Abstract:
A toenail treatment kit for treating onychomycosis and improving nail appearance for persons suffering onychomycosis, including a highly concentrated or supersaturated solution of boric acid. The boric acid solution is poured into a soaking tray having a fluid reservoir for containing said boric acid solution and a footrest proximate the reservoir on which to expose toenails to the boric acid solution. The method of treating onychomycosis using the solution and soaking tray includes the steps of pretreating skin proximate the affected nails; preparing and maintaining a fresh supply of highly concentrated or supersaturated boric acid solution; pouring the boric acid solution into the soaking tray; and soaking the affected nails for a period of time between a few seconds up to 30 minutes at least once per day every day for a sufficiently long period of time for the condition to appreciably improve or to resolve.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    1. Field of the Invention 
         [0002]    The present invention relates generally to compositions and methods of using such compositions for the treatment of skin conditions, and more particularly to dermatological compositions and methods of using such compositions for the treatment of onychomycosis. 
         [0003]    2. Background Discussion of Related Art 
         [0004]    Onychomycosis is a fungal infection of the fingernails or toenails. The condition is difficult to cure. Onychomycosis occurs when dermatophytes (specifically, tinea unguium fungi) infect one or more nails. In the early stage of the infection, the area around the base and the sides of the nail may become red and irritated. If the fungus is allowed to spread deeper into the bed of the nail, it may cause discomfort, itching, and pain around the cuticles, and even bleeding and detachment of the cuticles. The nail may become discolored, perhaps yellow-green or dark yellow-brown, and white spots occasionally appear in the nail. Eventually, the nail thickens and develops abnormal grooves, lines, and broken and crumbling edges. 
         [0005]    Tinea unguium fungi thrive in warm, moist environments, so fungal nail infections generally develop under nails continually exposed to warm, moist environments, e.g., swimming pools, showers, and sweaty shoes. Predictably, infection in toenails is significantly more common than infection in fingernails, due to the fact that toenails are covered with shoes—creating the very kind of warm, moist environment in which fungi thrive. Relatively low blood circulation may also be a contributing factor. 
         [0006]    Nail fungal infections can be painful and may cause permanent nail damage. They can pose a serious health risk for people with diabetes or a compromised immune systems. 
         [0007]    Unfortunately, nail fungus can be difficult to treat, and recurrence is common. Over-the-counter antifungal nail creams and ointments are largely ineffective. Prescription medications are generally much more effective. The better known medications available by prescription include itraconazole (Sporanox); fluconazole (Diflucan); and terbinafine (Lamisil). However, these medications require an aggressive six to twelve week drug regimen or repeat courses of oral ingestion and may require four to twelve months to entirely eliminate an infection. Additionally, a typical twelve week course of treatment can cost upwards of $700 or more and still has only a 50-70% chance of curing the condition. Furthermore, these antifungal drugs may cause serious side effects, including liver damage, and monitoring of liver function by a physician is imperative. 
         [0008]    For a relatively mild fungal nail infection, some doctors may prescribe an antifungal lacquer, such as ciclopirox (Penlac). This topical medication is painted onto the infected nails and surrounding tissue daily, so that several layers of lacquer build up over the course of a week. After one week, the seven layers are wiped off using an alcohol swab, and this is followed by another series of fresh applications. Studies show that this treatment is effective in less than 10 percent of patients using it. 
         [0009]    If the nail infection is severe or extremely painful, a doctor may even recommend removing the nail during topical treatment. While a new nail will eventually grow in its place, the discomfort is not inconsiderable, and protection from injury and other invasive organisms is lost for a length of time. 
         [0010]    Onychomycosis can be controlled and the appearance of the nails improved by applying undecylenic acid, which is approved by the FDA and is sold under a number of brand names, such as Blis-To-Sol Powder, Breezee Mist Foot Powder, Caldesene Powder, Cruex, Desenex, Fungoid AF, Pedi-Pro, and Protectol. This, however, is not a cure. 
         [0011]    Numerous other methods have been proposed for the treatment of fungal nail infections. Patents showing compositions and their use in such treatments include U.S. Pat. No. 6,986,896, to Bhagwat, et al, which discloses a method of treating fungal conditions and onychomycosis through the administration of a safe and effective amount of urea in a topical formulation to an affected area on the skin or around a nail of a patient in need of treatment. 
         [0012]    U.S. Pat. No. 6,960,201, to Cumbie, teaches a method of treating microbial infections occurring just below the skin and nails consisting of the application of electromagnetic radiation to an infected area of skin or nails for a time and at a proximity and intensity sufficient to render the microbes substantially inactivated and incapable of reproducing. 
         [0013]    U.S. Pat. No. 6,951,847, to Gibson, et al, teaches a method of treating fungal and yeast infections using lupeol or solvates, hydrates, or clathrates. 
         [0014]    U.S. Pat. No. 6,921,529, to Maley, shows a method of treating onychomychosis wherein a hydrogel is supersaturated with an antimycotic agent and supported on a backing The assembly is placed over an infected nail for an extended period of time. The antimycotic agent diffuses through the nail to the underlying infection. The antimycotic agent can be used alone or in conjunction with other active agents or carriers. Alternative therapeutic agents mentioned in the patent include iodine, DMSO, azole derivatives, undecylenic acid, tea tree oil, salicylic acid, urea, and any other recognized antimycotic agent. 
         [0015]    U.S. Pat. No. 6,878,365, to Brehove, discloses a topical application for treating onychomycosis using a composition that comprises, as an active ingredient, at least one species selected from the group consisting of 2,2′-(alkyldioxy)bis-(alkyl-1,3,2-dioxaborinane) and 2,2′-oxybis(alkyl-1,3,2-dioxaborinane). The composition comprises, as an active ingredient, at least one member selected from the group consisting of 2,2′-(1-methyltrimethylenedioxy)bis-(4-methyl-1,3,2-dioxaborinane) and 2,2′-oxybis(4,4,6-trimethyl-1,3,2-dioxaborinane). 
         [0016]    U.S. Pat. No. 6,846,837, to Maibach, et al, teaches a method and topical pharmaceutical formulations for the treatment of onychomycosis using a pharmacologically active antifungal agent, plus a pharmaceutically acceptable base in a formulation having a pH of 7.5 to about 13.0, preferably about 8.0 to 11.5, and most preferably about 8.5 to 10.5. The antifungal agent is selected from the group consisting of amorolfine, ciclopirox olamine, flucytosine, griseofulvin, haloprogrin, potassium iodide, sodium pyrithione, undecylenic acid, bifonazole, butoconazole, clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, sulconazole, itraconazole, fluconazole, terconazole, naftifine, amphotericin B, nystatin, benzoic acid, salicylic acid, propionic acid, and caprylic acid. 
         [0017]    U.S. Pat. No. 6,676,953, to Hexamer, discloses an antifungal composition for the treatment of fungal infections in human nails comprising an aqueous solution of a wetting agent such as alcohol and a source of fluoride ions sufficient to establish a pH ranging from about 2.8 to about 3.5 in the composition. 
         [0018]    U.S. Pat. No. 6,664,292, to Bogart, teaches a method of treating pathological conditions of the nail comprising topically applying an effective amount of an optionally substituted lower alcohol and an optionally substituted lower carboxylic acid. 
         [0019]    The foregoing patents and prior art methods are illustrative and exemplary only and reflect the current state of the art of which the present inventor is aware. Reference to, and discussion of, these patents is intended to aid in discharging Applicant&#39;s acknowledged duty of candor in disclosing information that may be relevant to the examination of prospective claims to the present invention. However, it is respectfully submitted that none of the above-indicated patents disclose, teach, suggest, show, or otherwise render obvious, either singly or when considered in combination, the invention described and claimed herein. 
