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

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

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.

Study Overview

• Status: Terminated
• Conditions: Eczema
• Intervention / Treatment: Device: EpiCeram Skin Barrier Emulsion; Drug: 1% Colloidal Oatmeal Balm

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Fair Lawn, New Jersey, United States, 07410
      • TKL Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates)
2. Male or female of any race or ethnicity, 6 months to 47 months of age;
3. Diagnosed as having eczema
4. Willing to stop use of all non-assigned moisturizers and/or creams for the entire duration of the study
5. Child must have bedtime/sleep issues due to their dry, itchy skin

Exclusion Criteria:

1. Use of a therapeutic (over-the-counter or prescription) body wash that contains an active ingredient for eczema
2. Participation in any clinical study within 30 days of Visit 1
3. Active infection of any type at the start of the study
4. Diagnosed as having severe eczema
5. Atopic Dermatitis requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids
6. Child wakes up 3 or more times during the night
7. Child is awake more than 60 minutes during the night
8. Child sleeps for less than a total of 9 hours (during the day or night)
9. Child requires greater than 2.0 mg per day of inhaled or intranasal corticosteroids

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EpiCeram Skin Barrier Emulsion; Marketed. Apply in a thin layer to the affected skin areas two times per day (or as needed) and massage gently into the skin.	Device: EpiCeram Skin Barrier Emulsion; EpiCeram Skin Barrier Emulsion
Experimental: 1% Colloidal Oatmeal Balm; Not Yet Marketed. Apply in a thin layer to the affected skin areas at least once at night or more if needed (anytime), and massage gently into the skin.	Drug: 1% Colloidal Oatmeal Balm; Experimental Product 1% Colloidal Oatmeal Balm; Other Names: Eczema Moisturizing Balm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment	Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.	Day 0 - Pretreatment (Baseline) to Day 0 - immediately post treatment
Change From Baseline in Mean Corneometer Measurement 12 Hours After Treatment	Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.	Day 0 - Pretreatment (Baseline) to 12 Hours After treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean Corneometer Measurement 24 Hours After Treatment	Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.	Day 0 - Pretreatment (Baseline) to 24 Hours After treatment
Change From Baseline in Mean Corneometer Measurement 3 Days After Treatment	Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.	Day 0 - Pretreatment (Baseline) to 3 Days After treatment
Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment	Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.	Day 0 - Pretreatment (Baseline) to 7 Days After treatment
Change From Baseline in Mean Corneometer Measurement 14 Days After Treatment	Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.	Day 0 - Pretreatment (Baseline) to 14 Days After treatment
Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline	The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.	Day 0 - Pretreatment (Baseline) to Day 1
Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline	The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.	Day 0 - Pretreatment (Baseline) to Day 3
Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline	The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.	Day 0 - Pretreatment (Baseline) to Day 7
Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline	The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.	Day 0 - Pretreatment (Baseline) to Day 14
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline	The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.	Day 0 - Pretreatment (Baseline) to Day 1
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline	The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.	Day 0 - Pretreatment (Baseline) to Day 3
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline	The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.	Day 0 - Pretreatment (Baseline) to Day 7
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline	The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.	Day 0 - Pretreatment (Baseline) to Day 14
Dryness Scale Score on Day 1 - Change From Baseline	An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).	Day 0 - Pretreatment (Baseline) to Day 1
Dryness Scale Score on Day 3 - Change From Baseline	An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).	Day 0 - Pretreatment (Baseline) to Day 3
Dryness Scale Score on Day 7 - Change From Baseline	An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).	Day 0 - Pretreatment (Baseline) to Day 7
Dryness Scale Score on Day 14 - Change From Baseline	An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).	Day 0 - Pretreatment (Baseline) to Day 14
Caregiver's Itch Assessment on Day 3 - Change From Baseline	An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).	Day 0 - Pretreatment (Baseline) to Day 3
Caregiver's Itch Assessment on Day 7 - Change From Baseline	An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).	Day 0 - Pretreatment (Baseline) to Day 7
Caregiver's Itch Assessment on Day 14 - Change From Baseline	An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).	Day 0 - Pretreatment (Baseline) to Day 14
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role	Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?	0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement	Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?	0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time Child Usually Put to Bed	Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).	0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime	Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.	0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time for Child to Fall Asleep	Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?	0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Times Child Awakes During the Night	Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?	0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Awake During the Night	Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?	0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Longest Time Child is Asleep During the Night	Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?	0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child is Asleep During the Night	Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?	0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Naps Child Takes During the Day	Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?	0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Sleeps During the Day	Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?	0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem	Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.	0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role	Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?	7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement	Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?	7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time Child Usually Put to Bed	Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).	7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime	Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.	7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time for Child to Fall Asleep	Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?	7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Times Child Awakes During the Night	Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?	7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Awake During the Night	Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?	7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Longest Time Child is Asleep During the Night	Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?	7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child is Asleep During the Night	Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?	7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Naps Child Takes During the Day	Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?	7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Sleeps During the Day	Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?	7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem	Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.	7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Responder Role	Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?	14 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement	Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?	14 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time Child Usually Put to Bed	Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).	14 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime	Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.	14 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time for Child to Fall Asleep	Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?	14 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Times Child Awakes During the Night	Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?	14 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Awake During the Night	Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?	14 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Longest Time Child is Asleep During the Night	Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?	14 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child is Asleep During the Night	Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?	14 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Naps Child Takes During the Day	Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?	14 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Sleeps During the Day	Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?	14 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem	Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.	14 Days
