Clinical comparison of the efficacy and tolerability of once daily Canesten^® with twice daily Nizoral^® (clotrimazole 1% cream vs. ketoconazole 2% cream) during a 28‐day topical treatment of interdigital tinea pedis

Abstract

The effects of two topical cream formulations containing clotrimazole 1% and ketoconazole 2%, respectively, were clinically compared in a double-blind, randomized manner for a 28-day therapy of interdigital tinea pedis in 106 treated patients. Ketoconazole was to be used twice daily whereas clotrimazole was administered only once daily. The primary response criterion defined as the number of patients with cure or improvement after 28 treatment days was comparable with 62.0% vs. 64.0% (clotrimazole vs. ketoconazole) for the full analysis set of 100 (50 vs. 50) patients. The mycological response revealed a negative culture and microscopy in 53.1% vs. 52.1% of the patients after 14, in 76.0% vs. 79.2% after 28, and in 83.7% vs. 76.9% after 56 days of observation, indicating a possibly better long-term efficacy of clotrimazole. The development of the overall score of tinea-related signs and symptoms did not show relevant differences between the two drugs and continuously decreased from 11+/-5 in both groups at baseline to 2+/-2 vs. 2+/-1 at day 56. As to the remission and improvement rates of single symptoms, better results were obtained under clotrimazole than under ketoconazole particularly for pruritus (97.8 vs. 89.6%) and burning/stinging (97.5 vs. 89.4%) which both are perceived as most bothersome by the patients. Furthermore, both substances appeared as comparably safe and well tolerable (8 vs. 7 adverse events with only 1 vs. 3 drug related). In conclusion, a successful therapy of tinea pedis can be achieved with both clotrimazole and ketoconazole within 28 days of treatment and once-daily clotrimazole is equally effective as twice-daily ketoconazole with favourable influences on the most irritating symptoms of the disease. Mycological and reliable clinical cure cannot be observed during two weeks after start of treatment.

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

“…[16][17][18] However, response to therapy was early in onset and higher in sertaconazole group. At end of " treatment phase," significantly higher proportion of patients treated with topical sertaconazole 2% cream had improvement of itching, erythema, and scaling as compared to clotrimazole 1% cream.…”

Transcriptional Profiles of the Response to Ketoconazole and Amphotericin B in Trichophyton rubrum

“…The azole antifungal agents such as itraconazole, clotrimazole, and ketoconazole are generally used to treat dermatomycosis (9,22,30). The mechanism of action of azoles involves inhibiting the cytochrome P450 enzyme lanosterol demethylase by binding to the heme in the active site of the enzyme (26).…”

In Vitro Activities of the New Antifungal Drug Eberconazole and Three Other Topical Agents against 200 Strains of Dermatophytes

“…Systemic drugs, such as terbinafine and itraconazole, are currently used for the treatment of severe and chronic dermatophytoses (13). However, in less-severe infections, topical antifungal therapy based on the use of imidazoles, such as clotrimazole (CTZ), miconazole (MCZ), and ketoconazole (KTZ), is most commonly used (17). Comparative studies on the in vitro activity of these drugs against a representative number of species are scarce.…”

“…As mentioned above, KTZ, CTZ, and MCZ are currently the most used in the topical treatment of dermatomycoses (2,17). In recent years, there has been an important increase in the use of topical agents, probably due to the fact that they produce fewer adverse effects than systemic therapy.…”