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

Oystershell

Status

Completed

Conditions

Onychomycosis

Treatments

Device: Excilor

Drug: Loceryl 5%

Study type

Interventional

Funder types

Industry

Identifiers

NCT03289871

14E0752

Details and patient eligibility

About

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.

Enrollment

112 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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...).