Eczema
Conditions
Keywords
Atopic Dermatitis
Brief summary
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.
Detailed description
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.
Interventions
DEVICEEpiCeram® Skin Barrier Emulsion
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.
DRUGColloidal Oatmeal Cream
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.
Sponsors
Johnson & Johnson Consumer and Personal Products Worldwide
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 35 Months
Healthy volunteers
No
Inclusion criteria
1. Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment; 2. Caregiver is able and willing to provide written informed consent for the participant to participate in the trial; 3. Male or female of any race or ethnicity, 2 months to 35 months of age; 4. Diagnosed as having Atopic Dermatitis (AD) on the basis of the criteria defined by Hanifin and Rajka 5. Rated as having mild to moderate AD (graded between 3.0 and 7.5 inclusive) as per Rajka-Langeland severity index 6. Willing to stop all emollients, moisturizers and/or other skin barrier cream or emulsion treatments for the AD condition during the test period. If using corticosteroids (not Class I, II, or III) or immunomodulators at study entry, must be on a stable dose for a minimum of 1 month; 7. Willing to undergo a washout period of 2 days before the trial initiation where no use of moisturizers or emollients will be allowed; and 8. Willing and able to comply with scheduled visits, treatment plan, and other trial procedures.
Exclusion criteria
1. Known sensitivity to any investigational product ingredient; 2. Use of a therapeutic (over the counter or prescription) body wash that contains an active ingredient for eczema; 3. Participation in any clinical study within 30 days of Visit 1; 4. Relative, partner or staff of any clinical research site personnel; 5. Active infection of any type at the start of the study; 6. Severe AD as determined by the Rajka-Langeland Severity Index 7. AD requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids. If a participant requires any of these medications as rescue therapy during the study, the participant will be discontinued from the trial; 8. Requires any inhaled or intranasal corticosteroids; 9. Other medical condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline | Baseline to Day 3 | 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. |
| Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline | Baseline to Day 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eczema Area and Severity Index (EASI) on Day 2 - Change From Baseline | Baseline to Day 2 | 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. |
| Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline | Baseline to Day 7 | 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. |
| Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline | Baseline to Day 14 | 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. |
| Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline | Baseline to Day 1 | 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. |
| Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 2 - Change From Baseline | Baseline to Day 2 | 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. |
| Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline | Baseline to Day 7 | 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. |
| Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline | Baseline to Day 14 | 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. |
| Corneometer Measurement on Day 0 - Post-Treatment - Change From Baseline | Baseline to Post -Treatment on Day 0 | 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. |
| Corneometer Measurement on Day 1 - Change From Baseline | Baseline to Day 1 | 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. |
| Corneometer Measurement on Day 2 - Change From Baseline | Baseline to Day 2 | 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. |
| Corneometer Measurement on Day 3 - Change From Baseline | Baseline to Day 3 | 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. |
| Corneometer Measurement on Day 7 - Change From Baseline | Baseline to Day 7 | 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. |
| Corneometer Measurement on Day 14 - Change From Baseline | Baseline to Day 14 | 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. |
| Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth | 0 Days - Pre-Treatment | 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.' |
| Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy | 0 Days - Pre-Treatment | 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.' |
| Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft | 0 Days - Pre-Treatment | 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.' |
| Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth | 0 Days - Pre-Treatment | 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.' |
| Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | 0 Days - Pre-Treatment | 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.' |
| Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | 0 Days - Pre-Treatment | 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.' |
| Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | 0 Days - Pre-Treatment | 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.' |
| Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | 0 Days - Pre-Treatment | 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.' |
| Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth | 0 Days - Post-Treatment | 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.' |
| Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy | 0 Days - Post-Treatment | 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.' |
| Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft | 0 Days - Post-Treatment | 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.' |
| Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth | 0 Days - Post-Treatment | 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.' |
| Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly | 0 Days - Post-Treatment | 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.' |
| Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | 0 Days - Post-Treatment | 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.' |
| Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | 0 Days - Post-Treatment | 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.' |
| Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | 0 Days - Post-Treatment | 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.' |
| Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | 0 Days - Post-Treatment | 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.' |
| Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly | 0 Days - Post-Treatment | 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.' |
| Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth | 1 Day | 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.' |
| Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy | 1 Day | 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.' |
| Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft | 1 Day | 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.' |
| Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth | 1 Day | 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.' |
| Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | 1 Day | 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.' |
| Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | 1 Day | 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.' |
| Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | 1 Day | 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.' |
| Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | 1 Day | 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.' |
| Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth | 2 Days | 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.' |
| Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft | 2 Days | 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.' |
| Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth | 2 Days | 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.' |
| Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | 2 Days | 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.' |
| Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | 2 Days | 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.' |
| Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | 2 Days | 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.' |
| Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | 2 Days | 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.' |
| Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth | 3 Days | 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.' |
| Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy | 3 Days | 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.' |
| Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft | 3 Days | 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.' |
| Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth | 3 Days | 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.' |
| Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | 3 Days | 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.' |
| Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | 3 Days | 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.' |
| Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | 3 Days | 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.' |
| Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | 3 Days | 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.' |
| Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth | 7 Days | 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.' |
| Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy | 7 Days | 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.' |
| Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft | 7 Days | 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.' |
| Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth | 7 Days | 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.' |
| Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | 7 Days | 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.' |
| Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | 7 Days | 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.' |
| Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | 7 Days | 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.' |
| Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | 7 Days | 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.' |
| Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth | 14 Days | 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.' |
| Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy | 2 Days | 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.' |
| Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft | 14 Days | 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.' |
| Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth | 14 Days | 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.' |
| Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | 14 Days | 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.' |
| Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | 14 Days | 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.' |
| Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | 14 Days | 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.' |
| Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | 14 Days | 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.' |
| Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent. | 14 Days | 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.' |
| Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy | 14 Days | 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.' |
| Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline | Baseline to Day 1 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1% Colloidal Oatmeal Eczema Cream 1% Colloidal Oatmeal Eczema Cream, thin layer twice a day | 39 |
| EpiCeram® Skin Barrier Emulsion EpiCeram® Skin Barrier Emulsion, thin layer twice a day | 12 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | 1% Colloidal Oatmeal Eczema Cream | EpiCeram® Skin Barrier Emulsion | Total |
|---|---|---|---|
| Age, Continuous | 19.4 months STANDARD_DEVIATION 9.78 | 22.3 months STANDARD_DEVIATION 10.29 | 20.1 months STANDARD_DEVIATION 9.88 |
| Gender Female | 22 Participants | 3 Participants | 25 Participants |
| Gender Male | 17 Participants | 9 Participants | 26 Participants |
| Region of Enrollment USA | 39 participants | 12 participants | 51 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 39 | 1 / 12 |
| serious Total, serious adverse events | 0 / 39 | 0 / 12 |
Outcome results
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.
Time frame: Baseline to Day 3
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline | -1.783 units on a scale | Standard Deviation 1.72 |
| EpiCeram® Skin Barrier Emulsion | Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline | -0.767 units on a scale | Standard Deviation 2.08 |
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: <0.0001One-sample t-test
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: 0.436One-sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.05195% CI: [-2.51, 0.01]ANCOVA
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.
Time frame: Baseline to Day 3
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline | -0.441 units on a scale | Standard Deviation 0.66 |
| EpiCeram® Skin Barrier Emulsion | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline | -0.364 units on a scale | Standard Deviation 0.5 |
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: 0.0004One-sample t-test
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: 0.0213One-sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.769895% CI: [-0.5, 0.37]ANCOVA
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.'
Time frame: 0 Days - Post-Treatment
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat disagree | 9 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat agree | 12 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly disagree | 7 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly agree | 8 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Neither agree nor disagree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Missing | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Missing | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat disagree | 6 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat agree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly agree | 0 participants |
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.'
Time frame: 0 Days - Post-Treatment
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat disagree | 7 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat agree | 13 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly disagree | 8 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly agree | 7 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Neither agree nor disagree | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Missing | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Missing | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat disagree | 6 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat agree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly agree | 0 participants |
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.'
Time frame: 0 Days - Post-Treatment
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly | Somewhat disagree | 7 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly | Somewhat agree | 10 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly | Strongly disagree | 6 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly | Strongly agree | 10 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly | Neither agree nor disagree | 6 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly | Missing | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly | Missing | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly | Somewhat disagree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly | Neither agree nor disagree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly | Somewhat agree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly | Strongly agree | 0 participants |
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.'
Time frame: 0 Days - Post-Treatment
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat disagree | 9 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat agree | 11 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly disagree | 8 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly agree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Neither agree nor disagree | 8 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Missing | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Missing | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat disagree | 8 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Neither agree nor disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat agree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly agree | 0 participants |
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.'
Time frame: 0 Days - Post-Treatment
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat disagree | 9 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat agree | 15 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly disagree | 9 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly agree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Neither agree nor disagree | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Missing | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Missing | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly disagree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat disagree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Neither agree nor disagree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat agree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly agree | 0 participants |
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.'
Time frame: 0 Days - Post-Treatment
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth | Somewhat disagree | 7 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth | Somewhat agree | 18 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth | Strongly disagree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth | Strongly agree | 7 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth | Neither agree nor disagree | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth | Missing | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth | Missing | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth | Somewhat disagree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth | Neither agree nor disagree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth | Somewhat agree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth | Strongly agree | 2 participants |
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.'
Time frame: 0 Days - Post-Treatment
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft | Missing | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft | Strongly disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft | Somewhat disagree | 10 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft | Neither agree nor disagree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft | Somewhat agree | 15 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft | Strongly agree | 9 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft | Missing | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft | Neither agree nor disagree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft | Strongly agree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft | Somewhat agree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft | Somewhat disagree | 2 participants |
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.'
Time frame: 0 Days - Post-Treatment
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly | Somewhat disagree | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly | Somewhat agree | 17 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly | Strongly disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly | Strongly agree | 8 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly | Neither agree nor disagree | 7 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly | Missing | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly | Missing | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly | Somewhat disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly | Neither agree nor disagree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly | Somewhat agree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly | Strongly agree | 2 participants |
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.'
Time frame: 0 Days - Post-Treatment
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy | Somewhat disagree | 11 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy | Somewhat agree | 19 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy | Strongly disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy | Strongly agree | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy | Neither agree nor disagree | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy | Missing | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy | Missing | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy | Somewhat disagree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy | Somewhat agree | 5 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy | Strongly agree | 2 participants |
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.'
Time frame: 0 Days - Post-Treatment
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth | Somewhat disagree | 11 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth | Somewhat agree | 14 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth | Strongly disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth | Strongly agree | 8 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth | Neither agree nor disagree | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth | Missing | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth | Missing | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth | Somewhat disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth | Neither agree nor disagree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth | Somewhat agree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth | Strongly agree | 2 participants |
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.'
Time frame: 0 Days - Pre-Treatment
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat disagree | 13 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat agree | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly disagree | 21 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly agree | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Neither agree nor disagree | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Missing | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Missing | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly disagree | 8 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat disagree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Neither agree nor disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat agree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly agree | 0 participants |
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.'
Time frame: 0 Days - Pre-Treatment
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat disagree | 10 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat agree | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly disagree | 21 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly agree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Neither agree nor disagree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Missing | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Missing | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly disagree | 8 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat disagree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Neither agree nor disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat agree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly agree | 0 participants |
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.'
Time frame: 0 Days - Pre-Treatment
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat disagree | 15 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat agree | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly disagree | 17 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly agree | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Neither agree nor disagree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Missing | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Missing | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly disagree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat disagree | 8 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Neither agree nor disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat agree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly agree | 0 participants |
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.'
Time frame: 0 Days - Pre-Treatment
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat disagree | 12 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat agree | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly disagree | 22 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly agree | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Neither agree nor disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Missing | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Missing | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly disagree | 8 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat disagree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Neither agree nor disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat agree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly agree | 0 participants |
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.'
Time frame: 0 Days - Pre-Treatment
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth | Somewhat disagree | 13 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth | Somewhat agree | 13 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth | Strongly disagree | 6 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth | Strongly agree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth | Neither agree nor disagree | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth | Missing | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth | Missing | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth | Strongly disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth | Somewhat disagree | 5 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth | Somewhat agree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth | Strongly agree | 2 participants |
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.'
Time frame: 0 Days - Pre-Treatment
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft | Somewhat disagree | 13 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft | Somewhat agree | 14 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft | Strongly disagree | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft | Strongly agree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft | Neither agree nor disagree | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft | Missing | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft | Missing | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft | Strongly disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft | Somewhat disagree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft | Somewhat agree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft | Strongly agree | 2 participants |
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.'
Time frame: 0 Days - Pre-Treatment
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy | Somewhat disagree | 17 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy | Somewhat agree | 12 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy | Strongly disagree | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy | Strongly agree | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy | Neither agree nor disagree | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy | Missing | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy | Missing | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy | Somewhat disagree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy | Somewhat agree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy | Strongly agree | 2 participants |
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.'
