P061 : The changes of scoring clinical index for onychomycosis in toenail onychomycosis treated with itraconazole capsules

Background: The Scoring Clinical Index for Onychomycosis (SCIO) is a scoring system to evaluate the severity of onychomycosis, but its validity has not been sufficiently elucidated. Objectives: To evaluate the changes of SCIO in toenail onychomycosis patients treated with itraconazole. Methods: A prospective 49-week, open-label, single-arm study was conducted in thirteen centers. Patients with toenail onychomycosis were enrolled, treated with three-pulse oral itraconazole therapy (200 milligram twice daily for 7 days at week 1, 5 and 9), and followed up until week 49. Results: Among 117 patients analyzed, the mean and standard deviation of SCIO were as follows: 20.7 ± 4.9 at baseline (week 1); 19.2 ± 6.0 at week 5; 17.3 ± 6.1 at week 9; 15.2 ± 5.9 at week 13; 12.7 ± 6.2 at week 25; 11.7 ± 6.3 at week 37; 11.9 ± 7.2 at week 49. The proportions of patents showing 10% or more improvements of SCIO compared to baseline were as follows: 25.6% at week 5; 50.4% at week 9; 71.8% at week 13; 84.6% at week 25; 86.3% at week 37; 80.3% at week 49. Mycological cure rates were 54.1% at week 13, 69.9% at week 25, 76.5% at week 37, and 75.5% at week 49. Conclusion: These results suggest that oral itraconazole therapy for toenail onychomycosis significantly decreases the SCIO, and shows a satisfactory mycological cure rate. Support: This study was conducted with support from Janssen Korea Ltd.