An open-label, multicenter study of the combination of amorolfine nail lacquer and oral itraconazole compared with oral itraconazole alone in the treatment of severe toenail onychomycosis

Abstract Background: Data indicate that combination therapy may provide enhanced clinical and economic benefits over monotherapy in the treatment of onychomycosis. Objective: The aim of this study was to compare the efficacy of 2 topical amorolfine/oral itraconazole combination regimens with oral itraconazole alone in the treatment of severe toenail onychomycosis. Cost implications of all treatments were assessed in a pilot pharmacoeconomic analysis. Methods: In this multicenter, open-label, 24-week study, patients were randomized to 3 parallel treatment groups: 5% solution of amorolfine nail lacquer applied once weekly for 24 weeks plus itraconazole 200 mg once daily for either 6 weeks (group AI-6) or 12 weeks (group AI-12), or itraconazole alone for 12 weeks (group I-12). Results: Mycologic cure at week 12 was achieved in 93% of patients in group AI-6, 83% in group AI-12, and 41% in group I-12. Combination therapies were significantly more effective than itraconazole monotherapy ( P P Conclusions: Our results show that topical amorolfine combined with oral itraconazole was more effective in treating severe toenail onychomycosis than was itraconazole monotherapy. Combination with a short course of oral therapy had a marked pharmacoeconomic advantage over the other regimen, suggesting that switching from the current 12-week itraconazole monotherapy to the 6-week combination therapy would cure more patients for a lower cost.