At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 200 enrolled
Drug / intervention
0.25 % Miconazole Nitrate Ointmentdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective 2-Year Longitudinal Study to Assess for Miconazole Resistance in Candida Spp. With Repeated Treatment Courses of 0.25% Miconazole Nitrate Ointment in Neonates and Infants up to 1 Year of Age With Recurrent Moderate-Severe Diaper Dermatitis Complicated by Cutaneous Candidiasis
In Brief
A Phase 4 clinical trial evaluating 0.25 % Miconazole Nitrate Ointment for Diaper Rash. Completed, enrolled 200 participants across 8 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiaper Rash
CountriesDominican Republic, Ecuador, Panama, United States
CollaboratorsGlaxoSmithKline
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2007
First PostedJun 2008
Primary CompletionDec 2010
TodayJul 2026
First PostedJun 20, 2008
Enrollment StartMay 1, 2007
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 18.0 years ago
Interventions
0.25 % Miconazole Nitrate Ointmentdrug
Topical Application