Eczema
Conditions
Keywords
Atopic Dermatitis
Brief summary
The purpose of this 3 week study is to test the effectiveness of an over-the-counter (OTC) skin balm in infants and toddlers with mild to moderate dry, itchy skin.
Detailed description
50 infants and toddlers will be enrolled in this study to yield 40 completed subjects, 30 babies in the active treatment group and 10 babies in the positive control group. Infants and toddlers aged 6 to 47 months inclusive will receive either a prescription or non-marketed investigational product for the treatment of eczema. Caregivers will be asked to stop use of prescription eczema treatments one week before the start of the study and during the study. Caregivers will apply study product to babies as indicated for 14 days to affected areas. Subject caregivers will record treatment use in a daily diary and complete questionnaires. A dermatologist will examine and score the babies eczema and symptoms. Skin moisture levels will also be tested.
Interventions
EpiCeram Skin Barrier Emulsion
DRUG1% Colloidal Oatmeal Balm
Experimental Product 1% Colloidal Oatmeal Balm
Sponsors
Johnson & Johnson Consumer Inc. (J&JCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 47 Months
Healthy volunteers
No
Inclusion criteria
1. Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) 2. Male or female of any race or ethnicity, 6 months to 47 months of age; 3. Diagnosed as having eczema 4. Willing to stop use of all non-assigned moisturizers and/or creams for the entire duration of the study 5. Child must have bedtime/sleep issues due to their dry, itchy skin
Exclusion criteria
1. Use of a therapeutic (over-the-counter or prescription) body wash that contains an active ingredient for eczema 2. Participation in any clinical study within 30 days of Visit 1 3. Active infection of any type at the start of the study 4. Diagnosed as having severe eczema 5. Atopic Dermatitis requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids 6. Child wakes up 3 or more times during the night 7. Child is awake more than 60 minutes during the night 8. Child sleeps for less than a total of 9 hours (during the day or night) 9. Child requires greater than 2.0 mg per day of inhaled or intranasal corticosteroids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment | Day 0 - Pretreatment (Baseline) to Day 0 - immediately post treatment | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. |
| Change From Baseline in Mean Corneometer Measurement 12 Hours After Treatment | Day 0 - Pretreatment (Baseline) to 12 Hours After treatment | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment | Day 0 - Pretreatment (Baseline) to 7 Days After treatment | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. |
| Change From Baseline in Mean Corneometer Measurement 14 Days After Treatment | Day 0 - Pretreatment (Baseline) to 14 Days After treatment | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. |
| Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline | Day 0 - Pretreatment (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 (absent) 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 3 - Change From Baseline | Day 0 - Pretreatment (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 (absent) 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 | Day 0 - Pretreatment (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 (absent) 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 | Day 0 - Pretreatment (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 (absent) 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 | Day 0 - Pretreatment (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 (absent) to 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 3 - Change From Baseline | Day 0 - Pretreatment (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 (absent) to 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 | Day 0 - Pretreatment (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 (absent) to 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 | Day 0 - Pretreatment (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 (absent) to 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. |
| Dryness Scale Score on Day 1 - Change From Baseline | Day 0 - Pretreatment (Baseline) to Day 1 | An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness). |
| Dryness Scale Score on Day 3 - Change From Baseline | Day 0 - Pretreatment (Baseline) to Day 3 | An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness). |
| Dryness Scale Score on Day 7 - Change From Baseline | Day 0 - Pretreatment (Baseline) to Day 7 | An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness). |
| Dryness Scale Score on Day 14 - Change From Baseline | Day 0 - Pretreatment (Baseline) to Day 14 | An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness). |
| Caregiver's Itch Assessment on Day 3 - Change From Baseline | Day 0 - Pretreatment (Baseline) to Day 3 | An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time). |
| Caregiver's Itch Assessment on Day 7 - Change From Baseline | Day 0 - Pretreatment (Baseline) to Day 7 | An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time). |
| Caregiver's Itch Assessment on Day 14 - Change From Baseline | Day 0 - Pretreatment (Baseline) to Day 14 | An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time). |
| Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role | 0 Days Pretreatment (Baseline) | Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement | 0 Days Pretreatment (Baseline) | Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time Child Usually Put to Bed | 0 Days Pretreatment (Baseline) | Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm). |
| Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime | 0 Days Pretreatment (Baseline) | Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'. |
| Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time for Child to Fall Asleep | 0 Days Pretreatment (Baseline) | Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Times Child Awakes During the Night | 0 Days Pretreatment (Baseline) | Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Awake During the Night | 0 Days Pretreatment (Baseline) | Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Longest Time Child is Asleep During the Night | 0 Days Pretreatment (Baseline) | Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child is Asleep During the Night | 0 Days Pretreatment (Baseline) | Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Naps Child Takes During the Day | 0 Days Pretreatment (Baseline) | Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Sleeps During the Day | 0 Days Pretreatment (Baseline) | Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem | 0 Days Pretreatment (Baseline) | Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'. |
| Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role | 7 Days | Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement | 7 Days | Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time Child Usually Put to Bed | 7 Days | Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm). |
| Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime | 7 Days | Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'. |
| Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time for Child to Fall Asleep | 7 Days | Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Times Child Awakes During the Night | 7 Days | Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Awake During the Night | 7 Days | Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Longest Time Child is Asleep During the Night | 7 Days | Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child is Asleep During the Night | 7 Days | Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Naps Child Takes During the Day | 7 Days | Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Sleeps During the Day | 7 Days | Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem | 7 Days | Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'. |
| Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Responder Role | 14 Days | Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement | 14 Days | Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time Child Usually Put to Bed | 14 Days | Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm). |
| Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime | 14 Days | Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'. |
| Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time for Child to Fall Asleep | 14 Days | Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Times Child Awakes During the Night | 14 Days | Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Awake During the Night | 14 Days | Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Longest Time Child is Asleep During the Night | 14 Days | Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child is Asleep During the Night | 14 Days | Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Naps Child Takes During the Day | 14 Days | Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Sleeps During the Day | 14 Days | Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day? |
| Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem | 14 Days | Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'. |
| Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall | 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). The question is Overall, my baby's skin looks smooth. |
| Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall | 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). The question is Overall, my baby's skin looks healthy. |
| Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall | 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). The question is Overall, my baby's skin feels soft. |
| Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | 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). The question is In the areas affected by eczema, my baby's skin looks smooth. |
| Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | 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). The question is In the areas affected by eczema, my baby's skin looks healthy. |
| Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | 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). The question is In the areas affected by eczema, my baby's skin feels soft. |
| Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week | 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). The question is Over this past week, what has your child's mood been? |
| Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning | 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). The question is Typically, how would you rate your child's mood when he/she wakes up in the morning? |
| Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week | 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). The question is Over this past week, how much has your child wanted to play? |
| Caregiver Questionnaire on Day 0 Pre-treatment - Amount of Sleep Caregiver Got Over Past Week | 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). The question is Over this past week, how much sleep did you get at night? |
| Caregiver Questionnaire on Day 0 Pre-treatment - Number of Times Caregiver Woke Up | 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). The question is How many times did you wake up during the night? |
| Caregiver Questionnaire on Day 0 Pre-treatment - Amount of Time Caregiver Awake | 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). The question is If you did wake up during the night, how much time were you awake (on average) before falling back asleep? |
| Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week | 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). The question is Over this past week, how much energy have you had to engage with your family? |
| Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week | 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). The question is Over this past week, how rested have you felt? |
| Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week | 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). The question is Over this past week, how alert have you felt? |
| Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week | 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). The question is Over this past week, how productive have you been at work? |
| Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall | 0 Days - Post-treatment | Questions were answered after 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). The question is Overall, my baby's skin looks smooth. |
| Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall | 0 Days - Post-treatment | Questions were answered after 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). The question is Overall, my baby's skin looks healthy. |
| Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall | 0 Days - Post-treatment | Questions were answered after 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). The question is Overall, my baby's skin feels soft. |
| Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | 0 Days - Post-treatment | Questions were answered after 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). The question is In the areas affected by eczema, my baby's skin looks smooth. |
| Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | 0 Days - Post-treatment | Questions were answered after 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). The question is In the areas affected by eczema, my baby's skin looks healthy. |
| Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | 0 Days - Post-treatment | Questions were answered after 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). The question is In the areas affected by eczema, my baby's skin feels soft. |
| Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall | 3 Days | Questions were answered after three days of 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). The question is Overall, my baby's skin looks smooth. |
| Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall | 3 Days | Questions were answered after three days of 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). The question is Overall, my baby's skin looks healthy. |
| Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall | 3 Days | Questions were answered after three days of 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). The question is Overall, my baby's skin feels soft. |
| Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema | 3 Days | Questions were answered after three days of 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). The question is In the areas affected by eczema, my baby's skin looks smooth. |
| Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema | 3 Days | Questions were answered after three days of 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). The question is In the areas affected by eczema, my baby's skin looks healthy. |
| Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema | 3 Days | Questions were answered after three days of 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). The question is In the areas affected by eczema, my baby's skin feels soft. |
| Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall | 7 Days | Questions were answered after seven days of 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). The question is Overall, my baby's skin looks smooth. |
| Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall | 7 Days | Questions were answered after seven days of 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). The question is Overall, my baby's skin looks healthy. |
| Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall | 7 Days | Questions were answered after seven days of 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). The question is Overall, my baby's skin feels soft. |
| Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema | 7 Days | Questions were answered after seven days of 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). The question is In the areas affected by eczema, my baby's skin looks smooth. |
| Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema | 7 Days | Questions were answered after seven days of 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). The question is In the areas affected by eczema, my baby's skin looks healthy. |
| Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema | 7 Days | Questions were answered after seven days of 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). The question is In the areas affected by eczema, my baby's skin feels soft. |
| Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week | 7 Days | Questions were answered after seven days of 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). The question is Over this past week, what has your child's mood been? |
| Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning | 7 Days | Questions were answered after seven days of 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). The question is Typically, how would you rate your child's mood when he/she wakes up in the morning? |
| Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week | 7 Days | Questions were answered after seven days of 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). The question is Over this past week, how much has your child wanted to play? |
| Caregiver Questionnaire on Day 7 - Amount of Sleep Caregiver Got Over Past Week | 7 Days | Questions were answered after seven days of 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). The question is Over this past week, how much sleep did you get at night? |
| Caregiver Questionnaire on Day 7 - Number of Times Caregiver Woke Up | 7 Days | Questions were answered after seven days of 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). The question is How many times did you wake up during the night? |
| Caregiver Questionnaire on Day 7 - Amount of Time Caregiver Awake | 7 Days | Questions were answered after seven days of 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). The question is If you did wake up during the night, how much time were you awake (on average) before falling back asleep? |
| Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week | 7 Days | Questions were answered after seven days of 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). The question is Over this past week, how much energy have you had to engage with your family? |
| Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week | 7 Days | Questions were answered after seven days of 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). The question is Over this past week, how rested have you felt? |
| Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week | 7 Days | Questions were answered after seven days of 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). The question is Over this past week, how alert have you felt? |
| Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week | 7 Days | Questions were answered after seven days of 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). The question is Over this past week, how productive have you been at work? |
| Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall | 14 Days | Questions were answered after 14 days of 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). The question is Overall, my baby's skin looks smooth. |
| Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall | 14 Days | Questions were answered after 14 days of 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). The question is Overall, my baby's skin looks healthy. |
| Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall | 14 Days | Questions were answered after 14 days of 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). The question is Overall, my baby's skin feels soft. |
| Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema | 14 Days | Questions were answered after 14 days of 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). The question is In the areas affected by eczema, my baby's skin looks smooth. |
| Change From Baseline in Mean Corneometer Measurement 24 Hours After Treatment | Day 0 - Pretreatment (Baseline) to 24 Hours After treatment | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. |
| Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema | 14 Days | Questions were answered after 14 days of 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). The question is In the areas affected by eczema, my baby's skin feels soft. |
| Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week | 14 Days | Questions were answered after 14 days of 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). The question is Over this past week, what has your child's mood been? |
| Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning | 14 Days | Questions were answered after 14 days of 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). The question is Typically, how would you rate your child's mood when he/she wakes up in the morning? |
| Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week | 14 Days | Questions were answered after 14 days of 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). The question is Over this past week, how much has your child wanted to play? |
| Caregiver Questionnaire on Day 14 - Amount of Sleep Caregiver Got Over Past Week | 14 Days | Questions were answered after 14 days of 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). The question is Over this past week, how much sleep did you get at night? |
| Caregiver Questionnaire on Day 14 - Number of Times Caregiver Woke Up | 14 Days | Questions were answered after 14 days of 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). The question is How many times did you wake up during the night? |
| Caregiver Questionnaire on Day 14 - Amount of Time Caregiver Awake | 14 Days | Questions were answered after 14 days of 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). The question is If you did wake up during the night, how much time were you awake (on average) before falling back asleep? |
| Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week | 14 Days | Questions were answered after 14 days of 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). The question is Over this past week, how much energy have you had to engage with your family? |
| Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week | 14 Days | Questions were answered after 14 days of 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). The question is Over this past week, how rested have you felt? |
| Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week | 14 Days | Questions were answered after 14 days of 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). The question is Over this past week, how alert have you felt? |
| Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week | 14 Days | Questions were answered after 14 days of 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). The question is Over this past week, how productive have you been at work? |
| Caregiver Questionnaire on Day 14 - Recommend Product | 14 Days | Questions were answered after 14 days of 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). The question is I would recommend this product to another parent. |
| Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema | 14 Days | Questions were answered after 14 days of 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). The question is In the areas affected by eczema, my baby's skin looks healthy. |
| Change From Baseline in Mean Corneometer Measurement 3 Days After Treatment | Day 0 - Pretreatment (Baseline) to 3 Days After treatment | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1% Colloidal Oatmeal Balm 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed | 17 |
| EpiCeram Skin Barrier Emulsion EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed | 6 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
Baseline characteristics
| Characteristic | 1% Colloidal Oatmeal Balm | EpiCeram Skin Barrier Emulsion | Total |
|---|---|---|---|
| Age, Continuous | 21.8 months STANDARD_DEVIATION 9.66 | 22.5 months STANDARD_DEVIATION 10.78 | 22.0 months STANDARD_DEVIATION 9.72 |
| Region of Enrollment USA | 17 participants | 6 participants | 23 participants |
| Sex: Female, Male Female | 7 Participants | 0 Participants | 7 Participants |
| Sex: Female, Male Male | 10 Participants | 6 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 17 | 4 / 6 |
| serious Total, serious adverse events | 0 / 17 | 0 / 6 |
Outcome results
Primary
Change From Baseline in Mean Corneometer Measurement 12 Hours After Treatment
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time frame: Day 0 - Pretreatment (Baseline) to 12 Hours After treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Change From Baseline in Mean Corneometer Measurement 12 Hours After Treatment | 55.12 arbitrary units | Standard Deviation 47.124 |
| EpiCeram Skin Barrier Emulsion | Change From Baseline in Mean Corneometer Measurement 12 Hours After Treatment | 2.11 arbitrary units | Standard Deviation 15.629 |
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: <0.001One sample t-test
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.754One sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.01395% CI: [12.23, 92.373]ANCOVA
Primary
Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time frame: Day 0 - Pretreatment (Baseline) to Day 0 - immediately post treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment | 656.31 arbitrary units | Standard Deviation 273.322 |
| EpiCeram Skin Barrier Emulsion | Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment | 234.72 arbitrary units | Standard Deviation 176.566 |
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: <0.001One-sample t-test
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.023One sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.00395% CI: [166.435, 679.186]ANCOVA
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.
Time frame: 0 Days Pretreatment (Baseline)
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem | Not a problem at all | 11.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem | A very small problem | 41.2 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem | A small problem | 23.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem | A moderate problem | 23.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem | A serious problem | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem | A moderate problem | 33.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem | A small problem | 33.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem | Not a problem at all | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem | A serious problem | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem | A very small problem | 16.7 percentage of participants |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.
Time frame: 0 Days Pretreatment (Baseline)
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime | Somewhat easy | 52.9 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime | Moderately difficult | 17.6 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime | Somewhat difficult | 17.6 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime | Very difficult | 5.9 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime | Very easy | 5.9 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime | Very difficult | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime | Very easy | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime | Somewhat easy | 50.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime | Somewhat difficult | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime | Moderately difficult | 0 percentage of participants |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Longest Time Child is Asleep During the Night
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?
Time frame: 0 Days Pretreatment (Baseline)
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Longest Time Child is Asleep During the Night | 6.28 hours | Standard Deviation 2.296 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Longest Time Child is Asleep During the Night | 5.58 hours | Standard Deviation 3.105 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Naps Child Takes During the Day
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?
Time frame: 0 Days Pretreatment (Baseline)
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Naps Child Takes During the Day | 1.2 number of naps | Standard Deviation 0.56 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Naps Child Takes During the Day | 1.0 number of naps | Standard Deviation 0.89 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Times Child Awakes During the Night
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?
Time frame: 0 Days Pretreatment (Baseline)
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Times Child Awakes During the Night | 1.6 number of times | Standard Deviation 1 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Times Child Awakes During the Night | 2.3 number of times | Standard Deviation 1.03 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?
Time frame: 0 Days Pretreatment (Baseline)
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role | Father | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role | Mother | 100 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role | Grandparent | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role | Other | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role | Other | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role | Father | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role | Grandparent | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role | Mother | 100 percentage of participants |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?
Time frame: 0 Days Pretreatment (Baseline)
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement | Infant crib parent's room | 41.2 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement | Infant crib in room with sibling | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement | In parent's bed | 17.6 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement | Other | 17.6 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement | Infant crib separate room | 23.5 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement | Other | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement | Infant crib separate room | 33.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement | Infant crib parent's room | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement | In parent's bed | 50.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement | Infant crib in room with sibling | 0 percentage of participants |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time Child Usually Put to Bed
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).
Time frame: 0 Days Pretreatment (Baseline)
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time Child Usually Put to Bed | 9.04 hours.minutes | Standard Deviation 1.16 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time Child Usually Put to Bed | 9.10 hours.minutes | Standard Deviation 0.35 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time for Child to Fall Asleep
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?
Time frame: 0 Days Pretreatment (Baseline)
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time for Child to Fall Asleep | 27.6 minutes | Standard Deviation 11.74 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time for Child to Fall Asleep | 27.5 minutes | Standard Deviation 15.08 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Awake During the Night
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?
Time frame: 0 Days Pretreatment (Baseline)
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Awake During the Night | 26.0 minutes | Standard Deviation 21.85 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Awake During the Night | 44.2 minutes | Standard Deviation 48.21 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child is Asleep During the Night
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?
Time frame: 0 Days Pretreatment (Baseline)
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child is Asleep During the Night | 8.46 hours | Standard Deviation 1.921 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child is Asleep During the Night | 9.08 hours | Standard Deviation 1.908 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Sleeps During the Day
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?
Time frame: 0 Days Pretreatment (Baseline)
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Sleeps During the Day | 2.32 hours | Standard Deviation 0.642 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Sleeps During the Day | 1.57 hours | Standard Deviation 1.023 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem | Not a problem at all | 31.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem | A very small problem | 31.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem | A small problem | 25.0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem | A moderate problem | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem | A serious problem | 6.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem | A moderate problem | 20.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem | A small problem | 20.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem | Not a problem at all | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem | A serious problem | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem | A very small problem | 60.0 percentage of participants |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime | Somewhat easy | 56.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime | Somewhat difficult | 25.0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime | Moderately difficult | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime | Very difficult | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime | Very easy | 12.5 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime | Very easy | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime | Very difficult | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime | Somewhat difficult | 40.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime | Somewhat easy | 60.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime | Moderately difficult | 0 percentage of participants |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Longest Time Child is Asleep During the Night
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Longest Time Child is Asleep During the Night | 8.19 hours | Standard Deviation 2.237 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Longest Time Child is Asleep During the Night | 4.90 hours | Standard Deviation 2.966 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Naps Child Takes During the Day
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Naps Child Takes During the Day | 1.2 number of naps | Standard Deviation 0.54 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Naps Child Takes During the Day | 1.2 number of naps | Standard Deviation 0.84 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Times Child Awakes During the Night
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Times Child Awakes During the Night | 1.1 number of times | Standard Deviation 0.93 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Times Child Awakes During the Night | 1.6 number of times | Standard Deviation 1.14 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Responder Role
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Responder Role | Grandparent | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Responder Role | Father | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Responder Role | Other | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Responder Role | Mother | 100 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Responder Role | Other | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Responder Role | Father | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Responder Role | Grandparent | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Responder Role | Mother | 100 percentage of participants |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement | Infant crib parent's room | 37.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement | Infant crib in room with sibling | 12.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement | In parent's bed | 18.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement | Other | 12.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement | Infant crib separate room | 18.8 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement | Other | 20.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement | Infant crib separate room | 20.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement | Infant crib parent's room | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement | In parent's bed | 60.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement | Infant crib in room with sibling | 0 percentage of participants |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time Child Usually Put to Bed
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time Child Usually Put to Bed | 8.48 hours.minutes | Standard Deviation 1.02 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time Child Usually Put to Bed | 9.14 hours.minutes | Standard Deviation 0.31 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time for Child to Fall Asleep
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time for Child to Fall Asleep | 23.8 minutes | Standard Deviation 12.85 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time for Child to Fall Asleep | 27.0 minutes | Standard Deviation 11.51 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Awake During the Night
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Awake During the Night | 14.7 minutes | Standard Deviation 9.91 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Awake During the Night | 37.0 minutes | Standard Deviation 47.64 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child is Asleep During the Night
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child is Asleep During the Night | 8.99 hours | Standard Deviation 1.3 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child is Asleep During the Night | 9.00 hours | Standard Deviation 2.236 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Sleeps During the Day
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Sleeps During the Day | 2.06 hours | Standard Deviation 0.722 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Sleeps During the Day | 1.55 hours | Standard Deviation 2.095 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem | Not a problem at all | 18.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem | A very small problem | 50.0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem | A small problem | 18.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem | A moderate problem | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem | A serious problem | 6.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem | A moderate problem | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem | A small problem | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem | Not a problem at all | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem | A serious problem | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem | A very small problem | 50.0 percentage of participants |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime | Somewhat easy | 43.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime | Moderately difficult | 12.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime | Somewhat difficult | 31.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime | Very difficult | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime | Very easy | 6.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime | Very difficult | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime | Very easy | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime | Somewhat easy | 50.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime | Somewhat difficult | 33.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime | Moderately difficult | 16.7 percentage of participants |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Longest Time Child is Asleep During the Night
