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A Therapeutic Equivalence Study of Two Oxiconazole Nitrate Topical Cream Treatments for Patients With Tinea Pedis

NCT01519752 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 661

Last updated 2014-01-22

No results posted yet for this study

Summary

The objective of this study is to demonstrate that Oxiconazole nitrate 1% topical cream is effective for the treatment of patients with moderate to severe Tinea pedis.

Conditions

  • Tinea Pedis

Interventions

DRUG

Oxiconazole Nitrate Cream 1%

Oxiconazole Nitrate Cream 1% applied to affected area once a day for 28 days

DRUG

Oxiconazole Nitrate Cream 1% (Oxistat®)

Oxiconazole Nitrate Cream 1%(Oxistat®)applied to affected area once a day for 28 days

DRUG

Placebo

Placebo applied to affected area once a day for 28 days

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-08-31
Completion
2012-11-30

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Drugs

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 NCT01519752 on ClinicalTrials.gov