JULY 9, 2009--PathoLase Inc. (Chico, CA) says it has begun a major multi-site clinical trial to evaluate its PinPointe FootLaser treatment for infected toenails (onychomycosis) at four separate research centers in North America. The company uses a patented laser technology to target the pathogens that cause toenail fungus (onychomycosis), an infection that afflicts an estimated 40 million people in the US. PinPointe FootLaser recently received CE Mark approval, certifying that it has met EU consumer and health safety standards and can be offered by PinPointe certified healthcare providers throughout Europe.
The current clinical trial initiative is a controlled multi-center study to evaluate the effectiveness of the PinPointe FootLaser treatment. It is a significantly expanded follow-up to an initial PinPointe FootLaser clinical study conducted among a small group of patients (Harris, McDowell and Strisower, Laser Treatment for Toenail Fungus, Proc. SPIE 7161A, 2009). The early study indicated a potential efficacy rate as high as 87%, a finding which the current study aims to verify.
The new study's randomized blind trial will evaluate the right and left great toes of approximately 125 subjects infected with onychomycosis. The subjects will be randomized and analyzed based on treatment or no-treatment with PinPointe FootLaser. Before and after samples from infected areas of each toe will be evaluated for the presence and species of fungus with the KOH, PCR and culture tests. In addition, a blind study of nail bed clearing and nail plate growth will be measured using high-resolution photographs by evaluators. Research subjects will be evaluated at baseline and at intervals out to 48 weeks for both safety and effectiveness of the PinPointe FootLaser treatment.
The four sites at which PinPointe FootLaser clinical trials will be held include:
1. London Ontario, Canada. The dermatology clinic and research facility of Aditya K. Gupta, M.D., Ph.D., M.A.(Cantab), DABD, FAAD, FRCPC, one of the world's most respected researchers in Onychomycosis and Director of Mediprobe Research, a world class dermatology research and clinical trials center where the study will be conducted.
2. Seattle, WA. The private practice/clinical research facility of Bernard Goffe, MD, Dermatology Associates, a dermatologist and world authority on nail diseases.
3. San Antonio TX. The chief investigator will be Richard Pollak DPM, a leading researcher in the field of Onychomycosis. The facility, Endeavor Clinical Trials, PA, located in the Medical Center of San Antonio, is a privately owned, multi-therapeutic, dedicated research center set up to conduct Phase II-V trials.
4. Rochester, NY. The trial will be conducted under the guidance of Dr. Raymond Lanzafame MD MBA FACS and Rochester University. Dr. Lanzafame has been a pioneer in the development of lasers in surgery and medicine. He is past president of the American Society for Laser Medicine and Surgery (ASLMS) is currently Director of CME for ASLMS, and President of the North American Association for Laser Therapy (NAALT). He is also the editor of Photomedicine magazine.
PinPointe FootLaser was developed to treat patients safely and quickly with no drugs, no anesthesia and no pain: Laser light passes through the toenail without causing damage to the nail or surrounding skin. Following the procedure, the new nail will grow in healthy and clear. Unlike medication-driven treatments for toenail fungus, PinPointe FootLaser presents minimal risk of side effects whereas competing medications can result in a wide variety of side effects, including liver toxicity.