Back to resultsTest to Determine the Effectiveness of Moisturizing Balm Used on Babies With Dry, Itchy Skin
Primary Purpose
Eczema
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EpiCeram Skin Barrier Emulsion
1% Colloidal Oatmeal Balm
Sponsored by
About this trial
This is an interventional treatment trial for Eczema focused on measuring Atopic Dermatitis
Eligibility Criteria
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
Sites / Locations
- TKL Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
EpiCeram Skin Barrier Emulsion
1% Colloidal Oatmeal Balm
Arm Description
Marketed. Apply in a thin layer to the affected skin areas two times per day (or as needed) and massage gently into the skin.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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).
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).
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).
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?
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?
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).
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'.
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?
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?
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?
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?
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?
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?
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?
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'.
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?
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?
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).
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'.
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?
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?
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?
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?
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?
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?
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?
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'.
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?
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?
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).
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'.
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?
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?
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?
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?
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?
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?
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?
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'.
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".
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".
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".
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".
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".
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".
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?"
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?"
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?"
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?"
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?"
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?"
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?"
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?"
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?"
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?"
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".
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".
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".
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".
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".
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".
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".
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".
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".
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".
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".
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".
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".
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".
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".
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".
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".
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".
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?"
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?"
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?"
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?"
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?"
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?"
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?"
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?"
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?"
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?"
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".
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".
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".
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".
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".
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".
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?"
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?"
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?"
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?"
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?"
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?"
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?"
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?"
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?"
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?"
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".
Full Information
NCT ID
NCT02404493
First Posted
March 18, 2015
Last Updated
February 6, 2017
Sponsor
Johnson & Johnson Consumer Inc. (J&JCI)
1. Study Identification
Unique Protocol Identification Number
NCT02404493
Brief Title
Test to Determine the Effectiveness of Moisturizing Balm Used on Babies With Dry, Itchy Skin
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of subject enrollment and the eczema season has completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Consumer Inc. (J&JCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this 3 week study is to test the effectiveness of an over-the-counter (OTC) skin balm in infants and toddlers with mild to moderate dry, itchy skin.
Detailed Description
50 infants and toddlers will be enrolled in this study to yield 40 completed subjects, 30 babies in the active treatment group and 10 babies in the positive control group.
Infants and toddlers aged 6 to 47 months inclusive will receive either a prescription or non-marketed investigational product for the treatment of eczema. Caregivers will be asked to stop use of prescription eczema treatments one week before the start of the study and during the study. Caregivers will apply study product to babies as indicated for 14 days to affected areas.
Subject caregivers will record treatment use in a daily diary and complete questionnaires. A dermatologist will examine and score the babies eczema and symptoms. Skin moisture levels will also be tested.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema
Keywords
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EpiCeram Skin Barrier Emulsion
Arm Type
Active Comparator
Arm Description
Marketed. Apply in a thin layer to the affected skin areas two times per day (or as needed) and massage gently into the skin.
Arm Title
1% Colloidal Oatmeal Balm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
EpiCeram Skin Barrier Emulsion
Intervention Description
EpiCeram Skin Barrier Emulsion
Intervention Type
Drug
Intervention Name(s)
1% Colloidal Oatmeal Balm
Other Intervention Name(s)
Eczema Moisturizing Balm
Intervention Description
Experimental Product 1% Colloidal Oatmeal Balm
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment
Description
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time Frame
Day 0 - Pretreatment (Baseline) to Day 0 - immediately post treatment
Title
Change From Baseline in Mean Corneometer Measurement 12 Hours After Treatment
Description
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time Frame
Day 0 - Pretreatment (Baseline) to 12 Hours After treatment
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Corneometer Measurement 24 Hours After Treatment
Description
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time Frame
Day 0 - Pretreatment (Baseline) to 24 Hours After treatment
Title
Change From Baseline in Mean Corneometer Measurement 3 Days After Treatment
Description
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time Frame
Day 0 - Pretreatment (Baseline) to 3 Days After treatment
Title
Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment
Description
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time Frame
Day 0 - Pretreatment (Baseline) to 7 Days After treatment
Title
Change From Baseline in Mean Corneometer Measurement 14 Days After Treatment
Description
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time Frame
Day 0 - Pretreatment (Baseline) to 14 Days After treatment
Title
Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline
Description
The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.
