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This study sought to explore the effectiveness and safety of efinaconazole 10% solution in older patients battling toenail fungal infection.
Efinaconazole 10% solution markedly improves complete and mycologic cure rates in adults aged ≥65 years with toenail onychomycosis, offering a safe and effective topical treatment despite age-related nail changes.
This study sought to explore the effectiveness and safety of efinaconazole 10% solution in older patients battling toenail fungal infection.
Data were drawn from two randomized phase 3 trials, in which participants with mild-to-moderate toenail onychomycosis were allocated in a 3:1 ratio to receive either efinaconazole 10% solution or a vehicle control once daily for 48 weeks, followed by a 4-week observation period. A post-hoc analysis was executed on pooled data from volunteers aged ≥65 years (n = 162 efinaconazole; n = 56 vehicle). The key outcome was complete cure at week 52. It was characterized as 0% clinical involvement of the target nail combined with mycologic cure (negative potassium hydroxide test and culture). Treatment-emergent adverse events (TEAEs) were also assessed throughout the study.
At week 52, volunteers (aged 65–71 years) treated with efinaconazole exhibited a significantly higher complete cure rate when compared to those receiving vehicle. The rate of mycologic cure and complete or almost complete cure (≤5% nail involvement and mycologic cure) was also markedly higher with efinaconazole (Table 1).
The incidence of treatment-related TEAEs with efinaconazole was low (6.0%) and comparable to the overall study population.
Efinaconazole 10% solution proved to be equally effective and well-tolerated in individuals aged 65 years and older, despite age-related alterations in nail characteristics, aligning with outcomes seen in the broader phase 3 study group
Mycoses
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
Shari R. Lipner et al.
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