Actively Recruiting
CLINICAL INVESTIGATION FOR THE EVALUATION OF EFFICACY AND SAFETY OF TWO PRODUCTS FOR THE TREATMENT OF ONYCHOMYCOSIS
Led by Oystershell NV · Updated on 2025-09-03
88
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
Sponsors
O
Oystershell NV
Lead Sponsor
E
Eurofins Dermscan Pharmascan
Collaborating Sponsor
AI-Summary
What this Trial Is About
The efficacy and safety of ENRICHED (X92001591) will be evaluated in a multicentric, randomized, evaluator blinded clinical investigation in 88 patients.
CONDITIONS
Official Title
CLINICAL INVESTIGATION FOR THE EVALUATION OF EFFICACY AND SAFETY OF TWO PRODUCTS FOR THE TREATMENT OF ONYCHOMYCOSIS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has given freely informed, written consent.
- Patient is in good general health.
- Age between 18 and 70 years.
- Patient has superficial onychomycosis on at least one great toenail or fingernail (at least 10% involvement) or light to moderate disto-lateral onychomycosis without matrix involvement and less than two-thirds of the nail affected.
- Positive KOH staining confirming fungal infection.
- Patient is cooperative and understands product use and study requirements for adherence.
- Patient is psychologically able to understand information and give consent.
- Patient has stopped any systemic antifungal treatment at least 6 months before screening and/or topical antifungal treatment at least 3 months before screening.
- Patient agrees to avoid pedicure, manicure, artificial nails, cosmetic nail varnish, or other nail medications on treated nails during the study.
- Female patients of childbearing potential use recognized effective contraception starting at least 12 weeks before screening, throughout the study, and for 1 month after study end.
You will not qualify if you...
- Pregnant, breastfeeding women or women planning pregnancy during the study.
- Patients considered likely to be non-compliant with the protocol.
- Patients currently enrolled in another clinical trial or within the exclusion period.
- Patients with conditions or medications that put them at undue risk as judged by the investigator.
- Patients with severe or progressive diseases such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, or immunosuppressive conditions.
- Patients with known allergy or hypersensitivity to any components of the tested products.
- Patients with other skin conditions on the studied area besides onychomycosis, such as angioma or dermatitis.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Eurofins Dermscan Pharmascan
Villeurbanne, France, France, 69100
Actively Recruiting
Research Team
M
Manon Laune, Project manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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