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For professionals in the Podiatric community that are interested, here is the current information on this study:
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 major 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
Optical energy treatment for onychomycosis
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