Time Frame
Day 0 - Pretreatment (Baseline) to Day 1
Title
Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline
Description
The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.
Time Frame
Day 0 - Pretreatment (Baseline) to Day 3
Title
Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline
Description
The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.
Time Frame
Day 0 - Pretreatment (Baseline) to Day 7
Title
Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline
Description
The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.
Time Frame
Day 0 - Pretreatment (Baseline) to Day 14
Title
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline
Description
The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.
Time Frame
Day 0 - Pretreatment (Baseline) to Day 1
Title
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline
Description
The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.
Time Frame
Day 0 - Pretreatment (Baseline) to Day 3
Title
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline
Description
The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.
Time Frame
Day 0 - Pretreatment (Baseline) to Day 7
Title
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline
Description
The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.
Time Frame
Day 0 - Pretreatment (Baseline) to Day 14
Title
Dryness Scale Score on Day 1 - Change From Baseline
Description
An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).
Time Frame
Day 0 - Pretreatment (Baseline) to Day 1
Title
Dryness Scale Score on Day 3 - Change From Baseline
Description
An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).
Time Frame
Day 0 - Pretreatment (Baseline) to Day 3
Title
Dryness Scale Score on Day 7 - Change From Baseline
Description
An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).
Time Frame
Day 0 - Pretreatment (Baseline) to Day 7
Title
Dryness Scale Score on Day 14 - Change From Baseline
Description
An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).
Time Frame
Day 0 - Pretreatment (Baseline) to Day 14
Title
Caregiver's Itch Assessment on Day 3 - Change From Baseline
Description
An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).
Time Frame
Day 0 - Pretreatment (Baseline) to Day 3
Title
Caregiver's Itch Assessment on Day 7 - Change From Baseline
Description
An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).
Time Frame
Day 0 - Pretreatment (Baseline) to Day 7
Title
Caregiver's Itch Assessment on Day 14 - Change From Baseline
Description
An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).
Time Frame
Day 0 - Pretreatment (Baseline) to Day 14
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role
Description
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?
Time Frame
0 Days Pretreatment (Baseline)
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement
Description
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?
Time Frame
0 Days Pretreatment (Baseline)
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time Child Usually Put to Bed
Description
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).
Time Frame
0 Days Pretreatment (Baseline)
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime
Description
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.
Time Frame
0 Days Pretreatment (Baseline)
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time for Child to Fall Asleep
Description
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?
Time Frame
0 Days Pretreatment (Baseline)
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Times Child Awakes During the Night
Description
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?
Time Frame
0 Days Pretreatment (Baseline)
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Awake During the Night
Description
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?
Time Frame
0 Days Pretreatment (Baseline)
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Longest Time Child is Asleep During the Night
Description
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?
Time Frame
0 Days Pretreatment (Baseline)
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child is Asleep During the Night
Description
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?
Time Frame
0 Days Pretreatment (Baseline)
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Naps Child Takes During the Day
Description
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?
Time Frame
0 Days Pretreatment (Baseline)
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Sleeps During the Day
Description
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?
Time Frame
0 Days Pretreatment (Baseline)
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem
Description
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.
Time Frame
0 Days Pretreatment (Baseline)
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role
Description
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?
Time Frame
7 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement
Description
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?
Time Frame
7 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time Child Usually Put to Bed
Description
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).
Time Frame
7 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime
Description
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.
Time Frame
7 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time for Child to Fall Asleep
Description
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?
Time Frame
7 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Times Child Awakes During the Night
Description
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?
Time Frame
7 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Awake During the Night
Description
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?
