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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02120833
Recruitment Status : Completed
First Posted : April 23, 2014
Results First Posted : September 7, 2015
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Eczema
Interventions Device: EpiCeram® Skin Barrier Emulsion
Drug: Colloidal Oatmeal Cream
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description 1% Colloidal Oatmeal Eczema Cream, thin layer twice a day EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Period Title: Overall Study
Started 39 12
Completed 35 11
Not Completed 4 1
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             2             0
Lost to Follow-up             1             1
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion Total
Hide Arm/Group Description 1% Colloidal Oatmeal Eczema Cream, thin layer twice a day EpiCeram® Skin Barrier Emulsion, thin layer twice a day Total of all reporting groups
Overall Number of Baseline Participants 39 12 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 39 participants 12 participants 51 participants
19.4  (9.78) 22.3  (10.29) 20.1  (9.88)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 12 participants 51 participants
Female
22
  56.4%
3
  25.0%
25
  49.0%
Male
17
  43.6%
9
  75.0%
26
  51.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
USA Number Analyzed 39 participants 12 participants 51 participants
39 12 51
1.Primary Outcome
Title Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline
Hide Description 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.
Time Frame Baseline to Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 30 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.783  (1.72) -0.767  (2.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4360
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream, EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0510
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Treatment and study site as factors, baseline score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.25
Confidence Interval (2-Sided) 95%
-2.51 to 0.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.62
Estimation Comments [Not Specified]
2.Primary Outcome
Title Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline
Hide Description 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.
Time Frame Baseline to Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 34 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.441  (0.66) -0.364  (0.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0213
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream, EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7698
Comments [Not Specified]
Method ANCOVA
Comments The significance threshold level was 0.05 (two-sided).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.50 to 0.37
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.22
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline
Hide Description 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.
Time Frame Baseline to Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 32 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.672  (0.92) -0.438  (1.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6063
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream, EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3686
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Treatment and study site as factors, baseline score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-1.27 to 0.48
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.43
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Eczema Area and Severity Index (EASI) on Day 2 - Change From Baseline
Hide Description 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.
Time Frame Baseline to Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 31 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.194  (1.10) -0.489  (2.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6118
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream, EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1485
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Treatment and study site as factors, baseline score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.83
Confidence Interval (2-Sided) 95%
-1.98 to 0.31
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.56
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline
Hide Description 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.
Time Frame Baseline to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 30 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.410  (2.49) -1.233  (1.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2447
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream, EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0216
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Treatment and study site as factors, baseline score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.60
Confidence Interval (2-Sided) 95%
-2.95 to -0.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.67
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline
Hide Description 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.
Time Frame Baseline to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 31 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.403  (2.30) -1.833  (2.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0476
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream, EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2349
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Treatment and study site as factors, baseline score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.94
Confidence Interval (2-Sided) 95%
-2.52 to 0.64
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.78
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline
Hide Description 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.
Time Frame Baseline to Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 37 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.027  (0.16) -0.100  (0.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7842
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6083
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream, EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3599
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Treatment and study site as factors, baseline score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.08 to 0.22
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 2 - Change From Baseline
Hide Description 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.
Time Frame Baseline to Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 36 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.417  (0.55) -0.364  (0.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0317
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream, EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8037
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Treatment and study site as factors, baseline score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.42 to 0.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.19
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline
Hide Description 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.
Time Frame Baseline to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 35 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.743  (0.66) -0.364  (0.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0244
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream, EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0900
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Treatment and study site as factors, baseline score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-0.80 to 0.06
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.21
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline
Hide Description 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.
Time Frame Baseline to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 36 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.861  (0.90) -0.455  (0.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0065
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream, EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1561
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Treatment and study site as factors, baseline score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-0.97 to 0.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.28
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Corneometer Measurement on Day 0 – Post-Treatment - Change From Baseline
Hide Description 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.
Time Frame Baseline to Post -Treatment on Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Mean (Standard Deviation)
Unit of Measure: arbitrary units
17.277  (14.58) 11.544  (12.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0049
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream, EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2409
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Treatment and study site as factors, baseline score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.59
Confidence Interval (2-Sided) 95%
-3.88 to 15.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.71
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Corneometer Measurement on Day 1 - Change From Baseline
Hide Description 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.
