Trial reportMycoses2025
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.
Trial report in Mycoses, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis
Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis
Who cites it
1 citing paper in PubMed.
- Treating Onychomycosis with Efinaconazole: Considerations for Diverse Patient Groups.Journal of fungi (Basel, Switzerland) · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
backgroundOnychomycosis is common in older adults and can be difficult to treat owing to slower nail growth, increased nail thickness, comorbidities, and concomitant medications. Oral treatments can be complicated by contraindications, drug-drug interactions, and adverse effects. Topical treatments such as efinaconazole 10% solution may be beneficial for treating older adults.
objectivesTo evaluate the efficacy/safety of efinaconazole 10% solution in adults aged ≥ 65 years with toenail onychomycosis. PATIENTS/
methodsIn two multicenter, double-blind, phase 3 studies (NCT01008033; NCT01007708), patients with mild to moderate toenail onychomycosis were randomised (3:1) to once-daily efinaconazole or vehicle for 48 weeks, with a 4-week follow-up. Pooled data for participants aged ≥ 65 years were analysed post hoc (n = 162 efinaconazole, n = 56 vehicle). The primary endpoint was complete cure (0% involvement of target toenail plus mycologic cure [negative KOH and fungal culture]) at week 52. Treatment-emergent adverse events (TEAEs) were assessed throughout.
resultsAt week 52, a significantly greater proportion of older adults (aged 65-71 years) achieved complete cure with efinaconazole than vehicle (13.6% vs. 3.6%; p < 0.05). Complete/almost complete cure rate was also significantly greater (≤ 5% involvement and mycologic cure; 19.1% vs. 5.4%; p = 0.01), and over half (59.2%) of participants achieved mycologic cure with efinaconazole versus 12.5% with vehicle (p < 0.001). Treatment-related TEAE rates with efinaconazole were low (6.0%) and similar to the overall study population.
conclusionsEfinaconazole 10% solution showed similar efficacy/safety in participants aged ≥ 65 years to the overall phase 3 population, despite potential age-related nail changes. These results demonstrate the benefits of efinaconazole in older patients with onychomycosis.
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Registered trials
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