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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Diaper Rash

Intervention / Treatment
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* Drug: 0.25 % Miconazole Nitrate Ointment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 15 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Miconazole Nitrate<br> | Drug: 0.25 % Miconazole Nitrate Ointment<br>* Topical Application<br>* Other names: Vusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Overall Cure (OC) | OC was defined as both clinical (therapeutic) cure with total resolution of signs/symptoms (no clinical signs of infection) and microbiological cure with mycological eradication (both negative potassium hydroxide [KOH] and culture results). Participants who had OC were categorized as Successes; those without OC were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure. | Test-of-cure visit (Day 14) of initial treatment episode | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinical Cure | Participants were evaluated for clinical cure, which was defined as therapeutic cure with total resolution of signs and symptoms (i.e., no clinical signs of infection). Participants who had clinical cure were categorized as Successes; those without clianical cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure. | Test-of-cure visit (Day 14) of initial treatment episode | 
| Number of Participants With Mycological Cure | Participants were evaluated for mycological cure, which was defined as mycological eradication with negative KOH and culture results. Participants who had mycological cure were categorized as Successes; those without mycological cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure. | Test-of-cure visit (Day 14) of initial treatment episode | 
| Clinical Evaluations Using the Diaper Dermatitis Severity Index Score for Initial Treatment Episode | The diaper dermatitis severity index score was calculated as the sum of severity grades for each parameter evaluated (erythema, papules or pustules, and erosions) for the initial treatment episode. The maximum score possible for the diaper dermatitis severity index is 8. Rating scale for Erythema: 0 (none to trace), 1 (mild [pink]), 2 (moderate [red]), 3 (severe [beefy red]). Rating scale for Papules or Pustules: 0 (none to trace [0]), 1 (few [1-10]), 2 (multiple [11-20]), 3 (many [21-40]), 4 (abundant [more than 40]. Rating scale for Erosions: 0 (absent), 1 (present). | 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 | The diaper dermatitis severity index score was calculated as the sum of severity grades for each parameter evaluated (erythema, papules or pustules, and erosions). Change from baseline=baseline value minus Day 14 value. The maximum score possible for the diaper dermatitis severity index is 8. Rating scale for Erythema: 0 (none to trace), 1 (mild [pink]), 2 (moderate [red]), 3 (severe [beefy red]). Rating scale for Papules or Pustules: 0 (none to trace [0]), 1 (few [1-10]), 2 (multiple [11-20]), 3 (many [21-40]), 4 (abundant [more than 40]. Rating scale for Erosions: 0 (absent), 1 (present). | Test-of-cure visit (Day 14) of initial treatment episode | 
| Number of Participants With Overall Cure (OC) of First to Third Recurrent Episodes (RE) | OC was defined as both clinical (therapeutic) cure with total resolution of signs/symptoms (no clinical signs of infection) and microbiological cure with mycological eradication (both negative potassium hydroxide and culture results) at TOC visit for initial episode (ep.) to third ep. Participants (par) who had OC were categorized as Successes; those without OC were categorized as Failures (discontinued/lost to follow-up par were also failures). A RE is not temporally associated with a prior episode (PE) irrespective of whether the PE involves continuing treatment with study medication. | 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 | Participants were evaluated for clinical cure, which was defined as therapeutic cure with total resolution of signs and symptoms (i.e., no clinical signs of infection). Participants who had clinical cure were categorized as Successes; those without clinical cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure. | 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 | Participants were evaluated for mycological cure, which was defined as mycological eradication with negative KOH and culture results. Participants who had mycological cure were categorized as Successes; those without mycological cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure. | Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diaper dermatitis complicated by candidiasis