Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT06254027
Eligibility Criteria:
Inclusion Criteria:
1. Patient having given freely her/his informed, written consent.
2. Patient having a good general health.
3. Age: more than 18 years.
4. Patient with superficial onychomycosis on at least one great toenail or fingernail (for at least 10% in each arm) or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement \<2/3 of the tablets).
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 having stopped any systemic antifungal treatment since at least 6 months before screening.
9. Patient having stopped any topical antifungal treatment since at least 3 months before screening.
10. Patient who agrees 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.
11. Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after study end.
Exclusion Criteria:
1. Pregnant, breastfeeding woman or woman planning a pregnancy during the study.
2. Patient considered by the investigator likely to be non-compliant with the protocol.
3. Patient enrolled in another clinical trial or which exclusion period is not over.
4. Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk.
5. 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…
6. Patient having a known allergy or hypersensitivity to one of the constituents of the tested products.
7. Patient with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06254027
Study Brief:
Protocol Section:
NCT06254027