- Topical treatments:
- Last thing…
- Are topical and device-based treatments effective in people with fungal infections of the toenails?
- Ciclopirox Topical
PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, is not for ophthalmic, oral, or intravaginal use. For use on nails and immediately adjacent skin only.
If a reaction suggesting sensitivity or chemical irritation should occur with the use of PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, treatment should be discontinued and appropriate therapy instituted.
So far there is no relevant clinical experience with patients with insulin dependent diabetes or who have diabetic neuropathy. The risk of removal of the unattached, infected nail, by the health care professional and trimming by the patient should be carefully considered before prescribing to patients with a history of insulin dependent diabetes mellitus or diabetic neuropathy.
Information for Patients
Patients should have detailed instructions regarding the use of PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, as a component of a comprehensive management program for onychomycosis in order to achieve maximum benefit with the use of this product.
The patient should be told to:
- Use PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, as directed by a health care professional. Avoid contact with the eyes and mucous membranes. Contact with skin other than skin immediately surrounding the treated nail(s) should be avoided. PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, is for external use only.
- PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, should be applied evenly over the entire nail plate and 5 mm of surrounding skin. If possible, PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (e.g., onycholysis). Contact with the surrounding skin may produce mild, transient irritation (redness).
- Removal of the unattached, infected nail, as frequently as monthly, by a health care professional is needed with use of this medication. Inform a health care professional if they have diabetes or problems with numbness in your toes or fingers for consideration of the appropriate nail management program.
- Inform a health care professional if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing).
- Up to 48 weeks of daily applications with PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, and professional removal of the unattached, infected nail, as frequently as monthly, are considered the full treatment needed to achieve a clear or almost clear nail (defined as 10% or less residual nail involvement).
- Six months of therapy with professional removal of the unattached, infected nail may be required before initial improvement of symptoms is noticed.
- A completely clear nail may not be achieved with use of this medication. In clinical studies less than 12% of patients were able to achieve either a completely clear or almost clear toenail.
- Do not use the medication for any disorder other than that for which it is prescribed.
- Do not use nail polish or other nail cosmetic products on the treated nails.
- Avoid use near heat or open flame, because product is flammable.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No carcinogenicity study was conducted with PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, formulation. A carcinogenicity study of ciclopirox (1% and 5% solutions in polyethylene glycol 400) in female mice dosed topically twice per week for 50 weeks followed by a 6-month drug-free observation period prior to necropsy revealed no evidence of tumors at the application sites.
In human systemic tolerability studies following daily application (~340 mg of PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%) in subjects with distal subungual onychomycosis, the average maximal serum level of ciclopirox was 31 28 ng/mL after two months of once daily applications. This level was 159 times lower than the lowest toxic dose and 115 times lower than the highest nontoxic dose in rats and dogs fed 7.7 and 23.1 mg ciclopirox (as ciclopirox olamine)/kg/day.
The following in vitro genotoxicity tests have been conducted with ciclopirox: evaluation of gene mutation in Ames Salmonella and E. coli assays (negative); chromosome aberration assays in V79 Chinese hamster lung fibroblasts, with and without metabolic activation (positive); gene mutation assay in the HGPRT-test with V79 Chinese hamster lung fibroblasts (negative); unscheduled DNA synthesis in human A549 cells (negative); and BALB/c3T3 cell transformation assay (negative). In an in vivo Chinese hamster bone marrow cytogenetic assay, ciclopirox was negative for chromosome aberrations at 5,000 mg/kg.
The following in vitro genotoxicity tests were conducted with PENLAC ®NAIL LACQUER (ciclopirox) Topical Solution, 8%: Ames Salmonella test (negative); unscheduled DNA synthesis in the rat hepatocytes (negative); cell transformation assay in BALB/c3T3 cell assay (positive). The positive response of the lacquer formulation in the BALB/c3T3 test was attributed to its butyl monoester of poly resin component (Gantrez® ES-435), which also tested positive in this test. The cell transformation assay may have been confounded because of the film-forming nature of the resin. Gantrez® ES-435 tested nonmutagenic in both the in vitro mouse lymphoma forward mutation assay with or without activation and unscheduled DNA synthesis assay in rat hepatocytes.
Oral reproduction studies in rats at doses up to 3.85 mg ciclopirox (as ciclopirox olamine)/kg/day did not reveal any specific effects on fertility or other reproductive parameters. MRHTD (mg/m2) is based on the assumption of 100% systemic absorption of 27.12 mg ciclopirox (~340 mg PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%) that will cover all the fingernails and toenails including 5 mm proximal and lateral fold area plus onycholysis to a maximal extent of 50%.
Teratogenic effects: Pregnancy Category B
Teratology studies in mice, rats, rabbits, and monkeys at oral doses of up to 77, 23, 23, or 38.5 mg, respectively, of ciclopirox as ciclopirox olamine/kg/day (14, 8, 17, and 28 times MRHTD), or in rats and rabbits receiving topical doses of up to 92.4 and 77 mg/kg/day, respectively (33 and 55 times MRHTD), did not indicate any significant fetal malformations.
There are no adequate or well-controlled studies of topically applied ciclopirox in pregnant women. PENLAC ®NAIL LACQUER (ciclopirox) Topical Solution, 8%, should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether this drug is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, is administered to a nursing woman.
Based on the safety profile in adults, PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8% is considered safe for use in children twelve years and older. No clinical trials have been conducted in the pediatric population.
Clinical studies of PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients.
Nail fungus is common and there are good treatments out there but you need to be patient. Nail changes are SLOW and improvement will continue after you stop your medication so hang in there. Here are the medications and treatments that do actually work for nail fungus.
The best pill for nail fungus is terbinafine (Lamisil) and evidence suggests it works better than the alternatives with the fewest side effects. Terbinafine results in resolution of nail fungus 76% of the time. It is taken once a day for 6 – 12 weeks. Another good pill for nail fungus is itraconazole (Sporanox) which results in cure 63% of the time. Itraconazole is also taken once a day for 6 – 12 weeks. Remember that improvement will continue AFTER oral therapy is stopped and it may take 9 to 12 months for you to see full results. Though not as effective as terbinafine and itraconazole, oral fluconazole 150 mg – 300 mg taken once a week does result in disappearance of fungus 48% of the time. A new player for nail fungus (a liquid you take by mouth) is Noxafil (posaconazole) which appears to be an effective option though the cost makes it difficult for anyone to afford.
Over the counter fungal creams like clotrimazole and the nail polishes (ciclopirox) are generally ineffective for clearing nail fungus. Ciclopirox (Penlac is the brand name) is a topical nail polish used for the treatment of mild to moderate nail fungus. It just doesn’t work very well resulting in cure only 7% of the time. Medicated chest rub (Vicks VapoRub) has some data looking at its effectiveness. In one study 18 patients applied it twice daily for 48 weeks and 4 patients had resolution. Vicks is a tempting option because it’s so safe and easy to use.
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Removal of the nail is only used when only 1 nail is infected, but it does work. Light therapy and lasers are also being studied. A multicenter trial investigating the efficacy of a device, the Pinpointe FootLaser, is currently underway so stay tuned on that.
All of the pills for nail fungus can cause liver toxicity so a baseline liver function blood test is required with another one midway in your treatment. Also, your doctor has to look at your medication list to make sure there aren’t any drug interactions. The liver toxicity (which is rare) is reversible after discontinuing the medication.
Treatment failures and recurrences are common so don’t get frustrated, you are not alone.
Limited pharmacologic treatment options exist for onychomycosis, especially for patients who wish to avoid or are unable to take oral antifungal medication. Ciclopirox 8% nail lacquer (Penlac) has long been the only prescription strength, Food and Drug Administration (FDA) approved topical antifungal for the treatment of onychomycosis. Unfortunately, ciclopirox 8% nail lacquer has had very poor therapeutic outcomes, even with concomitant nail debridement. Over the past 10 years, following the introduction of topical ciclopirox 8% nail lacquer, there has been a significant lack of development of topical antifungal therapies for the treatment of onychomycosis.
