Drug Design, Development and Therapy (Sep 2023)

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

  • Shenoy MM,
  • De A,
  • Shah B,
  • Das A,
  • Saraswat A,
  • Lahiri K,
  • Yadav S,
  • Sarda A,
  • Chakraborty D,
  • J D,
  • Kamat S,
  • Doshi Y,
  • Gonsalves N,
  • Choudhary A,
  • Dhoot D,
  • Mahadkar N,
  • Bhushan S,
  • Gadkari R,
  • Barkate H

Journal volume & issue
Vol. Volume 17
pp. 2899 – 2908

Abstract

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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 Barkate8 1Department of Dermatology, Omega Hospital, Mangalore, Karnataka, India; 2Department of Dermatology, Wizderm Specialty Skin and Hair Clinic, Kolkata, West Bengal, India; 3Department of Dermatology, BJ Medical College and Civil Hospital, Ahmedabad, Gujarat, India; 4Department of Dermatology, Iris Multispecialty Hospital, Kolkata, West Bengal, India; 5Department of Dermatology, Indushree Skin Clinic, Lucknow, Uttar Pradesh, India; 6Department of Dermatology, ABVIMS and Dr. RML Hospital, New Delhi, India; 7Department of Dermatology, Calcutta National Medical College, Kolkata, West Bengal, India; 8Department of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, Maharashtra, IndiaCorrespondence: Dhiraj Dhoot, Glenmark Pharmaceuticals Ltd, B D Sawant Marg, Chakala, Andheri (E), Mumbai, India, 400099, Tel +91 9619811219, Email [email protected]: 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: itraconazole, super-bioavailable itraconazole, 130mg, efficacy, safety, India, OD, dermatophytosis, relapse

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