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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stiefel, a GSK Company
• Collaborator: GlaxoSmithKline
• Treatments: Clotrimazole; Miconazole

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