Recently, efinaconazole 10% solution (Jublia, Valeant Pharmaceuticals) has emerged as a promising new prescription strength topical treatment option for onychomycosis. Efinaconazole reportedly has cure rates comparable to oral itraconazole (Sporanox, Janssen Pharmaceuticals) and mycological and complete cure rates two to three times greater than that of ciclopirox 8% nail lacquer.1
Nail debridement has been an integral part of therapeutic studies examining the efficacy of ciclopirox. Despite concomitant nail debridement, the efficacy of ciclopirox for the treatment of onychomycosis is very poor. Daily application of ciclopirox 8% nail lacquer in combination with nail debridement has shown mycological cure rates (negative culture and negative potassium hydroxide preparation) ranging from 29 to 36 percent.2,3 Complete cure rates (mycological cure and normal toenail appearance) of ciclopirox 8% nail lacquer are significantly lower, ranging from 5.5 to 8.5 percent.3 Given these outcomes, physicians usually reserve ciclopirox for very mild cases of onychomycosis, for palliative care, when patients cannot tolerate oral antifungal medication or when oral antifungals are contraindicated.3
How Efinaconazole 10% Solution Compares To Other Antifungals For Onychomycosis
Efinaconazole 10% solution, a new triazole topical antifungal specifically developed for onychomycosis, received FDA approval in June. Two parallel, double-blind, randomized phase III trials, — in which study participants applied efinaconazole daily for 48 weeks without nail debridement — showed mycological and complete cure rates two to three times greater than those for ciclopirox, and comparable to 12 weeks of oral itraconazole.1,3-5 Specifically, efinaconazole showed a 53.4 to 55.2 percent mycological cure rate at 52 weeks.4,5 The complete cure rate with efinaconazole treatment was 15.2 to 17.8 percent. In these studies, researchers considered 40 to 45 percent of patients as having treatment successes. They defined treatment success as an affected target toenail area of less than 10 percent.
Several factors, including the topical’s antifungal and physiochemical properties, theoretically contribute to the much higher efficacy of efinaconazole 10% solution. Efinaconazole is a broad spectrum antifungal with in vitro studies showing activity against dermatophytes, non-dermatophytes and yeast. Researchers have shown that efinaconazole is more potent than terbinafine, ciclopirox, itraconazole and amorolfine in in vitro testing against T. rubrum, T. mentagrophytes, Candida albicans and Epidermophyton floccosum.6
Physicochemical properties that contribute to the efficacy of efinaconazole 10% solution include improved nail unit penetration and distribution to the entire nail apparatus. Nail unit penetration is a primary limiting factor for topical antifungal medications. Keratin binding and the rate of keratin bound drug release are important factors in allowing topical antifungals to penetrate the nail plate and exert their antifungal activity at the deeper levels of the nail plate, the nail bed and the nail matrix.1
Research has shown efinaconazole 10% solution to have considerably lower keratin binding and faster keratin bound drug release in comparison to other topical antifungals.1 Alcohol, lipophilic esters and cyclomethicone in the efinaconazole solution help to create a low surface tension that allows application to the dry nail surface, nail folds, hyponychium and the undersurface of the nail, improving drug delivery and distribution.1 To date, researchers have evaluated the therapeutic efficacy of efinaconazole 10% solution without additional nail plate debridement. The hypothesis is that debridement may increase nail plate penetration and lead to even higher mycological and complete cure rates.
Onychomycosis can be a difficult disorder to treat, especially in patients who cannot tolerate or are not candidates for oral antifungal medications. Until recently, topical treatment options were very limited with ciclopirox 8% nail lacquer being the only prescription topical antifungal available for the treatment of onychomycosis. Efinaconazole 10% solution is a promising new topical treatment option of onychomycosis with cure rates comparable to oral itraconazole, and mycological and complete cure rates 2 to 3 times greater than that of ciclopirox 8% nail lacquer.
1. Del Rosso JQ. The role of topical antifungal therapy for onychomycosis and the emergence of newer agents. J Clin Aesthet Dermatol. 2014;7(7):10-8.
