Overview

1. The anatomy of the human nail
2. The organism behind nail fungus
3. How topical treatments work

1. The anatomy of the human nail

Overview

The skin is the largest organ in the body and its most important function is to provide a selectively permeable barrier to the outside environment. The outermost layer of skin is called the stratum corneum (SC), Latin for horned layer, which is a dynamic structure that functions to protect deep layers of the skin from infection and injury [1]. This layer is comprised of dense skin cells (15 layers deep) called corneocytes [2] that originate deep within the skin and migrate to the surface of the skin as they mature. Complete replacement of these cells in the epidermis takes approximately 1-2 weeks, as it takes about 24 hours to form a single layer of the SC. One of the most important structures of the SC is the nail, which is a flat, hardened covering at the tips of the fingers or toes that has evolved to function as a protectant for the tips of our digits. The nail covers and protects a part of the finger called the matrix (see below), which is a layer of skin under the nail from which all of the cells that become the nail arise [3].

Nail Structure

The nail itself is comprised of three main layers. From the outer structure in, they are the nail plate, the nail bed, and the nail matrix. The nail plate, also called the dorsal outer layer, is dense and hard, consisting of keratin [4]. The nail plate is a thin (0.25 -0.6mm for fingernails and up to 1.3mm for toenails), hard, yet slightly elastic, translucent, convex structure that is made up of approximately 25 layers of dead keratinized and flattened cells. These cells are tightly bound to one another via numerous intercellular links, membrane-coating granules and desmosomes, which are cell structures specialized for cell-to-cell adhesion [4].

The nail bed is the skin beneath the nail plate [5]. Like all skin, the nail bed is made of two types of tissues: deep dermis, (the living tissue fixed to the bone which includes capillaries and glands), and the superficial epidermis (the layer just beneath the nail plate, which moves forward with the plate). The epidermis is attached to the dermis by tiny longitudinal “grooves” known as matrix crests.

The nail matrix (sometimes called the matrix unguis, keratogenous membrane, or onychostroma) is the tissue that the nail protects [6]. This part of the nail bed rests beneath the nail and contains nerves, lymph and blood vessels. The matrix is responsible for producing cells that become the nail plate. The width and thickness of the nail plate is determined by the size, length, and thickness of the matrix, while the shape of the fingertip itself shows if the nail plate is flat, arched or hooked [6]. The nail matrix continuously produces nail. The matrix at the base of fingernails consists of the most rapidly dividing skin cells in the body, which grow four times faster than toenails at a rate of about 3mm a month. This tissue consists of rapidly proliferating skin cells that soon fill with the protein keratin. This is the protein that gives strength to the nail [7].

The nail-plate (corpus unguis) is the actual nail that we usually refer to as the “fingernail” or “toenail.” This part of the nail is made of a clear protein called keratin. Several layers of dead, flattened cells make the nail strong and able to protect the end of the finger, yet partially flexible. The nail-plate is comprised of dorsal, intermediate, and ventral layers. The dorsal outer layer is dense and hard, consisting of keratin. However, despite its hardness, this layer of the nail is only a few cells thick (approximately 0.5mm) [8]. The dorsal and ventral layers of the nail plate have the highest concentration of lipids in the nail, and affect penetrability of treatments (see below) [9]. In intermediate layer of the nail plate contains highly compressed, flattened cells, in comparison with the other two layers, which contain softer, less compressed cells [10].

The Protein Keratin: Giving Strength to Nails

Keratin refers to a family of fibrous structural proteins that give nails their hardness. Keratin is the key structural material that comprises the outer layer of human skin, hair and nails. Single pieces of keratin, or monomers, assemble into bundles to form intermediate filaments, which are tough and insoluble. These filaments are the building blocks of the nail.

Keratin filaments are comprised of keratinocytes, which are keratinized cells [11]. Keratinocytes serve many important functions, most important of which is the production of the structural protein keratin. Keratinocytes are formed deep in the skin and progresses up through the epidermis to the dorsal outer layer of the nail. During this migration, the cell is transformed right before reaching the SC into a mature keratinocyte, called a corneocyte (or squames, from the Latin word squama for scale or armor) [12].

This transformation causes the cell to change in a number of important ways. For example, the cell loses both its nucleus and cytoplasm, forms a tough outer structure called the cell envelope, expels a large amount of lipids into extracellular spaces, and aggregates large amounts of keratin inside itself. The resultant corneocyte is comprised of about 80% keratin by dry weight. By this stage the corneocyte is in reality a dead cell, as it lacks a nucleus and is no longer actively conducting biological processes. However, it now serves a structural purpose in the nail. Following maturation, this cell is shed in the normal skin cell turnover process.

2. Onychomycosis: nail fungus

Onychomycosis is a term that describes a number of different infections of keratinized tissues of the nail due to a fungus [13, 14]. A number of different fungi can cause onychomycosis, including Candida, dermatophytic molds, and nondermatophytic molds. Of these, dermatophytes are the fungi most commonly responsible for onychomycosis [13]. The most common dermatophyte species that causes onychomycosis infections is Trichophyton rubrum [15].

Onychomycosis can be picked up form the outside environment in a number of ways, but some of the most common factors that can lead to a infection include: an injury to the nail or skin near the nail, getting a manicure or pedicure with utensils that have been exposed to an infective fungi, having moist skin for a long time (for example, wearing closed-in shoes for an extended period of time), walking around in moist environments that harbor the fungi (for example, a gym locker-room) or having a nail deformity or disease. Essentially, fungi prefer warm, moist environments. Therefore, lengthy exposure of the nail to these conditions can increase one’s chances of picking up a fungal infection from the outside environment.

