BACKGROUND: Based on the results of numerous preclinical and clinical studies, sertaconazole can be considered a safe and effective drug for the treatment of fungal skin infections. OBJECTIVE: The objective of the study was to compare the efficacy of a solution containing 2% sertaconazole with the well established 2% sertaconazole cream formulation in patients with tinea corporis, tinea pedis interdigitalis, or a corresponding candidosis. METHODS: This was a prospective, open-label, randomized, controlled, parallel-group, multicenter, noninferiority therapy study. Patients received either sertaconazole solution or cream twice daily for 28 days. The full analysis set comprised 160 patients in the solution group and 153 patients in the cream group. The primary efficacy parameter was a combination of culture test result and total clinical score. Efficacy was defined by eradication of the pathogen and reduction of the total clinical score between pretreatment and the final visit. RESULTS:Efficacy was documented in 90.6% of patients using the solution and 88.9% of those using the cream (full analysis set). No adverse events occurred. CONCLUSION: Solution and cream formulations of 2% sertaconazole applied for 28 days were associated with comparable efficacy and safety in the treatment of fungal skin infections.
RCT Entities:
BACKGROUND: Based on the results of numerous preclinical and clinical studies, sertaconazole can be considered a safe and effective drug for the treatment of fungal skin infections. OBJECTIVE: The objective of the study was to compare the efficacy of a solution containing 2% sertaconazole with the well established 2% sertaconazole cream formulation in patients with tinea corporis, tinea pedis interdigitalis, or a corresponding candidosis. METHODS: This was a prospective, open-label, randomized, controlled, parallel-group, multicenter, noninferiority therapy study. Patients received either sertaconazole solution or cream twice daily for 28 days. The full analysis set comprised 160 patients in the solution group and 153 patients in the cream group. The primary efficacy parameter was a combination of culture test result and total clinical score. Efficacy was defined by eradication of the pathogen and reduction of the total clinical score between pretreatment and the final visit. RESULTS: Efficacy was documented in 90.6% of patients using the solution and 88.9% of those using the cream (full analysis set). No adverse events occurred. CONCLUSION: Solution and cream formulations of 2% sertaconazole applied for 28 days were associated with comparable efficacy and safety in the treatment of fungal skin infections.