Time Frame
7 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Longest Time Child is Asleep During the Night
Description
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?
Time Frame
7 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child is Asleep During the Night
Description
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?
Time Frame
7 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Naps Child Takes During the Day
Description
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?
Time Frame
7 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Sleeps During the Day
Description
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?
Time Frame
7 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem
Description
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.
Time Frame
7 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Responder Role
Description
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?
Time Frame
14 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement
Description
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?
Time Frame
14 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time Child Usually Put to Bed
Description
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).
Time Frame
14 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime
Description
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.
Time Frame
14 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time for Child to Fall Asleep
Description
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?
Time Frame
14 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Times Child Awakes During the Night
Description
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?
Time Frame
14 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Awake During the Night
Description
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?
Time Frame
14 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Longest Time Child is Asleep During the Night
Description
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?
Time Frame
14 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child is Asleep During the Night
Description
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?
Time Frame
14 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Naps Child Takes During the Day
Description
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?
Time Frame
14 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Sleeps During the Day
Description
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?
Time Frame
14 Days
Title
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem
Description
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.
Time Frame
14 Days
Title
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall
Description
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks smooth".
Time Frame
0 Days - Pre-treatment
Title
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall
Description
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks healthy".
Time Frame
0 Days - Pre-treatment
Title
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall
Description
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin feels soft".
Time Frame
0 Days - Pre-treatment
Title
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema
Description
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks smooth".
Time Frame
0 Days - Pre-treatment
Title
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema
Description
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks healthy".
Time Frame
0 Days - Pre-treatment
Title
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema
Description
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin feels soft".
Time Frame
0 Days - Pre-treatment
Title
Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week
Description
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, what has your child's mood been?"
Time Frame
0 Days - Pre-treatment
Title
Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning
Description
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Typically, how would you rate your child's mood when he/she wakes up in the morning?"
Time Frame
0 Days - Pre-treatment
Title
Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week
Description
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much has your child wanted to play?"
Time Frame
0 Days - Pre-treatment
Title
Caregiver Questionnaire on Day 0 Pre-treatment - Amount of Sleep Caregiver Got Over Past Week
Description
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much sleep did you get at night?"
Time Frame
0 Days - Pre-treatment
Title
Caregiver Questionnaire on Day 0 Pre-treatment - Number of Times Caregiver Woke Up
Description
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "How many times did you wake up during the night?"
Time Frame
0 Days - Pre-treatment
Title
Caregiver Questionnaire on Day 0 Pre-treatment - Amount of Time Caregiver Awake
Description
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "If you did wake up during the night, how much time were you awake (on average) before falling back asleep?"
Time Frame
0 Days - Pre-treatment
Title
Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week
Description
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much energy have you had to engage with your family?"
Time Frame
0 Days - Pre-treatment
Title
Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week
Description
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how rested have you felt?"
Time Frame
0 Days - Pre-treatment
Title
Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week
Description
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how alert have you felt?"
Time Frame
0 Days - Pre-treatment
Title
Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week
Description
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how productive have you been at work?"
Time Frame
0 Days - Pre-treatment
Title
Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall
Description
Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks smooth".
Time Frame
0 Days - Post-treatment
Title
Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall
Description
Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks healthy".
Time Frame
0 Days - Post-treatment
Title
Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall
Description
Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin feels soft".
Time Frame
0 Days - Post-treatment
Title
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema
Description
Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks smooth".
Time Frame
0 Days - Post-treatment
Title
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema
Description
Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks healthy".
Time Frame
0 Days - Post-treatment
Title
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema
Description
Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin feels soft".
Time Frame
0 Days - Post-treatment
Title
Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall
Description
Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks smooth".
Time Frame
3 Days
Title
Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall
Description
Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks healthy".
Time Frame
3 Days
Title
Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall
Description
Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin feels soft".
Time Frame
3 Days
Title
Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema
Description
Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks smooth".
