Onychomycosis (a fungal infection of the nails) Infections and Infestations
Conditions
Interventions
Randomized study investigating the effects of two medical devices and Loceryl (positive control) for the treatment of fungal nail infections
Intervention group 1: Fungal Nail 3-in-1 Treatment Solutio
Sponsors
Medical Brands
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient having given freely her/his informed, written consent 2. Patient having a good general health 3. Age between 18 and 70 years 4. Patient with light to moderate distolateral subungual onychomycosis involving up to 60% of the affected great toenail or fingernail (after the nail has been trimmed). Each subgroup (toenail or fingernail) needs to represent at least 10% of each treatment arm 5. Patient with positive KOH staining 6. Patient cooperative and aware of the products modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected 7. Patient being psychologically able to understand information and to give their/his/her consent 8. Patient who agree to refrain from receiving pedicure/manicure, artificial nails and/or cosmetic nail varnish or other medication on the nail being treated for the entire study duration 9. Patient having stopped any systemic antifungal treatment since at least 6 months before screening and/or any topical antifungal treatment since at least 3 months before screening 10. Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 4 weeks before screening visit and during the study
Exclusion criteria
Exclusion criteria: 1. Pregnant, breastfeeding woman or woman planning a pregnancy during the study 2. Patient enrolled in another clinical trial or which exclusion period is not over 3. Patient with a condition or receiving a medication which, in the investigator’s judgment, put the patient at undue risk 4. Patient suffering from a severe or progressive disease (to investigator’s discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology 5. Patient having a known allergy or hypersensitivity to one of the constituents of the tested products 6. Patient with cutaneous pathology on the studied zone (other than onychomycosis like angioma, dermatitis…)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage healthy nail determined by blind by digital analysis of photographs at day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage healthy nail will be determined by blind by digital analysis of photographs on day 7, day 30 and day 90 2. Evaluation of microbiological efficacy of both treatments versus baseline and versus comparator by KOH staining and fungal culture on day 90 and day 180 3. Patient evaluation of efficacy using a diary at day 7, day 30, day 90, day 180 | — |
Countries
Tunisia
Outcome results
None listed