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Roundtable Insights On Treating Onychomycosis

Given the prevalence of onychomycosis and the emergence of laser therapy, these panelists review their approaches to managing onychomycosis, discuss ethical considerations with non-FDA approved modalities and emphasize the importance of establishing realistic patient expectations.

Q:

In this current environment with no new antifungal drugs having been released in years, all previous agents now being generic, a lack of sales representatives calling on podiatry and little discussion of the topic at CME meetings, has your approach to the treatment of onychomycosis changed?

A:

The majority of the panelists say their approach to onychomycosis has not changed. Allen Jacobs, DPM, FACFAS, says this is particularly the case when it comes to treating onychomycosis in patients with diabetes mellitus. Dr. Jacobs notes that researchers have demonstrated that onychomycosis and tinea pedis increase the risks of cellulitis, ulceration and gangrene.1 He adds that terbinafine (Lamisil, Novartis Pharmaceuticals) has been proven to be safe and effective in patients with diabetes.2,3

   Bryan Markinson, DPM, FASPD, says he has “always” been satisfied with the results of oral terbinafine and continues to be satisfied.

    “In my opinion, (terbinafine) remains the only agent that reliably gets results in the highest percentage of patients with little side effects in relation to the number of uses in clinical practice worldwide for many years,” maintains Dr. Markinson.

   Richard Pollak, DPM, MS, FACFAS, says he uses quite a bit of oral antifungals and predominantly uses oral terbinafine. While he has used oral itraconazole (Sporanox, Ortho-McNeil/Janssen Pharmaceuticals) in the past, Dr. Pollak says he utilizes oral terbinafine 95 percent of the time for moderate to severe onychomycosis. Adam Landsman, DPM, FACFAS, PhD, notes he has “always had moderately good success” with terbinafine and continues to recommend this for his patients on a regular basis. However, Dr. Landsman points out the recurrence rate frequently turns patients away from this treatment.

   Given the availability of generic terbinafine, Drs. Jacobs and Landsman note the drug has become much more accessible to patients due to a significant decrease in cost.

   Since the article on intermittent pulse dosing by Zaias and Rebell in 2004, Dr. Markinson uses pulse dosing of oral terbinafine as opposed to 90-day continuous dosing.4

    “This method uses 70 percent less drug and is 95 percent as effective as 90-day continuous dosing,” notes Dr. Markinson.

   That said, Dr. Landsman says two-thirds of his patients with onychomycosis reject oral terbinafine due to continued fears about liver injury or an unwillingness to take pills for 90 days.

   More recently, Dr. Landsman has started to recommend laser treatment but he notes that cost still remains an issue for many patients. Conversely, Dr. Landsman notes that many new patients have sought out his practice, specifically to get laser treatment.

   Mark Kosinski, DPM, FIDSA, says many DPMs were so “heavily indoctrinated” during the marketing heyday of drugs like oral terbinafine and ciclopirox (Penlac, Sanofi-Aventis) that there has been an “autopilot” approach to onychomycosis. Dr. Kosinski says the routine approach to onychomycosis has involved oral therapy, topical therapy, debridement or some combination of the three until the recent introduction of laser therapy.

   Dr. Kosinski says he first learned about laser therapy from radio ads and patient inquiries. When he went to look for the research to support the anecdotal claims, Dr. Kosinski was disappointed to find “few, if any, large scale, randomized clinical trials.

    “In today’s world, we have to be careful not to let commercialism and public pressure drive medical decision-making,” emphasizes Dr. Kosinski.

   On a related note, Dr. Jacobs says the less frequent discussion of onychomycosis and tinea pedis at scientific sessions in podiatry “is more a reflection of the corporate dependency, which our scientific sessions have developed, rather than a reflection of the real needs of our profession in terms of daily practice.” That said, Dr. Jacobs notes that he has attended several recent podiatric meetings at which onychomycosis has been the subject of discussion. He adds that onychomycosis continues to be discussed at scientific sessions in dermatology.

   Dr. Jacobs says the converse is also true.

