Onychomycosis Due to Trichophyton Mentagrophytes Clinical Trial
Official title:
A Multi Center Open Label Early Feasibility Study to Evaluate the Efficacy and Safety of the RenewalNail™ Plasma Treatment System in Patients With Mild to Moderate Onychomycosis (Fungal Nail) of the Hallux Caused by Trichophyton Rubrum or Trichophyton Mentagrophytes.
Early feasibility study to determine if a three-treatment protocol with the RenewalNail™ plasma treatment system over a week will result in mycological cure and/or clear nail growth on the treated hallux toe.
The Sponsor has developed the RenewalNail™ plasma treatment system to topically treat fungal
infected toenails. The goal of the RenewalNail™ therapy is to overcome the shortcomings of
both topical and oral therapies by combining the safety of a topical treatment with the
efficacy of an oral treatment.
The primary objective of this early feasibility study is to evaluate the efficacy and safety
of the RenewalNail™ plasma treatment system and Protocol in achieving mycological cure for
the patient. The Protocol calls for three 45-minute treatments performed over a week to
achieve mycological cure. Mycological cure will be assessed with two consecutive mycological
culture tests done over a week. Two consecutive negative results will confirm the elimination
of fungus causing onychomycosis infection, as recommended by recent FDA guidance. There will
be no placebo arm in the study.
Secondary objectives include assessing if the treatment protocol results in clear nail growth
for the patient over a 5-month interval.
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