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| ID | Type | Description | Link |
|---|---|---|---|
| BT0100-402-USA | Other Identifier | Barrier Therapeutics |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Miconazole Nitrate | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.25 % Miconazole Nitrate Ointment | Drug | Topical Application |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheila Fallon Friedlander, MD | San Diego | California | 92123 | United States | ||
| David Rodriguez, MD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23675632 | Derived | 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. |
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The study consisted of 2 phases: initial treatment phase (14-day study period) and a follow-up phase (2-year study period).
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| ID | Title | Description |
|---|---|---|
| FG000 | Vusion Treatment | Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of diaper dermatitis complicated by candidiasis (DDCC) during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Treatment Phase |
|
| ||||||||||||||||||||||||
| Follow-up Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vusion Treatment | Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of diaper dermatitis complicated by candidiasis (DDCC) during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Modified Intent-to-Treat (MITT) Population: all participants who were dispensed study drug and had demonstrated clinical symptoms of diaper dermatitis (DD) (DD severity index score of 4-8; clinical erythema grade of >=2 [see outcome measure #4 for a description]) and confirmed Candida species (positive baseline KOH and culture for Candida species) | Posted | Number | participants | Test-of-cure visit (Day 14) of initial treatment episode |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vusion Initial Treatment Phase | Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D003963 | Diaper Rash |
| ID | Term |
|---|---|
| D017453 | Dermatitis, Irritant |
| D003877 | Dermatitis, Contact |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
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| 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) |
| Coral Gables |
| Florida |
| 33134 |
| United States |
| Lawrence Schachner, MD | Miami | Florida | 33136 | United States |
| Wilson P. Andrews Jr., MD | Marietta | Georgia | 30062 | United States |
| Lewis Purnell, MD | San Antonio | Texas | 78229 | United States |
| Daisy Blanco, MD | Santo Domingo | Dominican Republic |
| Manuel Briones, MD | Guayaquil | Ecuador |
| Zila Espinosa, MD | Panama City | Panama |
| Negative Candida Culture |
|
|
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment. |
|
|
|
| Secondary | 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. | MITT Population | Posted | Number | participants | Test-of-cure visit (Day 14) of initial treatment episode |
|
|
|
| Secondary | 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. | MITT Population | Posted | Number | participants | Test-of-cure visit (Day 14) of initial treatment episode |
|
|
|
| Secondary | 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). | MITT Population. Participants with missing data were not included in this analysis. | Posted | Median | Full Range | scores on a scale | Test-of-cure visit (Day 14) of initial treatment episode |
|
|
|
| Secondary | 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). | MITT Population. Participants with missing data were not included in this analysis. | Posted | Median | Full Range | scores on a scale | Test-of-cure visit (Day 14) of initial treatment episode |
|
|
|
| Secondary | 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. | MITT Population: only those participants with confirmed recurrence were analyzed | Posted | Number | participants | Test-of-cure (TOC) visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months) |
|
|
|
| Secondary | 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. | MITT Population: only those participants with confirmed recurrence were analyzed | Posted | Number | participants | Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months) |
|
|
|
| Secondary | 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. | MITT Population: only those participants with confirmed recurrence were analyzed | Posted | Number | participants | Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months) |
|
|
|
| 0 |
| 200 |
| 42 |
| 200 |
| EG001 | Vusion Follow-up Phase | After the Initial Treatment Phase participants were followed for 2 years. If there was a recurrent episode of diaper dermatitis complicated by candidiasis (DDCC) during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment containing 0.25 percent miconazole nitrate. | 3 | 168 | 133 | 168 |
| Staphylococcal Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Amoebiasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Diarrhoea infectious | Infections and infestations | MedDRA | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pharyngotonsilitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Viral rash | Infections and infestations | MedDRA | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D017437 |
| Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| Title | Measurements |
|---|---|
|
| Second Recurrence, Failure; n=10 |
|
| Third Recurrence, Success; n=4 |
|
| Third Recurrence Failure; n=4 |
|
| Title | Measurements |
|---|---|
|
| Second Recurrence, Failure; n=10 |
|
| Third Recurrence, Success; n=4 |
|
| Third Recurrence Failure; n=4 |
|
| Title | Measurements |
|---|---|
|
| Second Recurrence, Failure; n=10 |
|
| Third Recurrence, Success; n=4 |
|
| Third Recurrence Failure; n=4 |
|