       BRIEF SUMMARY OF THE INVENTION 
       [0020]    The present invention is a method and apparatus for treating nails affected by onychomycosis. The method improves the appearance of nails when a highly concentrated or supersaturated aqueous solution of boric acid is applied to the affected nails in a systematic and routine manner. 
         [0021]    The inventive apparatus is a treatment kit that includes premeasured boric acid (H 3 BO 3 ) preferably provided in a plurality of packets for mixing a solution either in a bottle of predetermined size or in the soaking tray included in the inventive apparatus. After preparing the solution, it is poured into a soaking tray (if not prepared in the tray itself). The tray has a fluid reservoir or basin in which to soak toenails. The tray also includes an angled footrest or ramp that descends down into the fluid reservoir so that the user can limit exposure to the forefoot or nails. A specially designed nail brush is provided to assist in minimizing unwanted cutaneous exposure. An effective treatment regimen entails exposing the affected nails daily for a period several second to several minutes for a long enough period of time to either resolve the condition entirely or to achieve discernible improvement in the appearance of the affected nails. 
         [0022]    The foregoing summary broadly sets out the more important features of the present invention so that the detailed description that follows may be better understood, and so that the present contributions to the art may be better appreciated. There are additional features of the invention that will be described in the detailed description of the preferred embodiments of the invention which will form the subject matter of the claims appended hereto. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0023]    The invention will be better understood and objects other than those set forth above will become apparent when consideration is given to the following detailed description thereof. Such description makes reference to the annexed drawings wherein: 
           [0024]      FIG. 1A  is an upper front perspective view of the soaking tray of the present invention, shown with a tamper proof lid installed; 
           [0025]      FIG. 1B  shows the apparatus of  FIG. 1A  with the lid removed; 
           [0026]      FIGS. 2A and 2B  are each cross-sectional side views in elevation showing the soaking tray containing a boric acid solution in a fluid reservoir and showing the solution used by a person suffering from onychomycosis; 
           [0027]      FIG. 2C  is a cross-sectional side view in elevation showing an alternative embodiment of the present invention and with the kit elements stored in storage compartments; and 
           [0028]      FIG. 3A and 3B  are upper perspective views showing the angled brush employed in the method of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0029]    The present invention is a method and apparatus for regularly and systematically treating onychomycosis using a highly concentrated or supersaturated solution of boric acid comprising 20 to 100% boric acid dissolved in warm water. Additional ingredients may include a keratolytic agent, such as urea or salicylic acid; an antifungal agent, such as clotrimazole or tolnaftate; a botanical or fragrance such as eucalyptus oil, menthol, camphor, melaleuca oil, or other essential oils. Additional therapeutic ingredients might include iodine, ethyl alcohol, and/or sulfur. As yet the mechanism of the treatment is not entirely understood and a determination of whether the treatment comprises a cure for onychomycosis has not yet been made. However, clearly discernible improvements in nail appearance result from disciplined application of the treatment. Accordingly, as used herein, the term “treatment” does not signify a proven mycological cure but only an effective program for improving nail appearance for persons suffering onychomycosis. 
         [0030]    The inventive apparatus is a treatment kit that includes packets of boric acid (H 3 BO 3 ), preferably provided in a plurality of pre-measured packets for mixing a solution either in a bottle of predetermined size or in the soaking tray included in the inventive apparatus. In preparing the treatment solution, the user simply pours a recommended amount of powder into a bottle, sealable bag, or in the soaking tray described below, covers the container with a lid, and the solution is shaken until a solution of desired saturation is produced. Some powder will invariably remain undissolved as the sought after solution is supersaturated. 
