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Sponsored by: |
Barrier Therapeutics |
---|---|
Information provided by: | Barrier Therapeutics |
ClinicalTrials.gov Identifier: | NCT00702507 |
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.
Condition | Intervention | Phase |
---|---|---|
Diaper Dermatitis Candidiasis |
Drug: 0.25 % Miconazole Nitrate Ointment |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 200 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | December 2010 |
Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator |
Drug: 0.25 % Miconazole Nitrate Ointment
Topical Application
|
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.
Ages Eligible for Study: | up to 15 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Sheila Fallon Friedlander, MD | |
San Diego, California, United States, 92123 | |
United States, Florida | |
Lawrence Schachner, MD | |
Miami, Florida, United States, 33136 | |
David Rodriguez, MD | |
Coral Gables, Florida, United States, 33134 | |
United States, Georgia | |
Wilson P. Andrews Jr., MD | |
Marietta, Georgia, United States, 30062 | |
United States, Texas | |
Lewis Purnell, MD | |
San Antonio, Texas, United States, 78229 | |
Dominican Republic | |
Daisy Blanco, MD | |
Santo Domingo, Dominican Republic | |
Ecuador | |
Manuel Briones, MD | |
Guayaquil, Ecuador | |
Panama | |
Zila Espinosa, MD | |
Panama City, Panama |
Responsible Party: | Barrier Therapeutics, Inc. ( Janice Cunningham ) |
Study ID Numbers: | BT0100-402-USA |
Study First Received: | June 18, 2008 |
Last Updated: | April 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00702507 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Diaper dermatitis complicated by candidiasis |
Candidiasis Skin Diseases Clotrimazole Miconazole Tioconazole Dermatitis, Contact Recurrence Diaper Rash |
Anti-Infective Agents, Local Exanthema Mycoses Antifungal Agents Skin Diseases, Eczematous Torulopsis Dermatitis |
Anti-Infective Agents Candidiasis Skin Diseases Clotrimazole Miconazole Tioconazole Dermatitis, Contact Pharmacologic Actions |
Diaper Rash Anti-Infective Agents, Local Mycoses Therapeutic Uses Antifungal Agents Skin Diseases, Eczematous Dermatitis, Irritant Dermatitis |