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Randomized Controlled Trial
. 2023 Sep 21:17:2899-2908.
doi: 10.2147/DDDT.S421583. eCollection 2023.

Efficacy of Super-Bioavailable Itraconazole and Conventional Itraconazole at Different Dosing Regimens in Glabrous Tinea Infection - A Randomized Clinical Trial

Manjunath M Shenoy  1 , Abhishek De  2 , Bela Shah  3 , Anupam Das  4 , Abir Saraswat  5 , Koushik Lahiri  2 , Sheetal Yadav  6 , Aarti Sarda  2 , Disha Chakraborty  7 , Dharmender J  2 , Shruti Kamat  2 , Yashika Doshi  2 , Nelry Gonsalves  2 , Ankita Choudhary  2 , Dhiraj Dhoot  8 , Namrata Mahadkar  8 , Sumit Bhushan  8 , Rujuta Gadkari  8 , Hanmant Barkate  8
Affiliations
Randomized Controlled Trial

Efficacy of Super-Bioavailable Itraconazole and Conventional Itraconazole at Different Dosing Regimens in Glabrous Tinea Infection - A Randomized Clinical Trial

Manjunath M Shenoy et al. Drug Des Devel Ther. .

Erratum in

Abstract

Introduction: Itraconazole follows non-linear pharmacokinetics and hence is recommended once daily, but in real-world practice, is commonly prescribed as twice daily. Hence, this study aimed to evaluate the efficacy and safety of super-bioavailable-itraconazole-130 mg (SB-130) and conventional-itraconazole-200 mg (CITZ-200) once daily compared with conventional-itraconazole-100 mg (CITZ-100) twice daily in glabrous tinea.

Methods: A total of 261 eligible patients were enrolled in this prospective, randomized, clinical study from December-2021 to August-2022 at seven centers in India. Efficacy and safety assessments were done at week-3 and 6, with follow-up at week-10 for relapse. The primary objective was to assess the proportion of patients who achieved complete cure at week-6 following treatment in all itraconazole groups. The secondary outcomes were safety and clinical and mycological cure rates.

Results: Of 261 patients, 240 were included in the analysis. At week-6, 140 patients were completely cured; thus, overall cure rate was 58.33%. Fifty-five patients (69%) in SB-130 while 47/77 (61%) and 38/83 (46%) patients were completely cured in CITZ-200 and CITZ-100 groups respectively (p<0.05; SB-130: CITZ-100, p=0.32; SB-130: CITZ-200, p=0.058; CITZ-200: CITZ-100). There was no statistical difference in the mycological cure rate and area clearance rate between any of the groups (p=0.14); however, a statistically significant difference was noted for OD dosing over BD dosing in achieving clinical cure rates (p<0.05). A total of 13/140 patients (9%) relapsed following complete cure, with no statistically significant difference between any of the groups (p=0.50). All treatments were safe and well-tolerated, with no discontinuation.

Conclusion: In this clinical study, moderate efficacy with all doses of ITZ was reported but was better with OD dosing. Although there was no statistical difference between SB-130 and CITZ-200, SB-130 may be preferred over CITZ-200 owing to the advantage of SB over the conventional ITZ.

Keywords: 130mg; India; OD; dermatophytosis; efficacy; itraconazole; relapse; safety; super-bioavailable itraconazole.

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Conflict of interest statement

Manjunath M Shenoy reports grants from Glenmark pharmaceuticals, India. Dhiraj Dhoot, Namrata Mahadkar, Sumit Bhushan, Rujuta Gadkari, and Hanmant Barkate are employees of Glenmark Pharmaceuticals Ltd., India. The authors declare no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Consort diagram.
Figure 2
Figure 2
Percentage of patients with complete cure and relapse in dermatophytosis.
See this image and copyright information in PMC

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