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| Name | Class |
|---|---|
| Galderma R&D | INDUSTRY |
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The goal of this study is to determine what effect Cetaphil® Restoraderm® system has on babies' skin versus Johnson & Johnson baby lotion and skin cleanser.
Subjects will randomly be divided into a group using Cetaphil® Restoraderm® system or a group using Johnson & Johnson baby lotion and skin cleanser . At 3, 6, and 12 months non-invasive measurements of barrier function will be used to test the babies' skin. The procedures are as follows:
Both groups will be reminded to follow the instructions about general good skin care of infants. Subjects will be asked if they agree to provide a saliva sample. If yes, a saliva sample will be collected from the inside of the infant's cheek at the 6 month visit and will be shipped to the laboratory of Dr. Irwin McLean at the University of Dundee, where it will be tested for gene defects in the skin barrier that might trigger the development of eczema. Defects in the gene called filaggrin have been shown to increase the risk of developing eczema. The samples will be identified by a code to protect your infant's identity. The saliva samples will be stored only for this study, and then the sample will be destroyed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser. |
|
| Cetaphil Restoraderm | Experimental | Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetaphil Restoraderm | Other | Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 12 Months | Percentage of cumulative Atopic Dermatitis diagnosed by a blinded investigator at 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of High Emollient Use | Patient-reported adherence to the emollient regimen in the intervention group and the treatment group. High emollient use was defined as applying the intervention or control emollient five or more days per week. | 2, 6, 12, 18, and 24 months |
| Age at Onset of Eczema |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Simpson, MD, MCR | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University Center for Health & Healing | Portland | Oregon | 97239 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cetaphil Restoraderm | Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser. Cetaphil Restoraderm: Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser. |
| FG001 | Standard of Care | Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser. Standard of Care: Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cetaphil Restoraderm | Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser. Cetaphil Restoraderm: Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser. |
| 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 | Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 12 Months | Percentage of cumulative Atopic Dermatitis diagnosed by a blinded investigator at 12 months | Around 28% of subjects enrolled were lost to follow-up by 12 months | Posted | Number | Percentage of participants | 12 months |
|
From the time informed consent is signed through the 24 month study follow-up telephone call.
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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 | Cetaphil Restoraderm | Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser. Cetaphil Restoraderm: Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Idiopathic Intracranial Hypertension | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Baby Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Simpson, MD, MCR | Oregon Health & Science University | 503-494-3968 | 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 |
|---|---|
| D059039 | Standard of Care |
| D000090984 | Ad26COVS1 |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Other | Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser. |
|
|
Age of subject at onset of eczema |
| Baseline through Month 24 Follow-up |
| Filaggrin Mutation Status | Filaggrin mutation status result | 6 month visit |
| Transepidermal Water Loss (TEWL) | Transepidermal water loss (TEWL) to measure skin barrier function | 2 month, 6 month, and 12 month visits |
| Skin Hydration (Skin Electrical Capacitance) | Determination of stratum corneum hydration from the dorsal forearm | 2 month, 6 month, and 12 month visits |
| Skin pH | Skin pH, as measured using a pH probe | 2 month, 6 month, and 12 month visits |
| BG001 |
| Standard of Care |
Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser. Standard of Care: Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser. Standard of Care: Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser. |
|
|
| Secondary | Percentage of High Emollient Use | Patient-reported adherence to the emollient regimen in the intervention group and the treatment group. High emollient use was defined as applying the intervention or control emollient five or more days per week. | Posted | Number | percentage of participants | 2, 6, 12, 18, and 24 months |
|
|
|
| Secondary | Age at Onset of Eczema | Age of subject at onset of eczema | Posted | Median | Full Range | months | Baseline through Month 24 Follow-up |
|
|
|
| Secondary | Filaggrin Mutation Status | Filaggrin mutation status result | Number of participants analyzed captures only those participants that completed 6 month filaggrin testing. Not all participants noted in the overall participant flow were able to complete filaggrin testing either due to study status (i.e., lost to follow up, withdrawn) or missed visit. | Posted | Count of Participants | Participants | 6 month visit |
|
|
|
| Secondary | Transepidermal Water Loss (TEWL) | Transepidermal water loss (TEWL) to measure skin barrier function | Number of participants analyzed captures only those participants that completed TEWL testing at all time points. Not all participants noted in the overall participant flow were able to complete TEWL testing either due to study status (i.e., lost to follow up, withdrawn) or missed visits. | Posted | Mean | Standard Deviation | (g/[m2hr]) | 2 month, 6 month, and 12 month visits |
|
|
|
| Secondary | Skin Hydration (Skin Electrical Capacitance) | Determination of stratum corneum hydration from the dorsal forearm | Number of participants analyzed captures only those participants that completed skin hydration testing at all time points. Not all participants noted in the overall participant flow were able to complete skin hydration testing either due to study status (i.e., lost to follow up, withdrawn) or missed visits. | Posted | Mean | Standard Deviation | farads | 2 month, 6 month, and 12 month visits |
|
|
|
| Secondary | Skin pH | Skin pH, as measured using a pH probe | Number of participants analyzed captures only those participants that completed Skin pH testing at all time points. Not all participants noted in the overall participant flow were able to complete Skin pH testing either due to study status (i.e., lost to follow up, withdrawn) or missed visits. | Posted | Mean | Standard Deviation | pH | 2 month, 6 month, and 12 month visits |
|
|
|
| Post-Hoc | Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 24 Months | Percentage of cumulative Atopic Dermatitis diagnosed by any MD at 24 Months | Number of participants analyzed captures only those participants still on study at 24 months. | Posted | Number | percentage of participants | 24 Months |
|
|
|
| 0 |
| 54 |
| 2 |
| 54 |
| 30 |
| 54 |
| EG001 | Standard of Care | Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser. Standard of Care: Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser. | 0 | 46 | 0 | 46 | 21 | 46 |
| RSV and Stridor | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Viral exanthems | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Heat rash/miliaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Candidiasis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Diaper dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Seborrheic Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bacterial Skin Infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Unspecified Transient Rashes | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash to Vaccination/Drug Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Irritant Contact Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Urticarial Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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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 |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| Percentage of high emollient use at 12 months |
|
| Percentage of high emollient use at 18 months |
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| Percentage of high emollient use at 24 months |
|
| Average TEWL (g/[m2hr]) at 12 months |
|
| Average capacitance at 12 months |
|
| Average pH at 12 months |
|