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(12) Patent Application Publication (10) Pub. No.: US 2011/0083692 A1 Bailey (43) Pub

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(12) Patent Application Publication (10) Pub. No.: US 2011/0083692 A1 Bailey (43) Pub US 2011 0083692A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2011/0083692 A1 Bailey (43) Pub. Date: Apr. 14, 2011 (54) METHOD AND APPARATUS FOR (52) U.S. Cl. ........................................... 132/200; 132/75 IMPROVING THE APPEARANCE OF NALS AFFECTED BY ONYCHOMYCOSIS THROUGH THE TOPCAL APPLICATION OF HIGHILY CONCENTRATED OR (57) ABSTRACT SUPERSATURATED BORIC ACID A toenail treatment kit for treating onychomycosis and (76) Inventor: Cynthia Bailey, Sebastopol, CA improving nail appearance for persons Suffering onychomy s s cosis, including a highly concentrated or Supersaturated solu (US) tion of boric acid. The boric acid solution is poured into a (21) Appl. No.: 12/901,456 soaking tray having a fluid reservoir for containing said boric acid solution and a footrest proximate the reservoir on which (22) Filed: Oct. 8, 2010 to expose toenails to the boric acid solution. The method of treating onychomycosis using the solution and soaking tray Related U.S. Application Data includes the steps of pretreating skin proximate the affected (60) Provisional application No. 61/250,453, filed on Oct. nails;OR preparing g Supersaturatedand maintaining stric a freshacid SupplyR of highlE. 9, 2009. the boric acid solution into the soaking tray; and soaking the affected nails for a period of time between a few seconds up Publication Classification to 30 minutes at least once per day every day for a sufficiently (51) Int. Cl. long period of time for the condition to appreciably improve A45D 29/20 (2006.01) or to resolve. is a -150 ces Patent Application Publication Apr. 14, 2011 Sheet 1 of 4 US 2011/0083692 A1 Patent Application Publication Apr. 14, 2011 Sheet 2 of 4 US 2011/0083692 A1 Patent Application Publication Apr. 14, 2011 Sheet 3 of 4 US 2011/0083692 A1 Patent Application Publication Apr. 14, 2011 Sheet 4 of 4 US 2011/0083692 A1 US 2011/0083692 A1 Apr. 14, 2011 METHOD AND APPARATUS FOR 0009. If the nail infection is severe or extremely painful, a IMPROVING THE APPEARANCE OF NALS doctor may even recommend removing the nail during topical AFFECTED BY ONYCHOMYCOSIS treatment. While a new nail will eventually grow in its place, THROUGH THE TOPCAL APPLICATION OF the discomfort is not inconsiderable, and protection from HIGHILY CONCENTRATED OR injury and other invasive organisms is lost for a length of time. SUPERSATURATED BORIC ACID 0010 Onychomycosis can be controlled and the appear ance of the nails improved by applying undecylenic acid, BACKGROUND OF THE INVENTION which is approved by the FDA and is sold under a number of 0001 1. Field of the Invention brand names, such as Blis-To-Sol Powder, Breezee Mist Foot 0002 The present invention relates generally to composi Powder, Caldesene Powder, Cruex, Desenex, Fungoid AF, tions and methods of using Such compositions for the treat Pedi-Pro, and Protectol. This, however, is not a cure. ment of skin conditions, and more particularly to dermato 0011 Numerous other methods have been proposed for logical compositions and methods of using Such the treatment of fungal nail infections. Patents showing com compositions for the treatment of onychomycosis. positions and their use in such treatments include U.S. Pat. 0003 2. Background Discussion of Related Art No. 6,986.896, to Bhagwat, etal, which discloses a method of 0004 Onychomycosis is a fungal infection of the finger treating fungal conditions and onychomycosis through the nails or toenails. The condition is difficult to cure. Onycho administration of a safe and effective amount of urea in a mycosis occurs when dermatophytes (specifically, tinea topical formulation to an affected area on the skin or around unguium fungi) infect one or more nails. In the early stage of a nail of a patient in need of treatment. the infection, the area around the base and the sides of the nail 0012 U.S. Pat. No. 6,960,201, to Cumbie, teaches a may become red and irritated. If the fungus is allowed to method of treating microbial infections occurring just below spread deeper into the bed of the nail, it may cause discom the skin and nails consisting of the application of electromag fort, itching, and pain around the cuticles, and even bleeding netic radiation to an infected area of skin or nails for a time and detachment of the cuticles. The nail may become discol and at a proximity and intensity Sufficient to render the ored, perhaps yellow-green or dark yellow-brown, and white microbes Substantially inactivated and incapable of reproduc spots occasionally appear in the nail. Eventually, the nail 1ng. thickens and develops abnormal grooves, lines, and broken 0013 U.S. Pat. No. 6,951,847, to Gibson, etal, teaches a and crumbling edges. method of treating fungal and yeast infections using lupeolor 0005 Tinea unguium fungi thrive in warm, moist environ solvates, hydrates, or clathrates. ments, so fungal nail infections generally develop under nails (0014 U.S. Pat. No. 6,921,529, to Maley, shows a method continually exposed to warm, moist environments, e.g., of treating onychomychosis wherein a hydrogel is Supersatu Swimming pools, showers, and Sweaty shoes. Predictably, rated with an antimycotic agent and Supported on a backing infection intoenails is significantly more common than infec The assembly is placed over an infected nail for an extended tion in fingernails, due to the fact that toenails are covered period of time. The antimycotic agent diffuses through the with shoes—creating the very kind of warm, moist environ nail to the underlying infection. The antimycotic agent can be ment in which fungi thrive. Relatively low blood circulation used alone or in conjunction with other active agents or car may also be a contributing factor. riers. Alternative therapeutic agents mentioned in the patent 0006 Nail fungal infections can be painful and may cause include iodine, DMSO, azole derivatives, undecylenic acid, permanent nail damage. They can pose a serious health risk tea tree oil, salicylic acid, urea, and any other recognized for people with diabetes or a compromised immune systems. antimycotic agent. 0007 Unfortunately, nail fungus can be difficult to treat, 0015 U.S. Pat. No. 6,878,365, to Brehove, discloses a and recurrence is common. Over-the-counter antifungal nail topical application for treating onychomycosis using a com creams and ointments are largely ineffective. Prescription position that comprises, as an active ingredient, at least one medications are generally much more effective. The better species selected from the group consisting of 2,2'-(alkyl known medications available by prescription include itra dioxy)bis-(alkyl-1,3,2-dioxaborinane) and 2,2'-oxybis(alkyl conazole (Sporanox); fluconazole (Diflucan); and terbinafine 1.3.2-dioxaborinane). The composition comprises, as an (Lamisil). However, these medications require an aggressive active ingredient, at least one member selected from the group six to twelve week drug regimen or repeat courses of oral consisting of 2,2'-(1-methyltrimethylenedioxy)bis-(4-me ingestion and may require four to twelve months to entirely thyl-1,3,2-dioxaborinane) and 2,2'-oxybis(4,4,6-trimethyl-1, eliminate an infection. Additionally, a typical twelve week 3.2-dioxaborinane). course of treatment can cost upwards of S700 or more and still 0016 U.S. Pat. No. 6,846,837, to Maibach, etal, teaches a has only a 50-70% chance of curing the condition. Further method and topical pharmaceutical formulations for the treat more, these antifungal drugs may cause serious side effects, ment of onychomycosis using a pharmacologically active including liver damage, and monitoring of liver function by a antifungal agent, plus a pharmaceutically acceptable base in a physician is imperative. formulation having a pH of 7.5 to about 13.0, preferably about 0008 For a relatively mild fungal nail infection, some 8.0 to 11.5, and most preferably about 8.5 to 10.5. The anti doctors may prescribe an antifungal lacquer, such as ciclo fungal agent is selected from the group consisting of amo pirox (Penlac). This topical medication is painted onto the rolfine, ciclopiroX olamine, flucytosine, griseofulvin, halo infected nails and Surrounding tissue daily, so that several progrin, potassium iodide, Sodium pyrithione, undecylenic layers of lacquer buildup over the course of a week. After one acid, bifonazole, butoconazole, clotrimazole, econazole, week, the seven layers are wiped off using an alcohol Swab, ketoconazole, miconazole, oxiconazole, Sulconazole, itra and this is followed by another series of fresh applications. conazole, fluconazole, terconazole, naftifine, amphotericin Studies show that this treatment is effective in less than 10 B, nystatin, benzoic acid, salicylic acid, propionic acid, and percent of patients using it. caprylic acid. US 2011/0083692 A1 Apr. 14, 2011 0017 U.S. Pat. No. 6,676,953, to Hexamer, discloses an (0025 FIG. 1B shows the apparatus of FIG.1A with the lid antifungal composition for the treatment of fungal infections removed; in human nails comprising an aqueous solution of a wetting 0026 FIGS. 2A and 2B are each cross-sectional side agent such as alcohol and a source of fluoride ions sufficient views in elevation showing the soaking tray containing a to establish a pH ranging from about 2.8 to about 3.5 in the boric acid solution in a fluid reservoir and showing the solu composition. tion used by a person Suffering from onychomycosis; 0018 U.S. Pat. No. 6,664,292, to Bogart, teaches a 0027 FIG. 2C is a cross-sectional side view in elevation method of treating pathological conditions of the nail com showing an alternative embodiment of the present invention prising topically applying an effective amount of an option and with the kit elements stored in storage compartments; and ally substituted lower alcohol and an optionally substituted 0028 FIG.
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