Status:
COMPLETED
Clinical Evaluation of the Efficacy of a Medical Device in Treatment of Toenail Onychomycosis
Lead Sponsor:
Oystershell NV
Conditions:
Onychomycosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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…).
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT03289871
Start Date
January 1 2015
End Date
November 1 2015
Last Update
September 21 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Habib Thameur
Tunis, Tunisia
2
Principal instruction military hospital
Tunis, Tunisia