Oral Itraconazole and Terbinafine vs. Itraconazole as a Novel Regimen for the Newly Emergent Chronic Tinea: A Comparative Clinical Study
DOI:
https://doi.org/10.31351/vol34iss3pp119-130Keywords:
Antifungal, Chronic dermatophytosis, Itraconazole, Terbinafine.Abstract
Dermatophytosis is the most common contagious fungal disease. Iraq, like the other many countries around the world, is facing an emergence of chronic, resistant and relapsing tinea infections. This study compared the efficacy, safety and the relapse rate of a combination therapeutic regimen of itraconazole and terbinafine vs. itraconazole alone in the treatment of chronic tinea infections. The research was conducted at the dermatology and venereology outpatient’s unit, Ramadi Teaching Hospital, Iraq, during the period from May 2022 to May 2023. Patients were divided equally into two groups. Group I received combination of itraconazole and terbinafine while group II was on itraconazole alone for eight weeks for each group. For assessment of relapse rate, follow-up was for two months. Only 148 out of 160 of enrolled patients completed the study. 98 (66.2 %) were males and 50 (33.8%) were females. The mean of the age (±SD) of the total was 33.04±12.65. There was no significant difference in their residency. Family history was positive in majority of patients 119 (80.4%). After two weeks, there was significant difference in response to treatment, where a marked clearance was achieved by 54 (73%) patients in group I, while only 17 (23%) patients in group II, (p value 0.00). After 8 weeks, complete clearance was 68 (92%) in group I, while 35 (47%) in group II (p value 0.00). Marked clearance was 6 (8%) in group I, while 33 (45%) in group II (p value 0.00). Relapse rate, after 16 weeks, was 5 (7%) in group I, while 42(57%) in group II (p value 0.00). We concluded that therapeutic regimen of itraconazole and terbinafine were effective, safe and well tolerated with low relapse rate.
How to Cite
Publication Dates
Received
Revised
Accepted
Published Online First
References
Bitew A. Dermatophytosis: prevalence of dermatophytes and non-dermatophyte fungi from patients attending Arsho advanced medical laboratory, Addis Ababa, Ethiopia. Dermatology research and practice. 2018;2018.
Brigida S, Elizabeth AA, Soujania G, Poornima R. A Comparative Study of Safety and Efficacy of Oral Terbinafine and Itraconazole in Patients of Tinea Corporis/Tinea Cruris Infection, A Randomized Open Label Parallel Group Study. Biomedical and Pharmacology Journal. 2021;14(3):1543-9.
Weitzman I, Summerbell RC. The dermatophytes. Clinical microbiology reviews. 1995;8(2):240-59.
Jena AK, Lenka RK, Sahu MC. Dermatophytosis in a tertiary care teaching hospital of Odisha: a study of 100 cases of superficial fungal skin infection. Indian J Pub Health Res Develop. 2018;9:7.
Havlickova B, Czaika VA, Friedrich M. Epidemiological trends in skin mycoses worldwide. Mycoses. 2008;51:2-15.
Sahoo AK, Mahajan R. Management of tinea corporis, tinea cruris, and tinea pedis: A comprehensive review. Indian dermatology online journal. 2016;7(2):77.
Jerajani H, Janaki C, Kumar S, Phiske M. Comparative assessment of the efficacy and safety of sertaconazole (2%) cream versus terbinafine cream (1%) versus luliconazole (1%) cream in patients with dermatophytoses: a pilot study. Indian journal of dermatology. 2013;58(1):34.
Sharquie KE, Jabbar RI. New multiple therapy of resistant and relapsing dermatophyte infections during epidemic status. Journal of Pakistan Association of Dermatologists. 2022;32(3):464-71.
Sharquie KE, Jabbar RI. Major Outbreak of dermatophyte infections leading into imitation of different skin diseases: Trichophyton mentagrophytes is the main criminal fungus. Journal of the Turkish Academy of Dermatology. 2021;15(4):91.
