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This study is for infants with mild to moderate dry and itchy skin. This study will involve going to the doctor for 6 visits over 2 weeks. All participants' skin will be examined by a dermatologist to determine if they have atopic dermatitis and have an active mild to moderate eczema wound. Participant's parents/guardians will be asked a few questions to determine if their child qualifies for the study.
Then all participants' caregivers will complete a questionnaire at the beginning of the study. The child's skin will be examined to rate the level of their eczema and a trained examiner will grade the looks and symptoms of their eczema. All parents or guardians will be instructed how to apply the test product and how to record usage on a diary card and then apply the test product. The test product will be applied at least 2 times per day or more as needed on all body areas, including the face affected throughout the study.
One digital picture will be taken of one eczema wound. Another digital picture will be taken of the area around this wound. These pictures will be taken on Day 0 (Baseline), Day 3, and Day 14.
Once product is applied the skin will be examined for any adverse events and all participants' caregivers will complete a questionnaire on study day 1, 3, 7 and 14.
This is a multi-center, two-arm clinical trial in participants aged 2 - 35 months with mild to moderate Atopic Dermatitis (AD) as determined by the study physician. A sufficient number of participants will be enrolled in this study to yield 40 participants who complete the trial, 30 in the investigational product group and 10 in the active control group.
The investigational and control (EpiCeram®) products will be used topically. Participant caregivers will be instructed to gently massage the assigned product into the participant's skin. The treatments will be applied at least 2 times per day on all body areas, including areas of the body and face affected by AD. No product should be applied within 4 hours of a site visit. These treatments will be used in place of the participant's current moisturizers and/or emollients.
Diaries will be completed by the participants' caregivers each day, beginning upon initiation of therapy and continuing until trial completion/discontinuation, and will include information on product application and use of rescue medication.
All participants will visit the clinical site for assessments at baseline (Day 0) and on Days 1, 2, 3, 7 and 14. Clinical assessments include the Eczema Area and Severity index (EASI) and Investigator's Global Atopic Dermatitis Assessment (IGADA). Instrumental assessment of hydration will be done using a Corneometer (Courage & Khazaka, Germany). Caregivers will also complete a questionnaire to assess product experience. The final visit will occur on Day 14 or on the day of participant withdrawal from the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPI | Active Comparator |
| |
| NEE | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EpiCeram® Skin Barrier Emulsion | Device | Device (including sham) Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin as directed. |
| Measure | Description | Time Frame |
|---|---|---|
| Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline | The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72. | Baseline to Day 3 |
| Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline | The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe. | Baseline to Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline | The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72. | Baseline to Day 1 |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Nunez | Johnson & Johnson Consumer and Personal Products Worldwide | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas J. Stephens and Associates, Colorado Research Center | Colorado Springs | Colorado | 80915 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | 1% Colloidal Oatmeal Eczema Cream | 1% Colloidal Oatmeal Eczema Cream, thin layer twice a day |
| FG001 | EpiCeram® Skin Barrier Emulsion | EpiCeram® Skin Barrier Emulsion, thin layer twice a day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1% Colloidal Oatmeal Eczema Cream | 1% Colloidal Oatmeal Eczema Cream, thin layer twice a day |
| BG001 | EpiCeram® Skin Barrier Emulsion | EpiCeram® Skin Barrier Emulsion, thin layer twice a day |
| 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 | Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline | The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72. | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 3 |
|
Day 14 ± 1 day, +30 days for serious adverse events.
