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Assessing The Role Of Onychomycosis Laser Therapy In Treating Concomitant Tinea Pedis
Dr. Vlahovic, I read with interest your feature article, “Current and Emerging Agents for Tinea Pedis,” in the April 2014 issue of Podiatry Today. 
In your article, you discussed current research concerning developing treatments for tinea pedis. There is an addition that I believe should be made to this discussion concerning laser therapy for onychomycosis.
The first FDA laser approval for onychomycosis was granted in October of 2010 for a photothermal Nd:YAG laser. Since then, all subsequent photo-thermal lasers were approved with equivalent 510(k) language but none had a mention of concurrent tinea pedis treatment with the laser therapy. This situation has now changed.
In March 2014, the Noveon® Nail Laser became the first photobiologic and hands-free device approved for the treatment of onychomycosis with the novel FDA language “only when used together with topical antifungal drug therapies approved to treat the accompanying tinea pedis and/or approved to treat onychomycosis.”
This new language is significant for a couple of reasons. First, in the pilot, pivotal and retrospective studies conducted by Nomir Medical Technologies and submitted to the FDA, all of the human protocols contained interdigital tinea pedis treatment with topical antifungals. These studies were published in the Journal of the American Podiatric Medical Association from 2009 to 2012.1-3
Second, there is a plethora of literature that clearly indicates the necessity of treating tinea pedis concurrently with any onychomycosis therapy. For example, in 2001, Ingber discussed that treating tinea pedis is important for preventing recurrence of onychomycosis as fungal pathogens infecting the skin may act as a reservoir for reinfection of the nail.4 In 2001, Sciandra discussed that even if the fungi on the foot is cleared, remaining organisms in the nail will re-infect the skin.5 In 2006, Szepietowski and colleagues found that 34 percent of patients studied had concomitant tinea pedis and many researchers have discussed that onychomycosis has a high relapse rate because of (a) under-treatment and (b) reinfection from surrounding areas.6
As the Noveon Nail Laser is the only non-thermal device approved with a multi-year history of data publication in the peer-review literature, all of which accompanied concomitant tinea pedis treatment, podiatric clinicians should understand the implications of these data when deciding on which system to purchase for their patients.
— Eric Bornstein, DMD
Chief Science Officer and Chief Medical Officer
Nomir Medical Technologies
ebornstein@nomirmedical.com
References
1. Bornstein E. A review of current research in light-based technologies for treatment of podiatric infectious disease states. J Am Podiatr Med Assoc. 2009;99(4):348-352.
2. Landsman AS, Robbins AH, Angelini PF, et al. Treatment of mild, moderate, and severe onychomycosis. J Am Podiatr Med Assoc. 2010;100(3):166-177.
3. Landsman AS, Robbins AH. Treatment of mild, moderate, and severe onychomycosis using 870- and 930-nm light exposure; some follow-up observations at 270 days. J Am Podiatr Med Assoc. 2012;102(2):169-171.
4. Ingber A. Intermittent low dose itraconazole treatment for onychomycosis: long-term follow up. Med Mycol. 2001;39(6):471-473.
5. Sciandra J. A closer look at onychomycosis. Podiatry Management. 2001;20(6):121-132.
6. Szepietowski JC, Reich A, Garlowska E, et al. Factors influencing coexistence of toenail onychomycosis with tinea pedis and other dermatomycoses: a survey of 2761 patients. Arch Dermatol. 2006;142(10):1279-84.
