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

Abstract

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.

Comparison of efficacy, safety and cost-effectiveness of clotrimazole 1% cream and sertaconazole 2% cream in patients suffering from of mild to moderate tinea corporis, attending tertiary care hospital out-patient department: a randomized, open-labeled, comparative, parallel group trial

“…A study by Sharma et al, has shown that the sertaconazole produced 62.3% clearance at the end of 2 weeks. 22 In the study by Alomar et al, 95.6% clinical cure rate was seen at the end of treatment with sertaconazole. 23 Mycological assessment with KOH mount showed that at the end of "treatment phase," 94% patients treated with sertaconazole 2% cream and 62% patients who received clotrimazole 1% cream were negative for fungal elements.…”

“…Sharma et al have reported five patients in the sertaconazole group and nine in the miconazole group developing mild to moderate adverse events. 22 del Palacio et al have reported premature termination of their trial due to adverse effects, which were 26.7% with clotrimazole 1% cream in candida and dermatophyte skin infections.…”

Superficial Mycoses Associated with Diaper Dermatitis

“…Sertaconazole nitrate is a broad-spectrum third-generation [36]. It is a fungicide with long skin perdurability (up to 72 h), which is one of the properties that makes it different from other imidazoles.…”

“…The most widely used antimycotics are clotrimazole, miconazole and ketoconazole [42, 43]. Ciclopirox [35, 43] and sertaconazole [36] are also effective. It is important to note that nystatin and mupirocin are not effective against dermatophytosis [19].…”

Chromoblastomycosis

“…Differences in the species which are the agents of CBM have been observed, depending on the region. F. pedrosoi is related to humid areas of a tropical and subtropical climate, whereas C. carrionii is dominant in a semi-arid climate [37, 39, 42, 50, 61]. It is particularly visible in Madagascar where in the tropical rainforest area in the north of the island, F. pedrosoi is prevalent, whereas in the south of the island with the “thorny desert” climate, Cladophialophora carrionii is more common [44, 62].…”