         [0031]    The treatment apparatus next includes a soaking tray  100  that provides a convenient basin in which to soak toenails, but which limits the exposure of the skin on the user&#39;s foot. This is due to the configuration of the soaking tray, which is a generally square or cuboid container base  110  having an angled footrest or interior ramp  120  that descends down to a small reservoir  130  into which only the forefoot or nail portion of the toes is submerged. A waffle ball  140  is provided to enhance the effectiveness of agitating the bottle or tray for mixing the solution and may be kept in the reservoir even during use. 
         [0032]    The mixed solution may be used repeatedly for up to one week. However, a boric acid solution may be poisonous when ingested. The soaking tray may be left on the floor for convenience. Accordingly, however, to prevent accidental poisoning of animals and small children the soaking tray includes a tamper proof lid  150  having front and rear latches  160   a ,  160   b  that require conscious and coordinated handling to remove. The tray further includes one or two pockets  170   a ,  170   b  covered with a hinged door  180  operatively connected to rear latch that may be opened to store a plurality of packets  190  of boric acid, as well as the nail brush described below. 
         [0033]    Additionally, a specially designed nail brush  200  is also provided. This brush is fashioned generally in the shape of a toothbrush having an angled handle  210 . The handle bends  220  immediately behind the bristle bed  230  at roughly a 45 degree angle and extends upwardly for a total length of approximately 8 inches. The uppermost portion of the handle  240  is provided with a ribbed grip  250  having indentations to conform to most finger types to facilitate easy handling. Moreover, the grip is divided into an upper handle  260  portion and a lower handle portion  270  that may be separated for easy storage and for product packaging. The halves may be assembled with snap fit male/female connection elements  280 ,  290 . This elongated brush will enable elderly, obese, disabled, or otherwise incapacitated persons to scrub the nails while soaking in the soaking tray without having to bend to over significantly. Furthermore, the brush will facilitate accurate painting of the nails with the treatment solution, thereby limiting unwanted cutaneous exposure. 
         [0034]    In an alternative embodiment, soaking tray also includes electric heating coils or elements  300  either integrated into the interior ramp  120  or disposed in a compartment immediately below the ramp for effective heat transfer through the ramp to the boric acid solution in the tray. 
         [0035]    Returning now to the treatment process, once the solution is prepared, it is either poured into the soaking tray or the soaking tray lid is simply removed to expose the solution and to provide access to the ramp for resting the feet and immersing the toes in the solution. 
         [0036]    Treatment Process: Patients treat their affected toenails every day for four months according to a therapeutically effective protocol. The following method steps comprise the recommended treatment procedure employing the inventive composition: 
         [0037]    First—Nail Maintenance: The affected nails should be trimmed and maintained as short as possible during the treatment period. The surface of the nail should be filed with a nail file or buffed with an emory board to keep the nail plate as thin as possible. Nails may be professionally filed, or removed either surgically or chemically by a physician in preparation for the treatment. 
         [0038]    Second—Surrounding Skin Treatment: The skin of the fingers or toes proximate the nails should be treated for fungal infection (tinea pedis/manus) using Lamasil (terbinafine hydrochloride) or clotrimazole cream twice a day for two months to ensure that no skin fungal infection exists prior to commencing treatment. Adjacent toe skin must be entirely intact and free from any injury, blister, or other condition that would allow increased absorption of the ingredients through the skin 
         [0039]    Third—Preparing the Boric Acid Solution: After completing the second step, the boric acid solution should be prepared to a strength of between 20% and 100% (or supersaturated). The supersaturated solution may be prepared by first preparing a saturated solution, i.e., one that contains the maximum amount of solute that the water solvent will dissolve at room temperature and pressure, and thereafter heating the solution to dissolve and accept more solute. Any excess solute may be filtered out and the temperature then reduced. 
