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This study compares the effectiveness of two topical creams for atopic dermatitis in pediatric subjects. Subjects will be randomly assigned to use one of the two creams twice daily for 6 weeks or until clear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | EpiCeram Skin Barrier Emulsion |
|
| 2 | Active Comparator | Desonide Cream 0.05% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EpiCeram Skin Barrier Emulsion | Device | topical cream, twice daily, 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Three Item Severity Score | The average of the sum of scores for erythema, edema/papulation, and excoriation for two target lesions. Scoring on a scale of 0 to 3 (none to severe). Maximum score is 9. | Baseline to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Fraser, PhD | Promius Pharma, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | United States | ||
| Northwestern University |
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| ID | Title | Description |
|---|---|---|
| FG000 | EpiCeram Skin Barrier Emulsion | EpiCeram Skin Barrier Emulsion topically twice daily |
| FG001 | Desonide Cream 0.05% | Desonide Cream 0.05% topically twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EpiCeram Skin Barrier Emulsion | EpiCeram Skin Barrier Emulsion |
| BG001 | Desonide Cream 0.05% | Desonide Cream 0.05% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change From Baseline in Three Item Severity Score | The average of the sum of scores for erythema, edema/papulation, and excoriation for two target lesions. Scoring on a scale of 0 to 3 (none to severe). Maximum score is 9. | All subjects with data were included in the analysis. No imputation was done for missing data. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 6 weeks |
|
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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 | EpiCeram Skin Barrier Emulsion | EpiCeram Skin Barrier Emulsion |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joanne Fraser | Promius Pharma | 908 429-4504 | joannefraser@promiuspharma.com |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Desonide Cream 0.05% |
| Drug |
topical cream, twice daily, 6 weeks |
|
| Chicago |
| Illinois |
| 60611 |
| United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Dermatology Research Associates | Cincinnati | Ohio | 45230 | United States |
| University of Texas | Houston | Texas | 77030 | United States |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Three item severity score | The average of the sum of scores for erythema, edema/papulation, and excoriation for two target lesions. Scoring on a scale of 0 to 3 (none to severe). Maximum score is 9. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 50 |
| 7 |
| 50 |
| EG001 | Desonide Cream 0.05% | Desonide Cream 0.05% | 0 | 50 | 3 | 50 |
| Dernatitis atopic | Skin and subcutaneous tissue disorders |
|
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |