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Safety and Efficacy of a 48-Month Efinaconazole 10% Solution Treatment/Maintenance Regimen: 24-Month Daily Use Followed by 24-Month Intermittent Use

Summary

Researchers studied a 4-year treatment plan for toenail fungal infections using efinaconazole, an antifungal solution applied daily for 2 years, then 2-3 times weekly for another 2 years. The treatment was safe and effective, with all patients who achieved a cure maintaining it through the maintenance phase, and even some non-cured patients improving further. The study included many elderly patients, showing the treatment is safe across all age groups and could help prevent infection relapse.

Background

Onychomycosis is a prevalent chronic fungal nail infection that is difficult to treat. Efinaconazole 10% topical solution was approved for mild to moderate dermatophyte toenail onychomycosis but shows relatively low efficacy with standard 12-month daily use. This study investigates extended efinaconazole use beyond the standard treatment period.

Objective

To evaluate the safety and efficacy of a 48-month efinaconazole treatment regimen consisting of 24 months of daily use followed by 24 months of intermittent use. The study aimed to determine if intermittent maintenance therapy could provide prophylaxis and prevent relapse in patients achieving clinical cure.

Results

All 6 patients with clinical cure at Month 24 sustained cure through Month 48 with intermittent therapy. Three additional patients achieved clinical cure by Month 48. Only 1 of 35 patients reported possible treatment-related adverse events during maintenance. No positive dermatophyte cultures occurred during intermittent maintenance, suggesting efinaconazole provides prophylactic therapy.

Conclusion

Efinaconazole 10% solution appears safe for use over 48 months, including in elderly patients, with no increased risk of adverse events. Intermittent maintenance use provides suitable prophylaxis for preventing relapse in cured patients and allows continued improvement in infected nail areas for uncured patients.
  • Published in:Infectious Diseases Reports,
  • Study Type:Clinical Trial, Phase IV,
  • Source: PMID: 39846710, DOI: 10.3390/idr17010007
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