Time frame: 0 Days - Pre-Treatment
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth | Neither agree nor disagree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth | Somewhat agree | 13 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth | Somewhat disagree | 12 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth | Strongly agree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth | Missing | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth | Strongly disagree | 9 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth | Missing | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth | Strongly disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth | Somewhat disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth | Somewhat agree | 5 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth | Strongly agree | 2 participants |
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.'
Time frame: 14 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat agree | 11 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly agree | 20 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Neither agree nor disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Missing | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Neither agree nor disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat agree | 6 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly agree | 4 participants |
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.'
Time frame: 14 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat agree | 14 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly agree | 17 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Neither agree nor disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Missing | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Neither agree nor disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat agree | 6 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly agree | 4 participants |
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.'
Time frame: 14 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat disagree | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat agree | 14 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly agree | 17 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Neither agree nor disagree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Missing | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat agree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly agree | 4 participants |
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.'
Time frame: 14 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat agree | 13 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly agree | 17 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Neither agree nor disagree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Missing | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Neither agree nor disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat agree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly agree | 4 participants |
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.'
Time frame: 14 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent. | Somewhat disagree | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent. | Somewhat agree | 9 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent. | Strongly disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent. | Strongly agree | 23 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent. | Neither agree nor disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent. | Missing | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent. | I don't have an opinion | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent. | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent. | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent. | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent. | Somewhat disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent. | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent. | Somewhat agree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent. | Strongly agree | 8 participants |
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.'
Time frame: 14 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth | Somewhat disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth | Somewhat agree | 13 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth | Strongly disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth | Strongly agree | 17 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth | Neither agree nor disagree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth | Missing | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth | Somewhat disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth | Neither agree nor disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth | Somewhat agree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth | Strongly agree | 7 participants |
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.'
Time frame: 14 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft | Somewhat agree | 15 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft | Strongly agree | 15 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft | Strongly disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft | Somewhat disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft | Neither agree nor disagree | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft | Missing | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft | Somewhat disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft | Somewhat agree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft | Neither agree nor disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft | Strongly agree | 7 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
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.'
Time frame: 14 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy | Strongly disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy | Somewhat disagree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy | Neither agree nor disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy | Somewhat agree | 14 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy | Strongly agree | 17 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy | Missing | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy | Somewhat agree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy | Neither agree nor disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy | Strongly agree | 6 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy | Somewhat disagree | 0 participants |
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.'
Time frame: 14 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth | Somewhat disagree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth | Somewhat agree | 11 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth | Strongly disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth | Strongly agree | 19 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth | Neither agree nor disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth | Missing | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth | Somewhat disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth | Neither agree nor disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth | Somewhat agree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth | Strongly agree | 7 participants |
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.'
Time frame: 1 Day
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat disagree | 10 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat agree | 13 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly disagree | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly agree | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Neither agree nor disagree | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Missing | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Missing | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat disagree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Neither agree nor disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat agree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly agree | 0 participants |
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.'
Time frame: 1 Day
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat disagree | 11 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat agree | 16 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly disagree | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly agree | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Neither agree nor disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Missing | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Missing | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat disagree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat agree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly agree | 0 participants |
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.'
Time frame: 1 Day
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat disagree | 11 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat agree | 11 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly disagree | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly agree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Neither agree nor disagree | 7 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Missing | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Missing | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat disagree | 6 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Neither agree nor disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat agree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly agree | 0 participants |
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.'
Time frame: 1 Day
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat disagree | 13 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat agree | 14 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly disagree | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly agree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Neither agree nor disagree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Missing | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Missing | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat disagree | 5 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Neither agree nor disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat agree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly agree | 0 participants |
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.'
Time frame: 1 Day
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth | Neither agree nor disagree | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth | Somewhat agree | 17 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth | Strongly disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth | Strongly agree | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth | Missing | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth | Somewhat disagree | 9 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth | Missing | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth | Somewhat disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth | Neither agree nor disagree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth | Somewhat agree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth | Strongly agree | 1 participants |
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.'
Time frame: 1 Day
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft | Somewhat disagree | 10 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft | Somewhat agree | 17 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft | Strongly disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft | Strongly agree | 6 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft | Neither agree nor disagree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft | Missing | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft | Missing | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft | Somewhat disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft | Neither agree nor disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft | Somewhat agree | 5 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft | Strongly agree | 1 participants |
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.'
