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

Phase 4 Completed 200 enrolled Stiefel, a GSK Company GlaxoSmithKline · collab

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2007-05
Primary completion: 2010-12
Completion: 2010-12

Publications

Blanco D, van Rossem K. A prospective two-year assessment of miconazole resistance in Candida spp. With repeated treatment with 0.25% miconazole nitrate ointment in neonates and infants with moderate to severe diaper dermatitis complicated by cutaneous candidiasis. Pediatr Dermatol. 2013 Nov-Dec;30(6):717-24. doi: 10.1111/pde.12107. Epub 2013 May 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Miconazole Nitrate	Unknown	0.25 %	Topical

Indications

No indication recorded.