Abstract
Background: Topical antifungal agents along with the steroids may provide not only rapid symptomatic relief but also clearance of disease causing fungi in inflamed cutaneous mycoses (ICM).
Aim: To assess the efficacy and safety of fixed dose combination (FDC) of Eberconazole nitrate 1% and Mometasone furoate 0.1% w/w cream, in subjects with ICM.
Methods: This was a multi-centric, non-comparative study conducted in 155 eligible adult Indian subjects with ICM. They were treated with study medication for 21 days (D21) and followed up on day 35 (D35). Efficacy (by Investigator’s Static Global Assessment–ISGA, symptom severity scores) and safety were assessed to evaluate the therapeutic response.
Results: Of 155 subjects, 129 completed the study. Lesions healed completely in 77.52% and improved markedly in 22.48% patients by D21. There was a statistically significant reduction (p< 0.001) in total symptom score (TSS) and mean severity scores of erythema, scaling and pruritus on days 7 and 21 compared to baseline. There was no treatment failure.
Only 11 patients remained culture positive on D21 compared to 68 at baseline. Physicians evaluated the drug as ‘Good’ in 72% and ‘Excellent’ in 28% of subjects; adverse events were reported in 27.74% subjects and none was severe. There was a decrease in serum cortisol level in 4.52% (7/155) subjects and was considered clinically significant in three subjects.
On D35, 18.55% and 24.20% subjects had greater ISGA score and TSS respectively, compared to D21.
Conclusion: Tested FDC demonstrated efficacy and was well tolerated by study population. It offers an effective and safe therapeutic option for the management of ICM.
Keywords: Eberconazole and mometasone, efficacy, inflamed cutaneous mycoses, ISGA, total symptom score.
Graphical Abstract
Related Journals
Applied Drug Research, Clinical Trials and Regulatory Affairs
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