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. 3A and 3B are upper perspective views show lower carboxylic acid. ing the angled brush employed in the method of the present 0019. The foregoing patents and prior art methods are invention. illustrative and exemplary only and reflect the current state of the art of which the present inventor is aware. Reference to, DETAILED DESCRIPTION OF THE INVENTION and discussion of these patents is intended to aid in discharg ing Applicant's acknowledged duty of candor in disclosing 0029. The present invention is a method and apparatus for information that may be relevant to the examination of pro regularly and systematically treating onychomycosis using a spective claims to the present invention. However, it is highly concentrated or Supersaturated Solution of boric acid respectfully submitted that none of the above-indicated pat comprising 20 to 100% boric acid dissolved in warm water. ents disclose, teach, Suggest, show, or otherwise render obvi Additional ingredients may include a keratolytic agent, Such ous, either singly or when considered in combination, the as urea or salicylic acid; an antifungal agent, Such as clotri invention described and claimed herein. mazole or tolnaftate; a botanical or fragrance Such as euca lyptus oil, menthol, camphor, melaleuca oil, or other essential BRIEF SUMMARY OF THE INVENTION oils. Additional therapeutic ingredients might include iodine, ethyl alcohol, and/or sulfur. As yet the mechanism of the 0020. The present invention is a method and apparatus for treatment is not entirely understood and a determination of treating nails affected by onychomycosis. The method whether the treatment comprises a cure for onychomycosis improves the appearance of nails when a highly concentrated has not yet been made. However, clearly discernible improve or Supersaturated aqueous solution of boric acid is applied to ments in nail appearance result from disciplined application the affected nails in a systematic and routine manner. of the treatment. Accordingly, as used herein, the term “treat 0021. The inventive apparatus is a treatment kit that ment” does not signify a proven mycological cure but only an includes premeasured boric acid (HBO) preferably pro effective program for improving nail appearance for persons vided in a plurality of packets for mixing a solution either in Suffering onychomycosis. a bottle of predetermined size or in the soaking tray included in the inventive apparatus. After preparing the Solution, it is 0030 The inventive apparatus is a treatment kit that poured into a soaking tray (if not prepared in the tray itself). includes packets of boric acid (HBO), preferably provided The tray has a fluid reservoir or basin in which to soak toe in a plurality of pre-measured packets for mixing a solution nails. The tray also includes an angled footrest or ramp that either in a bottle of predetermined size or in the soaking tray descends down into the fluid reservoir so that the user can included in the inventive apparatus. In preparing the treat limit exposure to the forefoot or nails. A specially designed ment solution, the user simply pours a recommended amount nail brush is provided to assist in minimizing unwanted cuta of powder into a bottle, Sealable bag, or in the soaking tray neous exposure. An effective treatment regimen entails described below, covers the container with a lid, and the exposing the affected nails daily for a period several second to Solution is shaken until a solution of desired saturation is several minutes for a long enough period of time to either produced. Some powder will invariably remain undissolved resolve the condition entirely or to achieve discernible as the sought after Solution is Supersaturated. improvement in the appearance of the affected nails. 0031. The treatment apparatus next includes a soaking 0022. The foregoing summary broadly sets out the more tray 100 that provides a convenient basin in which to soak important features of the present invention so that the detailed toenails, but which limits the exposure of the skin on the description that follows may be better understood, and so that user's foot. This is due to the configuration of the soaking tray, the present contributions to the art may be better appreciated. which is a generally square or cuboid container base 110 There are additional features of the invention that will be having an angled footrest or interior ramp 120 that descends described in the detailed description of the preferred embodi down to a small reservoir 130 into which only the forefoot or ments of the invention which will form the subject matter of nail portion of the toes is submerged. A waffle ball 140 is the claims appended hereto. provided to enhance the effectiveness of agitating the bottle or tray for mixing