An onychomycosis infection begins as a small, white spot of fungi underneath the fingernail or toenail, typically in a region of the nail called the hyponychium. This is the part of the nail immediately under the nail plate but above the nail bed that is located at the tip of the finger or toe, and is the most common location for initial nail infection. The fungi responsible for causing onychomycosis reproduce and increase in numbers by making copies of itself – a process called clonal reproduction [15]. This process can happen very quickly. As the fungal infection multiplies, it can invade deeper layers of the nail, and can eventually involve virtually any part of the nail anatomy, including the matrix, nail bed or nail plate. The extent of infection can vary greatly from individual to individual.

3. How Topical Treatments Work

Topical drugs are the usual course of action of treatment of Onycomycosis because drugs can travel between cells via intercellular channels, and there exist a diverse array of topical treatments available both on the market and over the counter. Depending on the extent of the infection, these treatments must penetrate the nail and even the nail bed and matrix in order to reach the infection.

Topical treatments are treatments that are applied directly to the nail, and then soak through the nail into the nail bed and matrix. Thus, the ability of a drug to get through the nail is of utmost importance. The nail is made up of both fat-like (“lipid”) and water-like elements. Intercellular lipids are part of the barrier system of the skin; thus, it is not surprising that the stratum corneum (SC) contains a large amount of intercellular lipids. These lipids are found in extracellular space between corneocytes. It is generally accepted that these lipids play a key role in limiting the diffusion of topical onychomycosis treatments through the SC. This was a problem originally in the development of treatments for onychomycosis, as most topical fungal treatments were originally designed for non-nail application; thus, they were lipophilic and not suitable for topical application to the nail.

What are lipids? Lipids are fat molecules that have a polar head and two non-polar tails. The polarity in the head results from a molecular interaction between oppositely charged phosphate and nitrogen groups. This results in one side of the molecule being hydrophilic, or water loving, while the other side of the molecule is hydrophobic, or water hating. These molecules can bind together based on their water-hating and water-loving properties to form chains of lipids called membranes. The polar, water-soluble heads of the membrane point toward the water on the inside and outside of the cell, while the non-polar, fatty-acid tails point away from water and toward the interior of the membrane. The resulting bi-layer of lipid molecules thus contains an oily inner core. This core functions as a selective barrier that prevents water-soluble substances from moving past them.

The nail itself is comprised of approximately 7-12% water [4], and its many layers of dense, flattened keratin are considered hydrophilic (water-loving) [16, 17]. Water-soluble treatments, therefore, are much more effective as topicals than are lipid-soluble treatments, given the water-loving properties of the nail. In fact, the nail has been found to be more permeable to water than skin is [17]. Given the fact that keratin forms a hard, compressed covering over the tip of the finger, how exactly do topical treatments that are water-based get through the nail into the nail bed? There exist water-filled channels or pores spanning the membrane through which these substances diffuse.

Some exceptions to the water-fat rule do apply. For example, Vitamin E is a fat-soluble vitamin. Although it can be “water solubilized” in the lab to help its absorption through the intestinal wall, once it is absorbed into the body it would appear to behave as a fat-soluble vitamin does. Thus, the properties of some treatments must be studied carefully to determine how they will interact with the nail anatomy when applied topically, rather than orally.

REFERENCES

[1] https://en.wikipedia.org/wiki/Stratum_corneum
[2] https://en.wikipedia.org/wiki/Corneocyte
[3-ed was 12] https://en.wikipedia.org/wiki/Nail_matrix
[4] https://en.wikipedia.org/wiki/Nail_plate
[5] https://en.wikipedia.org/wiki/Nail_bed
[6] https://en.wikipedia.org/wiki/Nail_matrix
[7] https://en.wikipedia.org/wiki/Keratin
[8] https://www.nyscc.org/cosmetiscope/archive/tech1101.html
[9] https://www.ncbi.nlm.nih.gov/pubmed/10344627
[10] https://www.ijdvl.com/article.asp?issn=0378-6323;year=2012;volume=78;issue=3;spage=263;epage=270;aulast=Grover
[11] https://en.wikipedia.org/wiki/Keratinocyte
[3] K. A. WALTERS and G. L. FLYNN, Permeability characteristics of the human nail plate, International Journal of Cosmetic Science 5, 231-246 (1983)
[12] https://www.cosmeticsandtoiletries.com/research/biology/130232783.html
[13] https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0002306/
[14] https://www.mayoclinic.com/health/nail-fungus/DS00084
[15] https://jcm.asm.org/content/37/11/3713.abstract
[16] https://www.anacor.com/pdf/Exp%20Opin%20%20Investig%20%20Drugs.pdf
[17] https://deepblue.lib.umich.edu/bitstream/2027.42/72442/1/j.1467-2494.1983.tb00348.x.pdf

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The two types of medical treatment are topical, medication applied directly to the affected nail or nails, or oral, taking medicine by mouth so it will get to the nail via the bloodstream. Oral medications usually have to be taken for 12 weeks, and achieve a “cure” from 60% to 75% of the time. However, these drugs have side effects including the potential for liver damage. Recurrence is common, from 10% to 50% of the time. Recurrence may be less likely if topical medicine is used on the nails; using both oral and topical medication may also improve the chance of eliminating the infection.

Oral medications are not able to actually kill all the fungus in infected nails, even if they can in the laboratory. The same thing can be said about topical medications. One idea is to combine the two to kill as many fungi as possible. For toenails, this must always be done along with cutting off as much infected nail as possible.

There are no FDA approved over-the-counter treatments available in the United States. There are creams made to treat athlete’s foot (a fungal infection of the skin) that can be used on toenails with varying success. These included Lamisil® (terbinafine), Nizoral® (ketoconazole), Mycelex® (clotrimazole), and Naftin® (naftifine), which are available without a prescription as well as with a prescription. The prescription medications are usually stronger. There are a couple of choices of topical medications FDA approved for fungal infection of the nails in the United States. These include ciclopirox lacquer (Penlac®) and tolnaftate 1% solution (called Formula 3).

