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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00702507
First received: June 18, 2008
Last updated: March 22, 2012
Last verified: March 2012

June 18, 2008
March 22, 2012
May 2007
December 2010   (final data collection date for primary outcome measure)
Number of Participants With Overall Cure (OC) [ Time Frame: Test-of-cure visit (Day 14) of initial treatment episode ] [ Designated as safety issue: No ]
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.
Negative cultures for the presence of Candida SPP. at post-treatment follow-up visit, study day 14 [ Time Frame: Day 7 and Day 14 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00702507 on ClinicalTrials.gov Archive Site
  • Number of Participants With Clinical Cure [ Time Frame: Test-of-cure visit (Day 14) of initial treatment episode ] [ Designated as safety issue: No ]
    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 [ Time Frame: Test-of-cure visit (Day 14) of initial treatment episode ] [ Designated as safety issue: No ]
    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 [ Time Frame: Test-of-cure visit (Day 14) of initial treatment episode ] [ Designated as safety issue: No ]
    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 [ Time Frame: Test-of-cure visit (Day 14) of initial treatment episode ] [ Designated as safety issue: No ]
    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) [ Time Frame: Test-of-cure (TOC) visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months) ] [ Designated as safety issue: No ]
    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.
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Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants
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

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diaper Rash
Drug: 0.25 % Miconazole Nitrate Ointment
Topical Application
Other Name: Vusion
Active Comparator: Miconazole Nitrate
Intervention: Drug: 0.25 % Miconazole Nitrate Ointment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
up to 15 Months
No
Contact information is only displayed when the study is recruiting subjects
United States,   Dominican Republic,   Ecuador,   Panama
 
NCT00702507
114678, BT0100-402-USA
No
GlaxoSmithKline ( Stiefel, a GSK Company )
Stiefel, a GSK Company
GlaxoSmithKline
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP