Dermatology Update 2018 FALL
SESSIONS & ABSTRACTS
MONTREAL, FAIRMONT THE QUEEN ELIZABETH - NOVEMBER 15-18, 2018
Long-term therapy with daily efinaconazole 10% solution for mild to moderate toenail onychomycosis
Preliminary results from an investigator-initiated clinical trial
- Assess cure rates with efinaconazole 10% nail solution at months 6, 12, 20, and 24.
- Assess safety of long-term therapy with efinaconazole 10% solution.
The prevalence of onychomycosis in Canada is approximately 6.4% with a higher frequency in individuals who are either: older ( >65 years of age) , suffering from diabetes , affected with poor peripheral circulation, or immunocompromised. Historically, topical therapies for onychomycosis have been ineffective. Ciclopirox nail lacquer was the first somewhat effective treatment that was approved in North America in 1999. Since then, efinaconazole 10% solution was approved in Canada in 2013. In Phase 3 trials, the mycological cure rate was 54.4%, complete cure rate was 16.6%, and complete/almost complete cure rate of 25%. An investigator-initiated trial evaluated the efficacy and safety of efinaconazole 10% solution used to treat dermatophyte toenail onychomycosis for 2 years. Interim results (n = 72) reveal that the mycological cure rate and the complete/almost complete cure rate after 2 years is 66.7% and 33.4%, respectively. There were no serious adverse events and most adverse events were deemed to be unrelated to drug. The most common side effect related to efinaconazole therapy was dermatitis (n=2) at the application site which resolved upon discontinuation of drug therapy. The data suggest that efinaconazole 10% solution for 2 years results in an incremental increase in efficacy with no additional adverse events.