A medicine used in many other parts of the world for the last 20 years is called amorolfine (trade name Loceryl®). It seems to be as safe and effective, if not more so, than the topical medications approved for use here. However, it is not FDA approved, and cannot be acquired in the United States or Canada. There are studies of its effectiveness and safety available because it is in use in Europe, the UK, and other places such as Australia. It can be ordered from other parts of the world.

Amorolfine is a different class of antifungal medication than the other topical drugs. It is active against essentially all the main classes of fungus that infect nails. Fungi called dermatophytes (meaning they like skin and skin structures like nails) are the most common causes of the infection. There are a few other fungi and mold that can cause onychomycosis and amorolfine can kill or stop these from growing in a laboratory setting. It works by damaging the membrane around the fungal cells. This kills dermatophytes like Trichophyton rubrum, the most common fungus involved. However, it does not always kill all the fungus in nails because it is very hard for it to reach every area of infection.

Amorolfine seems to be free of any serious side effects. At the beginning of treatment, some people (less than 1 in 10,000) develop some redness and/or burning that lasts only a few minutes. Usually this irritation stops happening after a number of applications. If the nail begins to separate from its base, it should be rechecked by the doctor. A tiny minority of people may develop an allergic reaction to the medication, which could cause itching and redness that do not go away quickly. Anyone with a true allergy to amorolfine cannot use it. But this is very unlikely. As of 2010, there had been so few allergic reactions that the company making Loceryl could not even estimate how often it happens.

Amorolfine comes as both a cream and a lacquer. A higher concentration of amorolfine (5%) works better than 2%. When used as a lacquer, the medication is applied to the entire nail. The lacquer does not dissolve in water, so it stays intact on the nail plate. It continues to release its medication over the site for a week at concentrations high enough to kill or damage the fungus. It does not seem to be absorbed into the system at those levels.

Amorolfine is able to get into the nails and areas under the nails. Sometimes, treatment with this alone has achieved clinical cures. A number of trials have yielded results for amorolfine that are as good or better than other topical treatment. In one such trial, after application of the 5% nail lacquer once or twice weekly for up to 6 months, 40–55% of patients with mild fungal nail infections were considered “cured” 3 months after treatment was stopped. Some experts believe amorolfine is the most effective topical agent.

In another study, testing the effect of amorolfine lacquer on infected big toenail material placed in humidified soil showed that the lacquer got rid of fungal growth in the majority of the nails. Experts believe that amorolfine may also be able to prevent fungi from attaching to the nail.

Combination therapy using amorolfine along with an oral medication has been found to be more successful than oral medication alone. Amorolfine attacks fungus in a synergistic way along with oral medications. This means that they work together to increase the cure rates because each attacks the fungal cell membrane in a different way. It should be possible to get better results more quickly, and lowering the amount of the oral agents should reduce their toxic side effects.

One study looked at using amorolfine with griseofulvin, one of the first oral medications for onychomycosis. Patients were either give griseofulvin for a year (standard treatment at the time) or 2 months of the oral medication along with amorolfine lacquer for 12 months. After 6 months, twice as many of the patients getting the combination were considered cured than those getting griseofulvin alone. Similar results have been obtained using amorolfine along with and after other oral medications, such as itraconazole.

Many experts believe the combination treatment is better, and that continuing the topical amorolfine after oral therapy can prevent recurrence.

Why is this medication not available in the USA or Canada? There is no obvious reason. A Swiss company applied to the FDA a number of years ago, but there is no evidence that any action was taken based on this application. All that can be found on the FDA website is that on 11/19/2002, SIEGFRIED LTD, was on a list of medications, which said, “AMOROLFINE HYDROCHLORIDE AS MANUFACTURED IN ZOFINGEN, SWITZERLAND.” Its status was listed as A II. The document containing this information is called “Development Approval Process /Forms, Submission Requirements/ DrugMasterFiles.” There is no other information available.

Amorolfine is safe and effective and used in many areas of the world. If you travel to another country, you may be able to get it there. It can also be ordered from online pharmacies, but not in Canada. Trade names include Curanail®, Locetar®, and Odenil®, in addition to Loceryl®. In most of Europe you need a prescription. In the UK and Australia it is now available over the counter. There does not appear to be any good reason not to use it.

References

Campbell, A.W., Anyanwu, E.C., Morad, M. Evaluation of the Drug Treatment and Persistence of Onychomycosis. TheScientificWorldJOURNAL 2004; 4: 760–777.

Choi, Sola. Manual of Dermatologic Therapeutics. Chapter 14. Dermatophyte Infections. Onychomycosis. Pages 87-90. 2007. Lippincott Williams & Wilkins. Philadelphia.

Flagothier, C., Piérard-Franchimont, C., Piérard G.E. New insights into the effect of amorolfine nail lacquer. Mycoses 2005; 48: 91–94.

Olafsson, J.H., Sigurgeirsson, B., Baran, R. Combination therapy for onychomycosis. British Journal of Dermatology 2003; 149 (Suppl. 65): 15–18.

Pittrof, F., Gerhards, J., Erni, W., and Klecak, G. Loceryl nail lacquer—realization of a new galenical approach to onychomycosis therapy. Clin. Exp. Dermatol 1992; 17(Suppl. 1): 26–28.

Roberts, D.T., Taylor, W.D., Boyle, J. Guidelines for treatment of onychomycosis. British Journal of Dermatology 2003; 148: 402–410.

The Merck Manual for Health Care Professionals. Onychomycosis. Last revision October 2009.

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A normally functioning immune system is typically capable of fighting an infection and controlling it, perhaps with the aid of a medication. At some point during a person’s lifetime they may experience a suppression of the immune system for one reason or another, which then allows the dormant fungus to become active causing health complications.

Onychomycosis, or nail fungus, is a gateway for fungus to cross the skin barrier. Normal health tissue is able to prevent invasion by dermatophytes or other harmful organisms, but if it is weak or compromised it opens up opportunities for the organisms to infect other areas of the body. For those that have a weak immune system a fungal infection can lead to pneumonia, septicemia and permanent organ, lung, or bone damage. In worst case scenarios, a seemingly simple nail infection can lead to death.