    “We have been advised by corporate sponsored ‘experts’ over the years to utilize various modalities for the treatment of onychomycosis which, in hindsight, were ineffective or minimally effective at best,” points out Dr. Jacobs. “I would suggest that absent such speakers from our meetings, we are now in a position to critically analyze what really works. I have always found it intriguing that with all the fungal nails and tinea pedis that present to the offices of all podiatrists daily that the overwhelming majority of literature on the subject of onychomycosis calling for treatment comes from dermatology literature and not podiatry literature.”

Q:

What percentage of onychomycosis patients in your practice do you manage with debridement alone, with topical agents, with oral agents or with a device (i.e. laser)? Relating to the first question, do you feel this has changed for you in the past few years?

A:

“Onychomycosis is a dermatological disease that deserves treatment,” notes Dr. Kosinski. “It is our practice to institute some form of medical therapy for those patients whom we feel have the best chance of achieving some benefit.”

   Dr. Kosinski says any percentages in regard to onychomycosis treatment are relative to demographics and vary from practice to practice. Additional patient factors would include: the severity and degree of affected nails; patient age; and the medical status of the patient.

   Dr. Kosinski estimates that 60 percent of his patients with onychomycosis receive medical treatment while 40 percent receive debridement alone. The patients who only receive debridement include those who are either unable or unwilling to have systemic therapy, and those with severe onychomycosis who would not benefit from topical therapy, according to Dr. Kosinski.

    “Palliation is aimed at keeping the patient comfortable and preventing complications, especially in our diabetic population,” explains Dr. Kosinski.

   Dr. Markinson says 95 percent of his elderly patients with onychomycosis receive debridement only. Dr. Pollak says at least 50 percent of his patients whom he is treating with debridement only are okay with that.

   Dr. Jacobs adds that debridement by itself provides only debulking of the nail and resultant nail bed pressure relief. He says it contributes to the resolution of onychomycosis only in combination with oral therapy. Dr. Landsman usually recommends either oral treatment or laser therapy, and will employ debridement as part of a regular treatment regimen.

   Dr. Pollak notes that he still uses oral terbinafine extensively. However, he concedes that at least 50 percent of his patients with onychomycosis are diabetic and many of them are not interested in oral agents. Dr. Kosinski concurs.

    “Many times, we think we have a candidate for systemic therapy only to find out the patient has a history of liver disease or is taking medication which would be incompatible with oral agents,” notes Dr. Kosinski. “This is not uncommon in our particular patient population.”

   When it comes to his patients in the 30 to 50 age group with onychomycosis, Dr. Markinson says about a third of these patients receive oral terbinafine. He says the rest of the patients may opt for any of the available topicals, either over-the-counter (OTC) or prescription, but notes that his “experience with completion of treatment in these cases is rare.” While Dr. Pollak does not feel that a topical antifungal such as ciclopirox is effective for patients with moderate to severe onychomycosis, he says it does have a place in the treatment of mild onychomycosis.

   Dr. Jacobs counters that no topical agents have proven to be effective for the clinical and mycologic cure of onychomycosis. When patients with onychomycosis initially present for treatment, Dr. Jacobs obtains a fungal histology and cultures. He does employ 40% urea cream to facilitate lysis of the nail plate from the nail bed. Dr. Jacobs says this permits aggressive removal of infected nail plate material. Subsequently, Dr. Jacobs utilizes topical antifungal therapy for the exposed nail bed in combination with oral antifungal therapy, typically terbinafine.

   When it comes to laser therapy, Dr. Jacobs says there is currently no evidence of clinical or mycologic cure in the long term. He notes that he has not incorporated laser therapy into his practice at this time due to the initially reported results of laser therapy demonstrating only temporary improvement and the significant financial cost to the patient.

    “I would think that ethical practitioners utilizing this modality would advise those patients paying for such therapy that the ultimate cure rate is unclear and that repeated laser management may very well be required,” maintains Dr. Jacobs.