2. De Berker D. Fungal nail disease. N Engl J Med. 2009;360(20):2108210800
3. Gupta AK, Joseph WS. Ciclopirox 8% nail lacquer in the treatment of onychomycosis of the toenails in the United States. J Am Podiatr Med Assoc. 2000;90(10):495495 2
5. Gupta AK, Elewski BE, Sugarman JL, et al. The efficacy and safety of efinaconazole 10% solution for treatment of mild to moderate onychomycosis: a pooled analysis of two phase 3 randomized trials. J Drugs Dermatol. 2014;13(7):815-20.
6. Jo Siu WJ, Tatsumi Y, Senda H, et al. Comparison of in vitro antifungal activities of efinaconazole and currently available antifungal agents against a variety of pathogenic fungi associated with onychomycosis. Antimicrob Agents Chemother. 2013;57(4):1610-6.
Are topical and device-based treatments effective in people with fungal infections of the toenails?
We reviewed evidence about the effect of topical and device-based treatments for fungal infections of the toenails (toenail onychomycosis) when compared against each other, placebo (an identical but inactive treatment), vehicle (inactive ingredients that help deliver an active treatment), or no treatment. We assessed adults, whose infection was diagnosed based on studying nail samples.
Toenail onychomycosis causes pain, discomfort, and disfigurement. Topical and device-based treatments can have less likelihood of drug interactions or side effects than oral drugs. Antifungal medications are either fungistatic (inhibiting fungal growth) or fungicidal (killing fungal pathogens). The shared goal of devices (e.g. laser, photodynamic therapy) is fungus destruction.
In searches up to May 2019, we found 56 studies including 12,501 men or women (average age: 27 to 68 years) who had mainly mild-to-moderate toenail onychomycosis. Onychomycosis duration was under-reported, but varied from months to years. Approximately 63% of the studies assessed onychomycosis caused by dermatophytes (fungi). Most studies lasted 48 to 52 weeks and were conducted in an outpatient setting. The studies used either device-based or topical treatments, including lacquers and creams, alone or in combination, compared to each other, to no treatment, to vehicle, or to placebo.
For the following key results, treatment lasted 36 or 48 weeks, and outcomes were measured at 40 to 52 weeks (side effects were measured throughout the study).
Compared to vehicle (no treatment), efinaconazole 10% topical solution is better at achieving complete cure (i.e. normal-looking nail coupled with fungus elimination determined using laboratory methods) (high-quality evidence). Tavaborole 5% solution (when compared to vehicle) and P-3051 (ciclopirox 8% hydrolacquer) (when compared to two other treatments: ciclopirox 8% lacquer or amorolfine 5%) are probably better at achieving this outcome (both moderate-quality evidence). Ciclopirox 8% lacquer may lead to higher complete cure rates than vehicle, but rates are low (not all patients can be expected to achieve complete cure) (low-quality evidence).
Ciclopirox 8% lacquer and efinaconazole 10% are probably more effective at eliminating the fungus (mycological cure) than vehicle, but for P-3051 (ciclopirox 8% hydrolacquer) there is probably little or no difference compared to the two comparator treatments (all moderate-quality evidence). Tavaborole 5% improves mycological cure compared to vehicle (high-quality evidence).
We found no evidence of a difference in side effects, including redness, rash, and burning, between P-3051 (ciclopirox 8% hydrolacquer) and the two other treatments (low-quality evidence), and ciclopirox 8% lacquer may increase side effects, including application-site reactions, rashes, and changes in the nail compared with vehicle, although treatment effects vary, so it is possible that it may actually make little or no difference (low-quality evidence). Compared to vehicle, participants were slightly more likely to experience side effects (commonly dermatitis and fluid-filled sacs) with efinaconazole 10% (high-quality evidence) and probably more likely to experience side effects with tavaborole 5% (commonly, application-site reactions, such as dermatitis, redness, and pain) (moderate-quality evidence).
We are uncertain of the effect of luliconazole 5% on complete cure when compared to vehicle (very low-quality evidence); there may be little or no difference between these groups in side effects (dry skin, eczema, and thickening of the skin were commonly reported, but improved after stopping treatment), and luliconazole 5% solution might increase mycological cure; however, the effects of this treatment vary, so it is possible that it may actually make little or no difference to mycological cure (both low-quality evidence).