Adverse events were systematically collected at each study visit through Visit 6 (Day 14 ± 1 day). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
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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 | 1% Colloidal Oatmeal Eczema Cream | 1% Colloidal Oatmeal Eczema Cream, thin layer twice a day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chirstopher Nunez, PhD/Study Director | Johnson & Johnson Consumer and Personal Products Worldwide | 973-385-7984 USA EST | cnunez1@its.jnj.com |
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| ID | Term |
|---|---|
| D004485 | Eczema |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| Colloidal Oatmeal Cream | Drug | Drug (including placebo) Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin as directed. |
|
| Eczema Area and Severity Index (EASI) on Day 2 - Change From Baseline | The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72. | Baseline to Day 2 |
| Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline | The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72. | Baseline to Day 7 |
| Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline | The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72. | Baseline to Day 14 |
| Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline | The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe. | Baseline to Day 1 |
| Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 2 - Change From Baseline | The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe. | Baseline to Day 2 |
| Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline | The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe. | Baseline to Day 7 |
| Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline | The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe. | Baseline to Day 14 |
| Corneometer Measurement on Day 0 - Post-Treatment - Change From Baseline | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. Post-treatment on Day 0, corneometer readings ranged from 10.3 to 86.3. | Baseline to Post -Treatment on Day 0 |
| Corneometer Measurement on Day 1 - Change From Baseline | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 1, corneometer readings ranged from 5.5 to 84.0. | Baseline to Day 1 |
| Corneometer Measurement on Day 2 - Change From Baseline | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 2, corneometer readings ranged from 8.5 to 74.0. | Baseline to Day 2 |
| Corneometer Measurement on Day 3 - Change From Baseline | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 3, corneometer readings ranged from 8.0 to 65.3. | Baseline to Day 3 |
| Corneometer Measurement on Day 7 - Change From Baseline | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 7, corneometer readings ranged from 6.8 to 65.0. | Baseline to Day 7 |
| Corneometer Measurement on Day 14 - Change From Baseline | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 14, corneometer readings ranged from 5.7 to 73.1. | Baseline to Day 14 |
| Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth | Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 0 Days - Pre-Treatment |
| Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy | Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 0 Days - Pre-Treatment |
| Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft | Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 0 Days - Pre-Treatment |
| Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth | Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 0 Days - Pre-Treatment |
| Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 0 Days - Pre-Treatment |
| Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 0 Days - Pre-Treatment |
| Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 0 Days - Pre-Treatment |
| Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 0 Days - Pre-Treatment |
| Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 0 Days - Post-Treatment |
| Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 0 Days - Post-Treatment |
| Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 0 Days - Post-Treatment |
| Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 0 Days - Post-Treatment |
| Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 0 Days - Post-Treatment |
| Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 0 Days - Post-Treatment |
| Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 0 Days - Post-Treatment |
| Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 0 Days - Post-Treatment |
| Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 0 Days - Post-Treatment |
| Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 0 Days - Post-Treatment |
| Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 1 Day |
| Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 1 Day |
| Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 1 Day |
| Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 1 Day |
| Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 1 Day |
| Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 1 Day |
| Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 1 Day |
| Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 1 Day |
| Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 2 Days |
| Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 2 Days |
| Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 2 Days |
| Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 2 Days |
| Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 2 Days |
| Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 2 Days |
| Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 2 Days |
| Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 2 Days |
| Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 3 Days |
| Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 3 Days |
| Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 3 Days |
| Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 3 Days |
| Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 3 Days |
| Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 3 Days |
| Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 3 Days |
| Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 3 Days |
| Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 7 Days |
| Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 7 Days |
| Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 7 Days |
| Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 7 Days |
| Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 7 Days |
| Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 7 Days |
| Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 7 Days |
| Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 7 Days |
| Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 14 Days |
| Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 14 Days |
| Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 14 Days |
| Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 14 Days |
| Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 14 Days |
| Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 14 Days |
| Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 14 Days |
| Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 14 Days |
| Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent. | Questions were answered immediately post-treatment by participant's caregiver. Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | 14 Days |
| Thomas J. Stephens and Associates, Dallas Research Center |
| Richardson |
| Texas |
| 75081 |
| United States |
| Lost to Follow-up |
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| BG002 | Total | Total of all reporting groups |
| months |
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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
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| Primary | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline | The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe. | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 3 |
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| Secondary | Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline | The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72. | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 1 |
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| Secondary | Eczema Area and Severity Index (EASI) on Day 2 - Change From Baseline | The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72. | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 2 |
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| Secondary | Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline | The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72. | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 7 |
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| Secondary | Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline | The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72. | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 14 |
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| Secondary | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline | The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe. | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 1 |
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| Secondary | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 2 - Change From Baseline | The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe. | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 2 |
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| Secondary | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline | The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe. | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 7 |
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| Secondary | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline | The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe. | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 14 |
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| Secondary | Corneometer Measurement on Day 0 - Post-Treatment - Change From Baseline | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. Post-treatment on Day 0, corneometer readings ranged from 10.3 to 86.3. | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Mean | Standard Deviation | arbitrary units | Baseline to Post -Treatment on Day 0 |
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| Secondary | Corneometer Measurement on Day 1 - Change From Baseline | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 1, corneometer readings ranged from 5.5 to 84.0. | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Mean | Standard Deviation | arbitrary units | Baseline to Day 1 |
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| Secondary | Corneometer Measurement on Day 2 - Change From Baseline | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 2, corneometer readings ranged from 8.5 to 74.0. | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Mean | Standard Deviation | arbitrary units | Baseline to Day 2 |
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| Secondary | Corneometer Measurement on Day 3 - Change From Baseline | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 3, corneometer readings ranged from 8.0 to 65.3. | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Mean | Standard Deviation | arbitrary units | Baseline to Day 3 |
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| Secondary | Corneometer Measurement on Day 7 - Change From Baseline | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 7, corneometer readings ranged from 6.8 to 65.0. | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Mean | Standard Deviation | arbitrary units | Baseline to Day 7 |
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| Secondary | Corneometer Measurement on Day 14 - Change From Baseline | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 14, corneometer readings ranged from 5.7 to 73.1. | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Mean | Standard Deviation | arbitrary units | Baseline to Day 14 |
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| Secondary | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth | Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 0 Days - Pre-Treatment |
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| Secondary | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy | Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 0 Days - Pre-Treatment |
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| Secondary | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft | Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 0 Days - Pre-Treatment |
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| Secondary | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth | Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 0 Days - Pre-Treatment |
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| Secondary | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 0 Days - Pre-Treatment |
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| Secondary | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 0 Days - Pre-Treatment |
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| Secondary | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 0 Days - Pre-Treatment |
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| Secondary | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 0 Days - Pre-Treatment |
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| Secondary | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 0 Days - Post-Treatment |
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| Secondary | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 0 Days - Post-Treatment |
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| Secondary | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 0 Days - Post-Treatment |
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| Secondary | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 0 Days - Post-Treatment |
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| Secondary | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 0 Days - Post-Treatment |
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| Secondary | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 0 Days - Post-Treatment |
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| Secondary | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 0 Days - Post-Treatment |
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| Secondary | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 0 Days - Post-Treatment |
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| Secondary | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 0 Days - Post-Treatment |
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| Secondary | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 0 Days - Post-Treatment |
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| Secondary | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 1 Day |
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| Secondary | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 1 Day |
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| Secondary | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 1 Day |
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| Secondary | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 1 Day |
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| Secondary | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 1 Day |
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| Secondary | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 1 Day |
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| Secondary | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 1 Day |
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|
|
| Secondary | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 1 Day |
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|
| Secondary | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 2 Days |
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|
|
| Secondary | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 2 Days |
|
|
|
| Secondary | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 2 Days |
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|
|
| Secondary | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 2 Days |
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|
| Secondary | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 2 Days |
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|
| Secondary | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 2 Days |
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|
|
| Secondary | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 2 Days |
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|
|
| Secondary | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 2 Days |
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| Secondary | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 3 Days |
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|
|
| Secondary | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 3 Days |
|
|
|
| Secondary | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 3 Days |
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| Secondary | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 3 Days |
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|
| Secondary | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 3 Days |
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|
| Secondary | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 3 Days |
|
|
|
| Secondary | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 3 Days |
|
|
|
| Secondary | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 3 Days |
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| Secondary | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 7 Days |
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|
|
| Secondary | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 7 Days |
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|
|
| Secondary | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 7 Days |
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| Secondary | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 7 Days |
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|
|
| Secondary | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 7 Days |
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|
|
| Secondary | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 7 Days |
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|
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| Secondary | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 7 Days |
|
|
|
| Secondary | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 7 Days |
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| Secondary | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 14 Days |
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|
|
| Secondary | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 14 Days |
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| Secondary | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 14 Days |
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| Secondary | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 14 Days |
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| Secondary | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 14 Days |
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| Secondary | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 14 Days |
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| Secondary | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 14 Days |
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|
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| Secondary | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 14 Days |
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| Secondary | Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent. | Questions were answered immediately post-treatment by participant's caregiver. Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.' | Analysis was based on Intent-to-Treat subjects, which included all randomized subjects. | Posted | Number | participants | 14 Days |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | EpiCeram® Skin Barrier Emulsion | EpiCeram® Skin Barrier Emulsion, thin layer twice a day | 0 | 12 | 1 | 12 |
Principal investigator agreed not to publish the study results without prior sponsor approval.
| D012873 |
| Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline. |
| One-sample t-test |
Adjusted by study site. |
| 0.0213 |
The significance level threshold level was 0.05 (two-sided). |
| 2-Sided |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | The significance threshold level was 0.05 (two-sided). | 0.7698 | Mean Difference (Final Values) | -0.06 | Standard Error of the Mean | 0.22 | 2-Sided | 95 | -0.50 | 0.37 | No | Superiority or Other |
The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline. |
| One-sample t-test |
Adjusted by study site. |
| 0.6063 |
The significance level threshold level was 0.05 (two-sided). |
| 2-Sided |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Treatment and study site as factors, baseline score as covariate. | 0.3686 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | -0.39 | Standard Error of the Mean | 0.43 | 2-Sided | 95 | -1.27 | 0.48 | No | Superiority or Other |
The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline. |
| One-sample t-test |
Adjusted by study site. |
| 0.6118 |
The significance level threshold level was 0.05 (two-sided). |
| 2-Sided |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Treatment and study site as factors, baseline score as covariate. | 0.1485 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | -0.83 | Standard Error of the Mean | 0.56 | 2-Sided | 95 | -1.98 | 0.31 | No | Superiority or Other |
The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline. |
| One-sample t-test |
Adjusted by study site. |
| 0.2447 |
The significance level threshold level was 0.05 (two-sided). |
| 2-Sided |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Treatment and study site as factors, baseline score as covariate. | 0.0216 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | -1.60 | Standard Error of the Mean | 0.67 | 2-Sided | 95 | -2.95 | -0.25 | No | Superiority or Other |
The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline. |
| One-sample t-test |
Adjusted by study site. |
| 0.0476 |
The significance level threshold level was 0.05 (two-sided). |
| 2-Sided |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Treatment and study site as factors, baseline score as covariate. | 0.2349 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | -0.94 | Standard Error of the Mean | 0.78 | 2-Sided | 95 | -2.52 | 0.64 | No | Superiority or Other |
The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline. |
| One-sample t-test |
Adjusted by study site. |
| 0.6083 |
The significance level threshold level was 0.05 (two-sided). |
| 2-Sided |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Treatment and study site as factors, baseline score as covariate. | 0.3599 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 0.07 | Standard Error of the Mean | 0.07 | 2-Sided | 95 | -0.08 | 0.22 | No | Superiority or Other |
The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline. |
| One-sample t-test |
Adjusted by study site. |
| 0.0317 |
The significance level threshold level was 0.05 (two-sided). |
| 2-Sided |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Treatment and study site as factors, baseline score as covariate. | 0.8037 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | -0.05 | Standard Error of the Mean | 0.19 | 2-Sided | 95 | -0.42 | 0.33 | No | Superiority or Other |
The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline. |
| One-sample t-test |
Adjusted by study site. |
| 0.0244 |
The significance level threshold level was 0.05 (two-sided). |
| 2-Sided |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Treatment and study site as factors, baseline score as covariate. | 0.0900 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | -0.37 | Standard Error of the Mean | 0.21 | 2-Sided | 95 | -0.80 | 0.06 | No | Superiority or Other |
The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline. |
| One-sample t-test |
Adjusted by study site. |
| 0.0065 |
The significance level threshold level was 0.05 (two-sided). |
| 2-Sided |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Treatment and study site as factors, baseline score as covariate. | 0.1561 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | -0.40 | Standard Error of the Mean | 0.28 | 2-Sided | 95 | -0.97 | 0.16 | No | Superiority or Other |
The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline. |
| One-sample t-test |
Adjusted by study site. |
| 0.0049 |
The significance level threshold level was 0.05 (two-sided). |
| 2-Sided |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Treatment and study site as factors, baseline score as covariate. | 0.2409 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 5.59 | Standard Error of the Mean | 4.71 | 2-Sided | 95 | -3.88 | 15.07 | No | Superiority or Other |
The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline. |
| One-sample t-test |
Adjusted by study site. |
| 0.2386 |
The significance level threshold level was 0.05 (two-sided). |
| 2-Sided |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Treatment and study site as factors, baseline score as covariate. | 0.0241 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 9.30 | Standard Error of the Mean | 3.98 | 2-Sided | 95 | 1.28 | 17.32 | No | Superiority or Other |
The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline. |
| One-sample t-test |
Adjusted by study site. |
| 0.0696 |
The significance level threshold level was 0.05 (two-sided). |
| 2-Sided |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Treatment and study site as factors, baseline score as covariate. | 0.0394 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 8.99 | Standard Error of the Mean | 4.23 | 2-Sided | 95 | 0.46 | 17.52 | No | Superiority or Other |
The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline. |
| One-sample t-test |
Adjusted by study site. |
| 0.0772 |
The significance level threshold level was 0.05 (two-sided). |
| 2-Sided |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Treatment and study site as factors, baseline score as covariate. | 0.0213 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 8.48 | Standard Error of the Mean | 3.54 | 2-Sided | 95 | 1.33 | 15.63 | No | Superiority or Other |
The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline. |
| One-sample t-test |
Adjusted by study site. |
| 0.0172 |
The significance level threshold level was 0.05 (two-sided). |
| 2-Sided |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Treatment and study site as factors, baseline score as covariate. | 0.1968 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 4.56 | Standard Error of the Mean | 3.48 | 2-Sided | 95 | -2.46 | 11.58 | No | Superiority or Other |
The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline. |
| One-sample t-test |
Adjusted by study site. |
| 0.0712 |
The significance level threshold level was 0.05 (two-sided). |
| 2-Sided |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Treatment and study site as factors, baseline score as covariate. | 0.0313 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 7.43 | Standard Error of the Mean | 3.34 | 2-Sided | 95 | 0.70 | 14.15 | No | Superiority or Other |
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Missing |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Missing |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Missing |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Missing |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Missing |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Missing |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Missing |
|
| Somewhat disagree |
|
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