   Dr. Kosinski says he has used the PinPointe FootLaser (PinPointe) for the past year at the New York College of Podiatric Medicine. “Right now, we are trying to gauge exactly how well it works and where it best fits in with the other treatments,” adds Dr. Kosinski. Dr. Markinson does not currently use laser therapy but he says this is more of a business decision related to being in a hospital-based practice where dermatology colleagues and lasers are readily available.

Q:

What are your thoughts on the onslaught of non-FDA approved treatment, including topical agents and devices, for onychomycosis that are being marketed to the profession? Which, if any, have you used? What sort of success are you finding? How do you define “success” in these patients?

A:

Dr. Jacobs says he does not utilize newer therapies with “unproven benefit” to the patient for the management of onychomycosis. For example, Dr, Jacobs notes that shoe disinfection techniques with chemical agents or ultraviolet light reduce the fungal load within the shoe, but have not been demonstrated to reduce the risk of re-infection.

   Dr. Markinson notes the commercial success of the “onslaught” of non-FDA approved therapies is dependent upon clinician rejection of using systemic therapy. While he notes that clinicians overwhelmingly attest that systemic therapy offers the best results for onychomycosis, Dr. Markinson says they may not employ systemic therapy due to “overstated safety concerns.” Nevertheless, Dr. Markinson says anecdotal evidence from both clinicians and patients support varying degrees of clinical success with these non-FDA approved agents.

    “Due to the low morbidity associated with onychomycosis in otherwise healthy patients and the emphasis on clinical success over negative mycology, I have no real problem with the use of these (non-FDA approved) agents,” notes Dr. Markinson.

   Dr. Kosinski concurs. If the products are not considered harmful and patients are informed that the products are not FDA-approved, Dr. Kosinski doesn’t have a problem with patients seeking out these therapies.

    “I find nothing wrong with patients trying them,” explains Dr. Kosinski. “What I do have a problem with is patients paying for expensive treatments (by companies) that make unrealistic claims.”

   Dr. Jacobs concurs. He says ciclopirox topical nail lacquer was an example of ineffective therapy, “which never had any compelling data to support the cost of the agent.”

   Dr. Kosinski says the Tetra Corporation has an interesting marketing strategy in that the company offers a 100 percent money-back guarantee with its Formula 3 product.

    “If it works, great. If it doesn’t, the patient is not out any money. I cannot see a downside,” notes Dr. Kosinski. “However, I again inform the patient as to the general success rate of topical agents before beginning treatment.”

   Being in a hospital-based practice, Dr. Markinson does not sell products. However, he has been informed recently that the Tetra Corporation plans to support a clinical trial on the Formula 3 product that will focus on clinical cure. “To my knowledge, this is the only company so far willing to do so,” adds Dr. Markinson.

   Although Dr. Landsman rarely recommends topical agents, he says nearly all of his patients with onychomycosis have tried topical agents. He says tea tree oil is the most common treatment but his patients have also tried bleach, ciclopirox and even Vicks Vaporub. Dr. Landsman notes he has not found any of these to be effective so he rarely recommends them. He does note, however, that sometimes regular treatment with these agents causes some softening of the nails and this may be beneficial for reducing the risk of onychocryptosis.

   Overall, the success of any topical for onychomycosis is dependent upon the severity of the disease and patient adherence, according to Dr. Kosinski.

    “The very fact the patient has to apply (the topical) daily for months on end usually dooms it to failure,” claims Dr. Kosinski. “This coupled with the fact that topicals work best (when they work) on mild disease has put my personal success rate below 5 percent.”

   While Dr. Landsman notes he has witnessed the benefits of laser therapy for onychomycosis, he is “very disturbed” about the influx of new, untested devices.

    “In my opinion, many device manufacturers are making unfounded claims of efficacy, based primarily on the wavelength(s) selected,” explains Dr. Landsman. “I feel that they are intentionally clouding the waters by ignoring pulse train patterns, energy density and all of the other parameters that will influence the outcomes. They are so anxious to get to market quickly that they are sidestepping the normal testing and approval process. It costs a lot of money to test these devices so if you are paying a small amount to get a laser, chances are that the price reflects that lack of clinical trials.”

   Dr. Pollak notes that one of the companies manufacturing laser therapy devices has been aggressive in marketing not only to the profession but to the patient population as well. He says he sees a newspaper ad for laser treatment every three days. Dr. Pollak says the marketing of laser therapy has been successful in bringing in patients who are looking for either a cure or a substantial improvement.

   Dr. Jacobs says laser therapy for onychomycosis remains unproven and it has not been demonstrated to reduce the risk of re-infection.

   While Dr. Pollak has used laser therapy, he only did so in a research setting so he declines to comment on whether the modality was successful. However, Dr. Pollak says success “doesn’t necessarily have to be a complete cure.” He says a complete cure would be a toenail with negative KOH, negative fungal culture and complete eradication of the fungus. However, this “pinnacle of success” remains elusive for any single modality, according to Dr. Pollak.

    “Even as successful as Lamisil was, (complete cure) only occurred in 38 percent of the patients studied and it only occurred in 14 percent of patients treated with Sporanox,” points out Dr. Pollak. “So if one defines success as a perfectly healthy toenail without laboratory evidence of fungus, the highest current benchmark is 38 percent, which, depending on your perspective, could not be considered very high.”5,6

   Dr. Pollak says a more “practical” definition of success is a substantial improvement of the nail from baseline. In the oral terbinafine and itraconazole trials, Dr. Pollak says researchers looked for 5 mm of healthy toenail growth from baseline.5,6

    “The thought process was if you allow the nail to grow out, ultimately it would continue to grow out without fungus,” adds Dr. Pollak.

   Dr. Kosinski agrees there are varying perceptions about what constitutes success in onychomycosis treatment. While he says the optimal goal is complete resolution 12 months after the beginning of treatment, Dr. Kosinski feels success is any improvement in the appearance of the nail after treatment.

    “I base it on clinical rather than mycological criteria since appearance is what the patient is concerned about,” notes Dr. Kosinski. “Each patient has his or her own definition of success, however. This is why realistic treatment goals must be fully discussed with the patient prior to embarking on therapy.”

Q:

Pursuant to the previous question, do you see any ethical/moral issues with dispensing or utilizing — at sometimes significant out of pocket cost to the patient — a product or device without FDA approval or any supportive clinical trials for the treatment of onychomycosis?

A:

From his vantage point, Dr. Jacobs finds no ethical dilemma in dispensing and selling anything that would be prescribed in any event. However, he says there are some instances when profit motive takes priority over patient need. Dr. Jacobs adds that this problem is not unique to the podiatry profession.

   In regard to the dispensing of unproven agents or therapies, Dr. Jacobs says if a practitioner has a “reasonable basis for belief that a particular agent will indeed be of benefit to a patient,” then the clinician should proceed accordingly.

    “One must remember that practitioner experience is also a part of evidence-based medicine,” maintains Dr. Jacobs.

   Dr. Markinson says he sees “far more ethical/moral problems” with everyday approved products like durable medical equipment (DME), internal fixation and orthotics “that really accrue some outrageous unnecessary expenditures with questionable need” than anything he has seen in regard to topical agents for onychomycosis.

   Dr. Pollak says he has ethical and moral issues about attracting patients to one’s practice with the perceived promise of toenail fungus removal when there is no clinical trial proof that the treatment would work. He says clinical trials are essential to prove a product or medication works.

    “The cost of some of these (laser) treatments could be $800 to $1,000. It is a costly treatment,” notes Dr. Pollak. “The concern is if the treatment is not effective, what do you do when the patient comes back a year later and his or her nail is no better than it was? I think that is a moral concern. Of course, no one can guarantee results any more than you can guarantee results from a surgical procedure.”

   Drs. Kosinski and Landsman say adequate disclosure is the key. Problems arise when the patient is not fully informed, according to Dr. Kosinski.