Three studies compared laser to no treatment or sham treatment, and there may be little or no difference in mycological cure (low-quality evidence). Complete cure was not measured, and we are uncertain if there is a difference in side effects between groups (very low-quality evidence).
Efinaconazole 10% solution is more effective in achieving clinical cure than vehicle (high-quality evidence); none of the other key comparisons measured this outcome.
Quality of the evidence
We base our conclusions on varied evidence quality. For complete cure, mycological cure, and side effects, quality ranged from low to high, with very low-quality evidence found for three key results.
Many studies were small, had design issues, and did not directly compare therapies. No studies reported quality of life.
Before using ciclopirox topical solution,
- tell your doctor and pharmacist if you are allergic to ciclopirox or any other medications.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: inhaled steroids such as beclomethasone (Beconase, Vancenase), budesonide (Pulmicort, Rhinocort), flunisolide (AeroBid); fluticasone (Advair, Flonase, Flovent), mometasone (Nasonex), and triamcinolone (Azmacort, Nasacort, Tri-Nasal); oral medications to treat fungal infections such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), terbinafine (Lamisil) and voriconazole (Vfend); medications for seizures; and steroid creams, lotions, or ointments such as alclometasone (Aclovate), betamethasone (Alphatrex, Betatrex, Diprolene, others), clobetasol (Cormax, Temovate), desonide (DesOwen, Tridesilon), desoximetasone (Topicort), diflorasone (Maxiflor, Psorcon), fluocinolone (DermaSmoothe, Synalar), fluocinonide (Lidex), flurandrenolide (Cordran), halcinonide (Halor), hydrocortisone (Cortizone, Westcort, others), mometasone (Elocon), prednicarbate (Dermatop), and triamcinolone (Aristocort, Kenalog, others). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had an organ transplant, if you have recently had chicken pox, and if you have or have ever had any disease that affects your immune system, such as human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) or severe combined immunodeficiency syndrome (SCID); cancer; cold sores; diabetes; flaky, itchy, or crusty skin; genital herpes (sexually transmitted disease that causes painful blisters on reproductive organs); shingles (painful blisters caused by the chicken pox virus); fungal infections on your skin such as athlete’s foot and ringworm (ring-shaped discolored patches of scales and blisters on the skin, hair, or nails); peripheral vascular disease (narrowing of blood vessels in feet, legs, or arms causing numbness, pain, or coldness in that part of the body); or seizures.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking ciclopirox, call your doctor.
- you should know that you should keep your nails clean and dry during treatment with ciclopirox topical solution. Do not share nail care tools. Use different tools for infected and healthy nails. If your toenails are affected, wear well-fitting, low heeled shoes, and change them change frequently, and do not go barefoot in public areas. Wear protective shoes and gloves when playing sports, using strong cleaners, or during work that might injure or irritate fingernails and toenails.
What should I discuss with my healthcare provider before using ciclopirox topical?
You should not use ciclopirox if you are allergic to it.
To make sure ciclopirox topical is safe for you, tell your doctor if you have:
- epilepsy or other seizure disorder;
- a weak immune system (caused by disease or by using certain medicines); or
- a condition for which you use steroid medication (including skin conditions or breathing disorders).
Ciclopirox topical is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
It is not known whether ciclopirox topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Do not use this medicine on a child without medical advice. Ciclopirox shampoo and gel are not approved for use by anyone younger than 16 years old. Ciclopirox nail laquer is not approved for use by anyone younger than 12 years old. Ciclopirox cream and lotion are not approved for use by anyone younger than 10 years old.
How should I use ciclopirox topical?
Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Wash your hands before and after using this medication, unless you are using ciclopirox to treat a hand condition.
To apply the cream, gel, or lotion:
- Clean and dry the affected area. Apply a small amount of the cream (usually twice daily) for 2 to 4 weeks. Follow your doctor’s instructions.
