The purpose of this 3 week study is to test the effectiveness of an over-the-counter (OTC) skin balm in infants and toddlers with mild to moderate dry, itchy skin.
50 infants and toddlers will be enrolled in this study to yield 40 completed subjects, 30 babies in the active treatment group and 10 babies in the positive control group. Infants and toddlers aged 6 to 47 months inclusive will receive either a prescription or non-marketed investigational product for the treatment of eczema. Caregivers will be asked to stop use of prescription eczema treatments one week before the start of the study and during the study. Caregivers will apply study product to babies as indicated for 14 days to affected areas. Subject caregivers will record treatment use in a daily diary and complete questionnaires. A dermatologist will examine and score the babies eczema and symptoms. Skin moisture levels will also be tested.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
23
EpiCeram Skin Barrier Emulsion
Experimental Product 1% Colloidal Oatmeal Balm
TKL Research
Fair Lawn, New Jersey, United States
Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time frame: Day 0 - Pretreatment (Baseline) to Day 0 - immediately post treatment
Change From Baseline in Mean Corneometer Measurement 12 Hours After Treatment
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time frame: Day 0 - Pretreatment (Baseline) to 12 Hours After treatment
Change From Baseline in Mean Corneometer Measurement 24 Hours After Treatment
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time frame: Day 0 - Pretreatment (Baseline) to 24 Hours After treatment
Change From Baseline in Mean Corneometer Measurement 3 Days After Treatment
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time frame: Day 0 - Pretreatment (Baseline) to 3 Days After treatment
Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Change From Baseline in Mean Corneometer Measurement 14 Days After Treatment
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time frame: Day 0 - Pretreatment (Baseline) to 14 Days After treatment
Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline
The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.
Time frame: Day 0 - Pretreatment (Baseline) to Day 1
Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline
The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.
Time frame: Day 0 - Pretreatment (Baseline) to Day 3
Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline
The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.
Time frame: Day 0 - Pretreatment (Baseline) to Day 7
Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline
The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.
Time frame: Day 0 - Pretreatment (Baseline) to Day 14
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline
The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.
Time frame: Day 0 - Pretreatment (Baseline) to Day 1
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline
The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.
Time frame: Day 0 - Pretreatment (Baseline) to Day 3
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline
The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.
Time frame: Day 0 - Pretreatment (Baseline) to Day 7
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline
The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.
Time frame: Day 0 - Pretreatment (Baseline) to Day 14
Dryness Scale Score on Day 1 - Change From Baseline
An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).
Time frame: Day 0 - Pretreatment (Baseline) to Day 1
Dryness Scale Score on Day 3 - Change From Baseline
An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).
Time frame: Day 0 - Pretreatment (Baseline) to Day 3
Dryness Scale Score on Day 7 - Change From Baseline
An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).
Time frame: Day 0 - Pretreatment (Baseline) to Day 7
Dryness Scale Score on Day 14 - Change From Baseline
An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).
Time frame: Day 0 - Pretreatment (Baseline) to Day 14
Caregiver's Itch Assessment on Day 3 - Change From Baseline
An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).
Time frame: Day 0 - Pretreatment (Baseline) to Day 3
Caregiver's Itch Assessment on Day 7 - Change From Baseline
An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).
Time frame: Day 0 - Pretreatment (Baseline) to Day 7
Caregiver's Itch Assessment on Day 14 - Change From Baseline
An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).
Time frame: Day 0 - Pretreatment (Baseline) to Day 14
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?
Time frame: 0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?
Time frame: 0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time Child Usually Put to Bed
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).
Time frame: 0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.
Time frame: 0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time for Child to Fall Asleep
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?
Time frame: 0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Times Child Awakes During the Night
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?
Time frame: 0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Awake During the Night
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?
Time frame: 0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Longest Time Child is Asleep During the Night
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?
Time frame: 0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child is Asleep During the Night
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?
Time frame: 0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Naps Child Takes During the Day
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?
Time frame: 0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Sleeps During the Day
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?
Time frame: 0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem
Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.
Time frame: 0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?
Time frame: 7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?
Time frame: 7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time Child Usually Put to Bed
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).
Time frame: 7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.
Time frame: 7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time for Child to Fall Asleep
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?
Time frame: 7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Times Child Awakes During the Night
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?
Time frame: 7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Awake During the Night
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?
Time frame: 7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Longest Time Child is Asleep During the Night
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?
Time frame: 7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child is Asleep During the Night
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?
Time frame: 7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Naps Child Takes During the Day
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?
Time frame: 7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Sleeps During the Day
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?
Time frame: 7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem
Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.
Time frame: 7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Responder Role
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?
Time frame: 14 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?
Time frame: 14 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time Child Usually Put to Bed
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).
Time frame: 14 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.
Time frame: 14 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time for Child to Fall Asleep
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?