    “The more a patient pays out of pocket, the more he or she will expect results,” emphasizes Dr. Kosinski. “Patients are paying to achieve the ideal result they have in their minds.”

   Dr. Kosinski says it is important to establish realistic expectations with the patient.

    “It is our duty to inform the patients, in realistic terms and in a way that they can understand, the odds for improvement,” notes Dr. Kosinski. “That goes for whether or not the treatment is covered by the patient’s insurance. If the patient begins treatment knowing his or her odds for improvement, and elects to go through with the treatment even in the face of out of pocket payment, then the patient does so with open eyes.”

   In his experience, Dr. Landsman has found that cost does not seem to be a barrier for patients suffering with onychomycosis. He says they are looking for a solution and are willing to pay if the treatment works.

   In regard to laser therapy, some studies are available with devices such as the Noveon (Nomir Medical) and PinPointe FootLaser so at least there is a basis for treatment and discussion of outcomes, according to Dr. Landsman.7,8 For most of the other laser devices without FDA clearance, Dr. Landsman says podiatrists have to ask themselves whether they would use these devices to treat members of their family, knowing that there “is almost no data to support the safety and efficacy.” Dr. Landsman asserts that all lasers are not interchangeable based on wavelength and improperly delivered energy can potentially burn the nail bed, disfigure the nail matrix and cause the nail to loosen or fall off.

Q:

Now that the PinPointe Foot Laser has received FDA clearance for the temporary clearing of fungal toenails and there is a good chance more cleared lasers are to follow (assuming the FDA logjam has broken down), what impact do you think laser therapy will have in podiatric practice?

A:

Oral and topical therapies will remain the “predominant forms of treatment” for onychomycosis for two reasons, according to Dr. Kosinski. He says the first reason is ease of treatment as anyone with a prescription pad can treat onychomycosis. Dr. Kosinski also notes these therapies are for the most part covered by insurance with little or no out of pocket expense for the patient.

   Dr. Kosinski says access to laser therapy now and for the foreseeable future will be limited to doctors who are willing to lease or purchase laser devices, and by a patient’s willingness to pay out of pocket for an expensive treatment. However, if it can be proven that laser therapy has higher efficacy than oral antifungal therapy, Dr. Kosinski says laser therapy would have the potential to become the more dominant mode of treatment.

   Dr. Jacobs says laser therapy will remain attractive to those who can afford it.

    “We live in a time when ‘anti-aging’ therapies, pharmacologic agents, plastic surgery and cosmetics are in great demand,” points out Dr. Jacobs. “There is a large market for such therapies among those unaffected by the current economic environment. … However, honest and ethical representation of what might actually be expected from such treatment modalities should be a priority.”

   Drs. Landsman and Pollak say podiatric physicians want to offer treatments that will work and documented evidence goes a long way in this regard.

    “The FDA clearance for the PinPointe FootLaser is important because it says the evidence of efficacy was strong and it spells out what the clinician should expect when he or she treats with this device,” says Dr. Landsman. “Due to the high risk of recurrence, the current wisdom is that onychomycosis is not cured but rather controlled. The FDA clearance of the PinPointe FootLaser indirectly references this by stating that this device has been shown to clear these infected nails.”

   Dr. Markinson counters that the verbiage of the FDA clearance for this device (“temporary clearing of fungus toenails”) is “anemic.” He notes that the issues at the FDA that resulted in this weak clearance are complicated and beyond the scope of this article.

   That said, Dr. Markinson says he has been involved with the development and clinical trials of a laser currently on the market. He says the results are impressive and may even be as good as oral therapy, both in clinical improvement and negative mycology. For now, Dr. Markinson says laser therapy for onychomycosis offers clinicians a cash basis alternative and removes the side effect issues of oral therapy. However, Dr. Markinson emphasizes that more research is needed to ascertain the benefits of each individual laser modality and, similar to the other panelists, expresses concern about marketing claims that are not backed up by evidence.

    “We will not know for some time how effectively each laser that gets approval will work until larger numbers of cases are completed,” says Dr. Markinson. “I am concerned that if current marketing techniques regarding the use of laser continue, it will only be a matter of time before FDA enforcement and many of our colleagues are staring into each others’ eyes. If that happens, we lose.”

   Dr. Jacobs is a Fellow of the American College of Foot and Ankle Surgeons, and the American Professional Wound Care Association. He is in private practice in St. Louis.

   Dr. Kosinski is a Professor of Podiatric Medicine at the New York College of Podiatric Medicine. He is a Fellow of the Infectious Diseases Society of America and the New York Academy of Medicine.

   Dr. Landsman is an Assistant Professor of Surgery at Harvard Medical School and the Chief of the Division of Podiatric Surgery at Cambridge Health Alliance. He is the Director of Research at the California School of Podiatric Medicine at Samuel Merritt University. Dr. Landsman is a Fellow of the American College of Foot and Ankle Surgeons.

   Dr. Landsman is a paid consultant for PinPointe USA and previously served as a paid consultant to Nomir Medical Technologies.

   Dr. Markinson is the Chief of Podiatric Medicine and Surgery in the Leni and Peter W. May Department of Orthopedic Surgery at the Mount Sinai School of Medicine in New York, N.Y. He is a Fellow of the American Society of Podiatric Dermatology. Dr. Markinson is an advisor to and shareholder of Shoe Care Innovations, the manufacturer of the Steri-Shoe. He is also a member of the podiatric advisory board for Nomir Medical Technologies.

   Dr. Pollak is a Diplomate of the American Board of Podiatric Surgery and is a Fellow of the American College of Foot and Ankle Surgeons. He has been a principal clinical investigator in over 80 clinical trials. Dr. Pollak is in private practice in San Antonio.

   Dr. Joseph is a consultant in lower extremity infectious diseases and is a Fellow of the Infectious Diseases Society of America. He is affiliated with the Roxborough Memorial Hospital in Philadelphia. Dr. Joseph has disclosed that he is a member of the podiatric advisory board for Nomir Medical Technologies.

References
1. Boyko EJ, Ahroni JH, Cohen V, Nelson KM, Heagerty PJ. Prediction of diabetic foot ulcer occurrence using commonly available clinical information: the Seattle Diabetic Foot Study. Diabetes Care. 2006:29(6):1202-7.
2. Pollak R, Billstein SA. Safety of oral terbinafine for toenail onychomycosis. J Am Podiatr Med Assoc. 1997;87(12):565-70.
3. Farkas B, Paul C, Dobozy A, et al. Terbinafine (Lamisil) treatment of toenail onychomycosis in patients with insulin-dependent and non-insulin-dependent diabetes mellitus: a multicentre trial. Br J Dermatol. 2002;146(2):254-60.
4. Zaias N, Rebell G. The successful treatment of Trichophyton rubrum nail bed (distal subungual) onychomycosis with intermittent pulse-dosed terbinafine. Arch Dermatol. 2004:140(6):691-5.
5. Terbinafine package insert, Novartis Pharmaceuticals.
6. Itraconazole package insert, Ortho-McNeil/Janssen Pharmaceuticals.
7. Landsman AS, Robbins AH, Angelini PF, et al. Treatment of mild, moderate, and severe onychomycosis using 870- and 930-nm light exposure. J Am Podiatr Med Assoc. 2010;100(3):166-77.
8. Harris DM, McDowell BA, Strisower J. Laser treatment for toenail fungus. Proc SPIE 2009;7161A:1-7.

   Editor’s note: As this issue went to press, Cutera, Inc. announced that it received FDA 510(k) clearance for its GenesisPlus laser.

Features
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Moderator: Warren S. Joseph, DPM, FIDSA

Panelists: Allen Jacobs, DPM, FACFAS, Mark Kosinski, DPM, FIDSA, Adam Landsman, DPM, FACFAS, PhD, Bryan Markinson, DPM, FASPD, and Richard Pollak, DPM, MS, FACFAS
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