When the nails of an individual are infected, there is the risk that scratching the skin can inadvertently introduce the fungus into the tissue and blood stream. Scratching too hard, or accidentally scratching that annoying bug bite can have a strong health consequence.

Another big worry is that fungal infections take a long time to grow, and as such, they also take a long time to heal. This healing process is further compromised when the immune system is not functioning correctly. A longer period of recuperation means there is additional time given to opportunistic organisms to invade the body, creating secondary infections and further complicating the body’s ability to mend. Keep in mind the full period of recovery from toenail fungus for a healthy individual is 12 to 18 months, in immunocompromised persons this time is doubled.

Anyone who has an infection should be assessed by a health care provider, this is especially important for those who are immunosuppressed. The medical treatment plan should be followed carefully and until completed in full. It is often the desire of individuals to stop treatment early because they are feeling better or notice results, this is a very poor idea. The therapy required to clear a fungal infection from the body can take over a year in some cases, but is essential to limiting the negative health effects that can occur.

There are a number of different treatment options that have become available to people. Oral prescriptions and topical treatments such as lacquers, oils, and creams have been developed by pharmaceutical companies. There are also a number of natural home remedies that have gained favor with the medical profession. Once you have been diagnosed with a fungal infection discuss your treatment preferences with your medical provider to best create a plan that you will be willing to comply with. Also become familiar with how to avoid onychomycosis.

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Fungal infections of the toenails are much more common than infections of the fingernails. It has been estimated that anywhere between 2 and 14% of adults have onychomycosis, and as people age, they are also more likely to have the infection. It is more likely to occur to the nails of people under a number of circumstances, including those who have had:

• Nail trauma
• A depressed immune system, such as after chemotherapy, HIV infection, or certain immunosuppressant medications
• Diabetes mellitus (as many as 26% of diabetics have onychomycosis)
• Poor circulation in the legs and feet
• Difficulty cutting their toenails correctly

Onychomycosis is not dangerous. The affected nails become thick and difficult to cut. People with affected toenails may experience discomfort. This is especially true for the big first toenail. The pressure of shoes on it can be painful. Affected nails can get caught on clothing. There is a definite cosmetic problem with onychomycosis, especially of the fingernails. Most people want to get rid of the infection and make the nails appear more normal.

Fortunately, there are a few good or guaranteed ways to treat onychomycosis and a few treatments to avoid. This is not for lack of trying. Medical doctors as well as homeopaths and people experiencing the problem have all tried many different ways to get rid of the fungus. While no one has found a perfect cure all,  there are a few treatments that are worth trying as the results are promising.

Most of the fungi that cause nail infections are called dermatophytes, meaning that they like to grow in the skin. Candida, commonly called yeast, can also cause onychomycosis.

The appearance of an involved nail depends on where the infection begins. Most of the time, fungus gets into the sides or end of the nail. This results in a thickened and yellowed nail with debris underneath that most people recognize as a fungal infection. It can also penetrate from straight above the nail, which causes a superficial white, powdery appearance. Fungus can get into the nail from where it begins, especially in people with depressed immune systems. In these cases the entire nail will grow out with fungus in it. The more of the nail that is involved, the harder it is to treat.

Diagnosis of Onychomycosis

Before starting any treatment for this condition, you want to make sure that you are diagnosed properly. Other things can look like onychomycosis, including but not limited to nail damage as well as the changes in nails seen in people with psoriasis. Ideally you should see a doctor, and the doctor should take a sample of the nail and the debris beneath to look at under a microscope and to send for culture. Sometimes the microscopic examination and culture have to be done twice to get a definite diagnosis. You should be positive of the fungal infection before you start on any oral medication, if that is what you decide to do.

If you want to try over-the-counter medication or home remedies first, if they aren’t dangerous, there is not much risk. However, since there are other conditions associated with abnormal nails, if you don’t see a doctor, you might be delaying the diagnosis of some other illness.

Treatment of Onychomycosis

All treatment of onychomycosis, whether traditional or alternative, in a doctor’s office or at home, using medicines or surgical techniques, is less successful than treatment of other fungal infections, for example, in the skin. The fungus seems to be quite successful at living in and around nails.

Before specific treatment of onychomycosis of the feet begins, there must be a general assessment of the feet. Tinea pedis or “athlete’s foot” should be treated with an antifungal cream. This can be obtained over the counter or as a prescription. Lamisil® (terbinafine), Nizoral® (ketoconazole), Mycelex® (clotrimazole), Naftin® (naftifine), Loprox® (ciclopirox olamine) and others, including generic formulations are all effective. Calluses should be smoothed and moisturizer applied to any dry, cracked skin. Toenails should be kept short.

The feet need to be kept dry. This means thoroughly drying feet and toes after bathing. Absorbent cotton socks should be worn and changed when wet.

If it is suspected that a common shower is the source of the infection, for example, at a college dormitory, flip flops or other sandals can be worn into the shower. The feet showed by washed thoroughly with soap, dried, and the above suggestions continued. Towels and bath mats must be washed frequently in warm water.

If family members have tinea pedis, they should also be treated.

Any treatable underlying problem, such as diabetes, needs to be controlled as well as possible.

Fungal fingernail infections are associated with different problems. There can be fungal infection of the skin of the hands, which should be treated. People with fungal fingernail infections often have wet hands a lot of the time. This can be work related or due to many activities at home, from doing the dishes to keeping the bathrooms clean. White cotton gloves can be worn under rubber gloves when cleaning.

If damage has been done to fingernails due to artificial nail application or other materials, it is possible that there is more than just a fungal infection present. It is harder to be sure of a diagnosis of onychomycosis of the fingernails than toenails. A visit to the doctor is probably a good idea.

Treatment by a Physician

Treatment must begin by making sure the hands and/or feet are being taken care of properly, as mentioned above. A primary care doctor, or podiatrist (foot specialist) or dermatologist (skin specialist) may be able to help with this, depending on what the person needs to have done, what the person expects, and what the experience of the physician is.

Usually in the case of fungal infection of the toenails, trimming and removing extra thick toenail material is the first thing that needs to be done. Sometimes the nails are so thick and hard that it is virtually impossible for a person to trim them at home. Doctors have special instruments that enable them to cut off more. Podiatrists have burrs, which are kind of like sanders and can file down the nails.

For some people, getting the nails trimmed and back to something like a normal size and shape may be all the treatment that is needed. They may just need regular visits to keep the nails trimmed. This is especially important for people with diabetes, poor circulation, and elderly people with bad vision. The feet and nails can become a source of serious bacterial infections if they are not taken care of.

There are no studies to show what the natural history of onychomycosis is. Does it always spread? It does not seem to cause any serious problems. So for some people, nail trimming and reassurance is all that is necessary.

All treatments attempt to kill the fungus and allow uninfected nail to grow out. It takes approximately 6 months for fingernails to completely regrow, 12 months for toenails to grow out, and 18 months for the great toenail to grow out. A person cannot know if the fungal infection has been cured for that amount of time.

Topical Medications

It seems reasonable to try to treat toenail infections with the same type of antifungal medications used on the skin. The only topical medicine approved for use in the United States is ciclopirox olamine 8% (Penlac) which is a lacquer. There are other medications available in other countries.
Penlac needs to be put on the surface of the entire nail and the skin around it every day. Once a week, it is removed along with debris and unattached nail.

Naftin, Lamisil, and Loprox creams may also be used for onychomycosis. There have only been small studies done using these creams. There are topical medications available in other countries that may at some point become available in the United States.

The use of urea cream may help any topical medication penetrate the nail. Urea can also dissolve the toenail.

There is very little chance of an actual cure with topical preparations. They must also be used for months to years. However, if a podiatrist or doctor can significantly trim and pare down the thickened nail, and topical treatment is used, the cosmetic result may be satisfactory for some people. Podiatrists may also drill a hole in the nail to allow medication to get underneath. This is not as painful as it sounds.

Topical treatment may be the only choice for anyone who cannot take oral medications for fungus.

Surgery

As described above, trimming the nail and removing debris should be part of all onychomycosis treatment. It was believed that removal of a nail at the beginning of therapy, especially the big toenail, might increase the chance of a cure. This is no longer done routinely. It is only done when everything else fails and the nail is creating a significant problem because of its shape and size.

Oral Medication

At one time it was thought that oral medication might be the answer to the problem of onychomycosis. Getting anti-fungal medicine into the bloodstream would deliver it to the base of the nail, and under the nail, making sure to kill all the infection. However, oral medicines do not work as well as expected, and their side effect profile may make the cure worse than the disease. It depends on the severity of the fungal infection, other medical problems that underlie the condition, and the medication itself.

The most commonly used oral medication, and the treatment of choice for onychomycosis is terbenafine (Lamisil®). This medication has been proved to kill most of the fungal organisms that infect nails in the laboratory as well as in actual patients. The dose is 250 mg a day for six weeks to treat fingernails, and 12 to 16 weeks to treat toenails.

Common side effects of terbenafine therapy include headache, rash, and upset stomach. Serious side effects occur in less than 1% of patients, including severe rash and reduction in white blood cells. The most worrisome side effect is liver damage, which is usually mild and reversible. Liver abnormalities that are enough to cause symptoms only happen in approximately one out of 50,000 exposures, with complete liver failure much less common than that. However, anyone with liver disease cannot take terbenafine. Liver function tests should be done before beginning therapy. Many doctors repeat these tests after 4 to 6 weeks. About 3.4% of patients who take terbinafine stop the medication because of side effects.

Itraconazole (Sporonox®) is also used. 200 mg a day can be given for 12 weeks to treat a toenail infection. There is also “pulse therapy.” This means giving 200 mg twice a day for one week out of a month, for two months to treat fingernails and three months to treat toenails. 5% to 10% of patients develop nausea, vomiting and/or liver damage. Sporonox can also cause congestive heart failure; patients with existing heart failure cannot take it. In general, there are fewer side effects with pulse therapy than daily therapy. However, even with pulse therapy there can be liver damage bad enough to necessitate a liver transplant.

Fluconazole has also been used to treat onychomycosis. It only needs to be taken once a week, for a total of 3 months for fingernails or 6 months for toenails. It does not work as well as terbinafine or itraconazole.

Whether or not any of these treatments have cured the fungal infection is never known for many months, until the fingernails or toenails have grown out. Terbenafine had a higher cure rate than itraconazole. The outcome can be measured by appearance of the nail or absence of fungal elements. The “cure” rates have been measured as low as 50%, and as high as 80%. Even when the fungi are gone, the nail may not appear completely normal because of some other underlying problem or damage to the nail bed. There are also frequent relapses. The use of creams applied to the nails after oral therapy may help prevent relapse.

The cost of this treatment is high. It is estimated that the cost to cure onychomycosis with terbinafine is from $2,500 to $8,000. There is still a 30% chance of recurrence after a cure.

Alternative Treatments and Home Remedies

Considering the cost, side effects, and low success rate of prescription medication, looking for alternative treatments seems very reasonable. Some alternatives have been mentioned in terms of general care of the skin and nails.

One herbal remedy that seems to be very successful in treating onychomycosis is tea tree oil. Tea tree oil has been studied for a number of skin problems and is already available as a prescription medication for genital warts. Tea tree oil can kill the fungi that cause nail infections in the laboratory setting. There have been some small clinical trials of tea tree oil in treating nail fungus that show promise, although rigorous, large scientific studies have not been published.

