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

CompletedPhase 4

Sponsor: Stiefel, a GSK Company

Conditions: Diaper Rash

Interventions: 0.25 % Miconazole Nitrate Ointment

Countries: United States, Dominican Republic, Ecuador, Panama

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.

Eligibility overview

Sex: ALL

Age: — to 15 Months

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Locations (8)

San Diego, California, United States
Coral Gables, Florida, United States
Miami, Florida, United States
Marietta, Georgia, United States
San Antonio, Texas, United States
Santo Domingo, Dominican Republic
Guayaquil, Ecuador
Panama City, Panama