Efinaconazole 10% Proven Safe and Effective for Toenail Fungus in Older Adults: Study
A post hoc study published in Mycoses has confirmed that efinaconazole 10% solution is both effective and safe for treating toenail onychomycosis in adults aged 65 and older. Despite age-related nail changes, the treatment showed comparable results in older adults and the general population, supporting its use in elderly patients. The study was conducted by Shari R. and colleagues.
Onychomycosis, a fungal toenail infection, is particularly common in the elderly. Thicker nails and slower growth, both associated with aging, as well as comorbid medical conditions, contribute to making the infection more difficult to treat. Oral antifungals, while effective, carry risks including liver injury and drug–drug interactions that are particularly problematic in this age category. Topical treatments such as efinaconazole 10% solution, which can be applied locally to the nail with minimal absorption into the body, provide a safer option. Hitherto, there have been sparse data on their efficacy particularly among elderly populations.
This analysis employed data from two multicenter, randomized, double-blind, vehicle-controlled phase 3 trials (NCT01008033 and NCT01007708), involving once-daily use of efinaconazole 10% solution or vehicle for 48 weeks with a post-treatment follow-up period of 4 weeks. The analysis was applied to a subgroup of patients 65 years of age or older, with mild to moderate toenail onychomycosis, consisting of 162 patients who received efinaconazole and 56 patients treated with vehicle. The main outcome was 52-week complete cure, which was taken as 0% clinical involvement of the target toenail and mycologic cure (negative potassium hydroxide [KOH] microscopy and fungal culture). Secondary outcomes were mycologic cure and complete or near complete cure (≤5% nail involvement + mycologic cure). Safety was evaluated through treatment-emergent adverse events (TEAEs).
Results
At week 52, 13.6% of the subjects between the ages of 65 and 71 years receiving efinaconazole had a complete cure, whereas only 3.6% in the vehicle group a statistically significant difference (p < 0.05).
Complete or near-complete cure rate was significantly greater in the efinaconazole group as well at 19.1%, compared with 5.4% with vehicle (p = 0.01).
Most significantly, 59.2% of the patients had a mycologic cure on efinaconazole, as compared to a mere 12.5% in the placebo group (p < 0.001).
TEAEs due to treatment were low with efinaconazole at 6.0%, which was comparable to the rates experienced by the total study population.
These results highlight the safety and efficacy of efinaconazole even among elderly patients, who often present with more recalcitrant nail conditions.
Efinaconazole 10% solution was both safe and effective in the treatment of toenail onychomycosis among adults aged 65 years and older. With notable improvement in cure rates and minimal adverse effects, efinaconazole is a worthwhile treatment option for older adults who are not candidates for systemic antifungal treatment.
Reference:
Lipner, S. R., Gupta, A. K., Joseph, W. S., Elewski, B., Guenin, E., & Vlahovic, T. C. (2025). Efficacy and safety of efinaconazole 10% topical solution for treatment of onychomycosis in older adults: A post hoc analysis of two phase 3 randomised trials. Mycoses, 68(5), e70069. https://doi.org/10.1111/myc.70069