Time frame: 1 Day
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy | Somewhat disagree | 8 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy | Somewhat agree | 16 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy | Strongly disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy | Strongly agree | 7 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy | Neither agree nor disagree | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy | Missing | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy | Missing | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy | Somewhat disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy | Neither agree nor disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy | Somewhat agree | 7 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy | Strongly agree | 1 participants |
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.'
Time frame: 1 Day
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth | Somewhat agree | 15 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth | Strongly disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth | Somewhat disagree | 9 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth | Neither agree nor disagree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth | Strongly agree | 9 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth | Missing | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth | Strongly agree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth | Somewhat agree | 6 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth | Missing | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth | Somewhat disagree | 1 participants |
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.'
Time frame: 2 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly disagree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat disagree | 13 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Neither agree nor disagree | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat agree | 13 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly agree | 7 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Missing | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly agree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat agree | 5 participants |
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.'
Time frame: 2 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat disagree | 10 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat agree | 13 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly agree | 7 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Neither agree nor disagree | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Missing | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat agree | 5 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly agree | 1 participants |
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.'
Time frame: 2 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Missing | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly disagree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat disagree | 8 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Neither agree nor disagree | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat agree | 16 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly agree | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat agree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Neither agree nor disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly agree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat disagree | 4 participants |
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.'
Time frame: 2 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Missing | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly disagree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly agree | 6 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat disagree | 9 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Neither agree nor disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat agree | 17 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat agree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly agree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat disagree | 3 participants |
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.'
Time frame: 2 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth | Somewhat disagree | 6 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth | Somewhat agree | 21 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth | Strongly disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth | Strongly agree | 7 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth | Neither agree nor disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth | Missing | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth | Somewhat disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth | Neither agree nor disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth | Somewhat agree | 6 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth | Strongly agree | 2 participants |
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.'
Time frame: 2 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft | Somewhat agree | 23 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft | Strongly disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft | Strongly agree | 7 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft | Neither agree nor disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft | Missing | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft | Somewhat disagree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft | Somewhat disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft | Somewhat agree | 6 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft | Strongly agree | 2 participants |
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.'
Time frame: 2 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy | Somewhat disagree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy | Somewhat agree | 18 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy | Strongly disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy | Strongly agree | 9 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy | Neither agree nor disagree | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy | Missing | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy | Somewhat disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy | Somewhat agree | 5 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy | Strongly agree | 2 participants |
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.'
Time frame: 2 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth | Somewhat disagree | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth | Somewhat agree | 16 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth | Strongly disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth | Strongly agree | 12 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth | Neither agree nor disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth | Missing | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth | Somewhat disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth | Neither agree nor disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth | Somewhat agree | 6 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth | Strongly agree | 2 participants |
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.'
Time frame: 3 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat disagree | 9 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat agree | 12 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly agree | 9 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Neither agree nor disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Missing | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat disagree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat agree | 5 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly agree | 1 participants |
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.'
Time frame: 3 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat disagree | 8 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat agree | 10 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly agree | 10 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Neither agree nor disagree | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Missing | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat disagree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat agree | 5 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly agree | 1 participants |
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.'
Time frame: 3 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat disagree | 7 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat agree | 16 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly agree | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Neither agree nor disagree | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Missing | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Neither agree nor disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat agree | 5 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly agree | 1 participants |
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.'
Time frame: 3 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat disagree | 8 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat agree | 15 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly agree | 7 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Neither agree nor disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Missing | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat agree | 5 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly agree | 2 participants |
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.'
Time frame: 3 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth | Somewhat disagree | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth | Somewhat agree | 19 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth | Strongly disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth | Strongly agree | 8 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth | Neither agree nor disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth | Missing | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth | Somewhat disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth | Somewhat agree | 5 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth | Strongly agree | 3 participants |
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.'
Time frame: 3 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft | Somewhat disagree | 6 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft | Somewhat agree | 18 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft | Strongly disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft | Strongly agree | 8 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft | Neither agree nor disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft | Missing | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft | Somewhat disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft | Somewhat agree | 6 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft | Strongly agree | 3 participants |
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.'
Time frame: 3 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy | Somewhat disagree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy | Somewhat agree | 18 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy | Strongly disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy | Strongly agree | 7 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy | Neither agree nor disagree | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy | Missing | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy | Somewhat disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy | Somewhat agree | 5 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy | Strongly agree | 3 participants |
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.'
Time frame: 3 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth | Somewhat disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth | Somewhat agree | 19 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth | Strongly disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth | Strongly agree | 9 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth | Neither agree nor disagree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth | Missing | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth | Somewhat disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth | Somewhat agree | 5 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth | Strongly agree | 3 participants |
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.'
Time frame: 7 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat agree | 11 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat disagree | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Neither agree nor disagree | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly agree | 12 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Missing | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly agree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Neither agree nor disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat agree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth | Somewhat disagree | 2 participants |
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.'
Time frame: 7 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat disagree | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat agree | 7 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly agree | 16 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Neither agree nor disagree | 6 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Missing | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Somewhat agree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft | Strongly agree | 3 participants |
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.'
Time frame: 7 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat disagree | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat agree | 16 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly agree | 11 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Neither agree nor disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Missing | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat disagree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Somewhat agree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy | Strongly agree | 3 participants |
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.'
Time frame: 7 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat disagree | 5 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat agree | 12 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly agree | 14 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Neither agree nor disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Missing | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Neither agree nor disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Somewhat agree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth | Strongly agree | 3 participants |
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.'
Time frame: 7 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth | Somewhat disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth | Somewhat agree | 19 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth | Strongly disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth | Strongly agree | 11 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth | Neither agree nor disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth | Missing | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth | Somewhat disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth | Neither agree nor disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth | Somewhat agree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth | Strongly agree | 4 participants |
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.'
Time frame: 7 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft | Somewhat disagree | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft | Somewhat agree | 16 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft | Strongly disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft | Strongly agree | 14 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft | Neither agree nor disagree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft | Missing | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft | Somewhat disagree | 2 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft | Neither agree nor disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft | Somewhat agree | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft | Strongly agree | 4 participants |
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.'
Time frame: 7 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy | Somewhat agree | 15 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy | Strongly disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy | Somewhat disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy | Neither agree nor disagree | 3 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy | Strongly agree | 14 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy | Missing | 4 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy | Strongly agree | 5 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy | Neither agree nor disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy | Somewhat agree | 3 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy | Somewhat disagree | 1 participants |
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.'
Time frame: 7 Days
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth | Somewhat disagree | 1 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth | Somewhat agree | 13 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth | Strongly disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth | Strongly agree | 17 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth | Neither agree nor disagree | 2 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth | Missing | 4 participants |
| 1% Colloidal Oatmeal Eczema Cream | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth | Missing | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth | I don't have an opinion | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth | Strongly disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth | Somewhat disagree | 1 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth | Neither agree nor disagree | 0 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth | Somewhat agree | 5 participants |
| EpiCeram® Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth | Strongly agree | 4 participants |
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.
Time frame: Baseline to Post -Treatment on Day 0
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Corneometer Measurement on Day 0 - Post-Treatment - Change From Baseline | 17.277 arbitrary units | Standard Deviation 14.58 |
| EpiCeram® Skin Barrier Emulsion | Corneometer Measurement on Day 0 - Post-Treatment - Change From Baseline | 11.544 arbitrary units | Standard Deviation 12.43 |
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: <0.0001One-sample t-test
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: 0.0049One-sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.240995% CI: [-3.88, 15.07]ANCOVA
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.
Time frame: Baseline to Day 14
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Corneometer Measurement on Day 14 - Change From Baseline | 15.253 arbitrary units | Standard Deviation 9.79 |
| EpiCeram® Skin Barrier Emulsion | Corneometer Measurement on Day 14 - Change From Baseline | 7.818 arbitrary units | Standard Deviation 12.58 |
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: <0.0001One-sample t-test
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: 0.0712One-sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.031395% CI: [0.7, 14.15]ANCOVA
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.
Time frame: Baseline to Day 1
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Corneometer Measurement on Day 1 - Change From Baseline | 15.182 arbitrary units | Standard Deviation 11.57 |
| EpiCeram® Skin Barrier Emulsion | Corneometer Measurement on Day 1 - Change From Baseline | 6.483 arbitrary units | Standard Deviation 13.37 |
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: <0.0001One-sample t-test
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: 0.2386One-sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.024195% CI: [1.28, 17.32]ANCOVA
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.
Time frame: Baseline to Day 2
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Corneometer Measurement on Day 2 - Change From Baseline | 17.019 arbitrary units | Standard Deviation 13.5 |
| EpiCeram® Skin Barrier Emulsion | Corneometer Measurement on Day 2 - Change From Baseline | 7.864 arbitrary units | Standard Deviation 10.96 |
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: <0.0001One-sample t-test
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: 0.0696One-sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.039495% CI: [0.46, 17.52]ANCOVA
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.
Time frame: Baseline to Day 3
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Corneometer Measurement on Day 3 - Change From Baseline | 16.276 arbitrary units | Standard Deviation 11.61 |
| EpiCeram® Skin Barrier Emulsion | Corneometer Measurement on Day 3 - Change From Baseline | 7.661 arbitrary units | Standard Deviation 11.01 |
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: <0.0001One-sample t-test
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: 0.0772One-sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.021395% CI: [1.33, 15.63]ANCOVA
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.
Time frame: Baseline to Day 7
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Corneometer Measurement on Day 7 - Change From Baseline | 15.167 arbitrary units | Standard Deviation 11.33 |
| EpiCeram® Skin Barrier Emulsion | Corneometer Measurement on Day 7 - Change From Baseline | 10.318 arbitrary units | Standard Deviation 16.01 |
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: <0.0001One-sample t-test
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: 0.0172One-sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.196895% CI: [-2.46, 11.58]ANCOVA
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.
Time frame: Baseline to Day 14
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline | -2.403 units on a scale | Standard Deviation 2.3 |
| EpiCeram® Skin Barrier Emulsion | Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline | -1.833 units on a scale | Standard Deviation 2.74 |
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: <0.0001One-sample t-test
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: 0.0476One-sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.234995% CI: [-2.52, 0.64]ANCOVA
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.
Time frame: Baseline to Day 1
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline | -0.672 units on a scale | Standard Deviation 0.92 |
| EpiCeram® Skin Barrier Emulsion | Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline | -0.438 units on a scale | Standard Deviation 1.65 |
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: 0.0003One-sample t-test
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: 0.6063One-sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.368695% CI: [-1.27, 0.48]ANCOVA
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.
Time frame: Baseline to Day 2
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Eczema Area and Severity Index (EASI) on Day 2 - Change From Baseline | -1.194 units on a scale | Standard Deviation 1.1 |
| EpiCeram® Skin Barrier Emulsion | Eczema Area and Severity Index (EASI) on Day 2 - Change From Baseline | -0.489 units on a scale | Standard Deviation 2.49 |
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: <0.0001One-sample t-test
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: 0.6118One-sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.148595% CI: [-1.98, 0.31]ANCOVA
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.
Time frame: Baseline to Day 7
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline | -2.410 units on a scale | Standard Deviation 2.49 |
| EpiCeram® Skin Barrier Emulsion | Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline | -1.233 units on a scale | Standard Deviation 1.41 |
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: <0.0001One-sample t-test
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: 0.2447One-sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.021695% CI: [-2.95, -0.25]ANCOVA
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.
Time frame: Baseline to Day 14
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline | -0.861 units on a scale | Standard Deviation 0.9 |
| EpiCeram® Skin Barrier Emulsion | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline | -0.455 units on a scale | Standard Deviation 0.52 |
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: <0.0001One-sample t-test
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: 0.0065One-sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.156195% CI: [-0.97, 0.16]ANCOVA
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.
Time frame: Baseline to Day 1
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline | -0.027 units on a scale | Standard Deviation 0.16 |
| EpiCeram® Skin Barrier Emulsion | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline | -0.100 units on a scale | Standard Deviation 0.32 |
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: 0.7842One-sample t-test
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: 0.6083One-sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.359995% CI: [-0.08, 0.22]ANCOVA
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.
Time frame: Baseline to Day 2
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 2 - Change From Baseline | -0.417 units on a scale | Standard Deviation 0.55 |
| EpiCeram® Skin Barrier Emulsion | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 2 - Change From Baseline | -0.364 units on a scale | Standard Deviation 0.5 |
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: 0.0001One-sample t-test
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: 0.0317One-sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.803795% CI: [-0.42, 0.33]ANCOVA
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.
Time frame: Baseline to Day 7
Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Eczema Cream | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline | -0.743 units on a scale | Standard Deviation 0.66 |
| EpiCeram® Skin Barrier Emulsion | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline | -0.364 units on a scale | Standard Deviation 0.5 |
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: <0.0001One-sample t-test
Comparison: The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.p-value: 0.0244One-sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.0995% CI: [-0.8, 0.06]ANCOVA