Emerging Concepts In Treating Onychomycosis

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Author(s): 
John D. Mozena, DPM, and Joshua P. Mitnick, DPM

   PinPointe FootLaser has received FDA approval for use in podiatry, dermatology and plastic surgery but it does not have a specific indication for onychomycosis at this time. However, in Europe, it recently received the CE Mark approval (certifying that it has met EU consumer and health safety standards) for the treatment of toenail fungus. The cost of the procedure is approximately $1,000.24

   Transungual laser therapy (TLT, Arpida) is a new device which makes partial micro-holes to the dorsal nail plate. This facilitates the permeation of terbinafine to the ventral side of the nail.25 Patients then apply a daily topical formulation of a terbinafine lacquer solution and ethanolic liquid on a daily basis. A European regulatory agency has initiated a phase III clinical trial to evaluate the efficacy, safety and tolerability of the TLT therapy.

   Keraderm is creating a UVC device that offers two to four phototherapy treatments using a germicidal light. The treatment uses UVC rays, which are shorter than UVA and UVB rays. Microorganisms are very sensitive to UVC light and therefore only small amounts of UVC light can make microorganisms harmless. The radiation that the nail bed experiences is approximately equal to 20 minutes of sun exposure.

   With respect to current clinical trials, the FDA has designated this device as having a non-significant risk. In the pilot trial, there were no significant side effects and 73 percent of those treated showed significant improvement in their nails.26

   The device will be introduced in 2010 at approximately $100 for several treatments. The goal is to eventually only need one treatment for about $100. Keraderm’s research with this device has been published in the peer-reviewed British Journal of Dermatology and presented at the 2007 World Congress of Dermatology.26,27

   Talima Therapeutics is working on a micro-implant to deliver a broad-acting time release antifungal molecule to the site of the nail infection. One would place the implant in a non-invasive manner with an applicator at the target site.28 Phase III clinical trials are currently underway in the U.S. to determine the safety and efficacy of the micro-implant. This technology has the potential to deliver high and sustained therapeutic levels of drug to the diseased area, thereby minimizing blood levels of the drug by up to a thousand-fold in comparison to conventional administration.

   A new device called the Toemate (Innovation Biomedical Devices) reportedly treats onychomycosis by heating (40ºC max) a viscous antifungal liquid through the keratin in the nail plate. The theory is that heat will increase kinetic energy and facilitate drug absorption.

   When keratin is heated, it has a tendency to absorb water into its structure and will absorb antifungal medication attached to absorbed fluid. Applying heat increases the rate and depth of this absorption by increasing the space between molecular bonds. This device is currently undergoing clinical trials at Temple University.29

Dr. Mozena is in private practice at the Town Center Foot Clinic in Portland, Ore. He is a Fellow of the American College of Foot and Ankle Surgeons and is board certified in foot and ankle surgery.

Dr. Mitnick is in private practice at Town Center Foot Clinic in Portland, Ore.

For further reading, see “Treating Fungal Infections,” a March 2004 supplement to Podiatry Today, “Managing Onychomycosis,” a June 2004 supplement, or “A Guide To Treatments For Onychomycosis” in the August 2003 issue.

For other related articles, please visit the archives at www.podiatrytoday.com.




References:

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Eric Bornsteinsays: October 13, 2009 at 11:01 am

For professionals in the Podiatric community that are interested, here is the current Pivotal Study information on the Noveon from Nomir Medical Technologies

There were 36 subjects (53 Toes) enrolled in the study.

Starting after the completion of the second of the four treatments, all subjects were required to use a non-prescriptive topical agent: 1% topical terbinafine cream applied only between the toes to control or prevent tinea interdigitalis.

Patients were instructed to not get any cream on the nails.

Use of this topical between the toes only, was in accordance with the current listed product information and is neither FDA indicated, nor FDA cleared as a treatment for onychomycosis. Other adjunctive actions that are "standard of care", such as nail debridement or nail trimming, were allowed at each investigator’s discretion.

Control subjects were handled identically in all respects to those who were treated, except for, of course, with sham “treatment” there was no energy delivery. The highest treatment site temperature was 100.5°F.

All study subjects had to have laboratory confirmation of onychomycosis by either positive culture using a selective dermatophyte test medium, or positive periodic acid-Schiff staining (PAS) from a toenail sample.

The mycology was followed and data taken for the 180 day balance of the study.

The top-line preliminary 120-day data analysis that was presented at the Council for Nail Disorders 13th Annual Scientific Meeting, and demonstrated that after Noveon treatment, 76.3 percent of the treated toes showed evidence of clinical improvement (p<0.02), and a significant drop in positive culture was seen in 74 percent of the treated toes after only two treatments (before the introduction of the tinea pedis cream.)

This data was based on at least 120 days of follow-up on all enrolled patients. Additionally, no significant adverse events were reported.

The final 180 day data, is currently under review by the FDA in an application for 510(k) approval for Onychomycosis treatment, and has been accepted for publication with a Podiatric peer-review journal.

Completed pilot study data with this device can be found at:

Bornstein, E.S., A.H. Robbins, M. Michelon (2008) Photo-inactivation of fungal pathogens that cause onychomycosis in vitro and in vivo with the noveon dual wavelength laser system. 2008 New Cardiovascular Horizons Meeting Abstracts.

http://www.nomirmedical.com/pdf/NCH_...L_08-26-08.pdf

A lengthy discussion on this and other light-based onychomycosis technologies can be found at:

http://www.podiatry-arena.com/podiat...ad.php?t=22925

Eric Bornstein
Chief Science Officer
Nomir Medical Technologies

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