Kubaisi TA. Recurrent Dermatophytosis: A Comparative Therapeutic Study using Oral Itraconazole Alone and in combination with Topical Tincture of Iodine. Research Journal of Pharmacy and Technology. 2022;15(12):5825-8.
Kubaisi T. Resistant Dermatophytosis: A Stubborn Habit and Major Challenge in Iraq. Al- Anbar Medical Journal. 2023;19:78-80.
Al-Yasiri MH, Alhuchami AA, Atiyah SA. The Survey of dermatophytic fungal infections in Thi-Qar proviance. Journal of Pakistan Association of Dermatologists. 2023;33(3):1045-50.
Hashoosh QH, AL-Araji AM. Molecular Identification of Tinea spp. Causing Tinea Disease using ITS Sequencing Analysis. Iraqi journal of biotechnology. 2023;22(1).
Alzubaidy TSN, Mohammed AJ, Al-Gburi AAH. Comparison of two conventional methods for identification of dermatophyte fungi. Ibn AL-Haitham Journal For Pure and Applied Sciences. 2018;31(2):21-30.
AL-Khikani FHO. Dermatophytosis a worldwide contiguous fungal infection: Growing challenge and few solutions. Biomedical and Biotechnology Research Journal (BBRJ). 2020;4(2):117-22.
Jawad AA, Al-Joboori OM, Abdul-Wahab MH. Emergence of Resistant Extensive Tinea Infections. Journal of Wasit for science and medicine. 2023;16(1):31-44.
Mohammed SJ, Noaimi AA, Sharquie KE, Karhoot JM, Jebur MS, Abood JR, et al. A survey of dermatophytes isolated from Iraqi patients in Baghdad City. Al-Qadisiyah Medical Journal. 2015;11(19):10-5.
Hainer BL. Dermatophyte infections. American family physician. 2003;67(1):101-8.
Saxena G, Sadawarte K, Songara P, Mehta A. Clinico-Mycological Profile of Dermatophytoses at a Tertiary Care Teaching Hospital of Central India. SVU-International Journal of Medical Sciences. 2022;5(2):216-27.
Nivoix Y, Ledoux M-P, Herbrecht R, editors. Antifungal therapy: new and evolving therapies. Seminars in Respiratory and Critical Care Medicine; 2020: Thieme Medical Publishers.
Mueller SW, Kedzior SK, Miller MA, Reynolds PM, Kiser TH, Krsak M, et al. An overview of current and emerging antifungal pharmacotherapy for invasive fungal infections. Expert Opinion on Pharmacotherapy. 2021;22(10):1355-71.
Lopes AI, Tavaria FK, Pintado ME. Conventional and natural compounds for the treatment of dermatophytosis. Medical mycology. 2020;58(6):707-20.
Sharma P, Bhalla M, Thami GP, Chander J. Evaluation of efficacy and safety of oral terbinafine and itraconazole combination therapy in the management of dermatophytosis. Journal of Dermatological Treatment. 2020;31(7):749-53.
Majid I, Sheikh G, Kanth F, Hakak R. Relapse after oral terbinafine therapy in dermatophytosis: a clinical and mycological study. Indian journal of dermatology. 2016;61(5):529.
De Doncker P, Pande S, Richarz U, Garodia N. Itraconazole: What clinicians should know? Indian Journal of Drugs in Dermatology. 2017;3(1):4.
Hassaan ZRAA, Mohamed HAK, Eldahshan RM, Elsaie ML. Comparison between the efficacy of terbinafine and itraconazole orally vs. the combination of the two drugs in treating recalcitrant dermatophytosis. Scientific Reports. 2023;13(1):19037.
Bhatia A, Kanish B, Badyal DK, Kate P, Choudhary S. Efficacy of oral terbinafine versus itraconazole in treatment of dermatophytic infection of skin–a prospective, randomized comparative study. Indian journal of pharmacology. 2019;51(2):116.
