Effectiveness and Safety of Eberconazole 1% Cream in Indian Patients with Tinea Corporis and Tinea Cruris: a Prospective Real-World Study
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International Journal of Research in Dermatology Thomas J et al. Int J Res Dermatol. 2021 Jan;7(1):96-107 http://www.ijord.com DOI: https://dx.doi.org/10.18203/issn.2455-4529.IntJResDermatol20205603 Original Research Article Effectiveness and safety of eberconazole 1% cream in Indian patients with Tinea corporis and Tinea cruris: a prospective real-world study Jayakar Thomas1, Siddhartha Das2, Sunil Ghate3, Manas Chatterjee4, Sharad Teltumde5, Sujeet Narayan Charugulla6*, Suyog Mehta6, Amey Mane6, Rahul Rathod6, Ravindra Kale6 1Department of Dermatology, Dr Jayakar Thomas Skin Care Centre, Chennai, Tamil Nadu, India 2 Department of Dermatology, Ramkrishna Mission Hospital, Kolkata, West Bengal, India 3Department of Dermatology, Dr. Ghate's Skin, Hair & Laser Center, Mumbai, Maharashtra, India 4Department of Dermatology, INHS Asvini Hospital, Mumbai, Maharashtra, India 5Department of Dermatology, Sparsh Skin and Dental Clinic, Mumbai, Maharashtra, India 6Department of Medical Affairs, Dr Reddy’s Laboratories Ltd, Hyderabad, Telangana, India Received: 01 December 2020 Accepted: 11 December 2020 *Correspondence: Dr. Sujeet Narayan Charugulla, E-mail: [email protected] Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. ABSTRACT 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. Keywords: Eberconazole, Effectiveness, Real-world, Tinea corporis, Tinea cruris INTRODUCTION throughout India incidence of dermatophytosis is >36%.3 Based on their anatomical location these dermatophytic Globally, the prevalence of superficial dermatophytes infections are seen with distinct clinical manifestations. was reported to be 20-25%.1,2 However, Indian Tinea corporis and Tinea cruris are superficial epidemiology data are scarce and inconclusive. dermatophyte infections commonly referred to as According to the previously published reports, ringworm and jock itch, respectively. A study conducted International Journal of Research in Dermatology | January-February 2021 | Vol 7 | Issue 1 Page 96 Thomas J et al. Int J Res Dermatol. 2021 Jan;7(1):96-107 in Karnataka showed that 53.5% of the included corporis and cruris.18 In two independent controlled participants had Tinea corporis and 25.0% had Tinea studies, eberconazole showed similar effectiveness as cruris.4 Another study conducted in Tamil Nadu showed terbinafine hydrochloride and miconazole.11,19 However, much lower prevalence of Tinea corporis (25.7%); unlike other topical azole drugs, evidence for real-world however, the prevalence of Tinea cruris was comparable effectiveness and safety of eberconazole in the Indian (23.5%) to that reported in Karnataka.5 Recent literature population with Tinea corporis and Tinea cruris remains suggested that prevalence of dermatophytosis in Indian scarce. The present prospective, real-world evidence patients ranged from 36.6–78.4%.3 The evidence seems (RWE) study was conducted to bridge this knowledge definitive about the negative impact of superficial gap and generate essential effectiveness and safety data dermatophyte infections on a patient’s social and for eberconazole in Indian setting. As loss to follow-up psychological health as well as overall health-related can significantly affect the outcomes of the study in a quality of life.6,7 real-world clinical scenario, a post-hoc analysis was performed on a subgroup of patients who reported use of Both Tinea corporis and cruris are often caused by eberconazole 1% for 3 weeks in the study. This study will dermatophytes of the genera- trichophyton, microsporum, provide a valuable reflection of daily clinical practice and epidermophyton.8 Patients with Tinea corporis especially in Indian scenario, where limited RWE data on present with lesions that appear as red rings with clear topical antifungals exists. center. These annular lesions may appear anywhere on the body except on the scalp, beard, feet, or hands and are METHODS well defined, scaly, and pruritic.9 Tinea cruris is characterized by red scaling plaques on thighs and Study participants inguinal folds and is more prevalent among adolescents and adults.9,10 Adult patients (≥18 years of age) of either gender who were prescribed eberconazole 1% cream for treatment of Most tinea infections are diagnosed based on the clinical Tinea cruris and Tinea corporis by their treating manifestations, previous history, and visual examination physician were included in the study. Patients requiring and rarely laboratory diagnosis using mycological systemic antifungal drugs, pregnant or lactating women, examination is carried out to confirm the diagnosis. But or patients with any significant medical illness such as laboratory investigation is preferred in conditions of diabetes, immunocompromised conditions, and other recalcitrant, chronic and recurrence of the infection. sexually transmitted diseases, etc. that would have Potassium hydroxide (KOH) microscopy is widely prevented study participation, were excluded from the advocated because of more sensitive and reliable than study per Investigator’s discretion. fungal cultures because culture techniques have limited role due to expense and long turnaround time. Molecular The study was conducted in compliance with the protocol diagnosis is helpful to identify subspecies levels of fungi approved by the Institutional review board and/or and there are very few centres offering those services in Independent ethics committee. Written informed consent India.11 was obtained from all the patients prior to participation in the study. This study is registered with a clinical trial Oral and topical antifungal agents are the mainstay of registry (www.ctri.nic.in) as CTRI/2019/05/019449. Tinea corporis and Tinea cruris treatment most of the time systemic antifungals therapy is empirically Study design and treatment administered.10,11 These agents disrupt the synthesis of ergosterol, a vital component of fungal cell membranes, This was a prospective, single-arm, observational study which leads to inhibition of fungal growth.12 Tinea conducted between June 11, 2019 and January 09, 2020. corporis and cruris are generally easily manageable with Eligible patients were recruited across five centers in topical antifungals and rarely require systemic therapy.13 India and were prescribed eberconazole 1% cream However, growing evidence highlights the persistence (Ebernet®, Dr. Reddy’s Laboratories Ltd., India) at the and atypicality of superficial dermatophytes infection in discretion of treating physician per approved dosage and India.11 A significant number of chronic, recurrent, or frequency of application. Patients were allowed to non-responsive dermatophytosis infections have been continue other concomitant medications except systemic observed in the Indian population.14,15 This could be due antifungal as per their ongoing treatment regimens. to growing urbanization, overpopulation, poverty, non- adherence to standard care, and other factors related to Eligible patient’s medical history, demographics, and host immunosuppression like diabetes, HIV/AIDS, and baseline clinical characteristics including site of lesion, immunosuppressive medications.16 Currently, limited extent of lesion, duration of current illness, clinical data is available on effectiveness of different topical symptoms and signs score, treatment history, and number antifungal agents due to lack of evidence-based studies.17 of previous episodes were recorded at baseline (day 1). The overall observation period was 21 days±3 days. Eberconazole, a topical broad-spectrum imidazole Patients were followed-up as per routine clinical practice, derivative is widely used for the treatment of Tinea and clinical assessments data were collected at baseline International Journal of Research in Dermatology