In one trial, a combination of a known antifungal (butenafine hydrochloride) together with tea tree oil was used in a randomized, double-blind study in 60 patients with fungal infection of toenails. Treatment included the cream as well as clipping and removing as much toenail as possible, for 8 weeks. At 16 weeks, 80% of participants given the active ingredients were said to be cured, in that their symptoms were better and involved toenail removed. The placebo in this case was tea tree oil, which did not cure any patients. This is an example of a possible way tea tree oil might be used along with another local cream but not by itself.

Other home remedies have included soaking the nails in vinegar, or water with baking soda, strong tea, and bleach. Bleach application can be dangerous. The bleach would have to be diluted to avoid chemical burns. When these home remedies are used along with care of the nail, such as cutting it correctly and removing debris, they may improve the appearance of onychomycosis. Tea tree oil is a home remedy at the current time; it may become a prescribed medication in the future. Any promising home remedy can interest doctors and researchers enough to look into it further.

Tea tree oil taken orally is also considered an alternative treatment for onychomycosis, but there is little evidence at this time that drinking tea tree oil does anything to cure the fungal infection.

There are 2 alternative treatments whose active ingrediants contain tea tree oil, Zetaclear & Funginix.

New Treatments for Onychomycosis

Doctors continue to look for a good way to cure onychomycosis. Studies have been done using photodynamic therapy. This is a way of using light to cure the infection. Doctors recently reported successful treatment of two patients. The affected toenails of the patients were pretreated with a substance called 5-aminolevulinic acid (ALA). They were also pretreated with urea, and the involved nails were covered with plastic film and aluminum foil to shut out light. Before treatment, the area was uncovered and light was used to make sure the ALA had penetrated the nail. A pulsed laser light was then used to treat the involved nail. The treatment was slightly painful for about a day. Treatment was repeated once a week for 6 to 7 treatments. At the end of treatment, the nails appeared cured. No fungi could be grown from the nails. Reevaluation at 3 to 6 months still showed apparently normal nails.

There are many different ways of delivering heat or light to infected nails. There are a number of different lasers capable of treating nail fungus. One is called the “Noveon.” It is a dual-wavelength, near-infrared diode laser. This particular wavelength kills fungi without damaging normal tissue. In one recent controlled study, 26 infected toes were treated. Treatment took place on days 1, 14, 42 and 120. All were followed for at least 180 days. 85% were judged improved because of clear nail growth. This study was done to make sure the treatment was both safe and effective. There are other laser systems under investigation.

Many laser systems are being tested or will be tested to see if they can help cure or control onychomycosis, and it appears that some of them will. Laser treatment will probably not completely cure the infection but help control it, and may be useful along with other therapies. Plastic (cosmetic) surgeons often possess a wide variety of lasers and devices that deliver heat or energy. It is likely that the best type of laser treatment will be found in the relatively near future. However, this treatment will always be expensive.

While some will be looking at lasers and other possible oral medications, other researchers will continue to evaluate herbal remedies and home remedies to look for safe and inexpensive treatment for onychomycosis.

References

Roberts DT, Taylor WD, Boyle J. Guidelines for treatment of onychomycosis. British Journal of Dermatology 2003; 148: 402–410.

De Berker D. Fungal Nail Disease. New England Journal of Medicine 2009; 360: 2108-16.

Choi S. Fungal Infections. Manual of Dermatologic Therapeutics 7th edition. 2007. Arndt KA, Hsu JTS, editors. Lippincott Williams & Williams. Philadelphia, PA 2007.

Elizabeth T, Meireles F, Gadelha Rocha MF, et al. Successive Mycological Nail Tests for Onychomycosis: A Strategy to Improve Diagnosis Efficiency. The Brazilian Journal of Infectious Diseases 2008; 12(4):333-337.

Syed TA, Qureshi ZA, Ali SM, et al. Treatment of toenail onychomycosis with 2% butenafine and 5% Melaleuca alternifolia (tea tree) oil in cream. Tropical Medicine and International Health 1999; 4(4): 284-287.

Martin KW, Ernst E. Herbal medicines for treatment of fungal infections: a systematic review of controlled clinical trials. Mycoses 2004; 47: 87–92.

Rehbock, D. Common Nail Conditions that are treated by the podiatrist. SA Pharmaceutical Journal – January/February 2009: 32-36.

Watanabe D, Kawamura C, Masuda Y, et al. Successful Treatment of Toenail Onychomycosis With Photodynamic Therapy. Archives of Dermatology 2008; 144(1).

Landsman AS, Robbins AH, Angelini PF, et al. Treatment of Mild, Moderate, and Severe Onychomycosis Using 870- and 930-nm Light Exposure. Journal of the American Podiatric Medical Association 2010; 100(3).

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The days of onychomycosis being considered simply a cosmetic problem are over. Nail fungus is certainly unpleasing to the eye but it can be much more than that. The emotional and social impact of onychomycosis can be significant. Those afflicted with onychomycosis avoid public places and social functions. They avoid touching friends and loved ones with affected hands which can lead to real interpersonal conflict.

Beyond the psychological suffering associated with onychomycosis, the nails of the fingers and toes provide normally provide protection against trauma. The nails contribute to the way in which we sense the world. Nails affected by onychomycosis can be painful and interfere with sensation and walking. In addition, a fungal infection of the hands and feet may lead to a process called a superinfection in which bacteria and viruses also invade and infect the tissue on top of the fungal infection.

Because of these symptoms and complications, physicians are treating onychomycosis more aggressively than they once did. Patients are increasingly requesting onychomycosis treatment from doctors as well, whether it is topical, oral, or even surgical.

