Randomized controlled trial of topical sertaconazole and eberconazole in comparison to topical miconazole in localized dermatophyte infection

Skinis a protective barrier also has cosmetic value. Dermatophyte infection iscommonest superficial fungal infection in the world which affect skin, hairnail. It is more prevalent in tropical countries like India. Dermatophyteinfection can cause significant morbidity. Working days may be lost and sociallife may be affected. Several environmental, social and immunological factorscontributes to the disease. Disease like diabetes malignancy HIV/AIDS  which decreases immunity andimmunosuppressive drugs, steroid use prolongs disease. For the treatment ofsuperficial fungal diseases topical antifungal agents are used. Imidiazolegroup antifungal miconazole is a common drugs used in this purpose. Newerimidiazole antifungals like sertaconazole and eberconazole claims to havebetter efficacy than miconazole as they have additional anti-inflammatoryproperty. The imidiazole group of antifungal drugs attains significant amountof concentration in superficial layers of skin. Drug level in deeper layer andsystemic absorption is negligible. They penetrate horny layer of skin andremains there for long time, so their use in superficial fungal infection ispreffered.

 Theobjective of the study was to carry out a head-to-head comparison of the newerimidazoles, topical sertaconazole and topical eberconazole, with theestablished topical antifungal miconazole in the management of cutaneousdermatophyte infection with respect to both effectiveness and safety.

 Over arecruitment period of 12 months 206 patients who gave consent were randomized tothree study arms. First follow up visit was at 2 weeks and end of study visitwas at 4 weeks. Overall, 69 patients on miconazole, 62 on sertaconazole and 68 oneberconazole completed the study.

 Baselinecharacteristics of all three groups were comparable. We looked for decrease inerythema, pruritus, scaling and total symptom score. These parameters decreasedsignificantly from base line to 2nd week follow-up and to study end in each ofthe three study groups, with no significant intergroup differences at any timepoint. Complete clinical cure (that is resolution of lesion with all associatedsymptoms) in miconazole, sertaconazole, eberconazole group was 46.38%, 46.77%and 58.82% respectively. This difference was not significant statistically. However,clinical cure rate at 2 weeks was 3.23% and 16.18% in sertaconazole andeberconazole group respectively (p = 0.018) without any such case in themiconazole. Compliance, assessed with the help of a medication adherence recordsheet, was good to excellent in most study subjects. No clinically significantadverse drug reactions were noted in any study arm.

 Therefore,in conclusion, despite an early trend favoring eberconazole, clinical cure at 4weeks was comparable with the older drug miconazole. Clinical cure was notachieved in approximately 50% of the subjects at 4 weeks. Tolerability of allthree preparations was excellent.