314
Views
5
CrossRef citations to date
0
Altmetric
Original Research

An Open-Label, Randomized, Double-Arm Clinical Trial to Compare the Effectiveness and Safety of Super Bioavailable Itraconazole Capsules and Itraconazole Capsules in the Management of Dermatophytosis in India

, ORCID Icon, &
Pages 1367-1376 | Published online: 27 Sep 2021

References

  • Rajagopalan M, Inamadar A, Mittal A, et al. Expert consensus on the management of dermatophytosis in India (ECTODERM India). BMC Dermatol. 2018;18(1):6. doi:10.1186/s12895-018-0073-1
  • Verma S, Madhu R. The great Indian epidemic of superficial dermatophytosis: an appraisal. Indian J Dermatol. 2017;62(3):227–236.
  • Dogra S, Uprety S. The menace of chronic and recurrent dermatophytosis in India: is the problem deeper than we perceive? Indian Dermatol Online J. 2016;7(2):73–76. doi:10.4103/2229-5178.178100
  • Das S, De A, Saha R, et al. The current Indian epidemic of dermatophytosis: a study on causative agents and sensitivity patterns. Indian J Dermatol. 2020;65(2):118–122. doi:10.4103/ijd.IJD_203_19
  • Boonk W, de Geer D, de Kreek E, Remme J, van Huystee B. Itraconazole in the treatment of tinea corporis and tinea cruris: comparison of two treatment schedules. Mycoses. 1998;41(11–12):509–514. doi:10.1111/j.1439-0507.1998.tb00714.x
  • Rengasamy M, Shenoy MM, Dogra S, et al. Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) Task Force against Recalcitrant Tinea (ITART) Consensus on the Management of Glabrous Tinea (INTACT). Indian Dermatol Online J. 2020;11(4):502–519.
  • Lindsay J, Mudge S, Thompson GR. Effects of food and omeprazole on a novel formulation of super bioavailability itraconazole in healthy subjects. Antimicrob Agents Chemother. 2018;62(12):e01723–18. doi:10.1128/AAC.01723-18
  • Vaughn B, Rotolo S, Roth H. Circadian rhythm and sleep influences on digestive physiology and disorders. Chrono Physiol Ther. 2014;4:67–77. doi:10.2147/CPT.S44806
  • SP0RANOX® (itraconazole) capsule [prescribing information]. Raritan, NJ: Ortho-McNeil-Janssen Pharmaceuticals, Inc; 2018.
  • LOZANOC® (itraconazole 50 mg) capsule [prescribing information]. Salisbury South, SA: Mayne Pharma International Pty Ltd; 2020.
  • Abuhelwa AY, Foster DJ, Mudge S, Hayes D, Upton RN. Population pharmacokinetic modeling of itraconazole and hydroxyitraconazole for oral SUBA-itraconazole and sporanox capsule formulations in healthy subjects in fed and fasted states. Antimicrob Agents Chemother. 2015;59(9):5681–5696. doi:10.1128/AAC.00973-15
  • Prentice AG, Glasmacher A. Making sense of itraconazole pharmacokinetics. J Antimicrob Chemother. 2005;56(Suppl 1):i17–i22. doi:10.1093/jac/dki220
  • Lindsay J, Sandaradura I, Wong K, et al. Serum levels, safety and tolerability of new formulation SUBA-itraconazole prophylaxis in patients with haematological malignancy or undergoing allogeneic stem cell transplantation. J Antimicrob Chemother. 2017;72(12):3414–3419. doi:10.1093/jac/dkx295
  • Nield B, Larsen SR, van Hal SJ. Clinical experience with new formulation SUBA®-itraconazole for prophylaxis in patients undergoing stem cell transplantation or treatment for haematological malignancies. J Antimicrob Chemother. 2019;74(10):3049–3055. doi:10.1093/jac/dkz303
  • Mahajan H, Dhoot D, Deshmukh G, Barkate H. Comparative clinical effectiveness and safety of super bioavailable itraconazole and conventional itraconazole in management of dermatophytosis: a retrospective data analysis. Int J Res Dermatol. 2021;7:388–394. doi:10.18203/issn.2455-4529.IntJResDermatol20211427
  • Ghate S, Dhoot D, Mahajan H, Barkate H. Clinical assessment of super bioavailable Itraconazole 50 mg in dermatophytosis (Clear 50). IP Indian J Clin Exp Dermatol. 2021;7(2):125–129. doi:10.18231/j.ijced.2021.024
  • Mahajan H, Dhoot D, Barkate H. Clinical assessment of itraconazole in dermatophytosis (CLEAR Study): a retrospective evaluation. Int J Sci Stud. 2020;8(2):1–5.
  • Gintjee TJ, Donnelley MA, Thompson GR. Aspiring antifungals: review of current antifungal pipeline developments. J Fungi (Basel). 2020;6(1):28. doi:10.3390/jof6010028
  • Brouwers J, Geboers S, Mols R, Tack J, Augustijns P. Gastrointestinal behavior of itraconazole in humans - Part 1: supersaturation from a solid dispersion and a cyclodextrin-based solution. Int J Pharm. 2017;525(1):211–217. doi:10.1016/j.ijpharm.2017.04.029
  • Abuhelwa AY, Mudge S, Hayes D, Upton RN, Foster DJ. Population in vitro-in vivo correlation model linking gastrointestinal transit time, pH, and pharmacokinetics: itraconazole as a model drug. Pharm Res. 2016;33(7):1782–1794. doi:10.1007/s11095-016-1917-1
  • Cauwenbergh G, Degreef H, Heykants J, Woestenborghs R, Van Rooy P, Haeverans K. Pharmacokinetic profile of orally administered itraconazole in human skin. J Am Acad Dermatol. 1988;18(2):263–268. doi:10.1016/S0190-9622(88)70037-7
  • Harshal M, Gaurav J, Dhiraj D, Gaurav D, Hanmant B. Serum and sebum pharmacokinetics evaluation of a novel formulation of itraconazole in healthy volunteers. Indian J Drugs Dermatol. 2021. In press.