Purpose
A new oral formulation of itraconazole, called super bioavailable itraconazole (SBITZ), has been launched in India, exhibiting greater bioavailability than conventional itraconazole (CITZ). No clinical studies on its effectiveness and safety in dermatophytosis in comparison with CITZ have been conducted in India. Hence, the aim of this clinical study was to compare the effectiveness and safety of SBITZ capsules and CITZ capsules in dermatophytosis.
Patients and Methods
This was an open-label, randomized, double-arm clinical study in which 70 patients (≥18 years of age) of either gender and diagnosed with tinea cruris, tinea corporis, and/or tinea faciei were included. The study was divided into two parts, the first part comprising a treatment period of 4 weeks and the second part an observation period for recurrence, comprised of another 4 weeks, thus making an entire study duration of 8 weeks.
Results
Of the 70 patients enrolled in this study, 59 (33 patients in the CITZ group and 26 patients in the SBITZ group) were included in the final analysis. In both groups, most patients were diagnosed with tinea cruris et corporis, with five or more lesions. At week 4, 11 patients (33.33%) and 17 patients (65.38%) had achieved complete cure (
p
<0.05), whereas 22 patients (66.67%) and 22 patients (84.61%) had achieved mycological cure (
p
=0.14), in the CITZ and SBITZ groups, respectively. During the observation period, recurrence was seen in 1/11 and 4/17 completely cured patients in the CITZ and SBITZ groups, respectively (
p
=0.15). A significant difference was noted in resolution of symptoms as well as lesions of dermatophytosis in the SBITZ group (
p
<0.05). Both treatments were found to be safe and well tolerated.
Conclusion
In the light of real-world evidence on effectiveness and safety, SBITZ should be considered as a potent therapeutic choice to effectively control the current menace of dermatophytosis in India.
<p class="abstract"><strong>Background:</strong> A newer itraconazole formulation i.e., super bioavailable itraconazole has been launched recently in India which is claimed to overcome all the pharmacokinetic challenges faced with conventional itraconazole. The present retrospective data analysis was undertaken to evaluate the effectiveness and safety of super bioavailable itraconazole in comparison with conventional itraconazole in the treatment of dermatophytosis in Indian patients.</p><p class="abstract"><strong>Methods:</strong> The present multi-centric, retrospective data analysis was done at 12 dermatological centers across India from July 2020 to December 2020. Medical records of patients of dermatophytosis, who were prescribed with either super bioavailable itraconazole 50 mg twice daily for four weeks or conventional itraconazole 100 mg twice daily for four weeks were included in the study.<strong></strong></p><p class="abstract"><strong>Results:</strong> 56% patients (n=30) in super bioavailable itraconazole group achieved complete clearance of their symptoms (cured) compared to only 34% patients (n=17) in conventional itraconazole group and this difference was statistically significant (p=0.02). Significantly more patients achieved complete clearance of their lesions in super bioavailable itraconazole-37 patients (69%) compared to conventional itraconazole group-25 patients (49%) at the end of 4 week therapy (p=0.04). The difference in total symptom score (∆TSS) in super bioavailable itraconazole group was more (5.81) as compared to conventional itraconazole group (4.75) (p=0.09). Both the treatment were well tolerated.</p><p class="abstract"><strong>Conclusions:</strong> From the findings of the present study, super bioavailable itraconazole was more effective with similar safety profile as compared to conventional itraconazole in the treatment of dermatophytosis.</p>
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.
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