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

16E1078

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.

2016-10-26

2017-08-26

2017-08-26

Completed

102

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...).

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 102, 'type': 'ACTUAL'}}

2024-03-15