EczemaPhase 3NCT02120833

A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin

A Phase 3 study testing EpiCeram® Skin Barrier Emulsion and Colloidal Oatmeal Cream in people with Eczema, run by Johnson & Johnson Consumer and Personal Products Worldwide at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is for infants with mild to moderate dry and itchy skin. This study will involve going to the doctor for 6 visits over 2 weeks. All participants' skin will be examined by a dermatologist to determine if they have atopic dermatitis and have an active mild to moderate eczema wound. Read more about this study

Who is it for?: Ages 2 to 35 months
Conditions the study is for: Eczema
What is being tested?: EpiCeram® Skin Barrier Emulsion and Colloidal Oatmeal Cream
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 2 sitesUnited States
Study dates: Mar 2014to Nov 2014
Phase: Phase 3
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 2 to 35 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) based upon research site personnel's assessment;
Caregiver is able and willing to provide written informed consent for the participant to participate in the trial;
Male or female of any race or ethnicity, 2 months to 35 months of age;
Diagnosed as having Atopic Dermatitis (AD) on the basis of the criteria defined by Hanifin and Rajka
Rated as having mild to moderate AD (graded between 3.0 and 7.5 inclusive) as per Rajka-Langeland severity index
Willing to stop all emollients, moisturizers and/or other skin barrier cream or emulsion treatments for the AD condition during the test period. If using corticosteroids (not Class I, II, or III) or immunomodulators at study entry, must be on a stable dose for a minimum of 1 month;
Willing to undergo a washout period of 2 days before the trial initiation where no use of moisturizers or emollients will be allowed; and
Willing and able to comply with scheduled visits, treatment plan, and other trial procedures.

Who cannot join

Known sensitivity to any investigational product ingredient;
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;
Relative, partner or staff of any clinical research site personnel;
Active infection of any type at the start of the study;
Severe AD as determined by the Rajka-Langeland Severity Index

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AD requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids. If a participant requires any of these medications as rescue therapy during the study, the participant will be discontinued from the trial;
Requires any inhaled or intranasal corticosteroids;
Other medical condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Thomas J. Stephens and Associates, Colorado Research Center
Colorado Springs, Colorado, 80915
Thomas J. Stephens and Associates, Dallas Research Center
Richardson, Texas, 75081

Other trials in United States

About this study

Official title: A Multi-Center Clinical Trial to Evaluate the Efficacy of an Over-the-Counter Cream in the Management of Mild to Moderate Atopic Dermatitis in Infants and Toddlers

Then all participants' caregivers will complete a questionnaire at the beginning of the study. The child's skin will be examined to rate the level of their eczema and a trained examiner will grade the looks and symptoms of their eczema. All parents or guardians will be instructed how to apply the test product and how to record usage on a diary card and then apply the test product. The test product will be applied at least 2 times per day or more as needed on all body areas, including the face affected throughout the study.

One digital picture will be taken of one eczema wound. Another digital picture will be taken of the area around this wound. These pictures will be taken on Day 0 (Baseline), Day 3, and Day 14.

Once product is applied the skin will be examined for any adverse events and all participants' caregivers will complete a questionnaire on study day 1, 3, 7 and 14.

Read the detailed description

This is a multi-center, two-arm clinical trial in participants aged 2 - 35 months with mild to moderate Atopic Dermatitis (AD) as determined by the study physician. A sufficient number of participants will be enrolled in this study to yield 40 participants who complete the trial, 30 in the investigational product group and 10 in the active control group.

The investigational and control (EpiCeram®) products will be used topically. Participant caregivers will be instructed to gently massage the assigned product into the participant's skin. The treatments will be applied at least 2 times per day on all body areas, including areas of the body and face affected by AD. No product should be applied within 4 hours of a site visit. These treatments will be used in place of the participant's current moisturizers and/or emollients.

Diaries will be completed by the participants' caregivers each day, beginning upon initiation of therapy and continuing until trial completion/discontinuation, and will include information on product application and use of rescue medication.

All participants will visit the clinical site for assessments at baseline (Day 0) and on Days 1, 2, 3, 7 and 14. Clinical assessments include the Eczema Area and Severity index (EASI) and Investigator's Global Atopic Dermatitis Assessment (IGADA). Instrumental assessment of hydration will be done using a Corneometer (Courage \& Khazaka, Germany). Caregivers will also complete a questionnaire to assess product experience. The final visit will occur on Day 14 or on the day of participant withdrawal from the trial.

Conditions: Eczema
Being tested: EpiCeram® Skin Barrier Emulsion, Colloidal Oatmeal Cream
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
Device (including sham) Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin as directed.
Colloidal Oatmeal CreamDrug
Drug (including placebo) Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin as directed.

Study groups in NCT02120833
Study group	Role	What they receive
EPI	Active comparator	Not described Receives: Device: EpiCeram® Skin Barrier Emulsion
NEE	Experimental	Not described Receives: Drug: Colloidal Oatmeal Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

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 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.
Measured: Baseline to Day 3
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 (none) and 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: Baseline to Day 3

Secondary outcomes (73)

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 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.
Measured: Baseline to Day 1
Eczema Area and Severity Index (EASI) on Day 2 - 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 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.
Measured: Baseline to Day 2
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 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.
Measured: 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 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.
Measured: 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 (none) and 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: Baseline to Day 1
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 2 - 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 (none) and 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: Baseline to Day 2
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 (none) and 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: 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 (none) and 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: Baseline to Day 14
Corneometer Measurement on Day 0 - Post-Treatment - Change From Baseline
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. Post-treatment on Day 0, corneometer readings ranged from 10.3 to 86.3.
Measured: Baseline to Post -Treatment on Day 0
Corneometer Measurement on Day 1 - Change From Baseline
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 1, corneometer readings ranged from 5.5 to 84.0.
Measured: Baseline to Day 1
Corneometer Measurement on Day 2 - Change From Baseline
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 2, corneometer readings ranged from 8.5 to 74.0.
Measured: Baseline to Day 2
Corneometer Measurement on Day 3 - Change From Baseline
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 3, corneometer readings ranged from 8.0 to 65.3.
Measured: Baseline to Day 3
Corneometer Measurement on Day 7 - Change From Baseline
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 7, corneometer readings ranged from 6.8 to 65.0.
Measured: Baseline to Day 7
Corneometer Measurement on Day 14 - Change From Baseline
Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 14, corneometer readings ranged from 5.7 to 73.1.
Measured: Baseline to Day 14
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth
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). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 0 Days - Pre-Treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy
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). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 0 Days - Pre-Treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft
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). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 0 Days - Pre-Treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth
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). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 0 Days - Pre-Treatment
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
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). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 0 Days - Pre-Treatment
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
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). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 0 Days - Pre-Treatment
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
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). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 0 Days - Pre-Treatment
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
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). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 0 Days - Pre-Treatment
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 0 Days - Post-Treatment
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 0 Days - Post-Treatment
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 0 Days - Post-Treatment
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 0 Days - Post-Treatment
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 0 Days - Post-Treatment
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 0 Days - Post-Treatment
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 0 Days - Post-Treatment
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 0 Days - Post-Treatment
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 0 Days - Post-Treatment
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 0 Days - Post-Treatment
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 1 Day
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 1 Day
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 1 Day
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 1 Day
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 1 Day
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 1 Day
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 1 Day
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 1 Day
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 2 Days
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 2 Days
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 2 Days
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 2 Days
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 2 Days
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 2 Days
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 2 Days
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 2 Days
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 3 Days
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 3 Days
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 3 Days
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 3 Days
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 3 Days
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 3 Days
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 3 Days
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 3 Days
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 7 Days
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 7 Days
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 7 Days
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 7 Days
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 7 Days
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 7 Days
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 7 Days
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 7 Days
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 14 Days
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 14 Days
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 14 Days
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 14 Days
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 14 Days
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 14 Days
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 14 Days
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 14 Days
Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent.
Questions were answered immediately post-treatment by participant's caregiver. Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'
Measured: 14 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Nov 2014

First posted23 Apr 2014 (estimated)
Study startMar 2014
Primary completionNov 2014
Study completionNov 2014

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Care provider, Investigator, Outcomes assessor
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02120833
Sponsor's protocol ID: CO-140206110636-SBCT
Status last verified: Jan 2017
First submitted: 28 Mar 2014
Last updated: 13 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
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

All Eczema trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center Clinical Trial to Evaluate the Efficacy of an Over-the-Counter Cream in the Management of Mild to Moderate Atopic Dermatitis in Infants and Toddlers
ClinicalTrials.gov ID: NCT02120833
Acronym / sponsor ID: CO-140206110636-SBCT
Conditions: Eczema
Keywords: Atopic Dermatitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 23 Apr 2014 (estimated)
Results: Posted 7 Sep 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

One digital picture will be taken of one eczema wound. Another digital picture will be taken of the area around this wound. These pictures will be taken on Day 0 (Baseline), Day 3, and Day 14.

Once product is applied the skin will be examined for any adverse events and all participants' caregivers will complete a questionnaire on study day 1, 3, 7 and 14.

Detailed description

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
EPI	Active comparator	Device: EpiCeram® Skin Barrier Emulsion
NEE	Experimental	Drug: Colloidal Oatmeal Cream

Who may qualify

Ages: 2 to 35 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
Caregiver is able and willing to provide written informed consent for the participant to participate in the trial;
Male or female of any race or ethnicity, 2 months to 35 months of age;
Diagnosed as having Atopic Dermatitis (AD) on the basis of the criteria defined by Hanifin and Rajka
Rated as having mild to moderate AD (graded between 3.0 and 7.5 inclusive) as per Rajka-Langeland severity index

Key exclusion criteria (9 listed)

Known sensitivity to any investigational product ingredient;
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;
Relative, partner or staff of any clinical research site personnel;
Active infection of any type at the start of the study;

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 EmulsionDevice (including sham) Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin as directed.	Device	EPI
Colloidal Oatmeal CreamDrug (including placebo) Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin as directed.	Drug	NEE

Primary outcome

Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline
Time frame: Baseline to Day 3
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 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline
Time frame: Baseline to Day 3
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 (none) and 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.

