Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants - Full Text View

Sponsored by:	Barrier Therapeutics
Information provided by:	Barrier Therapeutics
ClinicalTrials.gov Identifier:	NCT00702507

Purpose

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

MedlinePlus related topics: Yeast Infections

Drug Information available for: Miconazole nitrate Miconazole Clotrimazole Tioconazole

U.S. FDA Resources

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

Further study details as provided by Barrier Therapeutics:

Primary Outcome Measures:

Negative cultures for the presence of Candida spp. [ Time Frame: Day 7 and Day 14 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:	up to 15 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702507

Locations

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

Sponsors and Collaborators

Barrier Therapeutics

More Information

No publications provided

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

Keywords provided by Barrier Therapeutics:

Diaper dermatitis complicated by candidiasis

Study placed in the following topic categories:

Candidiasis
Skin Diseases
Clotrimazole
Miconazole
Tioconazole
Dermatitis, Contact
Recurrence
Diaper Rash

Anti-Infective Agents, Local
Exanthema
Mycoses
Antifungal Agents
Skin Diseases, Eczematous
Torulopsis
Dermatitis

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 07, 2009