Onychomycosis of Toenails Clinical Trial
Official title:
A Placebo Controlled, Randomized, Prospective Study to Evaluate the Efficacy and Safety of PinPointe FootLaser in Patients Who Have Failed Oral Terbinafine Treatment for Onychomycosis
The purpose of this study is to assess the clinical efficacy and safety of the PinPointe Foot Laser device for the treatment of patients with onychomycosis who have been previously treated with oral Terbinafine and failed.
This protocol is designed to demonstrate that the PinPointe FootLaser treatment is able to
produce clinical improvement treating onychomycosis in patients who have previously taken
Terbinafine and failed treatment. The duration of enrollment for each subject will be 2
years, with the expectation that this is the time period that will yield 100% reduction in
the area of involved nail. Enrollment is competitive and we expect to enroll 40 patients at
CHA.
The medical device that is the subject of this clinical trial is the PinPointe FootLaser,
manufactured by NuvoLase, Inc. It is a pulsed Nd:Yag laser device that uses a proprietary
pulse train, operating at 1064nm wavelength, with 100 μsec pulses. It received pre-market
Section 510(k) clearance by the FDA and subsequent clearance for the treatment of
onychomycosis in 2010.
Onychomycosis (OM), a fungal infection of the toes, is a major health problem around the
world. It is estimated that there are more than 40 million sufferers with this condition in
the USA. A recent European study showed that the prevalence of onychomycosis may be as high
as 26.9%. Importantly, it is a particular problem that disproportionately affects diabetics.
The main causative agent varies according to climate. Dermatophyte infections are common
worldwide.
Preliminary in vitro and in vivo work has demonstrated the proof of principle that the
PinPointe FootLaser device can kill microorganisms, including dermatophytes and other fungi,
which infect the toenail. Based on these preliminary results, this study has been designed
to demonstrate the efficacy and safety of the PinPointe FootLaser for clearing toenails,
including those with onychomycosis.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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