PathoLase, Inc. announced that it has started a multi-Center trial titled "Evaluation of PinPointe FootLaser Treatment for Infected Toenails (Onychomycosis)” at four separate research centers across North America.
PinPointe FootLaser targets the pathogens that cause toenail fungus (Onychomycosis) using a patented laser technology. PinPointe FootLaser recently received CE Mark approval, making it available to the healthcare providers throughout Europe.
The current multi-centered trial evaluates the effectiveness of the PinPointe FootLaser treatment. The study conducted among a small group of patients, which indicated potential efficacy rate as high as 87%.
The study will evaluate 125 subjects infected with Onychomycosis. The toes will be randomized and subjected to analysis based on treatment or no-treatment with PinPointe FootLaser. Each toe will be evaluated for the presence and species of fungus with the KOH, PCR and culture tests. Moreover, the study will evaluate nail bed clearing and nail plate growth using high-resolution photographs. The subjects will be evaluated at baseline and at intervals out to 48 weeks for safety and effectiveness of the PinPointe FootLaser.
The four sites where PinPointe FootLaser clinical trials will be held are the dermatology clinic and research facility of Aditya K. Gupta at London Ontario, the private practice/clinical research facility of Bernard Goffe at Seattle, the Medical Center of San Antonio and Rochester University.