Overview

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…).