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

Stiefel

Status and phase

Completed

Phase 4

Conditions

Diaper Rash

Treatments

Drug: 0.25 % Miconazole Nitrate Ointment

Study type

Interventional

Funder types

Industry

Identifiers

NCT00702507

114678

BT0100-402-USA (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

200 patients

Sex

All

Ages

Under 15 months old

Volunteers

No Healthy Volunteers

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