEN NATH & ROSENTHAL LLP A63L/92 (2006.01) P.O. BOX 061080, WACKER DRIVE STATION, A6II 3/474 (2006.01) SEARS TOWER A63L/35 (2006.01) CHICAGO, IL 60606-1080 (US) A6II 3/165. (2006.01) A6II 3/442 (2006.01) (21) Appl. No.: 12/047,992 A6IP3 L/10 (2006.01) (52) U.S. Cl. ......... 424/735; 424/725; 424/747: 514/739; (22) Filed: Mar. 13, 2008 514/731: 514/729; 514/456; 514/699; 514/570; 514/701: 514/399; 514/655; 514/599; 514/345 Related U.S. Application Data (63) Continuation-in-part of application No. 1 1/541,822, (57) ABSTRACT filed on Oct. 2, 2006. Provided is a method of treating a fungal infection on an animal epidermis, nail or hair, or in an orifice of an animal. (60) Provisional application No. 60/729,624, filed on Oct. The method comprises contacting the fungus infection with a 24, 2005. composition comprising an antifungal botanical. Patent Application Publication Sep. 11, 2008 Sheet 1 of 10 US 2008/022O103 A1 Patent Application Publication Sep. 11, 2008 Sheet 2 of 10 US 2008/022O103 A1 Figure 2 Patent Application Publication Sep. 11, 2008 Sheet 3 of 10 US 2008/022O103 A1 SSSNYSSYSSS SS . - . it.. SR SS &S . SS ''". 8 SS S 3. 8 SS S. l & S : O S S : O Š S ŠES S ESS Patent Application Publication Sep. 11, 2008 Sheet 4 of 10 US 2008/022O103 A1 SSXXXXXXXXXXXXXXXXXXXXXXXXXXXYYXXXYYXXXYYXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXYYXXXYYXXXYYXXXXXS, k (A) 90 70 SO 50 40 10 50 40 30 1O Leather Pretreatment Figure 4 Patent Application Publication Sep. 11, 2008 Sheet 5 of 10 US 2008/022O103 A1 Patent Application Publication Sep. 11, 2008 Sheet 6 of 10 US 2008/022O103 A1 Patent Application Publication Sep. 11, 2008 Sheet 7 of 10 US 2008/022O103 A1 Insole Post-infection treatment S.s S S.S SS. S. S. SS. SS. SS. S S SŠ S Leather Post-infection treatment Figure 7 Patent Application Publication Sep. 11, 2008 Sheet 8 of 10 US 2008/022O103 A1 Patent Application Publication Sep. 11, 2008 Sheet 9 of 10 US 2008/022O103 A1 6ounãIJ £ Patent Application Publication Sep. 11, 2008 Sheet 10 of 10 US 2008/022O103 A1 S SS S& ::$ Fig. 10A. Effect of pretreatment of insoles with (A) 0.01% tolnaftate, (B) 3% tea tree oil, or (C) 0.01% tolnaftate +3% tea tree oil on T. rubrum growth on shoe insoles. Fig. 10B. Effect of post- ment tolnaftate, (B) 3% tea tree oil, or (C) 0.01% tolnaftate +3% tea tree oil on T. rubrunt growth. Figure 10 US 2008/0220 1 03 A1 Sep. 11, 2008 METHOD FOR 0014 Secondary infections that can worsen diaper rash TREATING/CONTROLLING/KILLING FUNG include fungal organisms (for example yeasts of the genus AND BACTERA. ON LIVING ANIMALS Candida). 0015 The above fungi, as well as many other fungi, can CROSS-REFERENCE TO RELATED cause disease in pets and companion animals. The present APPLICATIONS teaching is inclusive of Substrates that contact animals directly or indirectly. Examples of organisms that cause dis 0001. This application is a continuation-in-part of U.S. ease in animals include Malassezia firfir: Epidermophyton patent application Ser. No. 1 1/541,822, filed Oct. 2, 2006, floccosur, Trichophyton mentagrophytes, Trichophyton which claims the benefit of U.S. Provisional Application No. rubrum, Trichophyton tonsurans, Trichophyton equinum, 60/729,624 filed Oct. 24, 2005, both of which are incorpo Dermatophilus congolensis, Microsporum Canis, rated herein by reference in their entirety. Microsporu audouinii, Microsporum gypseum, Malassezia BACKGROUND OF THE INVENTION ovale, Pseudallescheria, Scopulariopsis, Scedosporium, and Candida albicans. 0002 (1) Field of the Invention 0003. The present teachings relate to methods for treating/ BRIEF SUMMARY OF THE INVENTION preventing animal diseases and odors associated with fungi and bacteria on Surfaces or orifices of animals, including the 0016. The inventors have discovered that some botanicals, skin, hair, nails, mouth, nose and vagina of the animal. singly or combined with other antifungal agents, are effective 0004 (2) Description of the Related Art treatments for fungal diseases on Surfaces or orifices of ani 0005 Fungal diseases are some of the most common mals, including the skin, hair, nails, mouth, nose and vagina affecting mammals, and include some of the most common of the animal. The invention is thus directed to a method of infections in man. In humans these include, but are not limited treating a fungal infection on an animal epidermis, nail or tO: hair, or in an orifice of an animal. The method comprises 0006 Tinea corporis—(“ringworm of the body'). This