Actively Recruiting
Multicentric, Randomized, Evaluator Blinded 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
38 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
Researchers are evaluating the efficacy and safety of two products for treating onychomycosis, a fungal nail infection, in a multicenter, randomized, evaluator-blinded clinical study involving 88 patients. The study compares a test medical device called ENRICHED (X92001591) with a reference drug product, Loceryl (5% amorolfine). The main goal is to measure the increase in the percentage of healthy nail surface compared to the baseline, assessed by a blinded investigator. Participants will use either the ENRICHED device twice daily or Loceryl once weekly for nine months. The study includes follow-up visits at baseline (day 0), month 3 (day 90), month 6 (day 180), and month 9 (day 270). Both treatments are applied topically to the affected nails over the entire study period to assess their effects on nail health and fungal infection. During the trial, subjects will undergo regular evaluations including visual assessments of the nail's healthy surface, microbiological tests such as KOH staining, and clinical examinations for nail appearance and onychomycosis progression. Participants will also complete quality of life and subjective evaluation questionnaires. Tolerance and safety of the treatments will be monitored at multiple timepoints. The total participation duration is nine months, covering treatment and follow-up visits.
CONDITIONS
Brief 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 informed, written consent.
- Patient is in good general health.
- Age between 18 and 70 years.
- Presence of superficial onychomycosis on at least one great toenail or fingernail (at least 10% in each arm) 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 the treatment use and study schedule.
- Psychological ability to understand information and provide consent.
- No systemic antifungal treatment for at least 6 months before screening and no topical antifungal treatment for at least 3 months before screening.
- Agreement to avoid pedicure/manicure, artificial nails, cosmetic nail varnish, or other medications on the treated nail during the study.
- Females of childbearing potential must use effective contraception starting at least 12 weeks before screening, during the study, and for at least 1 month after study end.
You will not qualify if you...
- Pregnant or breastfeeding women, or women planning pregnancy during the study.
- Patients likely to be non-compliant with the protocol.
- Patients enrolled in another clinical trial or whose exclusion period is not over.
- Patients with conditions or medications posing undue risk per investigator judgment.
- Patients with severe or progressive diseases such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, or immunosuppressive conditions.
- Known allergy or hypersensitivity to any component of the tested products.
- Patients with other skin conditions on the studied area (e.g., angioma, dermatitis) other than onychomycosis.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 9 months
Participants use either the Enriched medical device twice daily or Loceryl 5% drug once weekly for onychomycosis treatment.
Visits at baseline, Month 3, Month 6, and Month 9
Duration - 9 months
Participants are monitored for treatment efficacy and safety through clinical assessments and questionnaires.
Visits at baseline, Month 3, Month 6, and Month 9
Trial Site Locations
Total: 1 location
1
Eurofins Dermscan Pharmascan
Villeurbanne, France, France, 69100
Actively Recruiting
Research Team
M
Manon Laune, Project manager
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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