Current Insights And Case Studies In Treating Onychomycosis

Emphasizing the treatment of onychomycosis as an infection and a cosmetic problem, this author offers insights from his experience with a synergistic management protocol and provides several case studies.

Onychomycosis (tinea unguium) is an extremely common and specific fungal infection caused by a keratinophilic dermatophyte, Trichophyton rubrum, that infects the nail plate, nail bed and nail matrix as well as the surrounding skin. The dermatophyte also causes dystrophic nails as well as tinea pedis.¹ The incidence of onychomycosis is increasing in the United States, reportedly affecting 6 to 12 percent of the population.² Symptoms of this infection range from itching and blistering of the skin to reduced self-esteem.  

Currently, onychomycosis not only presents as a true infection but more commonly as a cosmetic complaint. In our practice, we treat the infection and cosmetic complaint with equal importance.
The most common current treatments for onychomycosis are simple debridement, laser ablation, oral medication, topical medication or removal of the nail in its entirety. Rarely do clinicians use these treatments synergistically and in combination with patient education about the disease. We have found that when we treat a patient’s lower extremity as a whole with the skin, nail and surrounding environment, we may achieve clinical cure of the nail.  

Principles Of Patient Education On Onychomycosis
Before beginning treatment, I subject the patient to a thorough history and physical. One must rule out skin conditions such as psoriasis, contact dermatitis, eczema or previous traumatic deformation to the nail bed. Clinicians must also address any history of current or previous hepatic disease at the start.

Patients in my practice first see a video presentation about their onychomycosis. The video emphasizes that the infection is not only in their nails but in their skin as well. I address topical antifungal treatment, oral antifungal treatment, environmental awareness and nutrition. Patients get an education on patience as the fungal infection will take six months to a year to clear entirely from their nails. I also make it clear that patients will have to manage their disease well into the future as they will be forever prone to fungal infections. Recurrence is a real possibility and they will continue to have to spend time and money to keep it at bay. Lifelong maintenance and adherence are required. If a patient wishes to have treatment, we discuss a custom pathway treatment plan that will address the condition.

Pictures of a patient’s nails and his or her dorsal and plantar skin serve as a baseline. These pictures act as a progress indicator during the treatment. For most patients, tinea pedis presents as a scaling to the surrounding skin. Patients may or may not experience the sensations of itching and burning. Whether or not patients experience these symptoms, they must have treatment for their scaling skin. The condition of the skin on the foot is completely dependent on the success of our treatment. A nail with onychomycosis will not clear if the skin continues to present with tinea.  

A Closer Look At The Initial Antifungal Treatment Protocol
As I stated before, most common antifungal treatment protocols today are not synergistic and thorough. I cannot emphasize enough that we must treat all aspects of the lower extremity fungal infection. Our treatment protocol for onychomycosis is a coordinated combination of laser of the nails, oral terbinafine (Lamisil, Novartis) tablets, topical antifungal cream, topical antifungal polish, antifungal shoe spray and a vitamin supplement. In addition, we thoroughly follow all patients for a 12-month period.  

Terbinafine is an FDA-approved oral antifungal for the treatment of onychomycosis. Unlike the other antifungals, terbinafine is fungicidal. Interestingly, there has been some controversy with patients taking concurrent statin therapy. However, concerns regarding drug-to-drug interactions with statin therapy and systemic antifungal therapy are actually with the azole class of antifungals and not terbinafine.³ In addition, one can use terbinafine safely in children and the elderly.⁴

All patients taking the oral medication receive education that they should follow a strict medical guideline due to the possible hepatic risk and other associated complications. Oral antifungal medications are not for people with liver or kidney problems. For those taking the oral medication, they go for a complete blood count and testing of aspartate transaminase (AST) and alanine transaminase (ALT) levels prior to starting the medication. Each patient will have the tests again in four to six weeks while they are taking the oral therapy. No patient will get a prescription for terbinafine without taking the required blood test.

I tell all patients to watch for symptoms of liver problems while taking oral antifungals. Symptoms include persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain or jaundice, dark urine or pale stools. I explain to patients that if they do experience any of these symptoms or any other side effects, they should stop taking terbinafine immediately and call our office.

I also instruct patients with onychomycosis and tinea pedis to purchase and use the following topical medications.

They should thoroughly apply topical antifungal cream (tolnaftate 1%, Formula 3, Tetra Corp.) to the whole foot twice daily. We have found that the instructed “pearl-sized amount” is not sufficient for adequate antifungal results. We ask that patients use at least four pumps of the antifungal cream per foot. When patients do not adhere to this regimen, the fungal residue will remain visible on the plantar aspect of the foot and tips of the toes.

Spray antifungal spray (Clean Sweep, Tetra Corp.) to the shoes two times weekly.
Apply topical antifungal polish (tolnaftate 1%, Formula 3, Tetra Corp.) twice daily to the nails. 
Take vitamin supplement tablets (TheraNail, Bako Integrated Physician Solutions) containing biotin 2.5 mg, iron 10 mg and zinc 10 mg once a day

Next, if the patient has thickened nails, I debride them to patient pain toleration and perform laser ablation utilizing the PinPointe FootLaser (NuvoLase). This laser can deliver a “selective thermolysis,” which provides a short burst of laser light energy into the target tissue, causing a rapid elevation in temperature in the defined target area. Sufficient intervals between pulses can allow for tissue relaxation and cooling to occur, causing very little collateral damage to surrounding structures.⁵ The FDA has approved the PinPointe FootLaser for temporary clearing of mild to moderate onychomycosis.⁵

A Guide To Follow-Up Care
Here is my treatment protocol for subsequent patient visits.

Thirty days into treatment. The patient will present for an exam. I obtain a brief history and physical. If the exam findings are unremarkable, I then send the patient for a second blood test. If the findings of the blood results are again unremarkable, I make the second prescription of 30 pills of 250 mg of terbinafine. If the patient has been adherent with the medications, the usual exam finding will be clearing of the skin with minimal nail changes. Often we refer to our baseline pictures to establish this.

Sixty days into treatment. I obtain another brief history and physical. If the exam findings are unremarkable, the patient refills the remainder of the prescription of 30 pills of 250 mg of terbinafine. At this visit, the skin should be mostly clear of scaling and the nails may show some improvement.  

Ninety days into treatment. At this visit, nail clearing has typically begun and the skin continues to remain healthy.

Five months into treatment. At this visit, we expect the skin to be free of dryness and scaling. We expect the nails to be 50 percent cleared. To accurately assess the patient’s progress, I view the original picture and compare it with the current state. If the pace of the progression appears slow or minimal improvement has occurred, this is the date when we may vary our treatment. Before adjusting treatment, I verify the patient’s adherence. If adherence has occurred, we may begin a pulse dosing regimen of having the patient take one tablet daily of 250 mg terbinafine here for seven days per month for two months. In addition, we perform laser ablation again. On rare occasions, we will do another 30 days of terbinafine.

Eight months into treatment. If there is no further improvement, we then further modify the plan and consider changing the oral medication. We will use either itraconazole (Sporanox, Bristol-Myers Squibb) BID for seven days once a month or fluconazole (Diflucan, Pfizer) 200 mg BID for seven days as alternatives to terbinafine.

Upon nail clearance, I again explain to the patient that reinfection is likely and that the application of an antifungal medication can be lifelong. Even after the infection is gone, the patient needs to watch for signs of recurrence and apply the topical antifungal medications when needed.

I explain to all patients that in order to prevent recurrence, they must take the following precautions.
Do not share nail clippers.
Air out shoes.
Change shoes and socks twice a day.
Apply topical medications as directed.

A Closer Look At Case Studies Of Onychomycosis Treatment
Case study one. A 51-year-old female patient presents to the office with thick, yellow and scaly nails. Previous treatment includes over-the-counter antifungal medications with no improvement. She had the infection for approximately 10 years.

The patient started on our typical treatment protocol. This consisted of PinPointe laser on the first visit. The patient had instructions to apply antifungal cream to the skin and antifungal polish to the nails twice daily. I instructed her to use antifungal spray in her shoes twice weekly and take oral biotin and terbinafine for the 12-month treatment plan and terbinafine 250 mg daily for 90 days.  

Visual improvement of the skin occurred after 30 days. After 90 days, the skin was within normal limits and there was no presentation of tinea. At six months, almost full clearing of the nail had occurred. The infection was only visible in the distal ends of the nail plate.

Case study two. A 16-year-old female patient presented to the office with thickened nails along with painful, cracked and scaly skin. Her history is significant for psoriasis. The dermatologist has treated her skin and she had been self-treating with topical antifungal medications with no success.

The physical exam was significant for excessive scaly skin and dystrophic and thickened nails. The patient started on our typical treatment protocol. Her first visit consisted of PinPointe FootLaser treatment. She then applied topical antifungal polish to her nails, applied topical antifungal cream twice daily, and used antifungal shoe spray in her shoes twice weekly. She also took oral biotin for the 12-month treatment plan and terbinafine 250 mg daily for 90 days. Her skin completely cleared at four months.

