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

Completed · Phase 4

Conditions studied: Diaper Rash

In brief

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.

Key facts

Study ID

NCT00702507

Run by

Stiefel, a GSK Company

People needed

200

Starts

2007-05-01

Expected to finish

2010-12-01

Last updated by the study team

2012-03-27

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female neonate or infant up to 1 year of age with Fitzpatrick Skin Type I-VI
• Clinical evidence of diaper dermatitis and a positive KOH result for pseudohyphae and/or budding yeast at baseline visit
• Overall Diaper Dermatitis Severity Index score at baseline visit of 4-8 (must include an overall clinical grade of at least 2 for erythema)
• Wear commercially available diapers day and night for at least 7 days prior to enrollment and during the course of the 2 year study
• Caretaker must complete informed consent process

You may not qualify if…

• Known sensitivity to any component of the formulation
• No other skin conditions that may confound the evaluation of the drug efficacy or tolerability
• Known sensitivity to skin care toiletry products or diapers
• History of HIV positive
• Chronic illnesses that require systemic medication that may confound the evaluation of study drug efficacy or tolerability (antibiotic therapy is not included)
• Treatment with a prescription product for diaper dermatitis or other skin condition 7 days prior to enrollment

Where it is running

• Sheila Fallon Friedlander, MD — San Diego, California, United States
• David Rodriguez, MD — Coral Gables, Florida, United States
• Lawrence Schachner, MD — Miami, Florida, United States
• Wilson P. Andrews Jr., MD — Marietta, Georgia, United States
• Lewis Purnell, MD — San Antonio, Texas, United States
• Daisy Blanco, MD — Santo Domingo, Dominican Republic
• Manuel Briones, MD — Guayaquil, Ecuador
• Zila Espinosa, MD — Panama City, Panama

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.