Status:
COMPLETED
Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants
Lead Sponsor:
Stiefel, a GSK Company
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Diaper Rash
Eligibility:
All Genders
Up to 15 years
Phase:
PHASE4
Brief 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 resista...
Detailed 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 infa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00702507
Start Date
May 1 2007
End Date
December 1 2010
Last Update
March 27 2012
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Sheila Fallon Friedlander, MD
San Diego, California, United States, 92123
2
David Rodriguez, MD
Coral Gables, Florida, United States, 33134
3
Lawrence Schachner, MD
Miami, Florida, United States, 33136
4
Wilson P. Andrews Jr., MD
Marietta, Georgia, United States, 30062