Comparative efficacy and safety of amorolfine nail lacquer 2% versus 5% once weekly.

Altogether 157 patients with onychomycosis affecting not more than 80% of the surface area of nail with intact lunula and matrix were treated once weekly for up to 6 months with amorolfine nail lacquer (2 or 5%) in a double-blind randomized design. Clinical examinations were carried out before, monthly during, and 1 and 3 months after therapy. Mycological examinations were performed before, 1 and 3 months after therapy. One hundred patients were evaluated. According to the overall assessment by the investigators, which was based on the clinical response and mycological findings, there was cure in 12%, improvement in 55% and failure in 33+ of the 2% group. The corresponding figures in the 5% group were: cure in 38%, improvement in 32% and failure in 30%. The difference in the number of cures was statistically significant in favour of the 5% nail lacquer. The most common pathogens isolated were Trichophyton rubrum in 59% of cases and Trichophyton mentagrophytes in 22%. Three months after the end of the treatment the mycological culture was negative in 55% of the 2% group and in 60% of the 5% group. Both concentrations were well tolerated. Only three patients (2%) experienced mild local adverse events. No systemic side-effects occurred and no patient discontinued treatment due to an adverse event. In conclusion, the 5% nail lacquer was more effective than the 2% nail lacquer when used once weekly for up to 6 months for the treatment of mild to moderate onychomycosis, and both concentrations were well tolerated.

RCT Entities:   Population Interventions Outcomes