the Solution and may be kept in the reservoir BRIEF DESCRIPTION OF THE DRAWINGS even during use. 0032. The mixed solution may be used repeatedly for up to 0023 The invention will be better understood and objects one week. However, a boric acid solution may be poisonous other than those set forth above will become apparent when when ingested. The soaking tray may be left on the floor for consideration is given to the following detailed description convenience. Accordingly, however, to prevent accidental thereof. Such description makes reference to the annexed poisoning of animals and Small children the soaking tray drawings wherein: includes a tamper proof lid 150 having front and rear latches 0024 FIG. 1A is an upper front perspective view of the 160a, 160b that require conscious and coordinated handling soaking tray of the present invention, shown with a tamper to remove. The tray further includes one or two pockets 170a, proof lid installed; 170b covered with a hinged door 180 operatively connected US 2011/0083692 A1 Apr. 14, 2011 to rear latch that may be opened to store a plurality of packets Nails should be dry and ideally not exposed to water for one 190 of boric acid, as well as the nail brush described below. hour prior to treatment and two hours after treatment. Nails 0033. Additionally, a specially designed nail brush 200 is Soak up more water than hair or skin and the important ele also provided. This brush is fashioned generally in the shape ment with this treatment is that the nails will soak up the of a toothbrush having an angled handle 210. The handle medicated ingredients, bringing them in contact with the bends 220 immediately behind the bristle bed 230 at roughly fungus that is growing throughout the nail plate and in the a 45 degree angle and extends upwardly for a total length of outer layer of the skin underlying the plate. This will not approximately 8 inches. The uppermost portion of the handle happen if the nail is already significantly hydrated or if fresh 240 is provided with a ribbed grip 250 having indentations to water from bathing rinses out the medicated ingredients conform to most finger types to facilitate easy handling. immediately after they have soaked into the nail. The angled Moreover, the grip is divided into an upper handle 260 portion brush is provided to scrub the nails while they are in the and a lower handle portion 270 that may be separated for easy solution. The nails are then dried. This daily treatment must storage and for product packaging. The halves may be be done for many months because nails need to be treated assembled with Snap fit male/female connection elements until the fungal infected portion grows out. It takes about a 280, 290. This elongated brush will enable elderly, obese, year for a toenail to grow from the base of the cuticle to the disabled, or otherwise incapacitated persons to Scrub the nails end of the nail bed. while soaking in the soaking tray without having to bend to 0041. The soaking treatments should be continued an over significantly. Furthermore, the brush will facilitate accu additional four months even after the condition has resolved. rate painting of the nails with the treatment solution, thereby Further, treatment may be repeated as needed to maintain limiting unwanted cutaneous exposure. normal nails. During the course of treatment, the portion of 0034. In an alternative embodiment, soaking tray also the nail affected by fungus will slowly grow out to the end of includes electric heating coils or elements 300 either inte the nail and will be replaced by a normal appearing nail. Nail grated into the interior ramp 120 or disposed in a compart fungal infections have a high relapse rate and future treat ment immediately below the ramp for effective heat transfer ments may be necessary. through the ramp to the boric acid solution in the tray. 0042 Optional use notes: Rather than providing heating 0035 Returning now to the treatment process, once the elements in the soaking tray for heating the Solution, the boric Solution is prepared, it is either poured into the soaking tray or acid solution and the soaking tray may be heated prior to use the soaking tray lid is simply removed to expose the Solution by placing the tub on a heating pad or heating for several and to provide access to the ramp for resting the feet and seconds in a microwave. Additionally, the solution may be immersing the toes in the Solution. saved and reused for up to one week by placing lid on tub and 0036 Treatment Process: Patients treat their affected toe storing at room temperature. nails every day for four months according to a therapeutically 0043. To facilitate healing and to prevent recurrence, it is effective protocol. The following method steps comprise the recommended that the user take the following steps: (a) Wear recommended treatment procedure employing the inventive loose fitting shoes that breath and absorbent cotton Socks, or composition: sandals. Avoid occlusive shoes that do not breath while under 0037 First Nail Maintenance: The affected nails should going this treatment. (b) Dust shoes daily with an antifungal be trimmed and maintained as short as possible during the powder such as Zeasorb AF. (c) Do not apply nail polish or treatment period. The surface of the nail should be filed with ointments to the nail while undergoing this treatment as they a nail file or buffed with an emory board to keep the nail plate will interfere with the absorption of the medicine into the nail as thin as possible. Nails may be professionally filed, or plate. removed either Surgically or chemically by a physician in 0044 Empirical Support and Studies: A clinical study was preparation for the treatment. conducted to determine whether the novel toenail soak can 0038. Second Surrounding Skin Treatment: The skin of improve the appearance of onychomycotic toenails and/or the fingers or toes proximate the nails should be treated for toenails infected with dermatophytes and other fungal and fungal infection (tinea pedis/manus) using Lamasil (terbin yeast organisms. The study patients were selected based on afine hydrochloride) or clotrimazole cream twice a day for their personal interest. The design of the study was to dem two months to ensure that no skin fungal infection exists prior onstrate the feasibility of the treatment and prove or disprove to commencing treatment. Adjacent toe skin must be entirely the efficacy of the treatment. The study was not designed to intact and free from any injury, blister, or other condition that prove mycologic cure, nor was it conducted using a control would allow increased absorption of the ingredients through group, randomization of participants and blinding of the the skin investigator. 0039. Third Preparing the Boric Acid Solution: After 0045 Method: Patients were selected during the course of completing the second step, the boric acid solution should be their physical exams or referred by patients in my practice. prepared to a strength of between 20% and 100% (or super Prospective participants were excluded from the study if they saturated). The Supersaturated solution may be prepared by had used an oral antifungal, or topical antifungal product on first preparing a saturated Solution, i.e., one that contains the their toenails in the past 12 months. The initial study enroll maximum amount of solute that the water solvent will dis ment visit included a toenail fungal culture on DTM media, Solve at room temperature and pressure, and thereafter heat baseline toenail photographs, and instructions in oral and ing the solution to dissolve and accept more solute. Any written form (see the attached patient instruction sheet). The excess solute may be filtered out and the temperature then patients were given the materials for treatment. Patients were reduced. instructed to return in 4 months and 6 months during which 0040 Fourth Treating the Nails: The affected nails are time photos were taken. Office exams scheduled for other then soaked for only a few seconds to several minutes (up to purposes were also used to examine the toenails. Interested 30 minutes) every day until the fungal infection is resolved. patients could continue treatment for up to 12 months. The US 2011/0083692 A1 Apr. 14, 2011

study period was closed October 2008 at which time all 0053. The participants’ impressions of the treatment and participants in the treatment were given their final assessment their comments reflect the marketability of the product. regardless of treatment duration. Clinical assessment at the CP4746 had toenail fungus for over 30 years and her nails end of the treatment period was based on an assessment of the improved to normal appearance after five (5) months. She had appearance of the involved toenails as seen in the photo tried many topical remedies without response. Her pedicure graphs. Patients were assigned to one of several groups based technician had witnessed the process with her for many years on the degree of discernible improvement, i.e., no discernible and was also struck by the improvement. CP4746 said: “My improvement, Subtle improvement, significant improvement, nails were yellow, ridged, bumpy and thick for 30 years. My and dramatic improvement with near normal nail appearance. pedicurist is amazed . . . . People Suffering nail fungus are 0046 Results: 23 patients were included in the study. 21 disinclined to take oral medications because of the potential patients were enrolled from November 2007 to August 2008. risks. KK3102, a subtle responder, said “the treatment is 2 additional patients were included who used treatment helping more than anything he ever used before including that before the study began and had sufficient documentation to be expensive shellac. BP925, who had “significant improve included in the study. The entire study group is listed in Table ment in nail appearance following only four (4) months of 1 of the attached spreadsheet. treatment said “the nail is absolutely better.” Lastly, all four of the participants who had used Lamasil without success felt 0047 Four patients dropped out of the study after begin that they were improving on the treatment. ning treatment due to lack of interest or motivation and are not 0054. In summary, the novel daily topical treatment of the included in the analysis. There were no adverse events during present invention can improve the appearance of the onycho the treatment. mycotic nail. It works in the elderly, a group with a poor 0048. Of the 19 participants who completed the treatment, prognosis. In this patient group, a nonsystemic therapeutic four (4) had no change in the appearance of the nail (21%), alternative for improving the nail appearance has the advan three (3) had a subtle change in appearance (16%), seven (7) tage of avoiding medication drug interactions. It may also be had significant improvement in the appearance of the nail a beneficial topical adjunct to systemic therapy in patients (37%), and five (5) had dramatic improvement and near nor who want to use systemic antifungals. mal nail appearance (26%) The results are summarized in 0055 An important advantage of the present invention is Table 2 on the spreadsheet. its ease of use. Ultimately, the powder should be agitated and 0049. The groups with “significant' and “dramatic' stored in a childproof bottle. A plastic dipping pan that fits all improvement had “an improved appearance of the nail’ and foot sizes and is inclined toward the toenails aids in the ease thus 63% of treatment participants fell into this category. 37% of use. Aggressive debridement of the nail by the patient therefore had no change in the nail appearance during the correlated with treatment Success and needs to be stressed in treatment period. the instructions. The inventive method is an inexpensive, 0050. The average age of the study participants was 65.4 over-the-counter alternative to expensive pharmaceutical years. There was no appreciable difference in age between the antifungals and ineffective OTC home remedies. four response groups. The Response Summary in Table 3 lists 0056 Oral antifungal treatments, such as Lamasil, are average ages and treatment duration, and percent of partici possibly the most effective treatment for nail onychomycosis, pants within each response group. Average treatment duration though firm conclusion will require further study. However, for the group as a whole was 6 months. for people who do not wish to use a systemic antifungal 0051 Discussion: Topical treatment for onychomycosis therapy, the novel topical treatment disclosed herein affords has historically been disappointing. It is a Surprise that this improvement in the nail appearance. new topical treatment method produced improvement in the 0057 The above disclosure is sufficient to enable one of appearance of onychomycotic toenails. Even more Surprising ordinary skill in the art to practice the invention, and provides was that this improvement in appearance occurred in an eld the best mode of practicing the invention presently contem erly population of participants. The elderly are considered a plated by the inventor. While there is provided herein a full group with a poor prognosis for onychomycosis. The oldest and complete disclosure of the preferred embodiments of this patient in the study was 88 years old (MB9537). She had invention, it is not desired to limit the invention to the exact Suffered nail fungus for many years, and despite this, she had construction, dimensional relationships, and operation shown near normal nail appearance after 7 months of treatment. The and described. Various modifications, alternative construc same is true for 76 year old LC2837 and 62 year old KC7594. tions, changes and equivalents will readily occur to those 0.052 The results suggest that if nail appearance is going skilled in the art and may be employed, as suitable, without to respond favorably to this treatment, it does so promptly. If departing from the true spirit and scope of the invention. Such the nail is not going to respond, then continuing to use the changes might involve alternative materials, components, treatment does not seem to alter the outcome. The average structural arrangements, sizes, shapes, forms, functions, treatment duration of the participants was six (6) months. The operational features or the like. group that improved (significant and dramatic) used the treat ment for five months nine days (5.3) months. The treatment duration in the non-improved group (no change and Subtle) was eight (8) months. Please note that this was calculated by What is claimed as invention is: removing a patient that was a late enrollee CB9188. This 1. A toenail treatment kit for treating onychomycosis and patient was only on the treatment for two months before the improving nail appearance for persons Suffering onychomy end of the study period, during which time he did not show an cosis, comprising: appreciable change in his nail photos, in spite of his assertion one or more pre-measured packets of boric acid powder for that he was improving. He was thus counted as a non-re preparing highly concentrated or Supersaturated aque sponder rather than being excluded from the study. ous boric acid solution; and US 2011/0083692 A1 Apr. 14, 2011

a soaking tray having a fluid reservoir for containing said 18. The toenail treatment kit of claim 1, wherein said kit boric acid solution and a footrest proximate said fluid further includes electric heating coils or elements disposed reservoir on which to expose toenails to said boric acid proximate said fluid reservoir for heating said boric acid Solution. Solution. 19. A method of treating onychomycosis and improving 2. The toenail treatment kit of claim 1, wherein said pre nail appearance for persons suffering onychomycosis, com measured packets further include a keratolytic agent. prising the steps of: 3. The toenail treatment kit of claim 2, wherein said kera (a) before commencing the treatment regimen, treating the tolytic agent is urea. skin proximate the affected nails for fungal infection 4. The toenail treatment kit of claim 2, wherein said kera with a topical antifungal composition for a Sufficiently tolytic agent is salicylic acid. long period of time to ensure that no skin fungal infec 5. The toenail treatment kit of claim 1, wherein said pre tion exists prior to commencing treatment with the boric measured packets further include an antifungal agent. acid solution; 6. The toenail treatment kit of claim 5, wherein said anti (b) providing a soaking tray having a fluid reservoir and an fungal agent is clotrimazole. angled footrest; 7. The toenail treatment kit of claim 5, wherein said anti (c) preparing a highly concentrated or Supersaturated boric fungal agent is tolnaftate. acid solution a highly concentrated or Supersaturated 8. The toenail treatment kit of claim 1, wherein said pre solution of boric acid comprising between 20 to 100% measured packets further include a fragrance. boric acid as a solute dissolved in water, 9. The toenail treatment kit of claim 1, wherein said pre (d) pouring the boric acid solution into the soaking tray; measured packets include iodine. (e) trimming, filing, and maintaining the affected nails as 10. The toenail treatment kit of claim 1, wherein said short and as thin as possible during the treatment period; pre-measured packet include ethyl alcohol. and (f) soaking the affected nails for a period of time between 11. The toenail treatment kit of claim 1, wherein said a few seconds up to 30 minutes at least once per day pre-measured packets include Sulfur. every day for a sufficiently long period of time for the 12. The toenail treatment kit of claim 1, wherein said condition to appreciably improve or to resolve. soaking tray includes an interior ramp that descends down to 20. The method of claim 19, further including the step of a small fluid reservoir for allowing the user to easily limit keeping the affected nails dry and not exposed to water for exposure of the foot to said boric acid solution to the forefoot one hour prior to treatment and two hours after treatment. or nail portion of the toes. 21. The method of claim 19, further including the step of 13. The toenail treatment kit of claim 1, wherein said using a brush to Scrub the nails while they are soaking in the soaking tray includes a tamper proof lid. boric acid solution. 14. The toenail treatment kit of claim 1, wherein said boric 22. The method of claim 19, further including the step of acid solution includes iodine. continuing the soaking treatments an additional four months 15. The toenail treatment kit of claim 14, wherein said after the condition has resolved. tamper proof lid includes front and rear latches that require 23. The method of claim 19, further including the step of coordinated handling in order to remove said lid. heating the boric acid solution before use. 16. The toenail treatment kit of claim 1, wherein said 24. The method of claim 19, wherein the antifungal com soaking tray further includes one or more storage compart position employed in step (a) is either terbinafine hydrochlo mentS. ride cream or clotrimazole cream. 17. The toenail treatment kit of claim 1, wherein said kit further includes a nail brush. c c c c c