Medical prescription treatments for onychomycosis fall into two main categories: oral and topical (placed directly on the infected nail). The decision to use one or the other treatment is dependent on several factors. If the lunula is involved in either distal subungual onychomycosis or proximal subungal onychomycosis, than an oral agent is the only way to eradicate the disease. Patient preference factors into the decision, too. In many cases, a combination of oral and topical drugs is prescribed because this leads to a more rapid clearance of the infection and full eradication of the onychomycosis, in general.
Despite psychological and physical discomfort, oral prescription treatment of onychomycosis should not be entered into lightly. All antimycotic (antifungal) treatments used for onychomycosis have the potential to damage the liver. In fact, if the patient has any history of liver disease whatsoever, oral prescription treatment for onychomycosis should not be used. Even without a history of liver disease, it is usually recommended that the treating physician check liver enzymes before starting oral antifungal onychomycosis treatment. For some treatments, liver function should be checked again after four weeks. Also any sign of liver disease such as jaundice (yellow skin or whites of the eyes), dark urine, pale colored stools, upper abdominal pain, fatigue or malaise should be reported to the doctor immediately.

Historically, Griseofulvin was the only oral treatment for onychomycosis. While it worked reasonably well (not great) it was associated with a lot of side effects, especially at moderately high doses. Griseofulvin also required long treatment courses and the disease would often come back once the drug was stopped. Fortunately there are newer, more effective oral antifungal onychomycosis treatments. In fact, there are three main prescriptions in use today.

Terbinafine, also known as Lamisil, is very good against onychomycosis caused by dermatophytes, which most cases are. Terbinafine is given as a 250 mg pill once a day for six weeks if treating fingernails and twelve weeks if treating toenails. Pulse therapy has been effective in some cases. Pulse therapy delivers a higher Lamisil dose but separated by times that no drug is administered. A complete blood count and liver function tests should be performed before treatment is started and after four weeks of therapy.
Itraconazole (Sporanox) is usually administered in pulse dosing. The most common treatment schedule is 200 mg orally once a day for one week per month over three months. Itraconazole can interact with a number of other medications so you must tell your doctor about all of your medications, both prescription and over-the-counter. Liver function tests should be performed before treatment is started and after four weeks of therapy
Fluconazole (Diflucan) is administered once per week (150 or 300 mg) until the symptoms resolve. Treatment may be six to nine months long before results are seen. This antifungal may interact with several other medications and must be used judiciously. Fortunately no blood tests are required when using fluconazole (though they may be performed anyway).
Topical prescription onychomycosis treatments are of limited usefulness and are usually combined with oral or surgical treatments. One of the more effective topical prescription products is ciclopirox (Penlac). This 8% topical solution is applied once a day, usually at night. While it is safer than oral antimycotics, complete cure was achieved in about 5% of those treated with ciclopirox alone.
In cases where prescription treatments for onychomycosis fail, there are a number of surgical options. They fall into three broad categories: chemical, mechanical, or surgical nail avulsion. A concentrated solution of urea (~50%) can remove the fungus and even a very thick nail. This approach is painless and can be quite effective. The nail can be mechanically or surgically avulsed (forcibly torn away) which may require local anesthesia because of the pain caused by the procedure. In people with severe disease, however, the nail may already be pulled away from the finger and avulsion is therefore less painful than it would be in the nail’s natural state. Avulsion is rarely painless, however, which should be considered in your treatment decisions. Also the finger or toe is left without a nail for a period of time after removal.

References
Ciclopirox (Penlac) prescribing information
Fluconazole (Diflucan) prescribing information
Itraconazole (Sporanox) prescribing information
Terbinafine (Lamisil) prescribing information

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Onychomycosis is generally a disease of older patients with most cases occurring in patients older than the age of 40. It is 30 times more likely for the disease to occur in adults that in children. Onychomycosis is very common and becomes more prevalent as people age. About 20 percent of all people between age 40 and 60 have onychomycosis. In fact, it has been estimated that as many as 90% of elderly patients have the disease.

Onychomycosis tends to occur more often in men than in women; however women are more likely to have an infection of a specific type of fungus called Candida. The disease occurs equally across all races.
Doctors have noticed that the number of cases of onychomycosis has been increasing over the past few decades. One major reason for this trend is that people are living longer lives. Since onychomycosis is extremely common in older people, an increasingly older population brings more cases of the illness.

As people are living longer, they are also dealing with chronic medical conditions that increase the likelihood of contracting onychomycosis. For example, diabetes is quite prevalent and we know that diabetes leads to problems with wound healing and increased susceptibility to certain infections.

Poor peripheral circulation, a problem for many people in Western countries, leads to poor wound healing, too. Poor circulation in the legs and feet is thought to provide an ideal situation for fungal infections since the immune system is less able to defend the body.

A fungal infection of the nails does not usually cause any symptoms, especially at first. By far the most common complaint from people that have onychomycosis is the way that the nail looks. The disease leaves the nail looking unappealing. Onychomycosis often disfigures the nail.

This cosmetic affect should not be dismissed—people often avoid social interactions because of the significant embarrassment and shame that a nail fungus can cause. Patients and associates may worry that the fungus is infectious or that the diseased nail means that the afflicted person is unhealthy or unclean. The psychological, emotional, and social impact can be surprisingly profound.
While the disease may start as purely cosmetic, over time onychomycosis may cause pain in the affected finger or toe. Because the nail can become thick, patients report that they cannot feel things like they normally would. In the hands, this lack of sensation leads to problems with writing and other daily activities. In the feet, people may have trouble sensing the floor which causes them to stumble or fall. This is a particular problem in patients with diabetes and peripheral vascular disease—diseases that already cause problems with the nerves of the legs.
There are four main types of onychomycosis: distal subungual onychomycosis, proximal subungual onychomycosis, white superficial onychomycosis, and candida onychomycosis. Distal subungual onychomycosis is the most common form of onychomycosis and is usually caused by a dermatophyte called Trichophyton rubrum. This dermatophyte invades the nail plate and nail bed. The term subungual means under the nail so in distal subungual onychomycosis, the infection the infection can be seen as a white-yellow growth under and on the nail, usually towards the tip. From the tip of the finger or toe, the infection can move under the nail toward the cuticle. The nail can become pitted and folded and yellow streaks can appear in the nail.
In proximal subungual onychomycosis, the onychomycosis is again under the nail, but the infection starts at the near the base of the nail at the cuticle side. The infection moves toward the tip as the nail grows. Proximal subungual onychomycosis is the least common cause of onychomycosis in healthy people though it is fairly common in patients that have immune system deficiencies. Proximal subungual onychomycosis is most often caused by Trichophyton rubrum, but can also be caused by molds and other fungi.
White superficial onychomycosis is found in only one out of ten cases of onychomycosis. This fungal infection occurs on top or in the topmost layers of the nail. As expected by the name, the lesion in this type of onychomycosis is white and forms islands on fungus on the nail. The disease can spread and cover the entire nail plate. In contrast to the other types of onychomycosis, white superficial onychomycosis is usually caused by Trichophyton mentagrophytes, another dermatophyte.