         [0040]    Fourth—Treating the Nails: The affected nails are then soaked for only a few seconds to several minutes (up to 30 minutes) every day until the fungal infection is resolved. Nails should be dry and ideally not exposed to water for one hour prior to treatment and two hours after treatment. Nails soak up more water than hair or skin and the important element with this treatment is that the nails will soak up the medicated ingredients, bringing them in contact with the fungus that is growing throughout the nail plate and in the outer layer of the skin underlying the plate. This will not happen if the nail is already significantly hydrated or if fresh water from bathing rinses out the medicated ingredients immediately after they have soaked into the nail. The angled brush is provided to scrub the nails while they are in the solution. The nails are then dried. This daily treatment must be done for many months because nails need to be treated until the fungal infected portion grows out. It takes about a year for a toenail to grow from the base of the cuticle to the end of the nail bed. 
         [0041]    The soaking treatments should be continued an additional four months even after the condition has resolved. Further, treatment may be repeated as needed to maintain normal nails. During the course of treatment, the portion of the nail affected by fungus will slowly grow out to the end of the nail and will be replaced by a normal appearing nail. Nail fungal infections have a high relapse rate and future treatments may be necessary. 
         [0042]    Optional use notes: Rather than providing heating elements in the soaking tray for heating the solution, the boric acid solution and the soaking tray may be heated prior to use by placing the tub on a heating pad or heating for several seconds in a microwave. Additionally, the solution may be saved and reused for up to one week by placing lid on tub and storing at room temperature. 
         [0043]    To facilitate healing and to prevent recurrence, it is recommended that the user take the following steps: (a) Wear loose fitting shoes that breath and absorbent cotton socks, or sandals. Avoid occlusive shoes that do not breath while undergoing this treatment. (b) Dust shoes daily with an antifungal powder such as Zeasorb AF. (c) Do not apply nail polish or ointments to the nail while undergoing this treatment as they will interfere with the absorption of the medicine into the nail plate. 
         [0044]    Empirical Support and Studies: A clinical study was conducted to determine whether the novel toenail soak can improve the appearance of onychomycotic toenails and/or toenails infected with dermatophytes and other fungal and yeast organisms. The study patients were selected based on their personal interest. The design of the study was to demonstrate the feasibility of the treatment and prove or disprove the efficacy of the treatment. The study was not designed to prove mycologic cure, nor was it conducted using a control group, randomization of participants and blinding of the investigator. 
         [0045]    Method: Patients were selected during the course of their physical exams or referred by patients in my practice. Prospective participants were excluded from the study if they had used an oral antifungal, or topical antifungal product on their toenails in the past 12 months. The initial study enrollment visit included a toenail fungal culture on DTM media, baseline toenail photographs, and instructions in oral and written form (see the attached patient instruction sheet). The patients were given the materials for treatment. Patients were instructed to return in 4 months and 6 months during which time photos were taken. Office exams scheduled for other purposes were also used to examine the toenails. Interested patients could continue treatment for up to 12 months. The study period was closed October 2008 at which time all participants in the treatment were given their final assessment regardless of treatment duration. Clinical assessment at the end of the treatment period was based on an assessment of the appearance of the involved toenails as seen in the photographs. Patients were assigned to one of several groups based on the degree of discernible improvement, i.e., no discernible improvement, subtle improvement, significant improvement, and dramatic improvement with near normal nail appearance. 
         [0046]    Results: 23 patients were included in the study. 21 patients were enrolled from November 2007 to August 2008. 2 additional patients were included who used treatment before the study began and had sufficient documentation to be included in the study. The entire study group is listed in Table 1 of the attached spreadsheet. 
         [0047]    Four patients dropped out of the study after beginning treatment due to lack of interest or motivation and are not included in the analysis. There were no adverse events during the treatment. 
         [0048]    Of the 19 participants who completed the treatment, four (4) had no change in the appearance of the nail (21%), three (3) had a subtle change in appearance (16%), seven (7) had significant improvement in the appearance of the nail (37%), and five (5) had dramatic improvement and near normal nail appearance (26%) The results are summarized in Table 2 on the spreadsheet. 
