Comparative Study Between Pulsed and Continuous Itraconazole for the  Treatment of Onychomycosis

Rohida Rahmat; Majid  Hussain; Bushra  Muzaffar; Nadia  Akbar; Muhammad Adeel  Siddique; Kanza  Aftab

doi:10.51253/pafmj.v74i5.9366

Authors

Rohida Rahmat Department of Dermatology, Combined Military Hospital, Abbottabad/National University of Medical Sciences (NUMS) Pakistan
Majid Hussain Department of Dermatology, Combined Military Hospital, Abbottabad/National University of Medical Sciences (NUMS) Pakistan
Bushra Muzaffar Department of Dermatology, Combined Military Hospital, Abbottabad/National University of Medical Sciences (NUMS) Pakistan
Nadia Akbar Department of Dermatology, Combined Military Hospital/National University of Medical Sciences (NUMS) Rawalpindi Pakistan
Muhammad Adeel Siddique Department of Dermatology, Combined Military Hospital, Abbottabad/National University of Medical Sciences (NUMS) Pakistan
Kanza Aftab Department of Dermatology, Combined Military Hospital/National University of Medical Sciences (NUMS) Rawalpindi Pakistan

DOI:

https://doi.org/10.51253/pafmj.v74i5.9366

Keywords:

Continuous Itraconazole Therapy, Fungal Infection, Onychomycosis, OSI (onychomycosis severity index), Pulsed Therapy.

Abstract

Objective: To compare efficacy of pulsed versus continuous daily oral Itraconazole in the treatment of onychomycosis.

Study Design: Randomized Control Trial (ClinicalTrials.gov: NCT05567484).

Place and Duration of Study: Department of Dermatology, Combined Military Hospital, Abbottabad, Pakistan, from May to Dec 2021.

Methodology: We enrolled 60 patients whose toenails showed signs of onychomycosis (crumbling nail plates, thicker nail beds, and yellowing). They were randomly divided into Group-A and Group-B, with 30 patients each. Group -A (Pulse Therapy) took two capsules of oral Itraconazole 100 mg twice weekly for one week every month for three months while Group-B (Continuous Therapy) received continuous oral 100 mg of Itraconazole once daily for 12 weeks continuously. Patients were subjected to an Onychomycosis Severity Index-based clinical evaluation.

Results: In Group-A (Pulse Therapy), 25(83.3%) patients showed mycological cure whereas in Group-B (Continuous Therapy), 23(76.7%) patients showed mycological cure but difference in the efficacy of both drugs was not statistically significant (p-value=0.519).

Conclusion: Pulsed therapy with Itraconazole and continuous Itraconazole therapy have comparable efficacies in treating dermatophyte toenail onychomycosis.

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References

Karaman BFO, Açıkalın A, Ünal İ, Aksungur VL. Diagnostic values of KOH examination, histological examination, and culture for onychomycosis: a latent class analysis. Int J Dermatol 2019; 58(3): 319-324. https://doi.org/10.1111/ijd.14268

Leung AKC, Lam JM, Leong KF. Onychomycosis: an updated review. Recent Pat Inflamm Allergy Drug Disc 2020; 14(1): 32-45.

https://doi.org/10.2174/1872213X14666200521124812

Piraccini BM, Alessandrini A. Onychomycosis: a review. J Fungi 2015; 1(1): 30-43. https://doi.org/10.3390/jof1010030

Gupta AK, Gover MD, Lynde CW. Pulse Itraconazole vs. continuous terbinafine for the treatment of dermatophyte toenail onychomycosis in patients with diabetes mellitus. J Eur Acad Dermatol Venereol 2006; 20(10): 1188-1193.

https://doi.org/10.1111/j.1468-3083.2006.01719.x

Havu V, Brandt H, Heikkilä H, Hollmen A, Oksman R, Rantanen T, et al. A double-blind, randomized study comparing Itraconazole pulse therapy with continuous dosing for the treatment of toenail onychomycosis. Br J Dermatol 1997; 136(2): 230-234.

https://doi.org/10.1046/j.1365-2133.1997.d01-1223.x

Gupta AK, Stec N, Bamimore MA. The efficacy and safety of pulse vs continuous therapy for dermatophyte toenail onychomycosis. J Eur Acad Dermatol Venereol. 2019; 33(10): 1978-1985.

