To evaluate the safety and efficacy of the PathoLase FootLaser treatment of infected toenails.
The study is a multi-center controlled study evaluating laser treatments of infected great toes in a randomized blinded study of approximately 125 subjects. Right and left great toes are randomized to treatment or no treatment. Samples from infected areas are sampled and evaluated for presence of fungus with KOH, PCR and culture tests. Nail bed clearing and nail plate growth are measured from high resolution photographs by a blinded evaluator. Subjects will be evaluated at baseline and at 8, 16, 24 and 48 weeks for safety and effectiveness of study treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
134
Medical laser
Rochester Laser Center
Rochester, New York, United States
Endeavor Clinical Trials, PA
San Antonio, Texas, United States
Dermatology Associates
Seattle, Washington, United States
Mediprobe Research Inc
London, Ontario, Canada
Nail Bed Clearing
Change in amount of clear nail over time.
Time frame: 48 weeks
Mycology
KOH, PCR and cultures of patients who were bilaterally positive or negative for each test.
Time frame: 48 weeks
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