Onychomycosis of Toenails Clinical Trial
Official title:
A Prospective, Open Label, Non-comparative Clinical Investigation to Evaluate the Performance of a Fungal Nail Treatment on the Visual Signs of Onychomycosis
This is a prospective, open label, non-comparative clinical investigation to evaluate the
performance of a Fungal Nail Treatment on the visual signs of onychomycosis.
The Fungal Nail Treatment is a CE Marked Class I Medical Device and is commercially
available as an over-the-counter product.
The ability of the Fungal Nail Treatment to treat the visual signs of mild fungal toenail
infections will be determined by a reduction in the surface area of the infection over time.
This will be assessed through visual quantification of the infected area from baseline, as
measured by image analysis, throughout the treatment period, where subjects will follow
instructions for use on the product pack and self-treat for the duration of the
investigation or until their condition has resolved. Both subject and podiatrist will assess
the improvement of signs and symptoms of the target nail.
n/a
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