The efficacy and safety of eberconazole nitrate 1% and mometasone furoate 0.1% w/w cream in subjects with inflamed cutaneous mycoses

Rao Gnaneshwar, A. S. Kumar, Fernandes Carol, Jacintha Martis, H. R. Jerajani, Maria Kuruvila, M. S. Latha, Binny Krishnankutty

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)161-170
Number of pages10
JournalReviews on Recent Clinical Trials
Volume10
Issue number2
DOIs
Publication statusPublished - 01-07-2015

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Mometasone Furoate
Mycoses
Nitrates
Safety
Skin
Antifungal Agents
Erythema
Pruritus
Treatment Failure
Hydrocortisone
Steroids
Research Personnel
eberconazole
Physicians

All Science Journal Classification (ASJC) codes

  • Pharmacology

Cite this

Gnaneshwar, Rao ; Kumar, A. S. ; Carol, Fernandes ; Martis, Jacintha ; Jerajani, H. R. ; Kuruvila, Maria ; Latha, M. S. ; Krishnankutty, Binny. / The efficacy and safety of eberconazole nitrate 1% and mometasone furoate 0.1% w/w cream in subjects with inflamed cutaneous mycoses. In: Reviews on Recent Clinical Trials. 2015 ; Vol. 10, No. 2. pp. 161-170.
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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.",
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The efficacy and safety of eberconazole nitrate 1% and mometasone furoate 0.1% w/w cream in subjects with inflamed cutaneous mycoses. / Gnaneshwar, Rao; Kumar, A. S.; Carol, Fernandes; Martis, Jacintha; Jerajani, H. R.; Kuruvila, Maria; Latha, M. S.; Krishnankutty, Binny.

In: Reviews on Recent Clinical Trials, Vol. 10, No. 2, 01.07.2015, p. 161-170.

Research output: Contribution to journalArticle

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T1 - The efficacy and safety of eberconazole nitrate 1% and mometasone furoate 0.1% w/w cream in subjects with inflamed cutaneous mycoses

AU - Gnaneshwar, Rao

AU - Kumar, A. S.

AU - Carol, Fernandes

AU - Martis, Jacintha

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AU - Kuruvila, Maria

AU - Latha, M. S.

AU - Krishnankutty, Binny

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