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| Name | Class |
|---|---|
| Galderma R&D | INDUSTRY |
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The purpose of this study is to determine whether early use of a bland emollient in newborns, prior to the clinical signs of skin disease, will delay the onset or prevent the development of atopic dermatitis.
All neonates will be treated with Cetaphil cream starting within 1 week of birth. All neonates enrolled will have an increased risk of developing atopic dermatitis because they have a family history of either asthma, hay fever, or atopic dermatitis. These neonates will then be followed for 2 years for the signs and symptoms of atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emollient | Experimental | Skin barrier protection from birth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| emollient (Cetaphil cream) | Drug | Cetaphil cream applied daily from birth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Skin Irritation | 1 and 2 year time points | |
| Incidence of Skin Infection | 1 and 2 year timepoints | |
| Compliance With Protocol | over two years |
| Measure | Description | Time Frame |
|---|---|---|
| Development of Eczema | 1 and 2 year time points |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Simpson, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University, Department of Dermatology | Portland | Oregon | 97239 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Emollient | Emollient (Cetaphil cream): Cetaphil cream applied daily from birth |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Emollient | Skin barrier protection from birth emollient (Cetaphil cream): Cetaphil cream applied daily from birth |
| 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 | Incidence of Skin Irritation | Posted | Count of Participants | Participants | 1 and 2 year time points |
|
|
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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 | Emollient | Emollient (Cetaphil cream): Cetaphil cream applied daily from birth |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Simpson, MD, MCR | Oregon Health & Science University | 503-494-2121 | simpsone@ohsu.edu |
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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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| ID | Term |
|---|---|
| D004643 | Emollients |
| ID | Term |
|---|---|
| D003879 | Dermatologic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Primary | Incidence of Skin Infection | Posted | Count of Participants | Participants | 1 and 2 year timepoints |
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| Primary | Compliance With Protocol | Posted | Number | participants | over two years |
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| Secondary | Development of Eczema | Posted | Count of Participants | Participants | 1 and 2 year time points |
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| 0 |
| 22 |
| 0 |
| 22 |
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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 |