Time Frame
3 Days
Title
Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema
Description
Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks healthy".
Time Frame
3 Days
Title
Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema
Description
Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin feels soft".
Time Frame
3 Days
Title
Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall
Description
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks smooth".
Time Frame
7 Days
Title
Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall
Description
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks healthy".
Time Frame
7 Days
Title
Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall
Description
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin feels soft".
Time Frame
7 Days
Title
Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema
Description
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks smooth".
Time Frame
7 Days
Title
Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema
Description
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks healthy".
Time Frame
7 Days
Title
Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema
Description
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin feels soft".
Time Frame
7 Days
Title
Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week
Description
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, what has your child's mood been?"
Time Frame
7 Days
Title
Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning
Description
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Typically, how would you rate your child's mood when he/she wakes up in the morning?"
Time Frame
7 Days
Title
Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week
Description
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much has your child wanted to play?"
Time Frame
7 Days
Title
Caregiver Questionnaire on Day 7 - Amount of Sleep Caregiver Got Over Past Week
Description
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much sleep did you get at night?"
Time Frame
7 Days
Title
Caregiver Questionnaire on Day 7 - Number of Times Caregiver Woke Up
Description
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "How many times did you wake up during the night?"
Time Frame
7 Days
Title
Caregiver Questionnaire on Day 7 - Amount of Time Caregiver Awake
Description
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "If you did wake up during the night, how much time were you awake (on average) before falling back asleep?"
Time Frame
7 Days
Title
Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week
Description
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much energy have you had to engage with your family?"
Time Frame
7 Days
Title
Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week
Description
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how rested have you felt?"
Time Frame
7 Days
Title
Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week
Description
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how alert have you felt?"
Time Frame
7 Days
Title
Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week
Description
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how productive have you been at work?"
Time Frame
7 Days
Title
Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall
Description
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks smooth".
Time Frame
14 Days
Title
Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall
Description
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks healthy".
Time Frame
14 Days
Title
Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall
Description
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin feels soft".
Time Frame
14 Days
Title
Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema
Description
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks smooth".
Time Frame
14 Days
Title
Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema
Description
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks healthy".
Time Frame
14 Days
Title
Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema
Description
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin feels soft".
Time Frame
14 Days
Title
Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week
Description
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, what has your child's mood been?"
Time Frame
14 Days
Title
Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning
Description
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Typically, how would you rate your child's mood when he/she wakes up in the morning?"
Time Frame
14 Days
Title
Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week
Description
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much has your child wanted to play?"
Time Frame
14 Days
Title
Caregiver Questionnaire on Day 14 - Amount of Sleep Caregiver Got Over Past Week
Description
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much sleep did you get at night?"
Time Frame
14 Days
Title
Caregiver Questionnaire on Day 14 - Number of Times Caregiver Woke Up
Description
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "How many times did you wake up during the night?"
Time Frame
14 Days
Title
Caregiver Questionnaire on Day 14 - Amount of Time Caregiver Awake
Description
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "If you did wake up during the night, how much time were you awake (on average) before falling back asleep?"
Time Frame
14 Days
Title
Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week
Description
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much energy have you had to engage with your family?"
Time Frame
14 Days
Title
Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week
Description
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how rested have you felt?"
Time Frame
14 Days
Title
Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week
Description
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how alert have you felt?"
Time Frame
14 Days
Title
Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week
Description
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how productive have you been at work?"
Time Frame
14 Days
Title
Caregiver Questionnaire on Day 14 - Recommend Product
Description
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "I would recommend this product to another parent".
Time Frame
14 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
47 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amisha Parikh-Das, PhD
Organizational Affiliation
Johnson & Johnson Consumer Inc. (J&JCI)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ethlynn Schorr, MD
Organizational Affiliation
TKL Research, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
TKL Research
City
Fair Lawn
State/Province
New Jersey
ZIP/Postal Code
07410
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Test to Determine the Effectiveness of Moisturizing Balm Used on Babies With Dry, Itchy Skin
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