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Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants

NCT00702507 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2012-03-27

Study results available
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Summary

The purpose of this study is to determine whether repeated use of 0.25% miconazole nitrate ointment in newborns and infants with a yeast infection in the diaper area causes the yeast to become resistant to the drug.

Conditions

  • Diaper Rash

Interventions

DRUG

0.25 % Miconazole Nitrate Ointment

Topical Application

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Stiefel, a GSK Company

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
15 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States
  • Dominican Republic
  • Ecuador
  • Panama

Study Locations

More Related Trials

Entities

Companies

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 NCT00702507 on ClinicalTrials.gov