Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants
NCT ID: NCT00702507
Last Updated: 2012-03-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2007-05-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Miconazole Nitrate
0.25 % Miconazole Nitrate Ointment
Topical Application
Interventions
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0.25 % Miconazole Nitrate Ointment
Topical Application
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
15 Months
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Stiefel, a GSK Company
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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Sheila Fallon Friedlander, MD
San Diego, California, United States
David Rodriguez, MD
Coral Gables, Florida, United States
Lawrence Schachner, MD
Miami, Florida, United States
Wilson P. Andrews Jr., MD
Marietta, Georgia, United States
Lewis Purnell, MD
San Antonio, Texas, United States
Daisy Blanco, MD
Santo Domingo, , Dominican Republic
Manuel Briones, MD
Guayaquil, , Ecuador
Zila Espinosa, MD
Panama City, , Panama
Countries
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References
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Blanco D, van Rossem K. A prospective two-year assessment of miconazole resistance in Candida spp. With repeated treatment with 0.25% miconazole nitrate ointment in neonates and infants with moderate to severe diaper dermatitis complicated by cutaneous candidiasis. Pediatr Dermatol. 2013 Nov-Dec;30(6):717-24. doi: 10.1111/pde.12107. Epub 2013 May 16.
Other Identifiers
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BT0100-402-USA
Identifier Type: OTHER
Identifier Source: secondary_id
114678
Identifier Type: -
Identifier Source: org_study_id
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