Last updated: 11/07/2018 08:08:53
Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of participants with overall cure (OC)
Timeframe: Test-of-cure visit (Day 14) of initial treatment episode
Secondary outcomes:
Number of participants with clinical cure
Timeframe: Test-of-cure visit (Day 14) of initial treatment episode
Number of participants with mycological cure
Timeframe: Test-of-cure visit (Day 14) of initial treatment episode
Clinical evaluations using the diaper dermatitis severity index score for initial treatment episode
Timeframe: Test-of-cure visit (Day 14) of initial treatment episode
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
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)
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)
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)
Interventions:
Drug: 0.25 % Miconazole Nitrate Ointment
Enrollment:
200
Observational study model:
Not applicable
Primary completion date:
2010-23-12
Time perspective:
Not applicable
Clinical publications:
Daisy Blanco, MD; Koen van Rossem, MD. A Prospective Two-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 with Recurrent Moderate to Severe Diaper Dermatitis Complicated by Cutaneous Candidiasis. Pediatr Dermatol. 2013;1-8.
Medical condition
Diaper rash
Product
miconazole
Collaborators
GSK
Study date(s)
May 2007 to December 2010
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
Not applicable N/A - 15 months
Accepts healthy volunteers
No
- 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
- Known sensitivity to any component of the formulation
- No other skin conditions that may confound the evaluation of the drug efficacy or tolerability
Inclusion and exclusion 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
Trial location(s)
Location
Lewis Purnell, MD
San Antonio, Texas, United States, 78229
Status
Recruitment Complete
Location
Wilson P. Andrews Jr., MD
Marietta, Georgia, United States, 30062
Status
Recruitment Complete
Location
Sheila Fallon Friedlander, MD
San Diego, California, United States, 92123
Status
Recruitment Complete
Location
Paul Darden, MD
Charleston, South Carolina, United States, 29425
Status
Terminated/Withdrawn
Location
David Rodriguez, MD
Coral Gables, Florida, United States, 33134
Status
Recruitment Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2010-23-12
Actual study completion date
2010-23-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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