Fungal infection of the nails, called onychomycosis, is very common but difficult to treat. There is still no guaranteed way to cure the infection, no matter what treatment is chosen, but there are a number of ways to improve the appearance of the nails, lessen the infection, and perhaps cure it in some people. While there is a lot of agreement between medical professionals who treat this all over the world, the same medicines are not always available in different countries.
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.
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Choi, Sola. Manual of Dermatologic Therapeutics. Chapter 14. Dermatophyte Infections. Onychomycosis. Pages 87-90. 2007. Lippincott Williams & Wilkins. Philadelphia.
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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.
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The Merck Manual for Health Care Professionals. Onychomycosis. Last revision October 2009.
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