Zoe Diana Draelos1, Tracey C Vlahovic2, Michael H Gold3, Lawrence Charles Parish4, Andrew Korotzer5. 1. Dermatology Consulting Services, High Point, North Carolina; 2. Temple University School of Podiatric Medicine, Philadelphia, Pennsylvania; 3. Tennessee Clinical Research Center, Nashville, Tennessee; 4. Department of Dermatology and Cutaneous Biology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania; 5. Valeant Pharmaceuticals North America LLC, Bridgewater, New Jersey.
Abstract
OBJECTIVE: To evaluate the efficacy and safety of luliconazole cream 1% applied once daily for 14 days in patients with interdigital tinea pedis. DESIGN: Multicenter, randomized, double-blind, parallel-group, vehicle-controlled study. SETTING:Private dermatology clinics and clinical research centers in the United States and Central America. PARTICIPANTS: Three hundred twenty-two male and female patients ≥12 years of age diagnosed with interdigital tinea pedis. MEASUREMENTS: 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. CONCLUSION:Luliconazole cream 1% was safe and well-tolerated and demonstrated significantly greater efficacy than vehicle cream in patients with interdigital tinea pedis.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of luliconazolecream 1% applied once daily for 14 days in patients with interdigital tinea pedis. DESIGN: Multicenter, randomized, double-blind, parallel-group, vehicle-controlled study. SETTING: Private dermatology clinics and clinical research centers in the United States and Central America. PARTICIPANTS: Three hundred twenty-two male and female patients ≥12 years of age diagnosed with interdigital tinea pedis. MEASUREMENTS: 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 luliconazolecream 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 luliconazolecream 1% group compared with vehicle on Day 14, Day 28, and Day 42. For all species and the same isolates, the MIC50/90 for luliconazolecream 1% was 6- to 12-fold lower than for other agents tested. No patients discontinued treatment because of a treatment-emergent adverse event. CONCLUSION:Luliconazolecream 1% was safe and well-tolerated and demonstrated significantly greater efficacy than vehicle cream in patients with interdigital tinea pedis.
Authors: L A Drake; S M Dinehart; E R Farmer; R W Goltz; G F Graham; M K Hardinsky; C W Lewis; D M Pariser; J W Skouge; S B Webster; D C Whitaker; B Butler; B J Lowery; B E Elewski; M L Elgart; P H Jacobs; J L Lesher; R K Scher Journal: J Am Acad Dermatol Date: 1996-02 Impact factor: 11.527