Trial Outcomes & Findings for A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin (NCT NCT02120833)
NCT ID: NCT02120833
Last Updated: 2017-01-13
Results Overview
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.
COMPLETED
PHASE3
51 participants
Baseline to Day 3
2017-01-13
Participant Flow
Participant milestones
| Measure |
1% Colloidal Oatmeal Eczema Cream
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
12
|
|
Overall Study
COMPLETED
|
35
|
11
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
1% Colloidal Oatmeal Eczema Cream
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin
Baseline characteristics by cohort
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.4 months
STANDARD_DEVIATION 9.78 • n=5 Participants
|
22.3 months
STANDARD_DEVIATION 10.29 • n=7 Participants
|
20.1 months
STANDARD_DEVIATION 9.88 • n=5 Participants
|
|
Gender
Female
|
22 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Gender
Male
|
17 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
USA
|
39 participants
n=5 Participants
|
12 participants
n=7 Participants
|
51 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 3Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=30 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=9 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline
|
-1.783 units on a scale
Standard Deviation 1.72
|
-0.767 units on a scale
Standard Deviation 2.08
|
PRIMARY outcome
Timeframe: Baseline to Day 3Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=34 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=11 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline
|
-0.441 units on a scale
Standard Deviation 0.66
|
-0.364 units on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Baseline to Day 1Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=32 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=8 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline
|
-0.672 units on a scale
Standard Deviation 0.92
|
-0.438 units on a scale
Standard Deviation 1.65
|
SECONDARY outcome
Timeframe: Baseline to Day 2Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=31 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=9 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Eczema Area and Severity Index (EASI) on Day 2 - Change From Baseline
|
-1.194 units on a scale
Standard Deviation 1.10
|
-0.489 units on a scale
Standard Deviation 2.49
|
SECONDARY outcome
Timeframe: Baseline to Day 7Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=30 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=9 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline
|
-2.410 units on a scale
Standard Deviation 2.49
|
-1.233 units on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Baseline to Day 14Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=31 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=9 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline
|
-2.403 units on a scale
Standard Deviation 2.30
|
-1.833 units on a scale
Standard Deviation 2.74
|
SECONDARY outcome
Timeframe: Baseline to Day 1Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=37 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=10 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline
|
-0.027 units on a scale
Standard Deviation 0.16
|
-0.100 units on a scale
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Baseline to Day 2Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=36 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=11 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 2 - Change From Baseline
|
-0.417 units on a scale
Standard Deviation 0.55
|
-0.364 units on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Baseline to Day 7Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=35 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=11 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline
|
-0.743 units on a scale
Standard Deviation 0.66
|
-0.364 units on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Baseline to Day 14Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=36 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=11 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline
|
-0.861 units on a scale
Standard Deviation 0.90
|
-0.455 units on a scale
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: Baseline to Post -Treatment on Day 0Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Corneometer Measurement on Day 0 - Post-Treatment - Change From Baseline
|
17.277 arbitrary units
Standard Deviation 14.58
|
11.544 arbitrary units
Standard Deviation 12.43
|
SECONDARY outcome
Timeframe: Baseline to Day 1Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=37 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=10 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Corneometer Measurement on Day 1 - Change From Baseline
|
15.182 arbitrary units
Standard Deviation 11.57
|
6.483 arbitrary units
Standard Deviation 13.37
|
SECONDARY outcome
Timeframe: Baseline to Day 2Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=36 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=11 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Corneometer Measurement on Day 2 - Change From Baseline
|
17.019 arbitrary units
Standard Deviation 13.50
|
7.864 arbitrary units
Standard Deviation 10.96
|
SECONDARY outcome
Timeframe: Baseline to Day 3Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=34 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=11 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Corneometer Measurement on Day 3 - Change From Baseline
|
16.276 arbitrary units
Standard Deviation 11.61
|
7.661 arbitrary units
Standard Deviation 11.01
|
SECONDARY outcome
Timeframe: Baseline to Day 7Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=35 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=11 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Corneometer Measurement on Day 7 - Change From Baseline
|
15.167 arbitrary units
Standard Deviation 11.33
|
10.318 arbitrary units
Standard Deviation 16.01
|
SECONDARY outcome
Timeframe: Baseline to Day 14Population: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=36 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=11 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Corneometer Measurement on Day 14 - Change From Baseline
|
15.253 arbitrary units
Standard Deviation 9.79
|
7.818 arbitrary units
Standard Deviation 12.58
|
SECONDARY outcome
Timeframe: 0 Days - Pre-TreatmentPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth
Somewhat agree
|
13 participants
|
5 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth
Strongly agree
|
2 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth
Missing
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth
Strongly disagree
|
9 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth
Somewhat disagree
|
12 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth
Neither agree nor disagree
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 0 Days - Pre-TreatmentPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy
Strongly agree
|
5 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy
Missing
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy
Strongly disagree
|
0 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy
Somewhat disagree
|
17 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy
Neither agree nor disagree
|
5 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy
Somewhat agree
|
12 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 0 Days - Pre-TreatmentPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft
Missing
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft
Strongly disagree
|
5 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft
Somewhat disagree
|
13 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft
Neither agree nor disagree
|
4 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft
Somewhat agree
|
14 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft
Strongly agree
|
3 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 0 Days - Pre-TreatmentPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth
Strongly disagree
|
6 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth
Somewhat disagree
|
13 participants
|
5 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth
Neither agree nor disagree
|
4 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth
Somewhat agree
|
13 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth
Strongly agree
|
2 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth
Missing
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0 Days - Pre-TreatmentPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Strongly disagree
|
22 participants
|
8 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Somewhat disagree
|
12 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Neither agree nor disagree
|
1 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Somewhat agree
|
4 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Strongly agree
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Missing
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0 Days - Pre-TreatmentPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Strongly disagree
|
17 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Somewhat disagree
|
15 participants
|
8 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Neither agree nor disagree
|
3 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Somewhat agree
