Status:
NOT_YET_RECRUITING
Evaluation of a Combination of Two Medical Devices and One Device Use in the Treatment of Toenail Onychomycosis
Lead Sponsor:
Swiss Footcare Laboratories - Poderm Professional
Conditions:
Onychomycosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical investigation is to evaluate the efficacy of the tested products in medium to moderate onychomycosis after 112 days of treatments. The main question it aims to answer is the...
Detailed Description
Onychomycosis is a fungal infection of the nail apparatus that causes discoloration, thickening, and separation from the nail bed. It is primarily caused by dermatophytes, which are infectious fungi ...
Eligibility Criteria
Inclusion
- Patient having given freely her/his informed, written consent.
- Patient having a good general health.
- Age: more than 18 years.
- Patient cooperative and aware of the devices' modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.
- Patient being psychologically able to understand information and to give his/her consent.
- Patient with nails 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)
- Patient with slight to moderate impact of thickness of the nail and no deformation of the nail.
- Patient with slight to moderate impact of thickness of the nail and no deformation of the nail.
- Patient with positive KOH staining.
- Women of childbearing potential should use an accepted contraceptive regimen (to investigator's discretion) since at least 12 weeks before the beginning of the study, during all the study.
Exclusion
- Pregnant or nursing woman or planning a pregnancy during the investigation.
- Patient considered by the investigator likely to be non-compliant with the protocol.
- Patient enrolled in another clinical trial during the test period.
- Patient having a known allergy or hypersensitivity to one of the constituents of the tested products.
- Patient with unstructured nail, severe microcracking or severe onycholysis.
- Patient with nails and nails contour with severe lesions
- Patient having used any systemic antifungal treatment in the last 6 months before inclusion.
- Patient having used any topical antifungal treatment in the last 3 months before inclusion.
- Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk.
- Patient suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, lichen planus, immunosuppressive pathology, chronic venous insufficiency, Peripheral Arterial Obstructive Disease, delay or lack of ungual growth …
- Patient with cutaneous pathology on studied zone (onychogryphosis, congenital ungual deformation, toe deformation or of the foot, Hallux Valgus, Hallux rigidus, Hallux extensus, toe claws or other pathologies than onychomycosis like angioma, dermatitis…).
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06175013
Start Date
September 1 2024
End Date
January 1 2025
Last Update
July 24 2024
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