A Randomized, Double-blind, Vehicle-controlled Trial of Luliconazole Cream 1% in the Treatment of Interdigital Tinea Pedis.
OBJECTIVE
To evaluate the efficacy and safety of luliconazole cream 1% applied once daily for 14 days in patients with interdigital tinea pedis.


METHODS
Multicenter, randomized, double-blind, parallel-group, vehicle-controlled study.


METHODS
Private dermatology clinics and clinical research centers in the United States and Central America.


METHODS
Three hundred twenty-two male and female patients ≥12 years of age diagnosed with interdigital tinea pedis.


METHODS
Complete clearance (i.e., clinical and mycological cure), effective treatment, and fungal culture and susceptibility.


RESULTS
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.


CONCLUSIONS
Luliconazole cream 1% was safe and well-tolerated and demonstrated significantly greater efficacy than vehicle cream in patients with interdigital tinea pedis.
Dermatology Consulting Services, High Point, North Carolina;
Zoe Diana
ZD
Draelos
Temple University School of Podiatric Medicine, Philadelphia, Pennsylvania;
Tracey C
TC
Vlahovic
Tennessee Clinical Research Center, Nashville, Tennessee;
Michael H
MH
Gold
Department of Dermatology and Cutaneous Biology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania;
Lawrence Charles
LC
Parish
Valeant Pharmaceuticals North America LLC, Bridgewater, New Jersey.
Andrew
A
Korotzer