Case study three. A 48-year-old male presented to our office with thickened nails along with painful, cracked and scaly skin. The patient started on our typical treatment protocol. This consisted of the PinPointe FootLaser and the topical antifungals Formula 3, FungiFoam (Tetra Corp.), Revitaderm Wound Care (Blaine Labs) and Clean Sweep. He applied his topical antifungal polish to his nails, applied topical antifungal cream twice daily, and sprayed antifungal shoe spray in his shoes twice weekly. He took oral biotin and terbinafine daily for 90 days. His foot showed remarkable results within five months.

Case study four. A 58-year-old male presented to the office with thickened nails as well as painful, cracking and scaly skin. The patient started on our typical treatment protocol. This consisted of the PinPointe FootLaser on the first visit. He then applied topical antifungal polish to his nails, topical antifungal cream twice daily, and used antifungal shoe spray in his shoes twice weekly. In addition, he took oral biotin and terbinafine daily for 90 days. As you can see in the photos at left, the patient presented 150 days into treatment with significant clearing.

Case study five. A 13-year-old male along with his mother presented to the office with a severe fungal infection to his toenails. We see many young children with fungal infections. For this young boy, we modified our typical treatment protocol. This consisted of the PinPointe FootLaser on his first visit. He then applied topical antifungal polish to his nails, applied topical antifungal cream twice daily and received instructions to use the antifungal shoe spray in his shoes twice weekly. The patient also took oral biotin for the 12-month treatment period and terbinafine 250 mg daily for 90 days. At month five, progression slowed so we began a pulse dose of oral terbinafine 250 mg consisting of seven pills. He took one pill a day for the first week of months five and six.

In Conclusion
As I have shown above with small case presentations, the treatment protocol we use in our practice has shown remarkable results. In my experience, these results can happen for many different types of patients whether they are old or young, or have had previous treatment for their onychomycosis. It is important to note that many of our patients have had a previous round of oral terbinafine, or topical antifungal application with complete failure. We believe that because these clinicians did not use these treatments synergistically with other modalities,the fungal infection did not clear.  

There is much concern with many podiatrists and general practitioners about side effects when using oral terbinafine. We have prescribed terbinafine for onychomycosis ever since its release with minimal side effects in thousands of patients. The side effects we have noted include diarrhea, rash and a handful of incidences of loss of the sense of taste. Both patients with side effects of loss of taste regained their sense of taste within two months of discontinuing the medication. Although this was an unfortunate experience for these two patients, we consider this an extremely safe drug after the many times we have prescribed it for the three-month period and subsequent pulse dosing.

With patient education, adherence and persistence, we can clinically cure this difficult skin and nail infection. We urge the podiatric community to attempt this protocol approach toward onychomycosis in their own office.

Dr. Sklar is in private practice at Foot First Podiatry in Illinois. He is a Fellow of the American College of Foot and Ankle Surgeons, and a Fellow of the American College of Foot and Ankle Orthopedics and Medicine. He is also board certified by the American Board of Foot and Ankle Surgery and the American Board of Podiatric Medicine.
    
References

1.     Charif MA, Elewski BE. A historical perspective on onychomycosis. Dermatol Ther. 1997;3(1):43-45.
2.     Gräser Y, Czaika V, Ohst T. Diagnostic PCR of dermatophytes--an overview. J Dtsch Dermatol Ges. 2012;10(10):721-6
3.     Jennings MB, Pollak R, Harkless LB, et al. Treatment of toenail Onychomycosis with oral terbinafine plus aggressive debridement: IRON-CLAD, a large, randomized, open-label, multicenter trial. J Am Podiatr Med Assoc. 2006; 96(6):465-73.
4.     Gupta AK, Ryder JE, Lynch LE, Tavakkol A. The use of terbinafine in the treatment of onychomycosis in adults and special populations: a review of the evidence. J Drugs Dermatol. 2005;4(3):302-8.
5.     United States Food and Drug administration medical device approval (K103626). Available at https://www.accessdata.fda.gov/cdrh_docs/pdf10/K103626.pdf .
6.     Hees H, Raulin C, Bäumler W. Laser treatment of onychomycosis: an in vitro pilot study. J Dtsch Dermatol Ges. 2012;10(12):913-7.

For further reading, see “Current Concepts In Treating Onychomycosis In Patients With Diabetes” in the March 2015 issue of Podiatry Today or “Current And Emerging Agents For Tinea Pedis” in the April 2014 issue.

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