|
4 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Strongly agree
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Missing
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0 Days - Pre-TreatmentPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Strongly agree
|
1 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Missing
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Strongly disagree
|
21 participants
|
8 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Somewhat disagree
|
10 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Neither agree nor disagree
|
3 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Somewhat agree
|
4 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0 Days - Pre-TreatmentPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Strongly disagree
|
21 participants
|
8 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Somewhat disagree
|
13 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Neither agree nor disagree
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Somewhat agree
|
5 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Strongly agree
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Missing
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0 Days - Post-TreatmentPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth
Strongly disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth
Somewhat disagree
|
11 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth
Neither agree nor disagree
|
4 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth
Somewhat agree
|
14 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth
Strongly agree
|
8 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth
Missing
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0 Days - Post-TreatmentPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy
Strongly disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy
Somewhat disagree
|
11 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy
Neither agree nor disagree
|
4 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy
Somewhat agree
|
19 participants
|
5 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy
Strongly agree
|
4 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy
Missing
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0 Days - Post-TreatmentPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft
Strongly disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft
Somewhat disagree
|
10 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft
Neither agree nor disagree
|
3 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft
Somewhat agree
|
15 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft
Strongly agree
|
9 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft
Missing
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0 Days - Post-TreatmentPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth
Strongly disagree
|
3 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth
Somewhat disagree
|
7 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth
Neither agree nor disagree
|
4 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth
Somewhat agree
|
18 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth
Strongly agree
|
7 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth
Missing
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0 Days - Post-TreatmentPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly
Strongly disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly
Somewhat disagree
|
5 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly
Neither agree nor disagree
|
7 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly
Somewhat agree
|
17 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly
Strongly agree
|
8 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly
Missing
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0 Days - Post-TreatmentPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Strongly disagree
|
9 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Somewhat disagree
|
9 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Neither agree nor disagree
|
4 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Somewhat agree
|
15 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Strongly agree
|
2 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Missing
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0 Days - Post-TreatmentPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Strongly disagree
|
8 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Somewhat disagree
|
9 participants
|
8 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Neither agree nor disagree
|
8 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Somewhat agree
|
11 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Strongly agree
|
3 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Missing
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0 Days - Post-TreatmentPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Strongly disagree
|
8 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Somewhat disagree
|
7 participants
|
6 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Neither agree nor disagree
|
4 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Somewhat agree
|
13 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Strongly agree
|
7 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Missing
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0 Days - Post-TreatmentPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Strongly disagree
|
7 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Somewhat disagree
|
9 participants
|
6 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Neither agree nor disagree
|
3 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Somewhat agree
|
12 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Strongly agree
|
8 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Missing
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0 Days - Post-TreatmentPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly
Strongly disagree
|
6 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly
Somewhat disagree
|
7 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly
Neither agree nor disagree
|
6 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly
Somewhat agree
|
10 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly
Strongly agree
|
10 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly
Missing
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 1 DayPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth
Strongly disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth
Somewhat disagree
|
9 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth
Neither agree nor disagree
|
3 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth
Somewhat agree
|
15 participants
|
6 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth
Strongly agree
|
9 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth
Missing
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 1 DayPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy
Missing
|
2 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy
Strongly disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy
Somewhat disagree
|
8 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy
Neither agree nor disagree
|
5 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy
Somewhat agree
|
16 participants
|
7 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy
Strongly agree
|
7 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 1 DayPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft
Strongly disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft
Somewhat disagree
|
10 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft
Neither agree nor disagree
|
3 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft
Somewhat agree
|
17 participants
|
5 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft
Strongly agree
|
6 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft
Missing
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 1 DayPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth
Strongly disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth
Somewhat disagree
|
9 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth
Neither agree nor disagree
|
5 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth
Somewhat agree
|
17 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth
Strongly agree
|
5 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth
Missing
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 1 DayPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Strongly disagree
|
4 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Somewhat disagree
|
13 participants
|
5 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Neither agree nor disagree
|
3 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Somewhat agree
|
14 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Strongly agree
|
3 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Missing
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 1 DayPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Strongly disagree
|
5 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Somewhat disagree
|
11 participants
|
6 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Neither agree nor disagree
|
7 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Somewhat agree
|
11 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Strongly agree