Time frame: 14 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Times Child Awakes During the Night
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?
Time frame: 14 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Awake During the Night
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?
Time frame: 14 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Longest Time Child is Asleep During the Night
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?
Time frame: 14 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child is Asleep During the Night
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?
Time frame: 14 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Naps Child Takes During the Day
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?
Time frame: 14 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Sleeps During the Day
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?
Time frame: 14 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem
Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.
Time frame: 14 Days
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks smooth".
Time frame: 0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks healthy".
Time frame: 0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin feels soft".
Time frame: 0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks smooth".
Time frame: 0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks healthy".
Time frame: 0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin feels soft".
Time frame: 0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, what has your child's mood been?"
Time frame: 0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Typically, how would you rate your child's mood when he/she wakes up in the morning?"
Time frame: 0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much has your child wanted to play?"
Time frame: 0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Amount of Sleep Caregiver Got Over Past Week
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much sleep did you get at night?"
Time frame: 0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Number of Times Caregiver Woke Up
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "How many times did you wake up during the night?"
Time frame: 0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Amount of Time Caregiver Awake
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "If you did wake up during the night, how much time were you awake (on average) before falling back asleep?"
Time frame: 0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much energy have you had to engage with your family?"
Time frame: 0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how rested have you felt?"
Time frame: 0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how alert have you felt?"
Time frame: 0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week
Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how productive have you been at work?"
Time frame: 0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall
Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks smooth".
Time frame: 0 Days - Post-treatment
Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall
Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks healthy".
Time frame: 0 Days - Post-treatment
Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall
Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin feels soft".
Time frame: 0 Days - Post-treatment
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema
Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks smooth".
Time frame: 0 Days - Post-treatment
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema
Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks healthy".
Time frame: 0 Days - Post-treatment
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema
Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin feels soft".
Time frame: 0 Days - Post-treatment
Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall
Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks smooth".
Time frame: 3 Days
Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall
Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks healthy".
Time frame: 3 Days
Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall
Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin feels soft".
Time frame: 3 Days
Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema
Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks smooth".
Time frame: 3 Days
Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema
Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks healthy".
Time frame: 3 Days
Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema
Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin feels soft".
Time frame: 3 Days
Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks smooth".
Time frame: 7 Days
Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks healthy".
Time frame: 7 Days
Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin feels soft".
Time frame: 7 Days
Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks smooth".
Time frame: 7 Days
Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks healthy".
Time frame: 7 Days
Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin feels soft".
Time frame: 7 Days
Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, what has your child's mood been?"
Time frame: 7 Days
Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Typically, how would you rate your child's mood when he/she wakes up in the morning?"
Time frame: 7 Days
Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much has your child wanted to play?"
Time frame: 7 Days
Caregiver Questionnaire on Day 7 - Amount of Sleep Caregiver Got Over Past Week
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much sleep did you get at night?"
Time frame: 7 Days
Caregiver Questionnaire on Day 7 - Number of Times Caregiver Woke Up
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "How many times did you wake up during the night?"
Time frame: 7 Days
Caregiver Questionnaire on Day 7 - Amount of Time Caregiver Awake
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "If you did wake up during the night, how much time were you awake (on average) before falling back asleep?"
Time frame: 7 Days
Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much energy have you had to engage with your family?"
Time frame: 7 Days
Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how rested have you felt?"
Time frame: 7 Days
Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how alert have you felt?"
Time frame: 7 Days
Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week
Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how productive have you been at work?"
Time frame: 7 Days
Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks smooth".
Time frame: 14 Days
Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks healthy".
Time frame: 14 Days
Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin feels soft".
Time frame: 14 Days
Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks smooth".
Time frame: 14 Days
Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks healthy".
Time frame: 14 Days
Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin feels soft".
Time frame: 14 Days
Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, what has your child's mood been?"
Time frame: 14 Days
Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Typically, how would you rate your child's mood when he/she wakes up in the morning?"
Time frame: 14 Days
Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much has your child wanted to play?"
Time frame: 14 Days
Caregiver Questionnaire on Day 14 - Amount of Sleep Caregiver Got Over Past Week
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much sleep did you get at night?"
Time frame: 14 Days
Caregiver Questionnaire on Day 14 - Number of Times Caregiver Woke Up
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "How many times did you wake up during the night?"
Time frame: 14 Days
Caregiver Questionnaire on Day 14 - Amount of Time Caregiver Awake
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "If you did wake up during the night, how much time were you awake (on average) before falling back asleep?"
Time frame: 14 Days
Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much energy have you had to engage with your family?"
Time frame: 14 Days
Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how rested have you felt?"
Time frame: 14 Days
Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how alert have you felt?"
Time frame: 14 Days
Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how productive have you been at work?"
Time frame: 14 Days
Caregiver Questionnaire on Day 14 - Recommend Product
Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "I would recommend this product to another parent".
Time frame: 14 Days