CLINICAL INVESTIGATION for the EVALUATION of EFFICACY and SAFETY of TWO PRODUCTS for the TREATMENT of ONYCHOMYCOSIS

Launched by OYSTERSHELL NV · Nov 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness and safety of a product called ENRICHED (X92001591) for treating a nail infection known as onychomycosis, which affects the appearance and health of toenails and fingernails. The study will involve 88 participants and will take place at multiple locations. To be eligible, participants should be between 18 and 70 years old, in good general health, and have a specific type of onychomycosis on at least one of their great toenails or fingernails. Additionally, they must not have used any antifungal treatments for a certain period before joining the trial.

Participants in the trial can expect to receive the product and will be monitored closely to see how well it works and if there are any side effects. It's important for them to follow the study rules, which include not using any nail treatments or cosmetics during the trial. The study is currently recruiting participants, so if you or someone you know is dealing with onychomycosis and meets the eligibility criteria, this could be a chance to help advance treatment options for this condition.

Gender

ALL

Eligibility 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 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 and/or any topical antifungal treatment since at least 3 months before screening.
• • 9. 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.
• • 10. 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...).