Clinical Evaluation of the Efficacy of a Medical Device in Treatment of Toenail Onychomycosis

Clinical Evaluation of the Efficacy of a Medical Device in Treatment of Toenail Onychomycosis

This study evaluates the effect of the medical device "Excilor® Fungal Nail Infection" in the treatment of toenail onychomycosis. Half of the participants will receive the tested product and the other half will receive a comparator (Amorolfin 5%). Patients will be followed during 6 months.

Inclusion Criteria:

• Subject having given her/his informed, written consent,
• Subject 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.
• Subject being psychologically able to understand information and to give their/his/her consent.
• Age: more than 18 years.
• 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).
• Subject with positive results of KOH staining.
• Subject 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.
• Female subjects 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 the study end.

Exclusion Criteria:

• Subject considered by the Investigator likely to be non-compliant with the protocol.
• Patient enrolled in another clinical trial during the test period.
• Woman being pregnant, nursing or planning a pregnancy during the course of this study.
• Subject having a known allergy to one of the constituents of the tested products.
• Patient suffering from serious or progressive diseases (to investigator's discretion), such as diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology….
• Subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).