contacting the fungus infection with a composition compris infection causes Small, red spots that grow into large rings ing an antifungal botanical. almost anywhere on the arms, legs, chest, or back. 0007 Tinea pedis fungal infection of the feet. Typically, BRIEF DESCRIPTION OF THE SEVERAL the skin between the toes (interdigital tinea pedis or "Athlete's VIEWS OF THE DRAWINGS foot) or on the bottom and sides of the foot (plantar or “moccasin type' tinea pedis) may be involved. Other areas of 0017 FIG. 1 is photographs of Petri plates showing assays the foot may be involved. for antifungal activity. Panels A and B show a pre-treatment 0008 Onychomycosis—fungal infection of the nail. The assay. In Panel A, active agents showed a clearance Zone most prevalent type is the DSO or Distal Subungual Onycho (arrow) around the biopsy disc, while (Panel B) inactive mycosis. Other types are White Superficial Onychomycosis, agents showed fungal growth around the disc. Panels Cand D Proximal Subungual Onychomycosis, Candidal Onychomy show a post-treatment assay. In Panel C, discs treated with cosis, and Total Dystrophic Onychomycosis. These can be active agents showed no fungal growth. In Panel D inactive caused by various fungi (esp. dermatophytes tinea unguium) agents showed fungal growth on discs. and yeast, including Candida albicans. 0018 FIG. 2 is photographs of Petri plates showing fungal 0009 Dandruff, which is the excessive shedding (exfolia growth assays using (A) CVS Double Air Foam Insoles, (B) tion) of the epidermis of the scalp. A fungus may cause, or Odor eater insoles, (C) CVS Odor Stop Insoles, (D) Dr aggravate, the condition. Scholl's Air Pillow Insoles, (E) Control. None of these com 0010 Tinea cruris: When the fungus grows in the moist, mercial insoles inhibited fungal growth. warm area of the groin, the rash is called tinea cruris. The 0019 FIG. 3 is photographs of Petri plates showing the common name for this infection is “jock itch.” effect of 30% isopropanol on Trichophyton mentagrophytes 0011 Tinea capitis, often called “ringworm of the scalp'. growth on (A) leather and (B) Dr. Scholl's insole. Isopropanol where the hair and scalp is affected, causes itchy, red areas, did not inhibit fungal growth. usually on the head. The hair is often destroyed, leaving bald 0020 FIG. 4 is graphs showing the effect of pretreatment patches. This tinea infection is most common in children, of insoles (A) or leather (B) biopsy discs with different agents although a carrier state has been reported in adults. on growth of dermatophytes. Zone diameter indicates Zone of 0012 Vaginal yeast infections, often caused by an over clearance. growth of a fungus that is a normal vaginal inhabitant, usually 0021 FIG. 5 is photographs of Petri plates showing the Candida albicans and Candida glabrata. effect of pretreatment of insoles with (A) 1% terbinafine. (B) 0013 The list above providing but a few of the most com 1% tolnaftate, or (C) 1% tea tree oil. mon of a long list of Such diseases in one mammal. Many 0022 FIG. 6 is photographs of Petri plates showing the diseases caused by fungi have been identified, and also effect of acetone on the activity of tolnaftate against dermato include Such common disease as oral thrush and diaper rash, phyte growth. Panels A and B shows the growth of T. menta often caused by members of the Candida genus. Fungi are grophytes on insole disc pretreated with (A) acetone or (B) often a complicating factor in diabetic and obese patients. In 4% tolnaftate (w/v. prepared in acetone). Panel C shows the addition, disease inhumans is caused by other fungi including activity of 4% tolnaftate (dissolved in acetone) on already but not limited to those from the genus Aspergillus, Blasto established contamination of T. mentagrophytes. (no fungal myces, Coccidioides, Cryptococcus, Histoplasma, Paracoc regrowth was observed). cidioides, Sporothrix, and at least three genera of Zygo 0023 FIG. 7 is graphs showing the effect of post-infection mycetes, as well as those mentioned below under animals. treatment of insole (A) or leather (B) biopsy discs with dif US 2008/0220 1 03 A1 Sep. 11, 2008 ferent agents on dermatophyte growth. Zone diameter indi natural in origin that possesses antifungal activity as defined. cates Zone of growth. Treatment with 30% isopropanol served "Antifungal compound also includes any Substance that can as vehicle control. destroy/kill/inhibit the growth of fungal spores, for example, 0024 FIG.