Efficacy and safety of itraconazole pulses vs. continuous regimen in cutaneous sporotrichosis.

ABSTRACT

BACKGROUND: Primary observation of using itraconazole pulse regimen (commonly used for onychomycosis) in five sporotrichosis patients produced satisfactory effect, but there are no randomized controlled trials to assess this regimen and to compare with routine continuous regimen. OBJECTIVES: The aim of this study was to compare the efficacy and safety of itraconazole pulse regimen, as a new treatment option for cutaneous sporotrichosis, with continuous regimen. METHODS: A prospective, randomized, evaluator-blind, controlled study was performed. A total of 50 cutaneous sporotrichosis patients were divided randomly into two groups Pulsed Rx (npulse=25), treated with itraconazole 200 mg b.i.d. for 1 week and off for 3 weeks; Daily Rx (ncont=25), treated with itraconazole 100 mg bid continuously. In total, 46 patients (npulse=22, ncont=24) were assessable at the end of the study. Cure rates at weeks 12, 24 and 48 along with the course of treatment and the rate of side effects were evaluated. RESULTS: In Pulsed Rx, the cure rates at weeks 12, 24 and 48 were 77.3%, 81.8%, 81.8% respectively. The mean course of treatment was 2.65±0.81 pulses and the rate of side effects was 4.5%; In Daily Rx, the corresponding cure rates were 79.2%, 91.7% and 95.8% respectively. The mean course of treatment was 2.80±2.33 months and the rate of side effects was 16.7%. These parameters had no significant difference between the two groups (P>0.05). CONCLUSION: The efficacy and safety of Itraconazole pulse regimen for cutaneous sporotrichosis were similar to the continuous regimen. It is an effective and safe alternative treatment for cutaneous sporotrichosis, which can also lower the cost by decreasing the number of capsules.