Clinical assessment of Super bioavailable Itraconazole 50 mg in dermatophytosis (Clear 50)

Abstract

Super bioavailable itraconazole (SBITZ) is a newer formulation of itraconazole which is recently launched in India. But there is no published clinical evidence of SBITZ in the management of dermatophytosis in Indian patients.A Real world retrospective data analysis was conducted with 346 dermatologists across India to assess the response of Indian patients with dermatophytosis who were prescribed super bioavailable itraconazole 50 mg twice a day for 4 weeks.Out of 4625 patients’ data, 2743 were included for final analysis. Mean age of patients was 36.17±12.05 years with male preponderance. Most of the patients were diagnosed as T. cruris. At the end of treatment, 51% of patients achieved complete clinical cure while 46% achieved clinical improvement (>50% symptom clearance) and 3% were labelled as clinical failure. About 70% patients achieved clearance in body surface area. Mean total symptom score (TSS) was reduced to 0.74±1.1 from 7.29±1.73 while mean BSA score was reduced from 1.96±0.83 to 0.38±0.65 (p<0.05). Similar type of improvements were seen in naïve, recurrent and chronic dermatophytosis patients. A total of 61 adverse effects (AE) were reported from 56 patients. All the AEs were mild to moderate in nature and did not require discontinuation of therapy.Patients treated with super bioavailable itraconazole showed greater improvement in clearance of symptoms as well as lesions. Additionally, it showed significant improvement in naïve, recurrent and chronic patients enabling its placement in armamentarium of management of all types of dermatophytosis.