Sertaconazole in the treatment of mycoses: from dermatology to gynecology

Torres, José Lucas Medeiros; Márquez, Miguel A.; Camps, Francis E.

doi:10.1016/s0020-7292(00)00349-0

Cited by 26 publications

(11 citation statements)

References 17 publications

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“…Even the double mode of action of sertaconazole could be an advantage. The dermal formulation of sertaconazole is retained for a long time in the stratum corneum [30] and combined with other positive effects of sertaconazole such as its anti-inflammatory activity [4], good dermal tolerance [31] and antibacterial activity [14], this may explain the successful clinical results obtained with sertaconazole dermal formulations, confirming the promising in vitro results as indicators for a good clinical outcome [32], which is in contrast to the long-term therapy profile and the low correlation of the in vitro and clinical outcome reached with fluconazole in the management of dermatophytoses. In our study, neither resistance to sertaconazole was noted in any of the isolates tested, nor was there evidence of cross-resistance between sertaconazole and fluconazole among isolates with reduced or moderate susceptibility to fluconazole.…”

Section: Discussionmentioning

confidence: 91%

In vitro Activity of Sertaconazole against Dermatophyte Isolates with Reduced Fluconazole Susceptibility

et al. 2003

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We have studied the in vitro antifungal activity of sertaconazole against 114 dermatophytes with low susceptibility to fluconazole following the National Committee for Clinical Laboratory Standards for filamentous fungi (M38-P). However, several important factors such as the temperature (28 vs. 35°C) and time of incubation (4–10 days vs. 21–74 h), have been found to affect dermatophytes. Isolates were recently recovered from human samples. Sertaconazole was active against 114 isolates of 12 fungal dermatophyte species, showing an overall geometric mean of 0.41 µg/ml with a minimum inhibitory concentration (MIC) range of 0.01–2 µg/ml against these isolates with reduced fluconazole susceptibility. Differences between both antifungals were significant (p < 0.05). MIC₅₀ and MIC₉₀ of sertaconazole were of 0.5 and 1 µg/ml, respectively, while the MIC of fluconazole was ≧16 µg/ml. None of the isolates was resistant to sertaconazole during the study while for four isolates the MIC of fluconazole was ≧64 µg/ml. No evidence of cross-resistance between both antifungals was found.

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Section: Discussionmentioning

confidence: 91%

In vitro Activity of Sertaconazole against Dermatophyte Isolates with Reduced Fluconazole Susceptibility

et al. 2003

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“…This could be attributed to the pharmacological property of any topical antifungal drug or hypersensitivity to the study drug, that could not be assessed since the patient was lost to follow-up. [13]…”

Section: Discussionmentioning

confidence: 99%

Comparative assessment of the efficacy and safety of sertaconazole (2%) cream versus terbinafine cream (1%) versus luliconazole (1%) cream in patients with dermatophytoses: A pilot study

Jerajani

Janaki

Kumar³

et al. 2013

Indian J Dermatol

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Background:Sertaconazole is a new, broad spectrum, fungicidal and fungistatic imidazole with added antipruritic and anti-inflammatory activity that would provide greater symptomatic relief and hence would be beneficial in improving the quality of life for the patient with dermatophytoses.Aims and Objectives:To compare efficacy and safety of sertaconazole, terbinafine and luliconazole in patients with dermatophytoses.Materials and Methods:83 patients with tinea corporis and tinea cruris infections were enrolled in this multicentre, randomized, open label parallel study. The initial ‘Treatment Phase’ involved three groups receiving either sertaconazole 2% cream applied topically twice daily for four weeks, terbinafine 1% cream once daily for two weeks, luliconazole 1% cream once daily for two weeks. At the end of treatment phase, there was a ‘Follow-up Phase’ at end of 2 weeks, where the patients were assessed clinically and mycologically for relapse.Results:Of the 83 patients, 62 completed the study, sertaconazole (n = 20), terbinafine (n = 22) and luliconazole (n = 20). The primary efficacy variables including change in pruritus, erythema, vesicle, desquamation and mycological cure were significantly improved in all the three groups, as compared to baseline, in the Treatment and Follow-up phase. Greater proportion of patients in sertaconazole group (85%) showed resolution of pruritus as compared to terbinafine (54.6%); and luliconazole (70%), (P < 0.05 sertaconazole vs terbinafine). There was a greater reduction in mean total composite score (pruritus, erythema, vesicle and desquamation) in sertaconazole group (97.1%) as compared to terbinafine (91.2%) and luliconazole (92.9%). All groups showed equal negative mycological assessment without any relapses. All three study drugs were well tolerated. Only one patient in sertaconazole group withdrew from the study due to suspected allergic contact dermatitis.Conclusion:Sertaconazole was better than terbinafine and luliconazole in relieving signs and symptoms during study and follow up period. At the end of ‘Treatment Phase’ and ‘Follow-up’ Phase, all patients showed negative mycological assessment in all three treatment groups suggesting no recurrence of the disease.

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“…Clinical safety and efficacy of sertaconazole nitrate on seborrheic dermatitis, versicolor, cutaneous candidiasis or dermatophytosis have also demonstrated that sertaconazole has comparable or superior efficacy to other imidazole anti‐fungal agents such as miconazole, clotrimazole and ketoconazole, with a better clinical safety profile 12 . In this study, most of the adverse events were mild to moderate in intensity and included localized adverse events such as burning, itching and irritation.…”

Section: Discussionmentioning

confidence: 67%

Efficacy and tolerability of sertaconazole nitrate 2% cream vs. miconazole in patients with cutaneous dermatophytosis

Sharma

Saple

Surjushe

et al. 2011

Mycoses

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Sertaconazole is a new antifungal agent. To compare the efficacy and tolerability of sertaconazole and miconazole cream in cutaneous dermatophytosis, this prospective, randomized, multicentric comparative, phase 4 study was undertaken in 260 patients with cutaneous dermatophytosis after approvals from Institutional Ethics Committees. Patients were assigned to sertaconazole cream (2%) or miconazole cream (2%) topically twice daily for 2 weeks after obtaining informed consent. Efficacy variables included changes in mean scores of erythema, pruritus, desquamation, erythema/itching, burning/weeping, scaling/pustule and overall global assessment. Safety and tolerability were also assessed. A total of 122 patients in the sertaconazole group and 128 in the miconazole group completed the study with 10 drop-outs. There was a significant decrease (P < 0.05) in mean symptom scores and total scores from the first week onwards, sustained till 2 weeks and statistically significant (P < 0.05) in favour of sertaconazole. Moreover, 62.3% patients had complete clinical cure in the sertaconazole group (P < 0.05) compared with 44.6% in miconazole users. Both drugs were well tolerated and five patients in the sertaconazole group and nine in the miconazole group reported mild to moderate adverse events. Therapy with sertaconazole cream (2%) provided a better efficacy and tolerability compared with the miconazole cream (2%) and could thus be a therapeutic option in cutaneous dermatophytosis.

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Sertaconazole in the treatment of mycoses: from dermatology to gynecology

Cited by 26 publications

References 17 publications

In vitro Activity of Sertaconazole against Dermatophyte Isolates with Reduced Fluconazole Susceptibility

In vitro Activity of Sertaconazole against Dermatophyte Isolates with Reduced Fluconazole Susceptibility

Comparative assessment of the efficacy and safety of sertaconazole (2%) cream versus terbinafine cream (1%) versus luliconazole (1%) cream in patients with dermatophytoses: A pilot study

Efficacy and tolerability of sertaconazole nitrate 2% cream vs. miconazole in patients with cutaneous dermatophytosis

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