Nenoff P, Verma SB, Ebert A, Süß A, Fischer E, Auerswald E, et al. Spread of terbinafine-resistant trichophyton mentagrophytes type VIII (India) in Germany–“the tip of the iceberg?”. Journal of Fungi. 2020;6(4):207.
Johnson M, MacDougall C, Ostrosky-Zeichner L, Perfect J, Rex J. 391 Combination antifungal therapy. Antimicrob Agents Chemother. 2004;48:693-715.
Singh S, Verma P, Chandra U, Tiwary NK. Risk factors for chronic and chronic-relapsing tinea corporis, tinea cruris and tinea faciei: Results of a case–control study. Indian Journal of Dermatology, Venereology and Leprology. 2019;85:197.
Naseri A, Fata A, Najafzadeh MJ, Shokri H. Surveillance of dermatophytosis in northeast of Iran (Mashhad) and review of published studies. Mycopathologia. 2013;176:247-53.
Adefemi S, Odeigah L, Alabi K. Prevalence of dermatophytosis among primary school children in Oke-oyi community of Kwara state. Nigerian Journal of Clinical Practice. 2011;14(1).
Vena GA, Chieco P, Posa F, Garofalo A, Bosco A, Cassano N. Epidemiology of dermatophytoses: retrospective analysis from 2005 to 2010 and comparison with previous data from 1975. Microbiologica-Quarterly Journal of Microbiological Sciences. 2012;35(2):207.
Das D, Mondal H, Roy AD, Anand A, Maiti P, Ray A. A Cross-Sectional Clinicomycological Study on Dermatophytosis: A Report From a Single Tertiary Healthcare Center in Eastern India. Cureus. 2022;14(11).
Kalita JM, Sharma A, Bhardwaj A, Nag VL. Dermatophytoses and spectrum of dermatophytes in patients attending a teaching hospital in Western Rajasthan, India. Journal of family medicine and primary care. 2019;8(4):1418.
Casas-Campillo C, Balandrano D, Galarza A. STEROIDS CLIX: Antimicrobial Properties of 21, 22-Dimethoxy Progesterone and other progesterone analogues. Journal of Bacteriology. 1961;81(3):366-75.
Čapek A, Šimek A. Antimicrobial agents: IX. Effect of steroids on dermatophytes. Folia Microbiologica. 1971;16:299-302.
Das S, De A, Saha R, Sharma N, Khemka M, Singh S, et al. The current Indian epidemic of dermatophytosis: a study on causative agents and sensitivity patterns. Indian journal of dermatology. 2020;65(2):118.
Balakumar S, Rajan S, Thirunalasundari T, Jeeva S. Epidemiology of dermatophytosis in and around Tiruchirapalli, Tamilnadu, India. Asian Pacific Journal of Tropical Disease. 2012;2(4):286-9.
Devliotou‐Panagiotidou D, Koussidou‐Eremondi T, Badillet G. Dermatophytosis in northern Greece during the decade 1981–1990: Dermatophytosen in Nordgriechenland während der Dekade 1981–1990. Mycoses. 1995;38(3‐4):151-7.
Mahajan S, Tilak R, Kaushal SK, Mishra RN, Pandey SS. Clinico-mycological study of dermatophytic infections and their sensitivity to antifungal drugs in a tertiary care center. Indian Journal of Dermatology, Venereology and Leprology. 2017;83:436.
Pathania S, Rudramurthy SM, Narang T, Saikia UN, Dogra S. A prospective study of the epidemiological and clinical patterns of recurrent dermatophytosis at a tertiary care hospital in India. Indian Journal of Dermatology, Venereology and Leprology. 2018;84:678.
Patro N, Panda M, Jena AK. The menace of superficial dermatophytosis on the quality of life of patients attending referral hospital in Eastern India: A cross-sectional observational study. Indian Dermatology Online Journal. 2019;10(3):262.
Verma S, Madhu R. The great Indian epidemic of superficial dermatophytosis: An appraisal. Indian journal of dermatology. 2017;62(3):227.