- Do not use bandages or dressings that do not allow air to circulate (occlusive dressings) on areas treated with ciclopirox cream or lotion, unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).
- If the infection does not clear up in 4 weeks, or if it appears to get worse, see your doctor.
To use ciclopirox shampoo:
- Wet the hair and apply approximately 1 teaspoon (5 mL) of the shampoo to the scalp. Up to 2 teaspoons (10 mL) may be used for long hair. Lather and leave on the hair and scalp for 3 minutes. A timer may be used.
- Treatment should be repeated twice per week for 4 weeks, with a minimum of 3 days between applications. If no improvement is seen after 4 weeks of treatment, contact your doctor.
It may take up to 4 weeks before your symptoms improve after using ciclopirox topical cream, gel, lotion, or shampoo. Keep using the medicine as directed and tell your doctor if your symptoms do not improve, or if they get worse.
To use ciclopirox nail lacquer:
- Use on the nails and immediately surrounding skin only. Avoid contact with other areas. Remove any loose nail or nail material using nail clippers or a nail file.
- Apply ciclopirox nail lacquer once daily (preferably at bedtime) to all affected nails with the applicator brush provided. Apply the lacquer evenly over the entire nail. Where possible, apply the nail lacquer to the underside of the nail and to the skin beneath it. Allow the lacquer to dry (approximately 30 seconds) before putting on socks or stockings. After applying the medication, wait 8 hours before taking a bath or shower.
- Apply ciclopirox nail lacquer daily over the previous coat. Once a week, remove the nail lacquer with alcohol. Remove as much as possible of the damaged nail using nail clippers or nail a file.
- To prevent the screw cap from sticking to the bottle, do not allow the solution to get into the bottle treads. To prevent the solution from drying out, close the bottle tightly after every use.
Treatment with ciclopirox nail lacquer may require several months before initial improvement of symptoms is noticed. Up to 48 weeks of daily application of the nail lacquer, monthly removal of the unattached infected nail by a health care professional, and weekly trimming by the patient may be required for complete treatment.
Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antifungal medicine.
Store all forms of this medicine at room temperature away from moisture, heat, and light. Once a bottle of ciclopirox shampoo is opened, it should be used within 8 weeks.
Ciclopirox nail lacquer is flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.
Editor’s note: In December 1999, the Food and Drug Administration approved a new preparation for the topical treatment of onychomychosis, which is by definition a fungus infection of the nail and would include both fingernails and toenails. The product, named Penlac Nail Lacquer Topical Solution 8%, was developed by Europe’s Aventis Pharma and is being marketed in the United States by Pensylvania-based Dermik Laboratories, a unit of Aventis. At press time, manufacturers said the prescription drug would begin selling this spring. Since up until the approval of this drug the FDA had prohibited companies from claiming topical antifungals worked on nails, we asked Dr. Richard Scher to comment on the approval of the first topical treatment approved for treating fingernail and toenail fungus in the United States.
Penlac Nail Lacquer Topical Solution 8% has been tested in two separate clinical trials in the United States and several clinical trials in Europe. The active ingredient is called ciclopirox, which is an antifungal agent in the hydroxyl pyridine family. It is not an azole or an allylamine, which are the products currently being used for the treatment of nail fungus.
These clinical trials demonstrated that the prescription nail lacquer does penetrate the nail lacquer does penetrate the nail, enabling it to get to the fungus, which begins and is active in the skin underneath the nail bed. This type of infection, also known as distal subungal onychomychoisis, makes up over 90% of fungal nail infections and usually begins at the tip of the finger or toe and then invades toward the body in what is called a proximal direction. This advance in treatment is extremely important because onychomychosis is a very common infection and is responsible for approximately 50% of all nail disorders.
The reason that the nail lacquer is shown to be effective in mild to moderate cases is because the active ingredient (ciclopirox) has been put into a transungual delivery system. In simple terms, this means that the nail lacquer is able to get the ciclopirox through the nail and into the nail bed where the fungus is most active. It is interesting to note that ciclopirox has been available in a cream and lotion form for many years for the treatment of skin fungus but it has never been approved for use in the nails. We know that creams and lotions can’t penetrate the nails, which is why they have been ineffective.
