Effectiveness and safety of eberconazole 1% cream in Indian patients with Tinea corporis and Tinea cruris: a prospective real-world study
DOI:
https://doi.org/10.18203/issn.2455-4529.IntJResDermatol20205603Keywords:
Eberconazole, Effectiveness, Real-world, Tinea corporis, Tinea crurisAbstract
Background: Tinea corporis and cruris are estimated to affect 22% to 55% of the Indian population. This real-world study was conducted to evaluate the effectiveness and safety of eberconazole 1% cream among Indian patients.
Methods: In this prospective, single-arm, observational study, patients with Tinea corporis and cruris aged ≥18 years were prescribed eberconazole 1% cream (Ebernet®, Dr. Reddy’s Laboratory, India) for up to 3 weeks. The primary endpoint was proportion of patients with improvement in total signs and symptoms score with 2 weeks of treatment. The key secondary endpoint was mean percent reduction in individual signs and symptoms score (erythema, itching, scaling) from baseline to the end of the 1st, 2nd, and 3rd week. A post-hoc analysis was performed on a subgroup of patients (completer set [CS]) who reported application of eberconazole 1% cream for 3 weeks in the study. There were no adverse effects reported.
Results: Of 120 enrolled patients;104 (86.7%) were included in the full analysis set (FAS) and 76 (63.3%) patients were included in the CS. After 2 weeks of treatment, total signs and symptoms score<2 was achieved by 25% of patients in the FAS and 28.9% in the CS. After 3 weeks of treatment, mean percent reduction in total sign and symptom score was 60.3% for erythema, 61.2% for itching, and 76.8% for scaling.
Conclusions: The evidence from this real-world observational study and a post-hoc analysis suggests that eberconazole 1% cream is effective and safe treatment option in the management of Tinea corporis and cruris in Indian patients.
References
Coulibaly O, L'Ollivier C, Piarroux R, Ranque S. Epidemiology of human dermatophytoses in Africa. Medic Mycol. 2018;56(2):145-61.
Shimoyama H, Sei Y. Epidemiological Survey of Dermatomycoses in Japan. Medic Mycol J. 2019;60(3):75-82.
Naglot A, Shrimali, Nath B, Gogoi H, Veer V, Chander J, et al. Original Research Article Recent Trends of Dermatophytosis in Northeast India (Assam) and Interpretation with Published Studies. Int J Curr Microbiol App Sci. 2015;4:111-20.
Nagaral GV VGV, Sudha P, Jagadevi. Prevalence of tinea corporis and tinea cruris in Chitradurga rural population. IP Indian J Clin Exp Dermatol. 2018;4(3):221-5.
S B. Prevalence of Tinea Corporis and Tinea Cruris in Outpatient Department of Dermatology Unit of a Tertiary Care Hospital. J Pharmacol Clinic Res. 2017;3(1).
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. Ind Dermatol J. 2019;10(3):262-6.
Rajashekar TS, Nandigonnanavar S, Kuppuswamy SK, Madhavi GS. Dermatology life quality index in patients with persisting and recurrent dermatophytoses. Int J Res Dermatol. 2019;5(1):139.
Gupta AK, Chaudhry M, Elewski B. Tinea corporis, tinea cruris, tinea nigra, and piedra. Dermatol Clinics. 2003;21(3):395-400.
Weinstein A, Berman B. Topical treatment of common superficial tinea infections. Am Fam Physic. 2002;65(10):2095-102.
Ely JW, Rosenfeld S, Seabury Stone M. Diagnosis and management of tinea infections. Am Fam Physic. 2014;90(10):702-10.
Shenoy M, Jayaraman J. Epidemic of difficult-to-treat tinea in India: Current scenario, culprits, and curbing strategies. Arch Medic Heal Sci. 2019;7(1):112.
Jamzivar F, Shams-Ghahfarokhi M, Khoramizadeh M, Yousefi N, Gholami-Shabani M, Razzaghi-Abyaneh M. Unraveling the importance of molecules of natural origin in antifungal drug development through targeting ergosterol biosynthesis pathway. Iran J Microbiol. 2019;11(6):448-59.
Simant Ankit TZ. Diagnosis and Treatment of Dermatophytes Infections. Int J Sci Invent. 2018;7(3):665-78.
Verma S, Madhu R. The Great Indian Epidemic of Superficial Dermatophytosis: An Appraisal. Ind J Dermatol. 2017;62(3):227-36.
Verma SB, Vasani R. Male genital dermatophytosis - clinical features and the effects of the misuse of topical steroids and steroid combinations - an alarming problem in India. Mycoses. 2016;59(10):606-14.
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). Bio Med Cent Dermatol. 2018;18(1):6.
Bishnoi A, Vinay K, Dogra S. Emergence of recalcitrant dermatophytosis in India. Lancet Infect Dis. 2018;18(3):250-1.
Repiso Montero T, Lopez S, Rodriguez C, del Rio R, Badell A, et al. Eberconazole 1% cream is an effective and safe alternative for dermatophytosis treatment: multicenter, randomized, double-blind, comparative trial with miconazole 2% cream. Int J Dermatol. 2006;45(5):600-4.
Choudhary SV, Aghi T, Bisati S. Efficacy and safety of terbinafine hydrochloride 1% cream vs eberconazole nitrate 1% cream in localised tinea corporis and tinea cruris. Ind Dermatol J. 2014;5(2):128-31.
Banerjee M, Ghosh AK, Basak S, Das KD, Gangopadhyay DN. Comparative evaluation of effectivity and safety of topical amorolfine and clotrimazole in the treatment of tinea corporis. Ind J Dermatol. 2011;56(6):657-62.
Sharma J, Kaushal J, Aggarwal K. A Comparative Study of Efficacy and Safety of Eberconazole versus Terbinafine in Patients of Tinea Versicolor. Indian J Dermatol. 2018;63(1):53-6.
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. Ind J Dermatol. 2020;65(2):118-22.
Nenoff P, Verma SB, Vasani R, Burmester A, Hipler UC, Wittig F, et al. The current Indian epidemic of superficial dermatophytosis due to Trichophyton mentagrophytes-A molecular study. Mycoses. 2019;62(4):336-56.
Sharma R, Adhikari L, Sharma RL. Recurrent dermatophytosis: A rising problem in Sikkim, a Himalayan state of India. Ind J Pathol Microbiol. 2017;60(4):541-5.
Jegadeesan M, Kuruvila S, Nair S. Clinico-etiological Study of Tinea Corporis: Emergence of Trichophyton mentagrophytes. Int J Scient Study. 2017;5(1):161-5.
Halvaee S, Daie Ghazvini R, Hashemi SJ, Zibafar E, Yekaninejad S, Geramishoar M, et al. Investigation of Intertriginous Mycotic and Pseudomycotic (Erythrasma) Infections and Their Causative Agents with Emphasize on Clinical Presentations. Iran J Public Health. 2018;47(9):1406-12.
Sahni K, Singh S, Dogra S. Newer Topical Treatments in Skin and Nail Dermatophyte Infections. Ind Dermatol J. 2018;9(3):149-58.
Moodahadu-Bangera LS, Martis J, Mittal R, Krishnankutty B, Kumar N, Bellary S, et al. Eberconazole--pharmacological and clinical review. Ind J Dermatol Venereol Leprol. 2012;78(2):217-22.
Shivamurthy RP, Reddy SG, Kallappa R, Somashekar SA, Patil D, Patil UN. Comparison of topical anti- fungal agents sertaconazole and clotrimazole in the treatment of tinea corporis-an observational study. J Clin Diagn Res. 2014;8(9):HC09-12.
Lakhani SJ, Joshi DB, Kumbhani KR, Haldia RB. Prospective study on comparison of efficacy of topical anti-fungal agents: clotrimazole 1% and sertaconazole 2% in treatment of tinea cruris. Int J Res Dermatol. 2019;6(1):43.
Fernandez-Torres B, Inza I, Guarro J. In vitro activities of the new antifungal drug eberconazole and three other topical agents against 200 strains of dermatophytes. J Clin Microbiol. 2003;41(11):5209-11.
Sahoo AK, Mahajan R. Management of tinea corporis, tinea cruris, and tinea pedis: A comprehensive review. Ind Dermatol J. 2016;7(2):77-86.
Singh A, Masih A, Khurana A, Singh PK, Gupta M, Hagen F, et al. High terbinafine resistance in Trichophyton interdigitale isolates in Delhi, India harbouring mutations in the squalene epoxidase gene. Mycoses. 2018;61(7):477-84.
Rudramurthy SM, Shankarnarayan SA, Dogra S, Shaw D, Mushtaq K, Paul RA, et al. Mutation in the Squalene Epoxidase Gene of Trichophyton interdigitale and Trichophyton rubrum Associated with Allylamine Resistance. Antimicrob Agent Chemother. 2018;62(5).
Zalacain A, Obrador C, Martinez JP, Vinas M, Vinuesa T. Characterization of the antimicrobial susceptibility of fungi responsible for onychomycosis in Spain. Medic Mycol. 2011;49(5):495-9.
El-Gohary M, van Zuuren EJ, Fedorowicz Z, Burgess H, Doney L, Stuart B, et al. Topical antifungal treatments for tinea cruris and tinea corporis. Cochrane Database Syst Rev. 2014;(8):CD009992.
Del Palacio A, Ortiz FJ, Perez A, Pazos C, Garau M, Font E. A double-blind randomized comparative trial: eberconazole 1% cream versus clotrimazole 1% cream twice daily in Candida and dermatophyte skin infections. Mycoses. 2001;44(5):173-80.