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall	Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks smooth".	0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall	Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks healthy".	0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall	Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin feels soft".	0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema	Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks smooth".	0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema	Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks healthy".	0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema	Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin feels soft".	0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week	Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, what has your child's mood been?"	0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning	Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Typically, how would you rate your child's mood when he/she wakes up in the morning?"	0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week	Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much has your child wanted to play?"	0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Amount of Sleep Caregiver Got Over Past Week	Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much sleep did you get at night?"	0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Number of Times Caregiver Woke Up	Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "How many times did you wake up during the night?"	0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Amount of Time Caregiver Awake	Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "If you did wake up during the night, how much time were you awake (on average) before falling back asleep?"	0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week	Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much energy have you had to engage with your family?"	0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week	Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how rested have you felt?"	0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week	Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how alert have you felt?"	0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week	Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how productive have you been at work?"	0 Days - Pre-treatment
Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall	Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks smooth".	0 Days - Post-treatment
Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall	Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks healthy".	0 Days - Post-treatment
Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall	Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin feels soft".	0 Days - Post-treatment
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema	Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks smooth".	0 Days - Post-treatment
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema	Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks healthy".	0 Days - Post-treatment
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema	Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin feels soft".	0 Days - Post-treatment
Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall	Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks smooth".	3 Days
Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall	Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks healthy".	3 Days
Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall	Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin feels soft".	3 Days
Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema	Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks smooth".	3 Days
Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema	Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks healthy".	3 Days
Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema	Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin feels soft".	3 Days
Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall	Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks smooth".	7 Days
Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall	Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks healthy".	7 Days
Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall	Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin feels soft".	7 Days
Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema	Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks smooth".	7 Days
Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema	Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks healthy".	7 Days
Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema	Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin feels soft".	7 Days
Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week	Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, what has your child's mood been?"	7 Days
Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning	Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Typically, how would you rate your child's mood when he/she wakes up in the morning?"	7 Days
Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week	Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much has your child wanted to play?"	7 Days
Caregiver Questionnaire on Day 7 - Amount of Sleep Caregiver Got Over Past Week	Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much sleep did you get at night?"	7 Days
Caregiver Questionnaire on Day 7 - Number of Times Caregiver Woke Up	Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "How many times did you wake up during the night?"	7 Days
Caregiver Questionnaire on Day 7 - Amount of Time Caregiver Awake	Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "If you did wake up during the night, how much time were you awake (on average) before falling back asleep?"	7 Days
Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week	Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much energy have you had to engage with your family?"	7 Days
Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week	Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how rested have you felt?"	7 Days
Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week	Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how alert have you felt?"	7 Days
Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week	Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how productive have you been at work?"	7 Days
Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall	Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks smooth".	14 Days
Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall	Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks healthy".	14 Days
Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall	Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin feels soft".	14 Days
Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema	Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks smooth".	14 Days
Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema	Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks healthy".	14 Days
Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema	Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin feels soft".	14 Days
Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week	Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, what has your child's mood been?"	14 Days
Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning	Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Typically, how would you rate your child's mood when he/she wakes up in the morning?"	14 Days
Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week	Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much has your child wanted to play?"	14 Days
Caregiver Questionnaire on Day 14 - Amount of Sleep Caregiver Got Over Past Week	Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much sleep did you get at night?"	14 Days
Caregiver Questionnaire on Day 14 - Number of Times Caregiver Woke Up	Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "How many times did you wake up during the night?"	14 Days
Caregiver Questionnaire on Day 14 - Amount of Time Caregiver Awake	Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "If you did wake up during the night, how much time were you awake (on average) before falling back asleep?"	14 Days
Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week	Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much energy have you had to engage with your family?"	14 Days
Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week	Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how rested have you felt?"	14 Days
Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week	Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how alert have you felt?"	14 Days
Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week	Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how productive have you been at work?"	14 Days
Caregiver Questionnaire on Day 14 - Recommend Product	Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "I would recommend this product to another parent".	14 Days

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
• Investigators: Study Director: Amisha Parikh-Das, PhD, Johnson & Johnson Consumer Inc. (J&JCI); Principal Investigator: Ethlynn Schorr, MD, TKL Research, Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 18, 2015
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Actual): March 24, 2017
• Last Update Submitted That Met QC Criteria: February 6, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Atopic Dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema; Anti-Infective Agents; Antifungal Agents; Decanoic acid
• Other Study ID Numbers: CO-141020101115-THCT