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

• Status: Completed
• Trial end date: 2017-08-26
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the effect of the medical device "Excilor® Forte" 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oystershell NV
• Treatments: Amorolfine

Criteria

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 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 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 uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology…

• Subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).