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

Abstract

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.

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.…”

Luliconazole Demonstrates Potent In Vitro Activity against Dermatophytes Recovered from Patients with Onychomycosis

“…In vitro studies with a limited number of isolates have also reported potent activity of this agent against dermatophytes and other causative agents of dermatophytosis, including onychomycosis (8)(9)(10). Results from animal models and small clinical studies have also suggested in vivo efficacy against dermatophytosis (11)(12)(13). Our objective was to measure the in vitro activity of luliconazole against dermatophytes isolated at screening from toenails in an ongoing phase 2b/3 study of patients with mild to moderate toenail onychomycosis (www.clinicaltrials.gov, identifier NCT01431820).…”

To Compare the Efficacy of Once a Day Versus Twice Daily Application of Amorolfine 0.25% Cream- A Single-Blinded, Randomized, Control Study

“…The present study and other studies have noted that dermatophytosis is mostly the disease of younger age. [9,10] Males were more affected than females, i.e. group A 22 (73.33%) and Group B 19 (63.33%), which may be due to outdoor working conditions.…”

“…Current study and most of the other studies had similar observation, which overall noted that dermatophytosis infects young population, males outnumber females, and tinea corporis is more common than cruris. [9,10,11,12] Global assessment of patients in Table 2 indicates response rate was more in group B from beginning to end. After 6 weeks (3 rd visit), clinical and mycological cure was 24 (80%) patients in group A, while it was 26 (86.67%) in Group B.…”