Comparison of the Efficacy of Topical Sertaconazole, Eberconazole, and Miconazole in Localized Dermatophyte Infection: A Randomized Double-blind Controlled Trial

Introduction: Dermatophyte infection is a common fungal infection in hot and humid tropical countries like India.Topical preparations with good local bioavailability are the preferred first-line agents in the treatment of localized, uncomplicated dermatophytosis.Though costlier, there is a tendency among practitioners to increasingly prescribe these newer agents in preference to older ones.However, head-to-head comparisons of these newer agents with older established agents are still limited.We conducted a head-to-head comparison of two newer agents, eberconazole and sertaconazole, with a widely used older agent miconazole through a double-blind randomized controlled trial (RCT).Materials and methods: A prospective, double-blind, parallel-group RCT was designed with the objective of comparing the efficacy and safety of topical sertaconazole and topical eberconazole with the established topical antifungal miconazole in the management of cutaneous dermatophyte infection.Patients were screened and recruited from the Dermatology outpatient department (OPD) of the Department of a Tertiary care referral hospital in Eastern India.Subjects who attended the Dermatology OPD were screened as per the subject selection criteria.Complete clinical cure was defined as resolution of the lesion with resolution of symptoms of erythema, scaling, and pruritus that was anticipated to be achievable at the end of 4 weeks of treatment.Subjects were randomized to receive any one of the three formulations, namely topical miconazole nitrate 2% (w/w in cream base), topical sertaconazole nitrate 2% (w/w in cream base), and topical eberconazole nitrate 1% (w/w in cream base), in a double-blind manner.Each enrolled subject received treatment for a total period of 4 weeks.The primary outcome measure was clinical cure at 4 weeks.Secondary outcome measures were clinical cure at 2 weeks and changes in total symptom score based on erythema, scaling, and pruritus scores, along with assessment for safety outcomes.Patients were assessed at baseline, the first follow-up visit was at 2 weeks, and at the end of the study visit at 4 weeks.Changes in symptom scores over time within respective groups were assessed by Friedman's analysis of variance followed by post hoc Dunn's test.Pearson's Chi-square test was employed for intergroup comparison of categorical variables.Results: Over a period of 12 months, 206 patients who gave consent were randomized in three study arms.A total of 69 patients in the miconazole group, 62 patients in the sertaconazole group, and 68 patients in the eberconazole group completed the study.Baseline characteristics of all three groups were comparable.Clinical cure rates in the sertaconazole and eberconazole groups at the second week were 3.23 and 16.18%, respectively, the difference being statistically significant (p = 0.018).Complete clinical cure in miconazole, sertaconazole, and eberconazole groups was 46.38, 46.77, 58.82%, respectively, at the end of 4 weeks, without any statistically significant difference between groups.There was no significant difference in compliance between the groups in this regard.No significant treatment-emergent adverse events of note were reported during the study.Discussion and conclusion: In this relatively short-term randomized controlled double-blind study, patients with localized dermatophytosis were divided into three groups who received topical miconazole, sertaconazole, and eberconazole.Diagnosis was clinical.Visits were at 2 weeks for the first follow-up and at 4 weeks for the study conclusion.Among the groups, eberconazole showed a relatively higher cure rate at 2 weeks, though the cure rate of all three drugs is comparable at the end of 4 weeks of treatment.All medications were well tolerated.Our study had its share of limitations.This was a single-center setting with a relatively small sample size for detecting moderate differences.Very severe tinea infections were excluded.Strain identification of the causative organism was not performed.In conclusion, we can say that, notwithstanding these limitations, our study indicated that sertaconazole, eberconazole, and miconazole can be used interchangeably for the treatment of superficial dermatophyte infection.Despite some differences, there are no remarkable advantages of one drug over another.While some newer, costlier agents claim superiority over the older ones, studies with greater power, inclusion of newer antifungal arms to such studies, and inclusion of provision for pharmaco-economic analysis may throw more light on whether the use of such costlier newer antifungal agents is justified.