Candida onychomycosis, the fourth form, usually begins as a chronic mucocutaneous candiasis. Chronic mucocutaneous candiasis is a long-lasting yeast infection of the skin. The yeast is called Candida (usually Candida albicans). While the other infections stay primarily on or in the nail, Candida onychomycosis often causes infection of the skin around the nail, in the proximal and lateral nail folds. Several nails are affected in Candida onychomycosis and the nails can be virtually or literally destroyed by this serious fungal infection.

References
Hainer BL. Dermatophyte infections. Am Fam Physician 2003;67:101-108.
Jaffe R. Onychomycosis: recognition, diagnosis, and management. Arch Fam Med 1998;7:587-592.
Kaur R, Kashyap B, Bhalla P. Onychomycosis–epidemiology, diagnosis and management. Indian J Med Microbiol 2008;26:108-116.

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Proximal subungual onychomycosis can cause a number of visible changes in the fingernail or toenail. In this disease, the nail plate becomes white and/or yellow near the cuticle. The distal portion of the nail (near the tip of the finger) is usually unaffected by the disease. This is especially true early in the course of proximal subungual onychomycosis. The fungus invades the nail rather deeply and can cause the nail bed (the soft fleshy area underneath the hard nail) to become bumpy and irregular. The nail near the cuticle is often destroyed as part of the disease process. As the nail grows it may have folds and pits. The combination of an irregular nail bed and misshapen nail plate may cause the nail to become loose.

Like distal subungual onychomycosis, most cases of proximal subungual onychomycosis are caused by a dermatophyte called Trichophyton rubrum. Another dermatophyte, Trichophyton mentagrophytes may be to blame in some case. Proximal subungual onychomycosis is sometimes caused by the invasion of molds.
Another curious feature of proximal subungual onychomycosis is that the skin surrounding the nail may become red, inflamed, and swollen. This is especially true if the disease is caused by molds. The nail and surrounding area may ooze pus in proximal subungual onychomycosis.

The inflammation and pus are what cause many physicians to incorrectly diagnose proximal subungual onychomycosis as a bacterial infection rather than a fungal infection. This can be a problem if antibiotics are prescribed since antibiotics do not kill fungi. An antifungal medication is required to kill dermatophytes, molds, and yeasts.

Proximal subungual onychomycosis is a fairly uncommon form of onychomycosis. It occurs most often in people with depressed or deficient immune systems. A person may have a depressed immune system due to certain blood cancers or because they are undergoing treatment for cancer like chemotherapy or radiation. Any immunosuppressive treatment can depress the immune system, by definition. Patients may be on an immunosuppressant if they are being treated for an autoimmune disease or have had an organ transplant and are on anti-rejection drugs.

While proximal subungual onychomycosis can occur in any of these patient groups, it seems to occur particularly frequently in patients with human immunodeficiency virus or HIV. In fact, it occurs in this patient population so frequently that when proximal subungual onychomycosis occurs in a patient without an obvious reason for a suppressed immune system, the treating physician may suggest a test to check for HIV. If you are seeking treatment for a fungal infection of the fingernail or toenail that has started at the cuticle side of the nail, be prepared to be asked to have an HIV test. This test can only be performed with your consent. Also keep in mind that a diagnosis of proximal subungual onychomycosis does not necessarily mean that you have a diagnosis of HIV.

Unlike some other onychomycoses, proximal subungual onychomycosis simply must be treated with an oral antifungal medicine in order to eradicate the problem. There are a number of possible oral onychomycosis treatments, however they are only available by prescription in United States. Topical medications are completely ineffective in treating proximal subungual onychomycosis.

If the proximal subungual onychomycosis is known to be caused by Trichophyton rubrum or Trichophyton mentagrophytes, then a good treatment choice is terbinafine, also known as Lamisil. Terbinafine is given as a 250 mg pill once a day for six weeks if treating fingernails and twelve weeks if treating toenails. Lamisil has no effect on Candida infections and should not be used to treat cases of proximal subungual onychomycosis caused by this organism. Lamisil has the advantage of being less expensive than the other new generation of onychomycosis treatments.

Itraconazole (Sporanox) is a good option for proximal subungual onychomycosis when the cause of the disease is known to be fungal but may or may not be a dermatophyte. Sporanox has some activity against Candida, too. This treatment is usually more expensive than other onychomycosis treatments, including Lamisil.

Fluconazole (Diflucan) can be used to treat proximal subungual onychomycosis, but this is not a first line drug for this disease. This medication halts the growth and spread of the disease rather than killing the fungus outright. In medical terms, fluconazole is fungistatic (fungus stopping) rather than fungicidal (fugus killing).

This means that the drug helps the immune system get a handle on the fungus by slowing down its growth. Since many cases of proximal subungual onychomycosis occur in people that already have depressed immune systems, this approach may not be terribly effective. When used, fluconazole (Diflucan) treatment usually continues until symptoms resolve.

References
Hainer BL. Dermatophyte infections. Am Fam Physician 2003;67:101-108.
Jaffe R. Onychomycosis: recognition, diagnosis, and management. Arch Fam Med 1998;7:587-592.

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