Dataset Information

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

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.

SUBMITTER: Draelos ZD

PROVIDER: S-EPMC4217292 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature

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Publications

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

Draelos Zoe Diana ZD Vlahovic Tracey C TC Gold Michael H MH Parish Lawrence Charles LC Korotzer Andrew A

The Journal of clinical and aesthetic dermatology 20141001 10

<h4>Objective</h4>To evaluate the efficacy and safety of luliconazole cream 1% applied once daily for 14 days in patients with interdigital tinea pedis.<h4>Design</h4>Multicenter, randomized, double-blind, parallel-group, vehicle-controlled study.<h4>Setting</h4>Private dermatology clinics and clinical research centers in the United States and Central America.<h4>Participants</h4>Three hundred twenty-two male and female patients ≥12 years of age diagnosed with interdigital tinea pedis.<h4>Measur ...[more]

PMID: 25371767

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Dataset Information

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

Objective

Design

Setting

Participants

Measurements

Results

Conclusion

Publications

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

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