EczemaNCT02404493
Test to Determine the Effectiveness of Moisturizing Balm Used on Babies With Dry, Itchy Skin
A study testing EpiCeram Skin Barrier Emulsion and 1% Colloidal Oatmeal Balm in people with Eczema, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
Trial summary
The purpose of this 3 week study is to test the effectiveness of an over-the-counter (OTC) skin balm in infants and toddlers with mild to moderate dry, itchy skin. Read more about this study
- Who is it for?
- Ages 6 to 47 months
- Conditions the study is for
- Eczema
- What is being tested?
- EpiCeram Skin Barrier Emulsion and 1% Colloidal Oatmeal Balm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 47 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates)
- Male or female of any race or ethnicity, 6 months to 47 months of age;
- Diagnosed as having eczema
- Willing to stop use of all non-assigned moisturizers and/or creams for the entire duration of the study
- Child must have bedtime/sleep issues due to their dry, itchy skin
Who cannot join
- Use of a therapeutic (over-the-counter or prescription) body wash that contains an active ingredient for eczema
- Participation in any clinical study within 30 days of Visit 1
- Active infection of any type at the start of the study
- Diagnosed as having severe eczema
- Atopic Dermatitis requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids
- Child wakes up 3 or more times during the night
Show all 9Show fewer
- Child is awake more than 60 minutes during the night
- Child sleeps for less than a total of 9 hours (during the day or night)
- Child requires greater than 2.0 mg per day of inhaled or intranasal corticosteroids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial to Evaluate the Efficacy of an Investigational Nighttime Moisturizing Balm in the Management of Mild to Moderate Atopic Dermatitis in Infants and Toddlers
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.
Read the 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.
- Conditions
- Eczema
- Being tested
- EpiCeram Skin Barrier Emulsion, 1% Colloidal Oatmeal Balm
- Keywords
- Atopic Dermatitis
- Medical subject headings
- Eczema, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiCeram Skin Barrier EmulsionDevice
EpiCeram Skin Barrier Emulsion
1% Colloidal Oatmeal BalmDrug
Also called Eczema Moisturizing Balm
Experimental Product 1% Colloidal Oatmeal Balm
| Study group | Role | What they receive |
|---|---|---|
| EpiCeram Skin Barrier Emulsion | Active comparator | Marketed. Apply in a thin layer to the affected skin areas two times per day (or as needed) and massage gently into the skin. Receives: Device: EpiCeram Skin Barrier Emulsion |
| 1% Colloidal Oatmeal Balm | Experimental | Not Yet Marketed. Apply in a thin layer to the affected skin areas at least once at night or more if needed (anytime), and massage gently into the skin. Receives: Drug: 1% Colloidal Oatmeal Balm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 0 - Pretreatment (Baseline) to 12 Hours After treatment
Secondary outcomes (116)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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?
Measured: 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?
Measured: 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).
Measured: 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'.
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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'.
Measured: 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?
Measured: 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?
Measured: 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).
Measured: 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'.
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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'.
Measured: 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?
Measured: 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?
Measured: 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).
Measured: 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'.
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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'.
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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".
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Lack of subject enrollment and the eczema season has completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amisha Parikh-Das, PhD, Study director, Johnson & Johnson Consumer Inc. (J&JCI)Ethlynn Schorr, MD, Principal investigator, TKL Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404493
- Sponsor's protocol ID
- CO-141020101115-THCT
- Status last verified
- Feb 2017
- First submitted
- 18 Mar 2015
- Last updated
- 24 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Efficacy of an Investigational Nighttime Moisturizing Balm in the Management of Mild to Moderate Atopic Dermatitis in Infants and Toddlers
- ClinicalTrials.gov ID
- NCT02404493
- Acronym / sponsor ID
- CO-141020101115-THCT
- Conditions
- Eczema
- Keywords
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of subject enrollment and the eczema season has completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Posted 24 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this 3 week study is to test the effectiveness of an over-the-counter (OTC) skin balm in infants and toddlers with mild to moderate dry, itchy skin.
Detailed description
50 infants and toddlers will be enrolled in this study to yield 40 completed subjects, 30 babies in the active treatment group and 10 babies in the positive control group.
Infants and toddlers aged 6 to 47 months inclusive will receive either a prescription or non-marketed investigational product for the treatment of eczema. Caregivers will be asked to stop use of prescription eczema treatments one week before the start of the study and during the study. Caregivers will apply study product to babies as indicated for 14 days to affected areas.
