Test to Determine the Effectiveness of Moisturizing Balm Used on Babies With Dry, Itchy Skin

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Clinical Trial to Evaluate the Efficacy of an Investigational Nighttime Moisturizing Balm in the Management of Mild to Moderate Atopic Dermatitis in Infants and Toddlers

Conditions
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Eczema

Intervention / Treatment
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* Device: EpiCeram Skin Barrier Emulsion
* Drug: 1% Colloidal Oatmeal Balm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) Male or female of any race or ethnicity, 6 months to 47 months of age; Diagnosed as having eczema Willing to stop use of all non-assigned moisturizers and/or creams for the entire duration of the study Child must have bedtime/sleep issues due to their dry, itchy skin Exclusion Criteria: Use of a therapeutic (over-the-counter or prescription) body wash that contains an active ingredient for eczema Participation in any clinical study within 30 days of Visit 1 Active infection of any type at the start of the study Diagnosed as having severe eczema Atopic Dermatitis requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids Child wakes up 3 or more times during the night Child is awake more than 60 minutes during the night Child sleeps for less than a total of 9 hours (during the day or night) Child requires greater than 2.0 mg per day of inhaled or intranasal corticosteroids

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 47 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EpiCeram Skin Barrier Emulsion<br>Marketed. Apply in a thin layer to the affected skin areas two times per day (or as needed) and massage gently into the skin. | Device: EpiCeram Skin Barrier Emulsion<br>* EpiCeram Skin Barrier Emulsion<br>|
| Experimental: 1% Colloidal Oatmeal Balm<br>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. | Drug: 1% Colloidal Oatmeal Balm<br>* Experimental Product 1% Colloidal Oatmeal Balm<br>* Other names: Eczema Moisturizing Balm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis