Evaluating two products for treating nail fungus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Eurofins Dermscan Pharmascan
  Villeurbanne, France, France Recruiting

Study contacts

• Study coordinator: Manon Laune, Project manager
• Email: manon.laune@cpt.eurofinseu.com
• Phone: +33472823656

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Dermatophyte antifungal susceptibility in Faisalabad: terbinafine and itraconazole MICs

  This study tests how common skin fungus infections in Faisalabad respond to terbinafine and itraconazole by measuring the lowest drug levels that stop growth in patient samples.

  Recruiting Allied Hospital Faisalabad · Faisalabad, Punjab Province · NCT07898475

• Comparing low-dose isotretinoin and excimer light as add-ons to itraconazole for nail fungus

  This tests whether adding low-dose isotretinoin or excimer light to standard itraconazole helps people with confirmed dermatophyte nail fungus clear their infection faster or more completely.

  Recruiting Phase 1 Zagazig University · Zagazig, Zagazig · NCT06485505

• Evaluating ATB1651 for treating mild to moderate onychomycosis

  This study is testing a new topical treatment called ATB1651 to see if it can help adults with mild to moderate toenail fungus feel better.

  Recruiting Phase 2 AmtixBio Co., Ltd. · Christchurch · NCT06327295

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.