73 secondary outcomes

Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline
Time frame: Baseline to Day 1
Eczema Area and Severity Index (EASI) on Day 2 - Change From Baseline
Time frame: Baseline to Day 2
Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline
Time frame: Baseline to Day 7
Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline
Time frame: Baseline to Day 14
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline
Time frame: Baseline to Day 1
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 2 - Change From Baseline
Time frame: Baseline to Day 2
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline
Time frame: Baseline to Day 7
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline
Time frame: Baseline to Day 14
Corneometer Measurement on Day 0 - Post-Treatment - Change From Baseline
Time frame: Baseline to Post -Treatment on Day 0
Corneometer Measurement on Day 1 - Change From Baseline
Time frame: Baseline to Day 1
Corneometer Measurement on Day 2 - Change From Baseline
Time frame: Baseline to Day 2
Corneometer Measurement on Day 3 - Change From Baseline
Time frame: Baseline to Day 3
Corneometer Measurement on Day 7 - Change From Baseline
Time frame: Baseline to Day 7
Corneometer Measurement on Day 14 - Change From Baseline
Time frame: Baseline to Day 14
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth
Time frame: 0 Days - Pre-Treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy
Time frame: 0 Days - Pre-Treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft
Time frame: 0 Days - Pre-Treatment
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth
Time frame: 0 Days - Pre-Treatment
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Time frame: 0 Days - Pre-Treatment
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Time frame: 0 Days - Pre-Treatment
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Time frame: 0 Days - Pre-Treatment
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Time frame: 0 Days - Pre-Treatment
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth
Time frame: 0 Days - Post-Treatment
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy
Time frame: 0 Days - Post-Treatment
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft
Time frame: 0 Days - Post-Treatment
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth
Time frame: 0 Days - Post-Treatment
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly
Time frame: 0 Days - Post-Treatment
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Time frame: 0 Days - Post-Treatment
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Time frame: 0 Days - Post-Treatment
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Time frame: 0 Days - Post-Treatment
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Time frame: 0 Days - Post-Treatment
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly
Time frame: 0 Days - Post-Treatment
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth
Time frame: 1 Day
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy
Time frame: 1 Day
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft
Time frame: 1 Day
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth
Time frame: 1 Day
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Time frame: 1 Day
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Time frame: 1 Day
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Time frame: 1 Day
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Time frame: 1 Day

Results and safety

Results posted to the registry on 7 Sep 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1% Colloidal Oatmeal Eczema Cream	39	35
EpiCeram® Skin Barrier Emulsion	12	11

Primary outcome: Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline

Time frame: Baseline to Day 3. Mean (Standard Deviation). Unit: units on a scale

Measure	1% Colloidal Oatmeal Eczema Cream n = 30	EpiCeram® Skin Barrier Emulsion n = 9
Value	-1.783 (1.72)	-0.767 (2.08)

1% Colloidal Oatmeal Eczema Cream: p <0.0001, One-sample t-test
EpiCeram® Skin Barrier Emulsion: p = 0.4360, One-sample t-test
1% Colloidal Oatmeal Eczema Cream vs EpiCeram® Skin Barrier Emulsion: Mean Difference (Final Values): -1.25 (95% CI -2.51 to 0.01), p = 0.0510, ANCOVA

Population analysed: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.

Primary outcome: Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline

Time frame: Baseline to Day 3. Mean (Standard Deviation). Unit: units on a scale

Measure	1% Colloidal Oatmeal Eczema Cream n = 34	EpiCeram® Skin Barrier Emulsion n = 11
Value	-0.441 (0.66)	-0.364 (0.50)

1% Colloidal Oatmeal Eczema Cream: p = 0.0004, One-sample t-test
EpiCeram® Skin Barrier Emulsion: p = 0.0213, One-sample t-test
1% Colloidal Oatmeal Eczema Cream vs EpiCeram® Skin Barrier Emulsion: Mean Difference (Final Values): -0.06 (95% CI -0.50 to 0.37), p = 0.7698, ANCOVA

Population analysed: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.

73 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 14 ± 1 day, +30 days for serious adverse events.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1% Colloidal Oatmeal Eczema Cream	0 of 39 (0%)	0 of 39 (0%)	Not reported
EpiCeram® Skin Barrier Emulsion	0 of 12 (0%)	1 of 12 (8.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Eczema

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
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
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Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
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RecruitingPhase 3
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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.

Christopher Nunez study director

Johnson & Johnson Consumer and Personal Products Worldwide

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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: finished, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Sep 2015). 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?

Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline (time frame: Baseline to Day 3). 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?

On the ClinicalTrials.gov record for NCT02120833.

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 13 Jan 2017.