Topical amorolfine for 15 months combined with 12 weeks of oral terbinafine, a cost-effective treatment for onychomycosis.

OBJECTIVE This open randomized study examined the efficacy of a combination of oral terbinafine and topical amorolfine in the treatment of severe dermatophyte toenail onychomycosis with matrix area involvement. PATIENTS/METHODS A total of 147 patients were randomized to one of three treatment groups: 15 months of once-weekly topical amorolfine lacquer in combination with 6 weeks (Group AT6) or 12 weeks (Group AT12) of oral terbinafine, 250 mg once daily: or terbinafine monotherapy for 12 weeks (Group T12). Patients were followed for a total of 18 months. The primary efficacy variable was the result of mycological examination after 3 months of therapy; secondary efficacy variables were mycological and clinical examination at 3-monthly intervals, with an additional clinical evaluation at 18 months. Safety and tolerance were also assessed. RESULTS Negative mycological results, assessed at 3 months, were recorded for 14 of 40 patients (35%) in Group AT6, 11 of 44 (27.5%) in Group AT12 and 7 of 41 (17.1%) in Group T12. At 18 months, the global response (mycological and clinical cure) was seen in 22 of 50 patients (44%), 34 of 47 (72.3% and 18 of 48 (37.5%) in the AT6, AT12 and T12 groups, respectively. CONCLUSIONS These results suggest that a combination therapy regime with oral and systemic treatment is superior in efficacy to monotherapy with a systemic drug alone in the treatment of severe onychomycosis. In addition, the cost per cure ratio was better in the combination groups.