Onychomycosis (OM) is a chronic fungal infection of the nail plate, nail bed, or both.
It is estimated to affect nearly 10% of the general population, with the incidence rising sharply, to nearly 30%, in patients over age 60.
LUNULA utilizes two unique wavelengths that target OM’s complex patho-physiology. LUNULA not only destroys the fungal pathogen, it also improves circulation and strengthens the body’s immune response.
LUNULA is the only
OM treatment available today!
UNITED STATES CLINICAL STUDY
The purpose of this study was to demonstrate through retrospective analysis the efficacy of the Erchonia LunulaLaser, manufactured by Erchonia Corporation, for the increase of clear nail in patients with toenail onychomycosis, when applying the LunulaLaser to the toenail for 12 minutes one time per week for a total of 4 procedure administrations.
This study was a retrospective analysis of a compilation of pre-procedure and six-month post procedure pholographs of fifty-four (54) great toenails with varying degrees of onychomycosis disease involvement selected from amongst an existing pool of photographs taken during three prior Erchonia Corporation research studies wherein 4 sequential weekly 12-minute procedures with the LunulaLaser were administered. The evaluating investigator was blinded to corresponding pre and post-procedure photographs through application of a randomized numeric coding methodology.
The linear measurement of millimeter (mm) of clear nail from the proximal nail fold to the most proximal area of nail dystrophy was objectively measured from unmarked digital photographic images using the validated GNU Image Manipulation Program (GIMP 2.8) software system, a multi-platform image/photo manipulation software system, at baseline evaluation (prior to LunulaLaser procedure administration) and at 6 months following completion of the LunulaLaser procedure administration protocol.
Primary Outcome Measure: Change in mm of Clear Nail from Baseline to Study Endpoint: The primary efficacy outcome measure in this study was the mm of clear nail growth at 6 months post procedure administration end relative to Baseline (pre-procedure administration). Individual toenail success was defined as 3 mm or more of clear nail growth at 6 months post-procedure end relative to baseline. Overall study success was defined as an anticipated 60% of treated toenails meeting the individual toenail success criteria.
Sixty seven per cent (67%) of all study treated toenails evaluated in this study met the study individual toenail success criteria, exceeding the pre-established overall study success goal of 60% by 7%. The magnitude of the mean change in mm of clear nail from baseline to 6 months post-procedure for all treated toenails was an increase of 5.18 mm, 2.18 mm in excess of the pre-established 3 mm increase success criteria. A t-test for paired samples found this mean change of +5.18 mm in clear nail to be statistically significant (t=-8.0; df=53; p<0.0001).
The Erchonia LunulaLaser is an effective tool for increasing clear nail in toenails infected with onychomycosis, significantly increasing mm of clear nail over a 6 month period following completion of the 4-week procedure administration phase.