Phase 4
Completed N=200
Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants
Diaper Rash
Source: ClinicalTrials.gov NCT00702507 ↗
Enrolled (actual)
200
Serious AEs
0.8%
Results posted
Oct 2011
Primary outcomePrimary: Number of Participants With Overall Cure (OC) — 49; 119 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Overall Cure (OC) |
49; 119 | — |
| SECONDARY Number of Participants With Clinical Cure |
83; 85 | — |
| SECONDARY Number of Participants With Mycological Cure |
77; 91 | — |
| SECONDARY Clinical Evaluations Using the Diaper Dermatitis Severity Index Score for Initial Treatment Episode |
0.0 | — |
| SECONDARY Clinical Evaluations Using Change From Baseline in the Dermatitis Severity Index Score at Day 14 of the Initial Treatment Episode |
-5.0 | — |
| SECONDARY Number of Participants With Overall Cure (OC) of First to Third Recurrent Episodes (RE) |
11; 24; 5; 5; 2; 2 | — |
| SECONDARY Number of Participants With Clinical Cure of First to Third Recurrent Episodes |
20; 15; 5; 5; 3; 1 | — |
| SECONDARY Number of Participants With Mycological Cure of First to Third Recurrent Episodes |
16; 19; 7; 3; 3; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT00702507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.