Comparison of efficacy, safety, and cost-effectiveness of sertaconazole and luliconazole cream in patients with dermatophytoses: A prospective, randomized, open-label study.

Abstract

Objective:To compare efficacy, safety, and cost-effectiveness of sertaconazole (2%) and luliconazole (1%) cream in patients with dermatophytoses.Materials and Methods:Sixty-four patients with tinea corporis and tinea cruris infections were enrolled in this single-center, randomized, open–label, parallel study. Following inclusion and exclusion criteria, patients were randomly divided into two treatment groups and received either sertaconazole 2% cream applied topically twice daily for 4 weeks and luliconazole 1% cream once daily for 2 weeks. At follow-up, efficacy was assessed clinically using 4-point physician global assessment (PGA) scale, composite score, and mycologically by KOH mount. Safety was assessed by monitoring adverse drug events at each visit.Results:The primary efficacy variables including changes in pruritus, erythema, vesicle, and desquamation (4-point PGA) were significantly (P < 0.0001) improved in both the groups, at the end of treatment. There was a significant reduction in mean total composite score (pruritus, erythema, vesicle, and desquamation) after the end of treatment in the sertaconazole group (P = 0.0002) compared to the luliconazole group. Both the groups showed equal negative mycological assessment. Both the study drugs were well tolerated. Only one patient in the sertaconazole group showed allergic contact dermatitis.Conclusion:Sertaconazole was better than luliconazole in relieving signs and symptoms during the study and follow-up period, but cost-effectiveness wise, luliconazole was better than sertaconazole.