Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis

Inclusion Criteria

• •1. Patient having given her/his informed, written consent.
• •2. Patient cooperative and aware of the modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.
• •3. Patient being psychologically able to understand information and to give their/his/her consent.
• •4. Age: more than 18 years.
• •5. Subject with superficial onychomycosis on at least one great toenail or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement \<2/3 of the tablet).
• •6. Patient with positive KOH staining.
• •7. Patient having stopped any systemic antifungal treatment since at least 6 months before inclusion and/or any topical antifungal treatment since at least 3 months before inclusion.
• •8. Women of childbearing potential should use an accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after study end.