https://doi.org/10.1111/jdv.15808

Falotico JM, Lipner SR. Updated perspectives on the diagnosis and management of onychomycosis. Clin Cosmet Investig Dermatol 2022; 15: 1933-1957.

https://doi.org/10.2147/CCID.S362635

Piraccini BM, Alessandrini A. Onychomycosis: a review. J Fungi (Basel). 2015; 1(1): 30-43.

https://doi.org/10.3390/jof1010030

Nenoff P, Paasch U, Handrick W. Infektionen an Finger- und Zehennägeln durch Pilze und Bakterien [Infections of finger and toe nails due to fungi and bacteria]. Hautarzt 2014; 65(4): 337-348.

https://doi.org/10.1007/s00105-013-2676-y

Li Z, Hui X, Yuling SJ, Yunjiao T, Xiuli L. An exploration of the optimum dosage and number of cycles of Itraconazole pulse therapy for severe onychomycosis. Mycoses 2018; 61(10): 736-772. https://doi.org/10.1111/myc.12802

Drago L, Micali G, Papini M, Piraccini BM, Veraldi S. Management of mycoses in daily practice. Italy Dermatol Venereol 2017; 152(6): 642-650.

https://doi.org/10.23736/S0392-0488.17.05642-4

Lok C. [What's new in clinical dermatology?]. Ann Dermatol Venereol 2016; 143 Suppl 3: S1-10.

https://doi.org/10.1016/S0151-9638(16)30046-1

Wollina U, Nenoff P, Haroske G, Haenssle HA. The diagnosis and treatment of nail disorders. Dtsch Arztebl Int 2016; 113(29-30): 509-518. https://doi.org/10.3238/arztebl.2016.0509

Gupta AK, Foley KA, Mays RR, Shear NH, Piguet V. Monotherapy for toenail onychomycosis: a systematic review and network meta-analysis. Br J Dermatol 2020; 182(2): 287-99.

https://doi.org/10.1111/bjd.18093

Leung AKC, Lam JM, Leong KF, Hon KL, Barankin B, Leung AAM, et al. Onychomycosis: an updated review. Recent Pat Inflamm Allergy Drug Discov 2020; 14(1): 32-45.

https://doi.org/10.2174/1872213X14666200521124812

Silva-Neves V, Hugo V, Alves P, Amado JC, Pais-Vieira C, Sousa F, et al. Quality of life and therapeutic regimen management in onychomycosis patients and in vitro study of antiseptic solutions. Sci Rep 2021; 11(1): 12789.

https://doi.org/10.1038/s41598-021-92147-x

Kawai M. Characteristics and efficacy of two topical therapeutic agents for onychomycosis. Med Mycol J 2019; 60(3): 71-74.

https://doi.org/10.3314/mmj.19-00001

Sprenger AB, Purim KSM, Sprenger F, Queiroz-Telles F. A week of oral terbinafine pulse regimen every three months to treat all dermatophyte onychomycosis. J Fungi 2019; 5(3): 82.

https://doi.org/10.3390/jof5030082

Shemer A, Gupta AK, Kamshov S, Babaev M, Hermush V, Farhi R, et al. Continuous terbinafine and pulse Itraconazole for the treatment of non-dermatophyte mold toenail onychomycosis. J Dermatolog Treat 2021; 32(3): 310-313.

https://doi.org/10.1080/09546634.2020.1761843

Gupta AK, Daigle D, Paquet M. Therapies for onychomycosis: a systematic review and network meta-analysis of mycological cure. J Am Podiatr Med Assoc 2015; 105(4): 357-366.

https://doi.org/10.7547/14-089

Hermush V, Farhi R, Daniel CR, Foley KA. Continuous terbinafine and pulse Itraconazole for the treatment of non-dermatophyte mold toenail onychomycosis. J Dermatolog Treat 2021; 32(3): 310-313.

https://doi.org/10.1080/09546634.2020.1761843

Fávero MLD, Bonetti AF, Domingos EL, Tonin FS, Pontarolo R. Oral antifungal therapies for toenail onychomycosis: a systematic review with network meta-analysis. J Dermatolog Treat 2022; 33(1): 121-130.

https://doi.org/10.1080/09546634.2020.1814908

Nighat F, Asma B, Uzma A, Kashif S. Comparison of efficacy of continuous terbinafine versus intermittent Itraconazole in the treatment of toenail onychomycosis. Pak J Med Health Sci 2020; 14(1): 41-43.