|
3 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Missing
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 1 DayPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Strongly disagree
|
4 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Somewhat disagree
|
11 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Neither agree nor disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Somewhat agree
|
16 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Strongly agree
|
5 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Missing
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 1 DayPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Strongly disagree
|
5 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Somewhat disagree
|
10 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Neither agree nor disagree
|
4 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Somewhat agree
|
13 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Strongly agree
|
5 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Missing
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 2 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth
Strongly disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth
Somewhat disagree
|
5 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth
Neither agree nor disagree
|
2 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth
Somewhat agree
|
16 participants
|
6 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth
Strongly agree
|
12 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth
Missing
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 2 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy
Strongly disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy
Somewhat disagree
|
3 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy
Neither agree nor disagree
|
5 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy
Somewhat agree
|
18 participants
|
5 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy
Strongly agree
|
9 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy
Missing
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 2 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft
Strongly disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft
Somewhat disagree
|
4 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft
Neither agree nor disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft
Somewhat agree
|
23 participants
|
6 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft
Strongly agree
|
7 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft
Missing
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 2 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth
Strongly disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth
Somewhat disagree
|
6 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth
Neither agree nor disagree
|
1 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth
Somewhat agree
|
21 participants
|
6 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth
Strongly agree
|
7 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth
Missing
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 2 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Somewhat agree
|
17 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Strongly disagree
|
3 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Somewhat disagree
|
9 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Neither agree nor disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Strongly agree
|
6 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Missing
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 2 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Somewhat agree
|
16 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Strongly disagree
|
3 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Somewhat disagree
|
8 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Neither agree nor disagree
|
5 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Strongly agree
|
4 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Missing
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 2 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Strongly disagree
|
2 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Somewhat disagree
|
10 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Neither agree nor disagree
|
4 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Somewhat agree
|
13 participants
|
5 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Strongly agree
|
7 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Missing
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 2 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Strongly disagree
|
3 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Somewhat disagree
|
13 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Neither agree nor disagree
|
0 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Somewhat agree
|
13 participants
|
5 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Strongly agree
|
7 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Missing
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 3 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth
Strongly disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth
Somewhat disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth
Neither agree nor disagree
|
3 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth
Somewhat agree
|
19 participants
|
5 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth
Strongly agree
|
9 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth
Missing
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 3 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy
Strongly disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy
Somewhat disagree
|
3 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy
Neither agree nor disagree
|
5 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy
Somewhat agree
|
18 participants
|
5 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy
Strongly agree
|
7 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy
Missing
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 3 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft
Strongly disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft
Somewhat disagree
|
6 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft
Neither agree nor disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft
Somewhat agree
|
18 participants
|
6 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft
Strongly agree
|
8 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft
Missing
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 3 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth
Strongly disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth
Somewhat disagree
|
5 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth
Neither agree nor disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth
Somewhat agree
|
19 participants
|
5 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth
Strongly agree
|
8 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth
Missing
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 3 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Missing
|
5 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Strongly disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Somewhat disagree
|
8 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Neither agree nor disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Somewhat agree
|
15 participants
|
5 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Strongly agree
|
7 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 3 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Strongly disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Somewhat disagree
|
7 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Neither agree nor disagree
|
4 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Somewhat agree
|
16 participants
|
5 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Strongly agree
|
5 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Missing
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 3 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Strongly disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Somewhat disagree
|
8 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Strongly agree
|
10 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Neither agree nor disagree
|
4 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Somewhat agree
|
10 participants
|
5 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Missing
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 3 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Strongly agree
|
9 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Strongly disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Somewhat disagree
|
9 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Neither agree nor disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Somewhat agree
|
12 participants
|
5 participants
|
|
Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Missing
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth
Somewhat agree
|
13 participants
|
5 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth
Strongly disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth
Somewhat disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth
Neither agree nor disagree
|
2 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth
Strongly agree
|
17 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth
Missing
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy
Strongly disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy
Somewhat disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy
Neither agree nor disagree
|
3 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy
Somewhat agree
|
15 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy
Strongly agree
|
14 participants
|
5 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy
Missing
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft
Strongly disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft
Somewhat disagree
|
0 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft
Neither agree nor disagree
|
3 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft
Somewhat agree
|
16 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft
Strongly agree
|
14 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft
Missing
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth
Strongly disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth
Somewhat disagree
|
2 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth
Neither agree nor disagree
|
1 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth
Somewhat agree
|
19 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth
Strongly agree
|
11 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth
Missing
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Strongly disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Somewhat disagree
|
5 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Neither agree nor disagree
|
2 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Somewhat agree
|
12 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Strongly agree
|
14 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Missing
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Strongly disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Somewhat disagree
|
4 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Neither agree nor disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Somewhat agree
|
16 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Strongly agree
|
11 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Missing
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Missing
|
4 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Strongly disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Somewhat disagree
|
4 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Neither agree nor disagree
|
6 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Somewhat agree
|
7 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Strongly agree
|
16 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Strongly agree
|
12 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Strongly disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Somewhat disagree
|
5 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Neither agree nor disagree
|
5 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Somewhat agree
|
11 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Missing
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 14 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth
Somewhat agree
|
11 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth
Strongly agree
|
19 participants
|
7 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth
Missing
|
3 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth
Strongly disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth
Somewhat disagree
|
3 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth
Neither agree nor disagree
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 14 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy
Strongly disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy
Somewhat disagree
|
3 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy
Neither agree nor disagree
|
1 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy
Somewhat agree
|
14 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy
Strongly agree
|
17 participants
|
6 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy
Missing
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 14 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft
Somewhat disagree
|
1 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft
Neither agree nor disagree
|
4 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft
Somewhat agree
|
15 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft
Strongly agree
|
15 participants
|
7 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft
Missing
|
3 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft
Strongly disagree
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 14 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth
Strongly disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth
Somewhat disagree
|
2 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth
Neither agree nor disagree
|
3 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth
Missing
|
3 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth
Somewhat agree
|
13 participants
|
3 participants
|
|
Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth
Strongly agree
|
17 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 14 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Missing
|
3 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Strongly disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Somewhat disagree
|
1 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Neither agree nor disagree
|
3 participants
|
2 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Somewhat agree
|
13 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Strongly agree
|
17 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 14 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Strongly disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Somewhat disagree
|
0 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Neither agree nor disagree
|
3 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Somewhat agree
|
14 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Strongly agree
|
17 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Missing
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 14 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Strongly disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Neither agree nor disagree
|
2 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Somewhat disagree
|
1 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Somewhat agree
|
14 participants
|
6 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Strongly agree
|
17 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Missing
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 14 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
I don't have an opinion
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Strongly disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Somewhat disagree
|
1 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Neither agree nor disagree
|
2 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Somewhat agree
|
11 participants
|
6 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Strongly agree
|
20 participants
|
4 participants
|
|
Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Missing
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 14 DaysPopulation: Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
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.'
Outcome measures
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 Participants
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 Participants
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent.
Somewhat agree
|
9 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent.
I don't have an opinion
|
1 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent.
Strongly disagree
|
1 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent.
Somewhat disagree
|
0 participants
|
0 participants
|
|
Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent.
Neither agree nor disagree
|
2 participants
|
1 participants
|
|
Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent.
Strongly agree
|
23 participants
|
8 participants
|
|
Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent.
Missing
|
3 participants
|
1 participants
|
Adverse Events
1% Colloidal Oatmeal Eczema Cream
EpiCeram® Skin Barrier Emulsion
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1% Colloidal Oatmeal Eczema Cream
n=39 participants at risk
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
|
EpiCeram® Skin Barrier Emulsion
n=12 participants at risk
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/39 • Day 14 ± 1 day, +30 days for serious adverse events.
Adverse events were systematically collected at each study visit through Visit 6 (Day 14 ± 1 day). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
|
8.3%
1/12 • Day 14 ± 1 day, +30 days for serious adverse events.
Adverse events were systematically collected at each study visit through Visit 6 (Day 14 ± 1 day). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
|
Additional Information
Chirstopher Nunez, PhD/Study Director
Johnson & Johnson Consumer and Personal Products Worldwide
Results disclosure agreements
- Principal investigator is a sponsor employee Principal investigator agreed not to publish the study results without prior sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER