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Lack of subject enrollment and the eczema season has completed
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EpiCeram Skin Barrier Emulsion | Active Comparator | Marketed. Apply in a thin layer to the affected skin areas two times per day (or as needed) and massage gently into the skin. |
|
| 1% Colloidal Oatmeal Balm | Experimental | Not Yet Marketed. Apply in a thin layer to the affected skin areas at least once at night or more if needed (anytime), and massage gently into the skin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EpiCeram Skin Barrier Emulsion | Device | EpiCeram Skin Barrier Emulsion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 - Pretreatment (Baseline) to Day 0 - immediately post treatment |
| 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. | Day 0 - Pretreatment (Baseline) to 12 Hours After treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 - Pretreatment (Baseline) to 24 Hours After treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amisha Parikh-Das, PhD | Johnson & Johnson Consumer Inc. (J&JCI) | Study Director |
| Ethlynn Schorr, MD | TKL Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TKL Research | Fair Lawn | New Jersey | 07410 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | EpiCeram Skin Barrier Emulsion | EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | EpiCeram Skin Barrier Emulsion |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | arbitrary units | Day 0 - Pretreatment (Baseline) to Day 0 - immediately post treatment |
|
14 ± 2 days, +30 days for serious adverse events.
Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1% Colloidal Oatmeal Balm | 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Motion Sickness | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
A decision was made by the sponsor to terminate the study prior to enrolling 50 subjects as enrollment was not completed prior to the summer months, and the incidence of atopic dermatitis is low in the summer months.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amisha Parikh-Das, PhD/Study Director | Johnson & Johnson Consumer, Inc | 973-255-8701 USA EST | AParikh1@its.jnj.com |
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| ID | Term |
|---|---|
| D004485 | Eczema |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| 1% Colloidal Oatmeal Balm |
| Drug |
Experimental Product 1% Colloidal Oatmeal Balm |
|
|
| 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. | Day 0 - Pretreatment (Baseline) to 3 Days After treatment |
| 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. | Day 0 - Pretreatment (Baseline) to 7 Days After treatment |
| 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. | Day 0 - Pretreatment (Baseline) to 14 Days After treatment |
| 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. | Day 0 - Pretreatment (Baseline) to Day 1 |
| 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. | Day 0 - Pretreatment (Baseline) to Day 3 |
| 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. | Day 0 - Pretreatment (Baseline) to Day 7 |
| Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline | The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72. | Day 0 - Pretreatment (Baseline) to Day 14 |
| Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline | The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (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. | Day 0 - Pretreatment (Baseline) to Day 1 |
| 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. | Day 0 - Pretreatment (Baseline) to Day 3 |
| 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. | Day 0 - Pretreatment (Baseline) to Day 7 |
| Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline | The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (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. | Day 0 - Pretreatment (Baseline) to Day 14 |
| 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). | Day 0 - Pretreatment (Baseline) to Day 1 |
| 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). | Day 0 - Pretreatment (Baseline) to Day 3 |
| 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). | Day 0 - Pretreatment (Baseline) to Day 7 |
| 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). | Day 0 - Pretreatment (Baseline) to Day 14 |
| 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). | Day 0 - Pretreatment (Baseline) to Day 3 |
| 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). | Day 0 - Pretreatment (Baseline) to Day 7 |
| 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). | Day 0 - Pretreatment (Baseline) to Day 14 |
| 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? | 0 Days Pretreatment (Baseline) |
| 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? | 0 Days Pretreatment (Baseline) |
| 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). | 0 Days Pretreatment (Baseline) |
| 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'. | 0 Days Pretreatment (Baseline) |
| 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? | 0 Days Pretreatment (Baseline) |
| 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? | 0 Days Pretreatment (Baseline) |
| 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? | 0 Days Pretreatment (Baseline) |
| 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? | 0 Days Pretreatment (Baseline) |
| 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? | 0 Days Pretreatment (Baseline) |
| 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? | 0 Days Pretreatment (Baseline) |
| 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? | 0 Days Pretreatment (Baseline) |
| 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'. | 0 Days Pretreatment (Baseline) |
| 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? | 7 Days |
| 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? | 7 Days |
| 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). | 7 Days |
| 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'. | 7 Days |
| 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? | 7 Days |
| 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? | 7 Days |
| 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? | 7 Days |
| 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? | 7 Days |
| 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? | 7 Days |
| 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? | 7 Days |
| 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? | 7 Days |
| 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'. | 7 Days |
| 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? | 14 Days |
| 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? | 14 Days |
| 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). | 14 Days |
| 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'. | 14 Days |
| 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? | 14 Days |
| 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? | 14 Days |
| 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? | 14 Days |
| 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? | 14 Days |
| 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? | 14 Days |
| 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? | 14 Days |
| 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? | 14 Days |
| 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'. | 14 Days |
| 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". | 0 Days - Pre-treatment |
| 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". | 0 Days - Pre-treatment |
| 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". | 0 Days - Pre-treatment |
| 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". | 0 Days - Pre-treatment |
| 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". | 0 Days - Pre-treatment |
| 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". | 0 Days - Pre-treatment |
| 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?" | 0 Days - Pre-treatment |
| 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?" | 0 Days - Pre-treatment |
| 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?" | 0 Days - Pre-treatment |
| 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?" | 0 Days - Pre-treatment |
| 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?" | 0 Days - Pre-treatment |
| 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?" | 0 Days - Pre-treatment |
| 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?" | 0 Days - Pre-treatment |
| 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?" | 0 Days - Pre-treatment |
| 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?" | 0 Days - Pre-treatment |
| 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?" | 0 Days - Pre-treatment |
| 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". | 0 Days - Post-treatment |
| 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". | 0 Days - Post-treatment |
| 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". | 0 Days - Post-treatment |
| 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". | 0 Days - Post-treatment |
| 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". | 0 Days - Post-treatment |
| 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". | 0 Days - Post-treatment |
| 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". | 3 Days |
| 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". | 3 Days |
| 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". | 3 Days |
| 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". | 3 Days |
| 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". | 3 Days |
| 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". | 3 Days |
| 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". | 7 Days |
| 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". | 7 Days |
| 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". | 7 Days |
| 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". | 7 Days |
| 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". | 7 Days |
| 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". | 7 Days |
| 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?" | 7 Days |
| 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?" | 7 Days |
| 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?" | 7 Days |
| 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?" | 7 Days |
| 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?" | 7 Days |
| 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?" | 7 Days |
| 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?" | 7 Days |
| 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?" | 7 Days |
| 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?" | 7 Days |
| 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?" | 7 Days |
| 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". | 14 Days |
| 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". | 14 Days |
| 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". | 14 Days |
| 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". | 14 Days |
| 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". | 14 Days |
| 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". | 14 Days |
| 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?" | 14 Days |
| 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?" | 14 Days |
| 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?" | 14 Days |
| 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?" | 14 Days |
| 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?" | 14 Days |
| 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?" | 14 Days |
| 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?" | 14 Days |
| 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?" | 14 Days |
| 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?" | 14 Days |
| 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?" | 14 Days |
| 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". | 14 Days |
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
| BG002 | Total | Total of all reporting groups |
| months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| EpiCeram Skin Barrier Emulsion |
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed |
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| 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. | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | arbitrary units | Day 0 - Pretreatment (Baseline) to 12 Hours After treatment |
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| 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. | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | arbitrary units | Day 0 - Pretreatment (Baseline) to 24 Hours After treatment |
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| 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. | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | arbitrary units | Day 0 - Pretreatment (Baseline) to 3 Days After treatment |
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| 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. | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | arbitrary units | Day 0 - Pretreatment (Baseline) to 7 Days After treatment |
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| 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. | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | arbitrary units | Day 0 - Pretreatment (Baseline) to 14 Days After treatment |
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| Secondary | Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline | The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72. | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | units on a scale | Day 0 - Pretreatment (Baseline) to Day 1 |
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| 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. | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | units on a scale | Day 0 - Pretreatment (Baseline) to Day 3 |
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| Secondary | Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline | The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72. | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | units on a scale | Day 0 - Pretreatment (Baseline) to Day 7 |
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| Secondary | Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline | The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72. | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | units on a scale | Day 0 - Pretreatment (Baseline) to Day 14 |
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| Secondary | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline | The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (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. | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | units on a scale | Day 0 - Pretreatment (Baseline) to Day 1 |
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| 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. | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | units on a scale | Day 0 - Pretreatment (Baseline) to Day 3 |
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| Secondary | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline | The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (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. | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | units on a scale | Day 0 - Pretreatment (Baseline) to Day 7 |
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| Secondary | Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline | The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (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. | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | units on a scale | Day 0 - Pretreatment (Baseline) to Day 14 |
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| 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). | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | units on a scale | Day 0 - Pretreatment (Baseline) to Day 1 |
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| 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). | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | units on a scale | Day 0 - Pretreatment (Baseline) to Day 3 |
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| 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). | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | units on a scale | Day 0 - Pretreatment (Baseline) to Day 7 |
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| 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). | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | units on a scale | Day 0 - Pretreatment (Baseline) to Day 14 |
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| 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). | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | units on a scale | Day 0 - Pretreatment (Baseline) to Day 3 |
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| 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). | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | units on a scale | Day 0 - Pretreatment (Baseline) to Day 7 |
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| 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). | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | units on a scale | Day 0 - Pretreatment (Baseline) to Day 14 |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days Pretreatment (Baseline) |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days Pretreatment (Baseline) |
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| 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). | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | hours.minutes | 0 Days Pretreatment (Baseline) |
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| 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'. | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days Pretreatment (Baseline) |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | minutes | 0 Days Pretreatment (Baseline) |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | number of times | 0 Days Pretreatment (Baseline) |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | minutes | 0 Days Pretreatment (Baseline) |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | hours | 0 Days Pretreatment (Baseline) |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | hours | 0 Days Pretreatment (Baseline) |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | number of naps | 0 Days Pretreatment (Baseline) |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | hours | 0 Days Pretreatment (Baseline) |
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| 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'. | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days Pretreatment (Baseline) |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 7 Days |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 7 Days |
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| 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). | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | hours.minutes | 7 Days |
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| 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'. | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 7 Days |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | minutes | 7 Days |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | number of times | 7 Days |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | minutes | 7 Days |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | hours | 7 Days |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | hours | 7 Days |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | number of naps | 7 Days |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | hours | 7 Days |
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| 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'. | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 7 Days |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 14 Days |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 14 Days |
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| 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). | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | hours.minutes | 14 Days |
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| 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'. | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 14 Days |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | minutes | 14 Days |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | number of times | 14 Days |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | minutes | 14 Days |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | hours | 14 Days |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | hours | 14 Days |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | number of naps | 14 Days |
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| 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? | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | hours | 14 Days |
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| 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'. | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 14 Days |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days - Pre-treatment |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days - Pre-treatment |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days - Pre-treatment |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days - Pre-treatment |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days - Pre-treatment |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days - Pre-treatment |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days - Pre-treatment |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days - Pre-treatment |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days - Pre-treatment |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | hours | 0 Days - Pre-treatment |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | number of times | 0 Days - Pre-treatment |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | hours | 0 Days - Pre-treatment |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days - Pre-treatment |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days - Pre-treatment |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days - Pre-treatment |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days - Pre-treatment |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days - Post-treatment |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days - Post-treatment |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days - Post-treatment |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days - Post-treatment |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days - Post-treatment |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 0 Days - Post-treatment |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 3 Days |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 3 Days |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 3 Days |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 3 Days |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 3 Days |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 3 Days |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 7 Days |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 7 Days |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 7 Days |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 7 Days |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 7 Days |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 7 Days |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 7 Days |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 7 Days |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 7 Days |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | hours | 7 Days |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | number of times | 7 Days |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | hours | 7 Days |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 7 Days |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 7 Days |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 7 Days |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 7 Days |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 14 Days |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 14 Days |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 14 Days |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 14 Days |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 14 Days |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 14 Days |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 14 Days |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 14 Days |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 14 Days |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | hours | 14 Days |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | number of times | 14 Days |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Mean | Standard Deviation | hours | 14 Days |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 14 Days |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 14 Days |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 14 Days |
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| 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?" | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 14 Days |
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| 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". | The analysis was based on the intent-to-treat subjects who had data available at the specified time point. | Posted | Number | percentage of participants | 14 Days |
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|
|
| 0 |
| 17 |
| 7 |
| 17 |
| EG001 | EpiCeram Skin Barrier Emulsion | EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed | 0 | 6 | 4 | 6 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Frequent Bowel Movements | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Teething | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Ear Infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Gastroenteritis Viral | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Scratch | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Dermatitis Diaper | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Keratosis Pilaris | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
Principal investigators agreed not to publish the study results without prior sponsor approval.
| D012873 |
| Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
| One sample t-test |
| 0.754 |
The significance level threshold level was 0.05. |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Change from baseline as response, baseline score as covariate and treatment as factor. | 0.013 | The significance level threshold level was 0.05. | Median Difference (Final Values) | 52.30 | Standard Error of the Mean | 19.210 | 2-Sided | 95 | 12.230 | 92.373 | Superiority or Other |
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.
| One sample t-test |
| 0.271 |
The significance level threshold level was 0.05. |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Change from baseline as response, baseline score as covariate and treatment as factor. | 0.002 | The significance level threshold level was 0.05. | Mean Difference (Final Values) | 167.95 | Standard Error of the Mean | 48.210 | 2-Sided | 95 | 67.046 | 268.854 | Superiority or Other |
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.
| One sample t-test |
| 0.260 |
The significance level threshold level was 0.05. |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Change from baseline as response, baseline score as covariate and treatment as factor. | 0.040 | The significance level threshold level was 0.05. | Mean Difference (Final Values) | 221.97 | Standard Error of the Mean | 100.674 | 2-Sided | 95 | 11.254 | 432.680 | Superiority or Other |
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.
| One sample t-test |
| 0.220 |
The significance level threshold level was 0.05. |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Change from baseline as response, baseline score as covariate and treatment as factor. | 0.011 | The significance level threshold level was 0.05. | Mean Difference (Final Values) | 194.00 | Standard Error of the Mean | 68.461 | 2-Sided | 95 | 50.712 | 337.291 | Superiority or Other |
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.
| One sample t-test |
| 0.060 |
The significance level threshold level was 0.05. |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Change from baseline as response, baseline score as covariate and treatment as factor. | 0.107 | The significance level threshold level was 0.05. | Mean Difference (Final Values) | 134.90 | Standard Error of the Mean | 79.567 | 2-Sided | 95 | -32.266 | 302.063 | Superiority or Other |
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.
| One sample t-test |
| 0.541 |
The significance level threshold level was 0.05. |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Change from baseline as response, baseline score as covariate and treatment as factor. | 0.492 | The significance level threshold level was 0.05. | Mean Difference (Final Values) | 0.13 | Standard Error of the Mean | 0.180 | 2-Sided | 95 | -0.250 | 0.502 | Superiority or Other |
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.
| One sample t-test |
| 0.223 |
The significance level threshold level was 0.05. |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Change from baseline as response, baseline score as covariate and treatment as factor. | 0.518 | The significance level threshold level was 0.05. | Mean Difference (Final Values) | -0.15 | Standard Error of the Mean | 0.231 | 2-Sided | 95 | -0.635 | 0.331 | Superiority or Other |
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.
| One sample t-test |
| 0.821 |
The significance level threshold level was 0.05. |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Change from baseline as response, baseline score as covariate and treatment as factor. | 0.060 | The significance level threshold level was 0.05. | Mean Difference (Final Values) | -0.70 | Standard Error of the Mean | 0.351 | 2-Sided | 95 | -1.435 | 0.032 | Superiority or Other |
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.
| One sample t-test |
| 0.051 |
The significance level threshold level was 0.05. |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Change from baseline as response, baseline score as covariate and treatment as factor. | 0.926 | The significance level threshold level was 0.05. | Mean Difference (Final Values) | -0.02 | Standard Error of the Mean | 0.188 | 2-Sided | 95 | -0.410 | 0.375 | Superiority or Other |
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.
| One sample t-test |
| 0.363 |
The significance level threshold level was 0.05. |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Change from baseline as response, baseline score as covariate and treatment as factor. | 0.539 | The significance level threshold level was 0.05. | Mean Difference (Final Values) | -0.1 | Standard Error of the Mean | 0.20 | 2-Sided | 95 | -0.531 | 0.286 | Superiority or Other |
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.
| One sample t-test |
| 0.076 |
The significance level threshold level was 0.05. |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Change from baseline as response, baseline score as covariate and treatment as factor. | 0.682 | The significance level threshold level was 0.05. | Mean Difference (Final Values) | -0.1 | Standard Error of the Mean | 0.27 | 2-Sided | 95 | -0.672 | 0.449 | Superiority or Other |
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.
| One sample t-test |
| 0.025 |
The significance level threshold level was 0.05. |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Change from baseline as response, baseline score as covariate and treatment as factor. | 0.991 | The significance level threshold level was 0.05. | Mean Difference (Final Values) | 0.0 | Standard Error of the Mean | 0.24 | 2-Sided | 95 | -0.509 | 0.514 | Superiority or Other |
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.
| One sample t-test |
| <0.001 |
The significance level threshold level was 0.05. |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Change from baseline as response, baseline score as covariate and treatment as factor. | 0.334 | The significance level threshold level was 0.05. | Mean Difference (Final Values) | 0.2 | Standard Error of the Mean | 0.19 | 2-Sided | 95 | -0.214 | 0.600 | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANCOVA |
Change from baseline as response, baseline score as covariate and treatment as factor. |
| 0.317 |
The significance level threshold level was 0.05. |
| Mean Difference (Final Values) |
| -0.3 |
| Standard Error of the Mean |
| 0.24 |
| 2-Sided |
| 95 |
| -0.778 |
| 0.278 |
| Superiority or Other |
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.
| One sample t-test |
| 0.182 |
The significance level threshold level was 0.05. |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Change from baseline as response, baseline score as covariate and treatment as factor. | 0.027 | The significance level threshold level was 0.05. | Mean Difference (Final Values) | -0.5 | Standard Error of the Mean | 0.19 | 2-Sided | 95 | -0.931 | -0.069 | Superiority or Other |
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.
| One sample t-test |
| 0.080 |
The significance level threshold level was 0.05. |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Change from baseline as response, baseline score as covariate and treatment as factor. | 0.699 | The significance level threshold level was 0.05. | Mean Difference (Final Values) | -0.1 | Standard Error of the Mean | 0.31 | 2-Sided | 95 | -0.824 | 0.574 | Superiority or Other |
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.
| One sample t-test |
| 0.058 |
The significance level threshold level was 0.05. |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Change from baseline as response, baseline score as covariate and treatment as factor. | 0.711 | The significance level threshold level was 0.05. | Mean Difference (Final Values) | 0.1 | Standard Error of the Mean | 0.33 | 2-Sided | 95 | -0.607 | 0.857 | Superiority or Other |
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.
| One sample t-test |
| 0.012 |
The significance level threshold level was 0.05. |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Change from baseline as response, baseline score as covariate and treatment as factor. | 0.932 | The significance level threshold level was 0.05. | Mean Difference (Final Values) | 0.02 | Standard Error of the Mean | 0.194 | 2-Sided | 95 | -0.391 | 0.424 | Superiority or Other |
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.
| One sample t-test |
| <0.001 |
The significance level threshold level was 0.05. |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Change from baseline as response, baseline score as covariate and treatment as factor. | 0.767 | The significance level threshold level was 0.05. | Mean Difference (Final Values) | 0.07 | Standard Error of the Mean | 0.228 | 2-Sided | 95 | -0.410 | 0.547 | Superiority or Other |
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.
| One sample t-test |
| 0.004 |
The significance level threshold level was 0.05. |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANCOVA | Change from baseline as response, baseline score as covariate and treatment as factor. | 0.571 | The significance level threshold level was 0.05. | Mean Difference (Final Values) | -0.14 | Standard Error of the Mean | 0.242 | 2-Sided | 95 | -0.650 | 0.370 | Superiority or Other |
| Grandparent |
|
| Other |
|
| In parent's bed |
|
| Infant crib in room with sibling |
|
| Other |
|
| Somewhat difficult |
|
| Moderately difficult |
|
| Very difficult |
|
| A very small problem |
|
| A small problem |
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| A moderate problem |
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| A serious problem |
|
| Grandparent |
|
| Other |
|
| In parent's bed |
|
| Infant crib in room with sibling |
|
| Other |
|
| Somewhat difficult |
|
| Moderately difficult |
|
| Very difficult |
|
| A very small problem |
|
| A small problem |
|
| A moderate problem |
|
| A serious problem |
|
| Grandparent |
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| Other |
|
| In parent's bed |
|
| Infant crib in room with sibling |
|
| Other |
|
| Somewhat difficult |
|
| Moderately difficult |
|
| Very difficult |
|
| A very small problem |
|
| A small problem |
|
| A moderate problem |
|
| A serious problem |
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| Somewhat disagree |
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| Neither agree nor disagree |
|
| Somewhat agree |
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| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat happy |
|
| No change |
|
| Somewhat fussy |
|
| Very fussy |
|
| Somewhat happy |
|
| No change |
|
| Somewhat fussy |
|
| Very fussy |
|
| No difference |
|
| A little more |
|
| A lot more |
|
| All the time |
|
| No difference |
|
| A little more |
|
| A lot more |
|
| All the time |
|
| No difference |
|
| A little more |
|
| A lot more |
|
| All the time |
|
| No difference |
|
| A little more |
|
| A lot more |
|
| All the time |
|
| No difference |
|
| A little more |
|
| A lot more |
|
| All the time |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat happy |
|
| No change |
|
| Somewhat fussy |
|
| Very fussy |
|
| Somewhat happy |
|
| No change |
|
| Somewhat fussy |
|
| Very fussy |
|
| No difference |
|
| A little more |
|
| A lot more |
|
| All the time |
|
| No difference |
|
| A little more |
|
| A lot more |
|
| All the time |
|
| No difference |
|
| A little more |
|
| A lot more |
|
| All the time |
|
| No difference |
|
| A little more |
|
| A lot more |
|
| All the time |
|
| No difference |
|
| A little more |
|
| A lot more |
|
| All the time |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|
| Somewhat happy |
|
| No change |
|
| Somewhat fussy |
|
| Very fussy |
|
| Somewhat happy |
|
| No change |
|
| Somewhat fussy |
|
| Very fussy |
|
| No difference |
|
| A little more |
|
| A lot more |
|
| All the time |
|
| No difference |
|
| A little more |
|
| A lot more |
|
| All the time |
|
| No difference |
|
| A little more |
|
| A lot more |
|
| All the time |
|
| No difference |
|
| A little more |
|
| A lot more |
|
| All the time |
|
| No difference |
|
| A little more |
|
| A lot more |
|
| All the time |
|
| Somewhat disagree |
|
| Neither agree nor disagree |
|
| Somewhat agree |
|
| Strongly agree |
|