MULTICENTRIC, RANDOMIZED, EVALUATOR BLINDED CLINICAL INVESTIGATION FOR THE EVALUATION OF EFFICACY AND SAFETY OF TWO PRODUCTS FOR THE TREATMENT OF ONYCHOMYCOSIS

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The efficacy and safety of ENRICHED (X92001591) will be evaluated in a multicentric, randomized, evaluator blinded clinical investigation in 88 patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Eurofins Dermscan Pharmascan
RECRUITING
Villeurbanne
Contact Information
Primary
Manon Laune, Project manager
manon.laune@cpt.eurofinseu.com
+33472823656
Time Frame
Start Date: 2024-10-30
Estimated Completion Date: 2026-04
Participants
Target number of participants: 88
Treatments
Experimental: Enriched
To be used twice daily during 9 month
Experimental: Loceryl
To be used 1 per week during 9 months
Related Therapeutic Areas
Sponsors
Collaborators: Eurofins Dermscan Pharmascan
Leads: Oystershell NV

This content was sourced from clinicaltrials.gov