Jaradat SW, Cubillos S, Krieg N, Lehmann K, Issa B, Piehler S, et al. Low DEFB4 copy number and high systemic hBD-2 and IL-22 levels are associated with dermatophytosis. Journal of Investigative Dermatology. 2015;135(3):750-8.
Sanmano B, Hiruma M, Mizoguchi M, Ogawa H. Abbreviated oral itraconazole therapy for tinea corporis and tinea cruris. Mycoses. 2003;46(8):298-303.
Basak P, Mallick B, Pattanaik S. Prevalence of dermatophytic infections including antifungal susceptibility pattern of dermatophytes in a tertiary care hospital. 2019.
Singh S, Chandra U, Anchan V, Verma P, Tilak R. Limited effectiveness of four oral antifungal drugs (fluconazole, griseofulvin, itraconazole and terbinafine) in the current epidemic of altered dermatophytosis in India: results of a randomized pragmatic trial. British Journal of Dermatology. 2020;183(5):840-6.
Karaca N, Koc AN. In vitro susceptibility testing of dermatophytes: comparison of disk diffusion and reference broth dilution methods. Diagnostic microbiology and infectious disease. 2004;48(4):259-64.
Diogo HC, Melhem M, Sarpieri A, Pires MC. Evaluation of the disk-diffusion method to determine the in vitro efficacy of terbinafine against subcutaneous and superficial mycoses agents. Anais brasileiros de dermatologia. 2010;85:324-30.
Bhatia VK, Sharma PC. Epidemiological studies on dermatophytosis in human patients in Himachal Pradesh, India. Springerplus. 2014;3:1-7.
Babu PR, Pravin A, Deshmukh G, Dhoot D, Samant A, Kotak B. Efficacy and safety of terbinafine 500 mg once daily in patients with dermatophytosis. Indian journal of dermatology. 2017;62(4):395.
Goldstein AO, Goldstein BG. Dermatophyte (tinea) infections. Walthman, MA: UpToDate. 2017.
Su S, Yan H, Min L, Wang H, Chen X, Shi J, et al. The antifungal activity of caspofungin in combination with antifungals or non-antifungals against Candida species in vitro and in clinical therapy. Expert Review of Anti-infective Therapy. 2022;20(2):161-78.
Gupta AK, Venkataraman M, Renaud HJ, Summerbell R, Shear NH, Piguet V. The increasing problem of treatment‐resistant fungal infections: a call for antifungal stewardship programs. International journal of dermatology. 2021;60(12):e474-e9.
Baran R, Kaoukhov A. Topical antifungal drugs for the treatment of onychomycosis: an overview of current strategies for monotherapy and combination therapy. Journal of the European Academy of Dermatology and Venereology. 2005;19(1):21-9.
Olafsson J, Sigurgeirsson B, Baran R. Combination therapy for onychomycosis. British Journal of Dermatology. 2003;149(s65):15-8.
Evans E. Drug synergies and the potential for combination therapy in onychomycosis. British Journal of Dermatology. 2003;149(s65):11-3.
Khurana A, Agarwal A, Agrawal D, Panesar S, Ghadlinge M, Sardana K, et al. Effect of different itraconazole dosing regimens on cure rates, treatment duration, safety, and relapse rates in adult patients with tinea corporis/cruris: a randomized clinical trial. JAMA dermatology. 2022;158(11):1269-78.
Gupta A, Taborda P, Sanzovo A. Alternate week and combination itraconazole and terbinafine therapy for chromoblastomycosis caused by Fonsecaea pedrosoi in Brazil. Medical Mycology. 2002;40(5):529-34.
Del Rosso J. Oral Antifungals: What you should know about drug interactions. Podiatry Today. 2004;116(61):5.
Downloads
Published
Issue
Section
License
Copyright (c) 2025 Iraqi Journal of Pharmaceutical Sciences
This work is licensed under a Creative Commons Attribution 4.0 International License.
