Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants
Information source: Barrier Therapeutics
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diaper Dermatitis; Candidiasis
Intervention: 0.25 % Miconazole Nitrate Ointment (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Barrier Therapeutics Overall contact:
Ann Dandurand, MD, Phone: 609-945-1200, Email: adandurand@barriertherapeutics.com
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: Negative cultures for the presence of Candida spp.
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
Minimum age: N/A.
Maximum age: 15 Months.
Gender(s): Both.
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
Locations and Contacts
Ann Dandurand, MD, Phone: 609-945-1200, Email: adandurand@barriertherapeutics.com
Daisy Blanco, MD, Santo Domingo, Dominican Republic; Recruiting
Manuel Briones, MD, Guayaquil, Ecuador; Recruiting
Zila Espinosa, MD, Panama City, Panama; Recruiting
Sheila Fallon Friedlander, MD, San Diego, California 92123, United States; Recruiting
Lawrence Schachner, MD, Miami, Florida 33136, United States; Recruiting
David Rodriguez, MD, Coral Gables, Florida 33134, United States; Recruiting
Suephy Chen, MD, Atlanta, Georgia 30322, United States; Recruiting
Wilson P. Andrews Jr., MD, Marietta, Georgia 30062, United States; Recruiting
Anne Lucky, MD, Cincinnati, Ohio 45230, United States; Recruiting
Paul Darden, MD, Charleston, South Carolina 29425, United States; Recruiting
Lewis Purnell, MD, San Antonio, Texas 78229, United States; Recruiting
Additional Information
Starting date: March 2007
Ending date: March 2010
Last updated: July 17, 2008
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