Study Comparing Safety and Effectiveness of Two Treatments for Onychomycosis Using Enriched Device and Loceryl 5% Drug

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 nails 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.

CLINICAL INVESTIGATION FOR THE EVALUATION OF EFFICACY AND SAFETY OF TWO PRODUCTS FOR THE TREATMENT OF ONYCHOMYCOSIS