A Randomized, Double-blind, Vehicle-controlled Trial of Luliconazole Cream 1% in the Treatment of Interdigital Tinea Pedis.

To evaluate the efficacy and safety of luliconazole cream 1% applied once daily for 14 days in patients with interdigital tinea pedis.
Multicenter, randomized, double-blind, parallel-group, vehicle-controlled study.
Private dermatology clinics and clinical research centers in the United States and Central America.
Three hundred twenty-two male and female patients ≥12 years of age diagnosed with interdigital tinea pedis.
Complete clearance (i.e., clinical and mycological cure), effective treatment, and fungal culture and susceptibility.
At study Day 42, complete clearance was obtained by a larger percentage (14.0% [15/107] vs. 2.8% [3/107]; p<0.001) of patients treated with luliconazole cream 1% compared with vehicle. Also at Day 42, more luliconazole-treated patients compared with vehicle-treated patients obtained effective treatment (32.7% vs. 15.0%), clinical cure (15.0% vs. 3.7%), and mycologic cure (56.1% vs. 27.1%). Erythema, scaling, and pruritus scores were lower for the luliconazole cream 1% group compared with vehicle on Day 14, Day 28, and Day 42. For all species and the same isolates, the MIC50/90 for luliconazole cream 1% was 6- to 12-fold lower than for other agents tested. No patients discontinued treatment because of a treatment-emergent adverse event.
Luliconazole cream 1% was safe and well-tolerated and demonstrated significantly greater efficacy than vehicle cream in patients with interdigital tinea pedis.
AuthorsZoe Diana Draelos, Tracey C Vlahovic, Michael H Gold, Lawrence Charles Parish, Andrew Korotzer
JournalThe Journal of clinical and aesthetic dermatology (J Clin Aesthet Dermatol) Vol. 7 Issue 10 Pg. 20-7 (Oct 2014) ISSN: 1941-2789 [Print] United States
PMID25371767 (Publication Type: Journal Article)

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