Subject caregivers will record treatment use in a daily diary and complete questionnaires. A dermatologist will examine and score the babies eczema and symptoms. Skin moisture levels will also be tested.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EpiCeram Skin Barrier Emulsion | Active comparator | Device: EpiCeram Skin Barrier EmulsionMarketed. Apply in a thin layer to the affected skin areas two times per day (or as needed) and massage gently into the skin. |
| 1% Colloidal Oatmeal Balm | Experimental | Drug: 1% Colloidal Oatmeal BalmNot 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. |
Who may qualify
- Ages
- 6 to 47 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates)
- Male or female of any race or ethnicity, 6 months to 47 months of age;
- Diagnosed as having eczema
- Willing to stop use of all non-assigned moisturizers and/or creams for the entire duration of the study
- Child must have bedtime/sleep issues due to their dry, itchy skin
Key exclusion criteria (9 listed)
- Use of a therapeutic (over-the-counter or prescription) body wash that contains an active ingredient for eczema
- Participation in any clinical study within 30 days of Visit 1
- Active infection of any type at the start of the study
- Diagnosed as having severe eczema
- Atopic Dermatitis requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpiCeram Skin Barrier EmulsionEpiCeram Skin Barrier Emulsion | Device | EpiCeram Skin Barrier Emulsion |
| 1% Colloidal Oatmeal BalmAlso: Eczema Moisturizing BalmExperimental Product 1% Colloidal Oatmeal Balm | Drug | 1% Colloidal Oatmeal Balm |
Primary outcome
Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment
Time frame: Day 0 - Pretreatment (Baseline) to Day 0 - immediately post treatment
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Change From Baseline in Mean Corneometer Measurement 12 Hours After Treatment
Time frame: Day 0 - Pretreatment (Baseline) to 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.
116 secondary outcomes
Change From Baseline in Mean Corneometer Measurement 24 Hours After Treatment
Time frame: Day 0 - Pretreatment (Baseline) to 24 Hours After treatment
Change From Baseline in Mean Corneometer Measurement 3 Days After Treatment
Time frame: Day 0 - Pretreatment (Baseline) to 3 Days After treatment
Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment
Time frame: Day 0 - Pretreatment (Baseline) to 7 Days After treatment
Change From Baseline in Mean Corneometer Measurement 14 Days After Treatment
Time frame: Day 0 - Pretreatment (Baseline) to 14 Days After treatment
Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline
Time frame: Day 0 - Pretreatment (Baseline) to Day 1
Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline
Time frame: Day 0 - Pretreatment (Baseline) to Day 3
Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline
Time frame: Day 0 - Pretreatment (Baseline) to Day 7
Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline
Time frame: Day 0 - Pretreatment (Baseline) to Day 14
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline
Time frame: Day 0 - Pretreatment (Baseline) to Day 1
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline
Time frame: Day 0 - Pretreatment (Baseline) to Day 3
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline
Time frame: Day 0 - Pretreatment (Baseline) to Day 7
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline
Time frame: Day 0 - Pretreatment (Baseline) to Day 14
Dryness Scale Score on Day 1 - Change From Baseline
Time frame: Day 0 - Pretreatment (Baseline) to Day 1
Dryness Scale Score on Day 3 - Change From Baseline
Time frame: Day 0 - Pretreatment (Baseline) to Day 3
Dryness Scale Score on Day 7 - Change From Baseline
Time frame: Day 0 - Pretreatment (Baseline) to Day 7
Dryness Scale Score on Day 14 - Change From Baseline
Time frame: Day 0 - Pretreatment (Baseline) to Day 14
Caregiver's Itch Assessment on Day 3 - Change From Baseline
Time frame: Day 0 - Pretreatment (Baseline) to Day 3
Caregiver's Itch Assessment on Day 7 - Change From Baseline
Time frame: Day 0 - Pretreatment (Baseline) to Day 7
Caregiver's Itch Assessment on Day 14 - Change From Baseline
Time frame: Day 0 - Pretreatment (Baseline) to Day 14
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role
Time frame: 0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement
Time frame: 0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time Child Usually Put to Bed
Time frame: 0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime
Time frame: 0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time for 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
Time frame: 0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Awake During the Night
Time frame: 0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Longest Time Child is Asleep During the Night
Time frame: 0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child is Asleep 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
Time frame: 0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Sleeps During the Day
Time frame: 0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem
Time frame: 0 Days Pretreatment (Baseline)
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role
Time frame: 7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement
Time frame: 7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time Child Usually Put to Bed
Time frame: 7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime
Time frame: 7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time for Child to Fall Asleep
Time frame: 7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Times Child Awakes During the Night
Time frame: 7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Awake During the Night
Time frame: 7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Longest Time Child is Asleep During the Night
Time frame: 7 Days
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child is Asleep During the Night
Time frame: 7 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amisha Parikh-Das, PhD study director
Johnson & Johnson Consumer Inc. (J&JCI)
Ethlynn Schorr, MD principal investigator
TKL Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EpiCeram Skin Barrier Emulsion and 1% Colloidal Oatmeal Balm in people with Eczema, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment (time frame: Day 0 - Pretreatment (Baseline) to Day 0 - immediately post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2017.