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Safety and Efficacy of Econazole Nitrate Foam 1% and Foam Vehicle in Subjects With Tinea Pedis

NCT01358240 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2012-09-28

No results posted yet for this study

Summary

This is a study of the safety and efficacy of Econazole Nitrate Foam 1% and the Foam Vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation. The study will also utilize Econazole Nitrate Cream 1% (for safety comparison) and a Placebo cream for blinding purposes only.

Conditions

  • Tinea Pedis
  • Athlete's Foot

Interventions

DRUG

Econazole Nitrate Foam 1%

Econazole Nitrate Foam 1% applied once a day for 4 weeks

DRUG

Vehicle Foam

Vehicle Foam applied once a day for 4 week

DRUG

Econazole Nitrate Cream 1%

Econazole Nitrate Foam 1% applied once a day for 4 weeks

OTHER

Placebo Cream

Placebo cream applied once a day for 4 weeks

Sponsors & Collaborators

  • AmDerma Pharmaceuticals, LLC

    collaborator INDUSTRY

  • AmDerma

    lead INDUSTRY

Principal Investigators

  • Daniel Piacquadio, MD · Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-04-30
Completion
2012-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01358240 on ClinicalTrials.gov