Evaluating two products for treating nail fungus
MULTICENTRIC, RANDOMIZED, EVALUATOR BLINDED CLINICAL INVESTIGATION FOR THE EVALUATION OF EFFICACY AND SAFETY OF TWO PRODUCTS FOR THE TREATMENT OF ONYCHOMYCOSIS
This study is testing a new device for treating nail fungus to see if it works better than an existing product in helping people improve their nail health over nine months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Oystershell NV Industry-sponsored |
| Locations | 1 site (Villeurbanne, France) |
| Trial ID | NCT06689852 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to evaluate the efficacy and safety of a new medical device, ENRICHED (X92001591), compared to a reference product, Loceryl (5% amorolfine), in treating onychomycosis. The study will involve 88 patients who will be randomly assigned to receive either treatment for a duration of 9 months. The primary goal is to assess the percentage of healthy nail surface improvement from baseline, as determined by a blinded investigator. Patients will have follow-up visits at baseline, 3 months, 6 months, and 9 months to monitor progress and adherence to the treatment protocol.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with superficial onychomycosis on at least one nail and who have not used systemic or topical antifungal treatments recently.
Not a fit: Patients with severe onychomycosis involving the nail matrix or those currently using antifungal treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective treatment option for patients suffering from onychomycosis.
How similar studies have performed: Other studies have shown varying degrees of success with similar topical treatments for onychomycosis, but this specific approach is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion 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…).
Where this trial is running
Villeurbanne, France
- Eurofins Dermscan Pharmascan — Villeurbanne, France, France (Recruiting)
Study contacts
- Study coordinator: Manon Laune, Project manager
- Email: manon.laune@cpt.eurofinseu.com
- Phone: +33472823656
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.