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Longest Time Child is Asleep During the Night | 7.70 hours | Standard Deviation 2.206 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Longest Time Child is Asleep During the Night | 6.58 hours | Standard Deviation 2.764 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Naps Child Takes During the Day
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Naps Child Takes During the Day | 1.3 number of naps | Standard Deviation 0.6 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Naps Child Takes During the Day | 1.2 number of naps | Standard Deviation 0.75 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Times Child Awakes During the Night
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Times Child Awakes During the Night | 1.1 number of times | Standard Deviation 0.81 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Times Child Awakes During the Night | 1.8 number of times | Standard Deviation 1.47 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role | Father | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role | Mother | 100 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role | Grandparent | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role | Other | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role | Other | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role | Father | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role | Grandparent | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role | Mother | 100 percentage of participants |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement | Infant crib parent's room | 37.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement | Infant crib in room with sibling | 18.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement | In parent's bed | 18.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement | Other | 12.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement | Infant crib separate room | 12.5 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement | Other | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement | Infant crib separate room | 33.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement | Infant crib parent's room | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement | In parent's bed | 50.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement | Infant crib in room with sibling | 0 percentage of participants |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time Child Usually Put to Bed
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time Child Usually Put to Bed | 8.46 hours.minutes | Standard Deviation 1.05 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time Child Usually Put to Bed | 9.27 hours.minutes | Standard Deviation 0.4 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time for Child to Fall Asleep
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time for Child to Fall Asleep | 28.8 minutes | Standard Deviation 14.2 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time for Child to Fall Asleep | 22.5 minutes | Standard Deviation 12.94 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Awake During the Night
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Awake During the Night | 17.8 minutes | Standard Deviation 11.97 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Awake During the Night | 44.2 minutes | Standard Deviation 53.61 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child is Asleep During the Night
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child is Asleep During the Night | 8.81 hours | Standard Deviation 1.41 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child is Asleep During the Night | 9.17 hours | Standard Deviation 1.633 |
Secondary
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Sleeps During the Day
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Sleeps During the Day | 2.10 hours | Standard Deviation 0.649 |
| EpiCeram Skin Barrier Emulsion | Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Sleeps During the Day | 2.29 hours | Standard Deviation 2.421 |
Secondary
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema
Questions were answered after 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). The question is In the areas affected by eczema, my baby's skin feels soft.
Time frame: 0 Days - Post-treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | Strongly disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | Somewhat disagree | 29.4 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | Neither agree nor disagree | 5.9 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | Somewhat agree | 41.2 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | Strongly agree | 23.5 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | Somewhat agree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | Neither agree nor disagree | 33.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | Strongly disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | Strongly agree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | Somewhat disagree | 50.0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema
Questions were answered after 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). The question is In the areas affected by eczema, my baby's skin looks healthy.
Time frame: 0 Days - Post-treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | Strongly disagree | 5.9 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | Somewhat disagree | 41.2 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | Neither agree nor disagree | 17.6 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | Somewhat agree | 23.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | Strongly agree | 11.8 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | Somewhat agree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | Neither agree nor disagree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | Strongly disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | Strongly agree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | Somewhat disagree | 66.7 percentage of participants |
Secondary
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema
Questions were answered after 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). The question is In the areas affected by eczema, my baby's skin looks smooth.
Time frame: 0 Days - Post-treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | Strongly disagree | 11.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | Somewhat disagree | 41.2 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | Neither agree nor disagree | 5.9 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | Somewhat agree | 23.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | Strongly agree | 17.6 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | Somewhat agree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | Neither agree nor disagree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | Strongly disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | Strongly agree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | Somewhat disagree | 66.7 percentage of participants |
Secondary
Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall
Questions were answered after 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). The question is Overall, my baby's skin feels soft.
Time frame: 0 Days - Post-treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall | Strongly disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall | Somewhat disagree | 23.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall | Neither agree nor disagree | 11.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall | Somewhat agree | 41.2 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall | Strongly agree | 23.5 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall | Somewhat agree | 33.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall | Neither agree nor disagree | 33.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall | Strongly disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall | Strongly agree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall | Somewhat disagree | 33.3 percentage of participants |
Secondary
Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall
Questions were answered after 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). The question is Overall, my baby's skin looks healthy.
Time frame: 0 Days - Post-treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall | Strongly disagree | 5.9 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall | Somewhat disagree | 35.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall | Neither agree nor disagree | 11.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall | Somewhat agree | 35.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall | Strongly agree | 11.8 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall | Somewhat agree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall | Neither agree nor disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall | Strongly disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall | Strongly agree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall | Somewhat disagree | 83.3 percentage of participants |
Secondary
Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall
Questions were answered after 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). The question is Overall, my baby's skin looks smooth.
Time frame: 0 Days - Post-treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall | Strongly disagree | 5.9 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall | Somewhat disagree | 35.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall | Neither agree nor disagree | 17.6 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall | Somewhat agree | 23.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall | Strongly agree | 17.6 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall | Somewhat agree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall | Neither agree nor disagree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall | Strongly disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall | Strongly agree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall | Somewhat disagree | 66.7 percentage of participants |
Secondary
Caregiver Questionnaire on Day 0 Pre-treatment - Amount of Sleep Caregiver Got Over Past Week
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). The question is Over this past week, how much sleep did you get at night?
Time frame: 0 Days - Pre-treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Amount of Sleep Caregiver Got Over Past Week | 6.48 hours | Standard Deviation 1.169 |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Amount of Sleep Caregiver Got Over Past Week | 6.19 hours | Standard Deviation 1.956 |
Secondary
Caregiver Questionnaire on Day 0 Pre-treatment - Amount of Time Caregiver Awake
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). The question is If you did wake up during the night, how much time were you awake (on average) before falling back asleep?
Time frame: 0 Days - Pre-treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Amount of Time Caregiver Awake | 0.79 hours | Standard Deviation 0.807 |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Amount of Time Caregiver Awake | 1.36 hours | Standard Deviation 0.645 |
Secondary
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema
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). The question is In the areas affected by eczema, my baby's skin feels soft.
Time frame: 0 Days - Pre-treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | Strongly disagree | 41.2 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | Somewhat disagree | 29.4 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | Neither agree nor disagree | 11.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | Somewhat agree | 11.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | Strongly agree | 5.9 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | Somewhat agree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | Neither agree nor disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | Strongly disagree | 50.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | Strongly agree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema | Somewhat disagree | 33.3 percentage of participants |
Secondary
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema
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). The question is In the areas affected by eczema, my baby's skin looks healthy.
Time frame: 0 Days - Pre-treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | Strongly disagree | 11.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | Somewhat disagree | 70.6 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | Neither agree nor disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | Somewhat agree | 11.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | Strongly agree | 5.9 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | Somewhat agree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | Neither agree nor disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | Strongly disagree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | Strongly agree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema | Somewhat disagree | 83.3 percentage of participants |
Secondary
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema
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). The question is In the areas affected by eczema, my baby's skin looks smooth.
Time frame: 0 Days - Pre-treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | Strongly disagree | 41.2 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | Somewhat disagree | 41.2 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | Neither agree nor disagree | 5.9 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | Somewhat agree | 5.9 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | Strongly agree | 5.9 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | Somewhat agree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | Neither agree nor disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | Strongly disagree | 33.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | Strongly agree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema | Somewhat disagree | 50.0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week
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). The question is Over this past week, how much energy have you had to engage with your family?
Time frame: 0 Days - Pre-treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week | I don't have an opinion | 5.9 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week | Less than last week | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week | No difference | 76.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week | A little more | 5.9 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week | A lot more | 5.9 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week | All the time | 5.9 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week | A lot more | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week | A little more | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week | Less than last week | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week | All the time | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week | No difference | 83.3 percentage of participants |
Secondary
Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week
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). The question is Over this past week, what has your child's mood been?
Time frame: 0 Days - Pre-treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week | Very happy | 35.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week | Somewhat happy | 17.6 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week | No change | 17.6 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week | Somewhat fussy | 29.4 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week | Very fussy | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week | Somewhat fussy | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week | No change | 50.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week | Very happy | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week | Very fussy | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week | Somewhat happy | 0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning
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). The question is Typically, how would you rate your child's mood when he/she wakes up in the morning?
Time frame: 0 Days - Pre-treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning | Very happy | 23.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning | Somewhat happy | 35.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning | No change | 11.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning | Somewhat fussy | 17.6 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning | Very fussy | 11.8 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning | Somewhat fussy | 50.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning | No change | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning | Very happy | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning | Very fussy | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning | Somewhat happy | 0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week
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). The question is Over this past week, how much has your child wanted to play?
Time frame: 0 Days - Pre-treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week | Less than last week | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week | No difference | 64.7 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week | A little more | 11.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week | A lot more | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week | All the time | 23.5 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week | A lot more | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week | A little more | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week | Less than last week | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week | All the time | 50.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week | No difference | 33.3 percentage of participants |
Secondary
Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week
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). The question is Over this past week, how alert have you felt?
Time frame: 0 Days - Pre-treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week | I don't have an opinion | 5.9 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week | Less than last week | 11.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week | No difference | 47.1 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week | A little more | 23.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week | A lot more | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week | All the time | 11.8 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week | A lot more | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week | A little more | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week | Less than last week | 33.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week | All the time | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week | No difference | 66.7 percentage of participants |
Secondary
Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week
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). The question is Over this past week, how productive have you been at work?
Time frame: 0 Days - Pre-treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week | I don't have an opinion | 23.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week | Less than last week | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week | No difference | 64.7 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week | A little more | 5.9 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week | A lot more | 5.9 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week | All the time | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week | A lot more | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week | I don't have an opinion | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week | A little more | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week | Less than last week | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week | All the time | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week | No difference | 66.7 percentage of participants |
Secondary
Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week
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). The question is Over this past week, how rested have you felt?
Time frame: 0 Days - Pre-treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week | I don't have an opinion | 5.9 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week | Less than last week | 17.6 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week | No difference | 64.7 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week | A little more | 5.9 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week | A lot more | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week | All the time | 5.9 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week | A lot more | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week | A little more | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week | Less than last week | 50.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week | All the time | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week | No difference | 50.0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 0 Pre-treatment - Number of Times Caregiver Woke Up
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). The question is How many times did you wake up during the night?
Time frame: 0 Days - Pre-treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Number of Times Caregiver Woke Up | 2.2 number of times | Standard Deviation 0.9 |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Number of Times Caregiver Woke Up | 5.7 number of times | Standard Deviation 7.06 |
Secondary
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall
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). The question is Overall, my baby's skin feels soft.
Time frame: 0 Days - Pre-treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall | Strongly disagree | 23.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall | Neither agree nor disagree | 17.6 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall | Somewhat agree | 17.6 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall | Strongly agree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall | Somewhat disagree | 41.2 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall | Strongly agree | 33.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall | Strongly disagree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall | Somewhat disagree | 50.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall | Somewhat agree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall | Neither agree nor disagree | 0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall
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). The question is Overall, my baby's skin looks healthy.
Time frame: 0 Days - Pre-treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall | Strongly disagree | 5.9 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall | Somewhat disagree | 58.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall | Neither agree nor disagree | 5.9 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall | Somewhat agree | 23.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall | Strongly agree | 5.9 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall | Somewhat agree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall | Neither agree nor disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall | Strongly disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall | Strongly agree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall | Somewhat disagree | 66.7 percentage of participants |
Secondary
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall
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). The question is Overall, my baby's skin looks smooth.
Time frame: 0 Days - Pre-treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall | Strongly disagree | 29.4 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall | Somewhat disagree | 41.2 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall | Neither agree nor disagree | 11.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall | Somewhat agree | 17.6 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall | Strongly agree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall | Somewhat agree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall | Neither agree nor disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall | Strongly disagree | 33.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall | Strongly agree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall | Somewhat disagree | 50.0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 14 - Amount of Sleep Caregiver Got Over Past Week
Questions were answered after 14 days of 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). The question is Over this past week, how much sleep did you get at night?
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Amount of Sleep Caregiver Got Over Past Week | 7.99 hours | Standard Deviation 1.543 |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Amount of Sleep Caregiver Got Over Past Week | 7.40 hours | Standard Deviation 1.71 |
Secondary
Caregiver Questionnaire on Day 14 - Amount of Time Caregiver Awake
Questions were answered after 14 days of 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). The question is If you did wake up during the night, how much time were you awake (on average) before falling back asleep?
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Amount of Time Caregiver Awake | 0.22 hours | Standard Deviation 0.385 |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Amount of Time Caregiver Awake | 0.87 hours | Standard Deviation 1.048 |
Secondary
Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema
Questions were answered after 14 days of 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). The question is In the areas affected by eczema, my baby's skin feels soft.
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema | Strongly disagree | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema | Somewhat disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema | Neither agree nor disagree | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema | Somewhat agree | 37.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema | Strongly agree | 50.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema | Somewhat agree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema | Neither agree nor disagree | 20.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema | Strongly disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema | Strongly agree | 60.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema | Somewhat disagree | 20.0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema
Questions were answered after 14 days of 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). The question is In the areas affected by eczema, my baby's skin looks healthy.
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Strongly disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Somewhat disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Neither agree nor disagree | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Somewhat agree | 56.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Strongly agree | 37.5 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Somewhat agree | 20.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Neither agree nor disagree | 20.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Strongly disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Strongly agree | 40.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Somewhat disagree | 20.0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema
Questions were answered after 14 days of 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). The question is In the areas affected by eczema, my baby's skin looks smooth.
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Strongly disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Somewhat disagree | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Neither agree nor disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Somewhat agree | 62.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Strongly agree | 31.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Somewhat agree | 20.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Neither agree nor disagree | 20.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Strongly disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Strongly agree | 40.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Somewhat disagree | 20.0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week
Questions were answered after 14 days of 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). The question is Over this past week, how much energy have you had to engage with your family?
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week | A little more | 31.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week | No difference | 43.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week | A lot more | 12.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week | All the time | 12.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week | Less than last week | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week | All the time | 20.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week | No difference | 60.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week | A little more | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week | A lot more | 20.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week | Less than last week | 0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week
Questions were answered after 14 days of 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). The question is Over this past week, what has your child's mood been?
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week | Somewhat happy | 25.0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week | Somewhat fussy | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week | No change | 56.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week | Very fussy | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week | Very happy | 12.5 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week | Very fussy | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week | Somewhat fussy | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week | Very happy | 20.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week | Somewhat happy | 40.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week | No change | 40.0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning
Questions were answered after 14 days of 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). The question is Typically, how would you rate your child's mood when he/she wakes up in the morning?
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning | No change | 31.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning | Somewhat fussy | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning | Very happy | 18.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning | Very fussy | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning | Somewhat happy | 37.5 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning | Very fussy | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning | Somewhat happy | 40.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning | Very happy | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning | No change | 40.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning | Somewhat fussy | 20.0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week
Questions were answered after 14 days of 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). The question is Over this past week, how much has your child wanted to play?
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week | A little more | 18.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week | Less than last week | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week | A lot more | 18.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week | No difference | 43.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week | All the time | 18.8 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week | No difference | 40.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week | Less than last week | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week | All the time | 40.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week | A little more | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week | A lot more | 20.0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week
Questions were answered after 14 days of 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). The question is Over this past week, how alert have you felt?
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week | Less than last week | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week | No difference | 50.0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week | A little more | 37.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week | A lot more | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week | All the time | 6.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week | A lot more | 20.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week | A little more | 20.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week | Less than last week | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week | All the time | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week | No difference | 60.0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week
Questions were answered after 14 days of 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). The question is Over this past week, how productive have you been at work?
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week | I don't have an opinion | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week | No difference | 50.0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week | A lot more | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week | A little more | 31.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week | All the time | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week | Less than last week | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week | All the time | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week | A little more | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week | Less than last week | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week | A lot more | 40.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week | No difference | 60.0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week
Questions were answered after 14 days of 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). The question is Over this past week, how rested have you felt?
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week | Less than last week | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week | No difference | 40.0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week | A little more | 40.0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week | A lot more | 13.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week | All the time | 6.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week | A lot more | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week | A little more | 20.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week | Less than last week | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week | All the time | 20.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week | No difference | 60.0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 14 - Number of Times Caregiver Woke Up
Questions were answered after 14 days of 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). The question is How many times did you wake up during the night?
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Number of Times Caregiver Woke Up | 1.0 number of times | Standard Deviation 1.07 |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Number of Times Caregiver Woke Up | 1.6 number of times | Standard Deviation 1.14 |
Secondary
Caregiver Questionnaire on Day 14 - Recommend Product
Questions were answered after 14 days of 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). The question is I would recommend this product to another parent.
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Recommend Product | Somewhat agree | 43.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Recommend Product | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Recommend Product | Strongly disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Recommend Product | Somewhat disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Recommend Product | Neither agree nor disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Recommend Product | Strongly agree | 56.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Recommend Product | Neither agree nor disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Recommend Product | Somewhat agree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Recommend Product | Somewhat disagree | 20.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Recommend Product | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Recommend Product | Strongly agree | 80.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Recommend Product | Strongly disagree | 0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall
Questions were answered after 14 days of 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). The question is Overall, my baby's skin feels soft.
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall | Strongly disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall | Somewhat disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall | Neither agree nor disagree | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall | Somewhat agree | 31.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall | Strongly agree | 62.5 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall | Somewhat agree | 20.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall | Neither agree nor disagree | 20.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall | Strongly disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall | Strongly agree | 60.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall | Somewhat disagree | 0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall
Questions were answered after 14 days of 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). The question is Overall, my baby's skin looks healthy.
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall | Strongly disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall | Somewhat disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall | Neither agree nor disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall | Somewhat agree | 68.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall | Strongly agree | 31.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall | Somewhat agree | 40.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall | Neither agree nor disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall | Strongly disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall | Strongly agree | 40.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall | Somewhat disagree | 20.0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall
Questions were answered after 14 days of 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). The question is Overall, my baby's skin looks smooth.
Time frame: 14 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall | Strongly disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall | Somewhat disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall | Neither agree nor disagree | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall | Somewhat agree | 62.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall | Strongly agree | 31.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall | Somewhat agree | 20.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall | Neither agree nor disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall | Strongly disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall | Strongly agree | 60.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall | Somewhat disagree | 20.0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema
Questions were answered after three days of 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). The question is In the areas affected by eczema, my baby's skin feels soft.
Time frame: 3 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema | Strongly disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema | Somewhat disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema | Neither agree nor disagree | 12.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema | Somewhat agree | 68.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema | Strongly agree | 18.8 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema | Somewhat disagree | 33.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema | Strongly agree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema | Somewhat agree | 33.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema | Strongly disagree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema | Neither agree nor disagree | 16.7 percentage of participants |
Secondary
Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema
Questions were answered after three days of 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). The question is In the areas affected by eczema, my baby's skin looks healthy.
Time frame: 3 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Strongly disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Somewhat disagree | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Neither agree nor disagree | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Somewhat agree | 75.0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Strongly agree | 12.5 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Somewhat agree | 33.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Neither agree nor disagree | 33.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Strongly disagree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Strongly agree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Somewhat disagree | 16.7 percentage of participants |
Secondary
Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema
Questions were answered after three days of 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). The question is In the areas affected by eczema, my baby's skin looks smooth.
Time frame: 3 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Neither agree nor disagree | 12.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Somewhat agree | 75.0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Somewhat disagree | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Strongly agree | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Strongly disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Strongly agree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Strongly disagree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Somewhat disagree | 33.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Neither agree nor disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Somewhat agree | 50.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall
Questions were answered after three days of 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). The question is Overall, my baby's skin feels soft.
Time frame: 3 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall | Strongly disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall | Somewhat disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall | Neither agree nor disagree | 18.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall | Somewhat agree | 56.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall | Strongly agree | 25.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall | Somewhat agree | 50.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall | Neither agree nor disagree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall | Strongly disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall | Strongly agree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall | Somewhat disagree | 16.7 percentage of participants |
Secondary
Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall
Questions were answered after three days of 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). The question is Overall, my baby's skin looks healthy.
Time frame: 3 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall | Strongly disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall | Somewhat disagree | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall | Neither agree nor disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall | Somewhat agree | 87.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall | Strongly agree | 6.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall | Somewhat agree | 66.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall | Neither agree nor disagree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall | Strongly disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall | Strongly agree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall | Somewhat disagree | 16.7 percentage of participants |
Secondary
Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall
Questions were answered after three days of 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). The question is Overall, my baby's skin looks smooth.
Time frame: 3 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall | Strongly disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall | Somewhat agree | 50.0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall | Somewhat disagree | 18.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall | Strongly agree | 18.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall | Neither agree nor disagree | 12.5 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall | Strongly agree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall | Strongly disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall | Somewhat disagree | 50.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall | Neither agree nor disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall | Somewhat agree | 50.0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 7 - Amount of Sleep Caregiver Got Over Past Week
Questions were answered after seven days of 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). The question is Over this past week, how much sleep did you get at night?
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Amount of Sleep Caregiver Got Over Past Week | 7.89 hours | Standard Deviation 1.626 |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Amount of Sleep Caregiver Got Over Past Week | 7.42 hours | Standard Deviation 2.154 |
Secondary
Caregiver Questionnaire on Day 7 - Amount of Time Caregiver Awake
Questions were answered after seven days of 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). The question is If you did wake up during the night, how much time were you awake (on average) before falling back asleep?
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Amount of Time Caregiver Awake | 0.32 hours | Standard Deviation 0.298 |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Amount of Time Caregiver Awake | 0.74 hours | Standard Deviation 0.754 |
Secondary
Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema
Questions were answered after seven days of 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). The question is In the areas affected by eczema, my baby's skin feels soft.
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema | Strongly disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema | Somewhat disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema | Neither agree nor disagree | 12.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema | Somewhat agree | 62.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema | Strongly agree | 25.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema | Somewhat agree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema | Neither agree nor disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema | Strongly disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema | Strongly agree | 50.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema | Somewhat disagree | 50.0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema
Questions were answered after seven days of 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). The question is In the areas affected by eczema, my baby's skin looks healthy.
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Strongly disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Somewhat disagree | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Neither agree nor disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Somewhat agree | 62.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Strongly agree | 31.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Somewhat agree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Neither agree nor disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Strongly disagree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Strongly agree | 33.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema | Somewhat disagree | 33.3 percentage of participants |
Secondary
Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema
Questions were answered after seven days of 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). The question is In the areas affected by eczema, my baby's skin looks smooth.
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Strongly disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Neither agree nor disagree | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Somewhat agree | 68.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Somewhat disagree | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Strongly agree | 18.8 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Strongly agree | 50.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Strongly disagree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Somewhat disagree | 33.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Neither agree nor disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema | Somewhat agree | 0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week
Questions were answered after seven days of 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). The question is Over this past week, how much energy have you had to engage with your family?
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week | Less than last week | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week | No difference | 37.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week | A little more | 37.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week | A lot more | 18.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week | All the time | 6.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week | A lot more | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week | A little more | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week | Less than last week | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week | All the time | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week | No difference | 66.7 percentage of participants |
Secondary
Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week
Questions were answered after seven days of 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). The question is Over this past week, what has your child's mood been?
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week | Very happy | 37.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week | Somewhat happy | 37.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week | No change | 25.0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week | Somewhat fussy | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week | Very fussy | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week | Somewhat fussy | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week | No change | 50.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week | Very happy | 33.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week | Very fussy | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week | Somewhat happy | 16.7 percentage of participants |
Secondary
Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning
Questions were answered after seven days of 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). The question is Typically, how would you rate your child's mood when he/she wakes up in the morning?
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning | Very happy | 25.0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning | Somewhat happy | 50.0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning | No change | 12.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning | Somewhat fussy | 12.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning | Very fussy | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning | Somewhat fussy | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning | No change | 66.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning | Very happy | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning | Very fussy | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning | Somewhat happy | 16.7 percentage of participants |
Secondary
Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week
Questions were answered after seven days of 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). The question is Over this past week, how much has your child wanted to play?
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week | Less than last week | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week | No difference | 56.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week | A little more | 18.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week | A lot more | 12.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week | All the time | 12.5 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week | A lot more | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week | A little more | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week | Less than last week | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week | All the time | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week | No difference | 50.0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week
Questions were answered after seven days of 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). The question is Over this past week, how alert have you felt?
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week | Less than last week | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week | No difference | 50.0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week | A little more | 37.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week | A lot more | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week | All the time | 6.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week | A lot more | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week | A little more | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week | Less than last week | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week | All the time | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week | No difference | 66.7 percentage of participants |
Secondary
Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week
Questions were answered after seven days of 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). The question is Over this past week, how productive have you been at work?
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week | Less than last week | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week | A little more | 31.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week | I don't have an opinion | 12.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week | A lot more | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week | No difference | 43.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week | All the time | 6.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week | No difference | 66.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week | Less than last week | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week | All the time | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week | A little more | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week | A lot more | 16.7 percentage of participants |
Secondary
Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week
Questions were answered after seven days of 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). The question is Over this past week, how rested have you felt?
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week | Less than last week | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week | No difference | 31.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week | A little more | 43.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week | A lot more | 12.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week | All the time | 6.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week | A lot more | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week | A little more | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week | Less than last week | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week | All the time | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week | No difference | 50.0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 7 - Number of Times Caregiver Woke Up
Questions were answered after seven days of 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). The question is How many times did you wake up during the night?
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Number of Times Caregiver Woke Up | 1.1 number of times | Standard Deviation 0.89 |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Number of Times Caregiver Woke Up | 1.7 number of times | Standard Deviation 1.63 |
Secondary
Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall
Questions were answered after seven days of 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). The question is Overall, my baby's skin feels soft.
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall | Strongly disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall | Neither agree nor disagree | 12.5 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall | Somewhat disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall | Strongly agree | 43.8 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall | Somewhat agree | 43.8 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall | Strongly agree | 66.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall | Strongly disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall | Somewhat disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall | Neither agree nor disagree | 33.3 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall | Somewhat agree | 0 percentage of participants |
Secondary
Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall
Questions were answered after seven days of 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). The question is Overall, my baby's skin looks healthy.
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall | Strongly disagree | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall | Somewhat disagree | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall | Neither agree nor disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall | Somewhat agree | 50.0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall | Strongly agree | 37.5 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall | Somewhat agree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall | Neither agree nor disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall | Strongly disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall | Strongly agree | 50.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall | Somewhat disagree | 33.3 percentage of participants |
Secondary
Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall
Questions were answered after seven days of 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). The question is Overall, my baby's skin looks smooth.
Time frame: 7 Days
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall | I don't have an opinion | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall | Strongly disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall | Somewhat disagree | 6.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall | Neither agree nor disagree | 0 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall | Somewhat agree | 56.3 percentage of participants |
| 1% Colloidal Oatmeal Balm | Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall | Strongly agree | 37.5 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall | Somewhat agree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall | I don't have an opinion | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall | Neither agree nor disagree | 16.7 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall | Strongly disagree | 0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall | Strongly agree | 50.0 percentage of participants |
| EpiCeram Skin Barrier Emulsion | Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall | Somewhat disagree | 16.7 percentage of participants |
Secondary
Caregiver's Itch Assessment on Day 14 - Change From Baseline
An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).
Time frame: Day 0 - Pretreatment (Baseline) to Day 14
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver's Itch Assessment on Day 14 - Change From Baseline | -1.00 units on a scale | Standard Deviation 0.845 |
| EpiCeram Skin Barrier Emulsion | Caregiver's Itch Assessment on Day 14 - Change From Baseline | -1.20 units on a scale | Standard Deviation 0.447 |
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: <0.001One sample t-test
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.004One sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.57195% CI: [-0.65, 0.37]ANCOVA
Secondary
Caregiver's Itch Assessment on Day 3 - Change From Baseline
An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).
Time frame: Day 0 - Pretreatment (Baseline) to Day 3
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver's Itch Assessment on Day 3 - Change From Baseline | -0.73 units on a scale | Standard Deviation 0.884 |
| EpiCeram Skin Barrier Emulsion | Caregiver's Itch Assessment on Day 3 - Change From Baseline | -1.00 units on a scale | Standard Deviation 0.632 |
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.006One sample t-test
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.012One sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.93295% CI: [-0.391, 0.424]ANCOVA
Secondary
Caregiver's Itch Assessment on Day 7 - Change From Baseline
An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).
Time frame: Day 0 - Pretreatment (Baseline) to Day 7
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Caregiver's Itch Assessment on Day 7 - Change From Baseline | -0.87 units on a scale | Standard Deviation 0.915 |
| EpiCeram Skin Barrier Emulsion | Caregiver's Itch Assessment on Day 7 - Change From Baseline | -1.17 units on a scale | Standard Deviation 0.408 |
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.003One sample t-test
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: <0.001One sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.76795% CI: [-0.41, 0.547]ANCOVA
Secondary
Change From Baseline in Mean Corneometer Measurement 14 Days After Treatment
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time frame: Day 0 - Pretreatment (Baseline) to 14 Days After treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Change From Baseline in Mean Corneometer Measurement 14 Days After Treatment | 158.65 arbitrary units | Standard Deviation 170.627 |
| EpiCeram Skin Barrier Emulsion | Change From Baseline in Mean Corneometer Measurement 14 Days After Treatment | 23.60 arbitrary units | Standard Deviation 20.298 |
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.002One sample t-test
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.06One sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.10795% CI: [-32.266, 302.063]ANCOVA
Secondary
Change From Baseline in Mean Corneometer Measurement 24 Hours After Treatment
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time frame: Day 0 - Pretreatment (Baseline) to 24 Hours After treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Change From Baseline in Mean Corneometer Measurement 24 Hours After Treatment | 178.35 arbitrary units | Standard Deviation 138.651 |
| EpiCeram Skin Barrier Emulsion | Change From Baseline in Mean Corneometer Measurement 24 Hours After Treatment | 14.83 arbitrary units | Standard Deviation 29.347 |
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: <0.001One sample t-test
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.271One sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.00295% CI: [67.046, 268.854]ANCOVA
Secondary
Change From Baseline in Mean Corneometer Measurement 3 Days After Treatment
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time frame: Day 0 - Pretreatment (Baseline) to 3 Days After treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Change From Baseline in Mean Corneometer Measurement 3 Days After Treatment | 226.85 arbitrary units | Standard Deviation 244.028 |
| EpiCeram Skin Barrier Emulsion | Change From Baseline in Mean Corneometer Measurement 3 Days After Treatment | 8.17 arbitrary units | Standard Deviation 15.769 |
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.002One-sample t-test
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.26One sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.0495% CI: [11.254, 432.68]ANCOVA
Secondary
Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time frame: Day 0 - Pretreatment (Baseline) to 7 Days After treatment
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment | 208.52 arbitrary units | Standard Deviation 169.098 |
| EpiCeram Skin Barrier Emulsion | Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment | 17.50 arbitrary units | Standard Deviation 30.615 |
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: <0.001One sample t-test
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.22One sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.01195% CI: [50.712, 337.291]ANCOVA
Secondary
Dryness Scale Score on Day 14 - Change From Baseline
An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).
Time frame: Day 0 - Pretreatment (Baseline) to Day 14
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Dryness Scale Score on Day 14 - Change From Baseline | -1.2 units on a scale | Standard Deviation 0.44 |
| EpiCeram Skin Barrier Emulsion | Dryness Scale Score on Day 14 - Change From Baseline | -1.5 units on a scale | Standard Deviation 1 |
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: <0.001One sample t-test
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.058One sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.71195% CI: [-0.607, 0.857]ANCOVA
Secondary
Dryness Scale Score on Day 1 - Change From Baseline
An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).
Time frame: Day 0 - Pretreatment (Baseline) to Day 1
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Dryness Scale Score on Day 1 - Change From Baseline | -0.2 units on a scale | Standard Deviation 0.44 |
| EpiCeram Skin Barrier Emulsion | Dryness Scale Score on Day 1 - Change From Baseline | 0.0 units on a scale | Standard Deviation 0 |
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.169One sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.31795% CI: [-0.778, 0.278]ANCOVA
Secondary
Dryness Scale Score on Day 3 - Change From Baseline
An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).
Time frame: Day 0 - Pretreatment (Baseline) to Day 3
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Dryness Scale Score on Day 3 - Change From Baseline | -0.9 units on a scale | Standard Deviation 0.33 |
| EpiCeram Skin Barrier Emulsion | Dryness Scale Score on Day 3 - Change From Baseline | -0.5 units on a scale | Standard Deviation 0.58 |
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: <0.001One sample t-test
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.182One sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.02795% CI: [-0.931, -0.069]ANCOVA
Secondary
Dryness Scale Score on Day 7 - Change From Baseline
An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).
Time frame: Day 0 - Pretreatment (Baseline) to Day 7
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Dryness Scale Score on Day 7 - Change From Baseline | -1.2 units on a scale | Standard Deviation 0.44 |
| EpiCeram Skin Barrier Emulsion | Dryness Scale Score on Day 7 - Change From Baseline | -1.3 units on a scale | Standard Deviation 0.96 |
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: <0.001One sample t-test
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.08One sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.69995% CI: [-0.824, 0.574]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 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.
Time frame: Day 0 - Pretreatment (Baseline) to Day 14
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline | -0.74 units on a scale | Standard Deviation 0.962 |
| EpiCeram Skin Barrier Emulsion | Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline | -0.85 units on a scale | Standard Deviation 0.814 |
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.007One sample t-test
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.051One sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.92695% CI: [-0.41, 0.375]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 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.
Time frame: Day 0 - Pretreatment (Baseline) to Day 1
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline | 0.04 units on a scale | Standard Deviation 0.434 |
| EpiCeram Skin Barrier Emulsion | Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline | -0.12 units on a scale | Standard Deviation 0.436 |
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.692One sample t-test
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.541One sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.49295% CI: [-0.25, 0.502]ANCOVA
Secondary
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 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.
Time frame: Day 0 - Pretreatment (Baseline) to Day 3
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline | -0.54 units on a scale | Standard Deviation 0.802 |
| EpiCeram Skin Barrier Emulsion | Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline | -0.48 units on a scale | Standard Deviation 0.852 |
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.017One sample t-test
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.223One sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.51895% CI: [-0.635, 0.331]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 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.
Time frame: Day 0 - Pretreatment (Baseline) to Day 7
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline | -0.73 units on a scale | Standard Deviation 0.884 |
| EpiCeram Skin Barrier Emulsion | Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline | -0.15 units on a scale | Standard Deviation 1.544 |
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.005One sample t-test
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.821One sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.0695% CI: [-1.435, 0.032]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 (absent) to 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: Day 0 - Pretreatment (Baseline) to Day 14
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline | -0.6 units on a scale | Standard Deviation 0.51 |
| EpiCeram Skin Barrier Emulsion | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline | -1.0 units on a scale | Standard Deviation 0 |
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: <0.001One sample t-test
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: <0.001One sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.33495% CI: [-0.214, 0.6]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 (absent) to 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: Day 0 - Pretreatment (Baseline) to Day 1
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline | -0.1 units on a scale | Standard Deviation 0.44 |
| EpiCeram Skin Barrier Emulsion | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline | -0.2 units on a scale | Standard Deviation 0.41 |
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.58One sample t-test
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.363One sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.53995% CI: [-0.531, 0.286]ANCOVA
Secondary
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 (absent) to 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: Day 0 - Pretreatment (Baseline) to Day 3
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline | -0.3 units on a scale | Standard Deviation 0.6 |
| EpiCeram Skin Barrier Emulsion | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline | -0.5 units on a scale | Standard Deviation 0.55 |
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.055One sample t-test
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.076One sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.68295% CI: [-0.672, 0.449]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 (absent) to 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: Day 0 - Pretreatment (Baseline) to Day 7
Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Colloidal Oatmeal Balm | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline | -0.4 units on a scale | Standard Deviation 0.51 |
| EpiCeram Skin Barrier Emulsion | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline | -0.7 units on a scale | Standard Deviation 0.52 |
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.004One sample t-test
Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: 0.025One sample t-test
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.99195% CI: [-0.509, 0.514]ANCOVA