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

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

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.

Subjects with a great toenail, affected by onychomycosis, were treated with the test medical device or reference product, respectively. After 180 days, blind assessment of the % of healthy surface (primary end point) of the great toenail was performed to compare the effect of both treatments, and to evaluate improvement versus baseline (day 0), respectively. Additionally, blind assessment of the percentage of healthy surface of the great toenail was performed at all other visits (D30, D60, D120) to evaluate changes from baseline between both treatment groups. For this purpose, digital macrophotographs were analysed by a blinded investigator using Adobe Photoshop software.

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…).