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

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

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.

The objective of this study is to investigate the potential for the development of resistance in Candida spp. after repeated treatment courses of 0.25% miconazole nitrate ointment in neonates and infants up to one year of age.

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