         [0049]    The groups with “significant” and “dramatic” improvement had “an improved appearance of the nail” and thus 63% of treatment participants fell into this category. 37% therefore had no change in the nail appearance during the treatment period. 
         [0050]    The average age of the study participants was 65.4 years. There was no appreciable difference in age between the four response groups. The Response Summary in Table 3 lists average ages and treatment duration, and percent of participants within each response group. Average treatment duration for the group as a whole was 6 months. 
         [0051]    Discussion: Topical treatment for onychomycosis has historically been disappointing. It is a surprise that this new topical treatment method produced improvement in the appearance of onychomycotic toenails. Even more surprising was that this improvement in appearance occurred in an elderly population of participants. The elderly are considered a group with a poor prognosis for onychomycosis. The oldest patient in the study was 88 years old (MB9537). She had suffered nail fungus for many years, and despite this, she had near normal nail appearance after 7 months of treatment. The same is true for 76 year old LC2837 and 62 year old KC7594. 
         [0052]    The results suggest that if nail appearance is going to respond favorably to this treatment, it does so promptly. If the nail is not going to respond, then continuing to use the treatment does not seem to alter the outcome. The average treatment duration of the participants was six (6) months. The group that improved (significant and dramatic) used the treatment 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 removing a patient that was a late enrollee CB9188. This patient was only on the treatment for two months before the end of the study period, during which time he did not show an appreciable change in his nail photos, in spite of his assertion that he was improving. He was thus counted as a non-responder rather than being excluded from the study. 
         [0053]    The participants&#39; impressions of the treatment and their comments reflect the marketability of the product. CP4746 had toenail fungus for over 30 years and her nails improved to normal appearance after five (5) months. She had tried many topical remedies without response. Her pedicure technician had witnessed the process with her for many years and was also struck by the improvement. CP4746 said: “My nails were yellow, ridged, bumpy and thick for 30 years. My pedicurist is amazed . . . ” People suffering nail fungus are disinclined to take oral medications because of the potential risks. KK3102, a subtle responder, said “the treatment is helping more than anything he ever used before including that expensive shellac.” BP925, who had “significant” improvement in nail appearance following only four (4) months of treatment said “the nail is absolutely better.” Lastly, all four of the participants who had used Lamasil without success felt that they were improving on the treatment. 
         [0054]    In summary, the novel daily topical treatment of the present invention can improve the appearance of the onychomycotic nail. It works in the elderly, a group with a poor prognosis. In this patient group, a nonsystemic therapeutic alternative for improving the nail appearance has the advantage of avoiding medication drug interactions. It may also be a beneficial topical adjunct to systemic therapy in patients who want to use systemic antifungals. 
         [0055]    An important advantage of the present invention is its ease of use. Ultimately, the powder should be agitated and stored in a childproof bottle. A plastic dipping pan that fits all foot sizes and is inclined toward the toenails aids in the ease of use. Aggressive debridement of the nail by the patient correlated with treatment success and needs to be stressed in the instructions. The inventive method is an inexpensive, over-the-counter alternative to expensive pharmaceutical antifungals and ineffective OTC home remedies. 
         [0056]    Oral antifungal treatments, such as Lamasil, are possibly the most effective treatment for nail onychomycosis, though firm conclusion will require further study. However, for people who do not wish to use a systemic antifungal therapy, the novel topical treatment disclosed herein affords improvement in the nail appearance. 
         [0057]    The above disclosure is sufficient to enable one of ordinary skill in the art to practice the invention, and provides the best mode of practicing the invention presently contemplated by the inventor. While there is provided herein a full and complete disclosure of the preferred embodiments of this invention, it is not desired to limit the invention to the exact construction, dimensional relationships, and operation shown and described. Various modifications, alternative constructions, changes and equivalents will readily occur to those skilled in the art and may be employed, as suitable, without departing from the true spirit and scope of the invention. Such changes might involve alternative materials, components, structural arrangements, sizes, shapes, forms, functions, operational features or the like.