This product is also very significant because it comes in the form of a nail lacquer so that it can be used as a nail polish would be used. It should be pointed out that Penlac Nail Lacquer will be recommended for what is called mild to moderate fungal nail infections and will not be recommended for the more severe type. This means that it will probably be indicated for nail fungus that affects less than 50% of the nail plate. It is also important to remember that it will not be effective against nail fungus that affects the nail growth center (or matrix), or lunula (or moon). When these parts of the nail are affected, this product will not be able to cure the nails. However, it may at least help to contain the fungus and slow down its spread, but for that type of fungal infection an internal medication will be required.
Many of the current antifungals that are being used (both the topical and systemic ones) interfere with the synthesis of ergosterol, which is required for the fungal cell membrane. In order for the fungus to survive, the fungal cell membrane must remain intact, which is how most of the current preparations work. But ciclopirox works by inhibiting certain enzymes in the fungus that require metals such as iron. Therefore it works differently. Medications previously available over the counter have not been subject to clinical trials and their effectiveness is not clearly established. Other products that dermatologists use for fungal nails topically have been approved for skin fungus and found to have some additional benefit to nail fungus, but because of their lack of penetrability, the effectiveness has not been great.
The studies with ciclopirox lasted 48 weeks. In patients who were cured, there was a follow-up period of 24 weeks. However, in the majority of patients, the fungus did not clear totally, although there was a significant improvement. These patients did not continue in the follow-up treatment after the initial 48-week period. Since the most common cause of onychomychosis is the group of fungus organisms known as dermatophytes (this group of fungi causes well over 90% of nail fungus), the ciclopirox it effective against this particular type of fungus. It is also been shown to be effective against some yeast and what I refer to as non-dermatophyte moulds, as well as some bacterial organisms.
Penlac Nail Lacquer has been found to be totally safe with no internal or systemic effect and no significant localized allergic reactions. It should also be stated that it is anticipated that there will be a significant relapse rate of fungus even if this preparation is used and even if it is able to clear the nail of fungus. This is because patients who get a fungal infection usually have a high susceptibility to this and even if they are cured there is at least a 25% chance that the fungus will reoccur, especially in the toenails.
The efficacy of this nail lacquer is not great, that is only a small percentage of the patients in the trials were totally cured and those who were totally cured required a six to 12 month period of time for this to happen. Daily applications of the product will be recommended. However, this product may reduce the cost of treating nail fungus because with a topical agent fewer doctor visits will be required. Patients may be able to have the product renewed by telephone from their physicians without coming in for periodic and regular observation.
There are other ramifications for the topical nail antifungal. If Penlac is used in conjunction with systemic antifungals, it is possible that this may shorten the time that the systemic antifungal is required. And it may be that once the fungus infection is clear, let’s say with the systemic antifungal, then by using the topical afterwards, perhaps on a less frequent basis, it may go a long way toward preventing the nail fungus from relapsing.
Nail technicians will not be able to recommend this product directly to their clients because it is a prescription medication. However, nail technicians can advise their clients to see a dermatologist who would be able to prescribe this medication. It is always good for nail techs to recommend that their clients see a dermatologist because many abnormal nail that look like fungal infections are in fact another nail condition altogether. The dermatologist will take samples from the nails to determine what it is, and then prescribe proper medications.
This medication is also very important because one of the fastest-growing population groups in the United States is the elderly age group, in whom fungus infection of the nails is much more common. (it can be as high as 25-50% of these individuals.) This is probably true because as on ages, the nails grow more slowly making it much easier for fungus to get into the nail and to continue to grow and flourish. Whereas in young individuals nails grow much faster, making it more difficult for the fungus to survive. It is also signification because in the elderly population, who are often taking many medications, systemic antifungal therapy is contraindicated because of interactions with other medications that they are taking or other illnesses that could be adversely affected by a systemic drug. In addition, trauma, which plays a role in the susceptibility to fugal infections, is even more significant in the elderly population. And because of arthritis and bony abnormalities (particularly in the feet), the elderly population is even more susceptible to fungus.