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COMPLETEDPhase 4NCT00702507

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

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 resista...

Lead sponsor: Stiefel, a GSK Company•5 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Stiefel, a GSK Company

Collaborators

GlaxoSmithKline

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.

Age

0 - 1 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 27, 2012Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment200

Start dateMay 2007

Last updatedMar 27, 2012

Condition

Locations shown

Sheila Fallon Friedlander, MD

San Diego, California

David Rodriguez, MD

Coral Gables, Florida

Lawrence Schachner, MD

Miami, Florida

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 27, 2012Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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