Clinical trial NCT00702507: Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants
Official title: Prospective 2-Year Longitudinal Study to Assess for Miconazole Resistance in Candida Spp. With Repeated Treatment Courses of 0.25% Miconazole Nitrate Ointment in Neonates and Infants up to 1 Year of Age With Recurrent Moderate-Severe Diaper Dermatitis Complicated by Cutaneous Candidiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diaper Rash
Keywords: Diaper dermatitis complicated by candidiasis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-06-20
Enrollment: 200
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 resistant to the drug.

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 infants up to one year of age.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Overall Cure (OC)
timeFrame: Test-of-cure visit (Day 14) of initial treatment episode
Secondary outcomes:
measure: Number of Participants With Clinical Cure
timeFrame: Test-of-cure visit (Day 14) of initial treatment episode
measure: Number of Participants With Mycological Cure
timeFrame: Test-of-cure visit (Day 14) of initial treatment episode
measure: Clinical Evaluations Using the Diaper Dermatitis Severity Index Score for Initial Treatment Episode
timeFrame: Test-of-cure visit (Day 14) of initial treatment episode
measure: Clinical Evaluations Using Change From Baseline in the Dermatitis Severity Index Score at Day 14 of the Initial Treatment Episode
timeFrame: Test-of-cure visit (Day 14) of initial treatment episode
measure: Number of Participants With Overall Cure (OC) of First to Third Recurrent Episodes (RE)
timeFrame: Test-of-cure (TOC) visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)
measure: Number of Participants With Clinical Cure of First to Third Recurrent Episodes
timeFrame: Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)
measure: Number of Participants With Mycological Cure of First to Third Recurrent Episodes
timeFrame: Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sheila Fallon Friedlander, MD
state: California
city: Coral Gables
country: United States
facility: David Rodriguez, MD
state: Florida
city: Miami
country: United States
facility: Lawrence Schachner, MD
state: Florida
city: Marietta
country: United States
facility: Wilson P. Andrews Jr., MD
state: Georgia
city: San Antonio
country: United States
facility: Lewis Purnell, MD
state: Texas
city: Santo Domingo
country: Dominican Republic
facility: Daisy Blanco, MD
city: Guayaquil
country: Ecuador
facility: Manuel Briones, MD
city: Panama City
country: Panama
facility: Zila Espinosa, MD
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.