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.

Comparison of Efficacy and Safety between Super-bioavailable Itraconazole and Conventional Itraconazole in the Treatment of Tinea Infection of Glabrous Skin – A Randomised Observer-blinded Pilot Study

“…The authors concluded that SB-Itraconazole is an effective alternate for new, chronic as well as recurrent cases of dermatophytosis. 18 However, we did not find any better clinical or mycological clearance with SB itraconazole as compared to conventional itraconazole. Limitation 1.…”

Comparative Efficacy of Super Bioavailable Itraconazole Capsules 50 mg vs 65 mg Twice Daily in the Management of Glabrous Tinea

“…While 78% of individuals in our study experienced a reduction in LSS, 93% of patients in the SB 50 group did so in a previously published study. 18 In our investigation, greater LSS clearance was seen with SB 65 group. Similar results were also found for ASS clearance demonstrating superiority of SB 65 over SB 50 group.…”

Clinical Use of Super-Bioavailable Itraconazole for the Management of Dermatophytosis: Consensus Statement by Dermatologists from India via the Modified Delphi Technique

“…Dermatophytosis responds well to systemically administered ITZ [31]. Over the last decade, ITZ has emerged as the mainstay of systemic treatment for recalcitrant dermatophytosis.…”

“…However, clinical data on the usage of SB ITZ in Indian patients are scarce. Different dosage forms are currently being marketed in the USA, Europe, and India [30,31]. This study aimed to reach a consensus on the suitability, dosage, duration of treatment, and advantages of SB ITZ in managing dermatophytosis in different clinical scenarios.…”

“…In India, multiple strengths of SB ITZ have been approved by the Central Drugs Standard Control Organization (CDSCO) over the last 2 years for the management of systemic mycoses [26][27][28][29]. Some recent studies have demonstrated that SB ITZ is more effective than CITZ in treating dermatophytosis [30][31][32]. A randomized, double-arm, open-label clinical study comparing the use of 100 mg BD CITZ with 50 mg BD SB ITZ in naïve, chronic, and recurrent dermatophytosis observed that SB ITZ usage resulted in faster improvement and a higher cure rate than CITZ (65.38% vs. 33.33%, respectively) [32].…”