COMPARATIVE STUDY OF SAFETY AND EFFICACY OF ORAL ITRACONAZOLE VERSUS FLUCONAZOLE IN THE TREATMENT OF SUPERFICIAL DERMATOPHYTOSIS
Main Article Content
Keywords
Dermatophytosis Severity Score (DSS), Itraconazole, Fluconazole, Efficacy, Safety, Antifungal Therapy
Abstract
Background:
With increasing resistance to antifungals in India, evaluating the effectiveness of current treatments is crucial. This study compared the efficacy and safety of oral itraconazole and fluconazole in superficial dermatophytosis, a common fungal skin infection.
Materials and Methods:
A prospective observational study was conducted with 200 newly diagnosed dermatophytosis patients. Group I (100 patients) received itraconazole 200 mg daily, and Group II (100 patients) received fluconazole 150 mg every alternate day, both for 4 weeks. Baseline parameters were measured. Follow-up evaluations were conducted at 2 and 4 weeks. Clinical improvement assessed via the Dermatophytosis Severity Score (DSS) and percentage improvement of erythema, pruritus, scaling, and raised borders, were measured. Safety was evaluated by adverse drug reactions (ADRs).
Results:
Group I showed significantly better results compared to Group II. By the 2nd follow-up, 84% of patients in Group I achieved complete clinical cure, compared to 62% in Group II (p = 0.008). Group I also showed greater improvement in erythema (78% vs. 64%, p = 0.012), raised borders (72% vs. 51%, p = 0.001), and scaling (74% vs. 63%, p = 0.001). Pruritus resolved in 79% of Group I versus 65% in Group II (p = 0.032). Both treatments were well-tolerated, with minimal ADRs.
Conclusion:
Itraconazole proved to be more effective and faster than fluconazole in treating dermatophytosis. Both drugs were safe, but itraconazole is recommended for faster and more comprehensive resolution of symptoms.
References
2. Weitzman I, Summerbell RC. The dermatophytes. Clin Microbiol Rev [Internet]. 1995;8(2):240–59. Available from: http://dx.doi.org/10.1128/cmr.8.2.240-259.1995
3. Yamada T, Yaguchi T, Salamin K, Guenova E, Feuermann M, Monod M. MFS1, a pleiotropic transporter in dermatophytes that plays a key role in their intrinsic resistance to chloramphenicol and fluconazole. J Fungi (Basel) [Internet]. 2021;7(7):542. Available from: http://dx.doi.org/10.3390/jof7070542
4. Verma SB, Panda S, Nenoff P, Singal A, Rudramurthy SM, Uhrlass S, et al. The unprecedented epidemic-like scenario of dermatophytosis in India: II. Diagnostic methods and taxonomical aspects. Indian J Dermatol Venereol Leprol [Internet]. 2021;87(3):326–32. Available from: http://dx.doi.org/10.25259/IJDVL_302_20
5. Rajagopalan M, Inamadar A, Mittal A, Miskeen AK, Srinivas CR, Sardana K, et al. Expert consensus on the management of dermatophytosis in India (ECTODERM India). BMC Dermatol [Internet]. 2018;18(1):6. Available from: http://dx.doi.org/10.1186/s12895-018-0073-1
6. Rogers D, Krysan DJ, Brunton L, Chabner BA, Knollman B. Antifungal Agents, Goodman and gilman’s the pharmacological basis of therapeutics. New York, NY: McGraw-Hill Medical; 2017.
7. Koregol SC, Naik SR, Hosthota A, Koregol AC. A comparative study of efficacy of oral itraconazole, terbinafine and fluconazole: a clinical trial. Int J Res Dermatol [Internet]. 2021;7(3):435. Available from: http://dx.doi.org/10.18203/issn.2455-4529.intjresdermatol20211705
8. Singh S, Chandra U, Anchan VN, 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. Br J Dermatol [Internet]. 2020;183(5):840–6. Available from: http://dx.doi.org/10.1111/bjd.19146
9. 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 J Pharmacol [Internet]. 2019;51(2):116–9. Available from: http://dx.doi.org/10.4103/ijp.IJP_578_17
10. Chatterjee D, Ghosh SK, Sen S, Sarkar S, Hazra A, De R. Efficacy and tolerability of topical sertaconazole versus topical terbinafine in localized dermatophytosis: A randomized, observer-blind, parallel group study. Indian J Pharmacol [Internet]. 2016;48(6):659–64. Available from: http://dx.doi.org/10.4103/0253-7613.194850
11. Bhat RM, Madhumita M, Jayaraman J. Dermatophytoses Severity Score - A novel point-of-care scoring tool to assess the severity of dermatophytosis. Mycoses [Internet]. 2023;66(4):354–61. Available from: http://dx.doi.org/10.1111/myc.13560
12. Garodia N, De Doncker P, Pande S, Richarz U. Itraconazole: What clinicians should know? Ind J Drugs Derm [Internet]. 2017;3(1):4. Available from: http://dx.doi.org/10.4103/ijdd.ijdd_20_17
13. Berkow EL, Lockhart SR. Fluconazole resistance in Candida species: a current perspective. Infect Drug Resist [Internet]. 2017;10:237–45. Available from: http://dx.doi.org/10.2147/IDR.S118892
14. Anand S, Desai A, Kesare SS. Fluconazole for common tinea infection: An updated review of evidence and treatment guidance. IP Indian J Clin Exp Dermatol [Internet]. 2022;8(2):74–81. Available from: http://dx.doi.org/10.18231/j.ijced.2022.018
15. Difonzo E. A double-blind comparison of itraconazole and fluconazole in tinea pedis and tinea manuum. J Eur Acad Dermatol Venereol [Internet]. 1995;4(2):148–52. Available from: http://dx.doi.org/10.1016/0926-9959(95)00027-b
16. Rajak B, Kumar R, Gupta A, Kasediya YK. Prospective comparative study to compare the efficacy and safety of oral itraconazole and oral terbinafine in relation with clinical and mycological clearance [Internet]. Ebsco.com. 2023 [cited 2024 Oct 8]. Available from: https://openurl.ebsco.com/EPDB%3Agcd%3A15%3A22557791/detailv2?sid=ebsco%3Aplink%3Ascholar&id=ebsco%3Agcd%3A174826106&crl=c
17. Dhoot D, Shah B, Shah S, Jangid N, Deshmukh G. Comparative evaluation of efficacy and safety of terbinafine and itraconazole in the management of tinea corporis et cruris. IP Indian J Clin Exp Dermatol [Internet]. 2020;6(3):231–6. Available from: http://dx.doi.org/10.18231/j.ijced.2020.047
18. Someshwar S, Salunke P, Bhobe M. Efficacy of daily oral terbinafine versus pulse fluconazole therapy in the treatment of tinea corporis, tinea cruris, and tinea faciei: A comparative study. MGM J Med Sci [Internet]. 2020;7(1):10. Available from: http://dx.doi.org/10.4103/mgmj.mgmj_30_20
19. Kumar A, Budania N, Sharma P, Singh M. A comparative study of mycological efficacy of terbinafine and fluconazole in patients of tinea corporis. Int J Biomed Res [Internet]. 2013;4(11):603. Available from: http://dx.doi.org/10.7439/ijbr.v4i11.388
20. Suchil P, Gei FM, Robles M, Perera-Ramírez A, Welsh O, Male O. Once-weekly oral doses of fluconazole 150 mg in the treatment of tinea corporis/cruris and cutaneous candidiasis. Clin Exp Dermatol [Internet]. 1992;17(6):397–401. Available from: http://dx.doi.org/10.1111/j.1365-2230.1992.tb00246.x
21. Chang C-H, Young-Xu Y, Kurth T, Orav JE, Chan AK. The safety of oral antifungal treatments for superficial dermatophytosis and onychomycosis: a meta-analysis. Am J Med [Internet]. 2007;120(9):791–8. Available from: http://dx.doi.org/10.1016/j.amjmed.2007.03.021