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

Primary Purpose

Diaper Rash

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
0.25 % Miconazole Nitrate Ointment
Sponsored by
Stiefel, a GSK Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diaper Rash focused on measuring Diaper dermatitis complicated by candidiasis

Eligibility Criteria

undefined - 15 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sheila Fallon Friedlander, MD
  • David Rodriguez, MD
  • Lawrence Schachner, MD
  • Wilson P. Andrews Jr., MD
  • Lewis Purnell, MD
  • Daisy Blanco, MD
  • Manuel Briones, MD
  • Zila Espinosa, MD

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Miconazole Nitrate

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
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).
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.
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.
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.

Full Information

First Posted
June 18, 2008
Last Updated
March 22, 2012
Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00702507
Brief Title
Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diaper Rash
Keywords
Diaper dermatitis complicated by candidiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Miconazole Nitrate
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
0.25 % Miconazole Nitrate Ointment
Other Intervention Name(s)
Vusion
Intervention Description
Topical Application
Primary Outcome Measure Information:
Title
Number of Participants With Overall Cure (OC)
Description
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.
Time Frame
Test-of-cure visit (Day 14) of initial treatment episode
Secondary Outcome Measure Information:
Title
Number of Participants With Clinical Cure
Description
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.
Time Frame
Test-of-cure visit (Day 14) of initial treatment episode
Title
Number of Participants With Mycological Cure
Description
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.
Time Frame
Test-of-cure visit (Day 14) of initial treatment episode
Title
Clinical Evaluations Using the Diaper Dermatitis Severity Index Score for Initial Treatment Episode
Description
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).
Time Frame
Test-of-cure visit (Day 14) of initial treatment episode
Title
Clinical Evaluations Using Change From Baseline in the Dermatitis Severity Index Score at Day 14 of the Initial Treatment Episode
Description
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).
Time Frame
Test-of-cure visit (Day 14) of initial treatment episode
Title
Number of Participants With Overall Cure (OC) of First to Third Recurrent Episodes (RE)
Description
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.
Time Frame
Test-of-cure (TOC) visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)
Title
Number of Participants With Clinical Cure of First to Third Recurrent Episodes
Description
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.
Time Frame
Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)
Title
Number of Participants With Mycological Cure of First to Third Recurrent Episodes
Description
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.
Time Frame
Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
15 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
Sheila Fallon Friedlander, MD
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
David Rodriguez, MD
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Lawrence Schachner, MD
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Wilson P. Andrews Jr., MD
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30062
Country
United States
Facility Name
Lewis Purnell, MD
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Daisy Blanco, MD
City
Santo Domingo
Country
Dominican Republic
Facility Name
Manuel Briones, MD
City
Guayaquil
Country
Ecuador
Facility Name
Zila Espinosa, MD
City
Panama City
Country
Panama

12. IPD Sharing Statement

Citations:
PubMed Identifier
23675632
Citation
Blanco D, van Rossem K. A prospective two-year assessment of miconazole resistance in Candida spp. With repeated treatment with 0.25% miconazole nitrate ointment in neonates and infants with moderate to severe diaper dermatitis complicated by cutaneous candidiasis. Pediatr Dermatol. 2013 Nov-Dec;30(6):717-24. doi: 10.1111/pde.12107. Epub 2013 May 16.
Results Reference
derived

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

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