A randomized, double-blind trial of amorolfine 0.25% cream and sertaconazole 2% cream in limited dermatophytosis

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dc.contributor.authorDas, Anirbanen_US
dc.contributor.authorSil, Amritaen_US
dc.contributor.authorSarkar, Tushar Kantien_US
dc.contributor.authorSen, Arpitaen_US
dc.contributor.authorChakravorty, Sriparnaen_US
dc.contributor.authorSengupta, Manideepaen_US
dc.contributor.authorDas, Anupamen_US
dc.contributor.authorChandra, Somodyutien_US
dc.contributor.authorPal, Santasmitaen_US
dc.contributor.authorBandyopadhyay, Debabrataen_US
dc.contributor.authorDas, Nilay Kantien_US
dc.date.accessioned2020-01-02T06:52:27Z
dc.date.available2020-01-02T06:52:27Z
dc.date.issued2019-05
dc.description.abstractBackground: Dermatophytosis is becoming increasingly unresponsive to conventional antifungals. Newer topical antifungals may be more effective in these patients. Aims: To evaluate and compare the efficacy and safety of amorolfine 0.25% cream and sertaconazole 2% cream in limited tinea cruris/corporis. Methods: A single-center, randomized (1:1), double-blind, parallel group, active-controlled trial (CTRI/2014/12/005246) was performed. Sixty-six untreated adults with acutely symptomatic tinea cruris/corporis were included in the study. All patients had limited cutaneous involvement and were KOH mount positive. Group A received amorolfine 0.25% cream, and group B received sertaconazole 2% cream twice daily application to the lesions for 4 weeks. After the baseline visit, four follow-up visits were carried out. The outcome measures for effectiveness were clinical and mycological cure. Safety parameters studied were treatment-emergent adverse events and changes in routine laboratory parameters. Results: Both sertaconazole and amorolfine significantly reduced symptoms (P < 0.001) in both groups. However, improvement in symptoms (pruritus, burning sensation, erythema, scaling and crusting) was significantly greater in the sertaconazole group at every follow-up visit. Sertaconazole cream was also more effective than amorolfine cream in reducing the number of lesions (P = 0.002 at 12 weeks) and improving the Dermatology Life Quality Index (P < 0.001) at all the follow-up visits. Adverse events were similar in the two groups (P = 0.117). Fungal cultures became negative in 92.3% of the sertaconazole group as compared to 80% in the amorolfine group (P = 0.010). Limitations: Antifungal susceptibility testing could not be done. Conclusion: Sertaconazole 2% is superior to amorolfine 0.25%, both in terms of effectiveness and tolerability. Improvement can be appreciated from second week onwards.en_US
dc.identifier.affiliationsDepartment of Dermatology, Murshidabad Medical College and Hospital, Berhampore, West Bengal, Indiaen_US
dc.identifier.affiliationsDepartment of Pharmacology, Rampurhat Government Medical College, Rampurhat, West Bengal, Indiaen_US
dc.identifier.affiliationsDepartment of Dermatology, Medical College and Hospital, Kolkata, West Bengal, Indiaen_US
dc.identifier.affiliationsDepartment of Microbiology, Medical College and Hospital, Kolkata, West Bengal, Indiaen_US
dc.identifier.affiliationsDepartment of Biochemistry, Medical College and Hospital, Kolkata, West Bengal, Indiaen_US
dc.identifier.affiliationsDepartment of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, Indiaen_US
dc.identifier.citationDas Anirban, Sil Amrita, Sarkar Tushar Kanti, Sen Arpita, Chakravorty Sriparna, Sengupta Manideepa, Das Anupam, Chandra Somodyuti, Pal Santasmita, Bandyopadhyay Debabrata, Das Nilay Kanti. A randomized, double-blind trial of amorolfine 0.25% cream and sertaconazole 2% cream in limited dermatophytosis. Indian Journal of Dermatology, Venereology and Leprology. 2019 May; 85(3): 276-281en_US
dc.identifier.issn0378-6323
dc.identifier.issn0973-3922
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/192492
dc.languageenen_US
dc.publisherIndian Association of Dermatologists, Venereologists & Leprologistsen_US
dc.relation.issuenumber3en_US
dc.relation.volume85en_US
dc.source.urihttps://dx.doi.org/10.4103/ijdvl.IJDVL_907_17en_US
dc.subjectAmorolfineen_US
dc.subjectrandomized controlled trial sertaconazoleen_US
dc.subjecttinea corporisen_US
dc.subjecttinea crurisen_US
dc.titleA randomized, double-blind trial of amorolfine 0.25% cream and sertaconazole 2% cream in limited dermatophytosisen_US
dc.typeJournal Articleen_US
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