Time Frame Baseline to Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 37 10
Mean (Standard Deviation)
Unit of Measure: arbitrary units
15.182  (11.57) 6.483  (13.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2386
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream, EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0241
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Treatment and study site as factors, baseline score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.30
Confidence Interval (2-Sided) 95%
1.28 to 17.32
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.98
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Corneometer Measurement on Day 2 - Change From Baseline
Hide Description 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.
Time Frame Baseline to Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 36 11
Mean (Standard Deviation)
Unit of Measure: arbitrary units
17.019  (13.50) 7.864  (10.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0696
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream, EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0394
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Treatment and study site as factors, baseline score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.99
Confidence Interval (2-Sided) 95%
0.46 to 17.52
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.23
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Corneometer Measurement on Day 3 - Change From Baseline
Hide Description 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.
Time Frame Baseline to Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 34 11
Mean (Standard Deviation)
Unit of Measure: arbitrary units
16.276  (11.61) 7.661  (11.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0772
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream, EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0213
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Treatment and study site as factors, baseline score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.48
Confidence Interval (2-Sided) 95%
1.33 to 15.63
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.54
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Corneometer Measurement on Day 7 - Change From Baseline
Hide Description 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.
Time Frame Baseline to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 35 11
Mean (Standard Deviation)
Unit of Measure: arbitrary units
15.167  (11.33) 10.318  (16.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0172
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream, EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1968
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Treatment and study site as factors, baseline score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.56
Confidence Interval (2-Sided) 95%
-2.46 to 11.58
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.48
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Corneometer Measurement on Day 14 - Change From Baseline
Hide Description 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.
Time Frame Baseline to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 36 11
Mean (Standard Deviation)
Unit of Measure: arbitrary units
15.253  (9.79) 7.818  (12.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0712
Comments The significance level threshold level was 0.05 (two-sided).
Method One-sample t-test
Comments Adjusted by study site.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Eczema Cream, EpiCeram® Skin Barrier Emulsion
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0313
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Treatment and study site as factors, baseline score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.43
Confidence Interval (2-Sided) 95%
0.70 to 14.15
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.34
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Caregiver Questionnaire on Day 0 Pre-treatment – Overall, my Baby’s Skin Looks Smooth
Hide Description 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.’
Time Frame 0 Days - Pre-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 9 2
Somewhat disagree 12 2
Neither agree nor disagree 3 1
Somewhat agree 13 5
Strongly agree 2 2
Missing 0 0
18.Secondary Outcome
Title Caregiver Questionnaire on Day 0 Pre-treatment – Overall, my Baby’s Skin Looks Healthy
Hide Description 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.’
Time Frame 0 Days - Pre-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 0 1
Somewhat disagree 17 4
Neither agree nor disagree 5 1
Somewhat agree 12 4
Strongly agree 5 2
Missing 0 0
19.Secondary Outcome
Title Caregiver Questionnaire on Day 0 Pre-treatment – Overall, my Baby’s Skin Feels Soft
Hide Description 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.’
Time Frame 0 Days - Pre-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 5 2
Somewhat disagree 13 3
Neither agree nor disagree 4 1
Somewhat agree 14 4
Strongly agree 3 2
Missing 0 0
20.Secondary Outcome
Title Caregiver Questionnaire on Day 0 Pre-treatment – Overall, my Baby’s Skin Feels Smooth
Hide Description 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.’
Time Frame 0 Days - Pre-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 6 2
Somewhat disagree 13 5
Neither agree nor disagree 4 1
Somewhat agree 13 2
Strongly agree 2 2
Missing 1 0
21.Secondary Outcome
Title Caregiver Questionnaire on Day 0 Pre-treatment – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Hide Description 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.’
Time Frame 0 Days - Pre-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 22 8
Somewhat disagree 12 4
Neither agree nor disagree 1 0
Somewhat agree 4 0
Strongly agree 0 0
Missing 0 0
22.Secondary Outcome
Title Caregiver Questionnaire on Day 0 Pre-treatment – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Hide Description 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.’
Time Frame 0 Days - Pre-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 17 4
Somewhat disagree 15 8
Neither agree nor disagree 3 0
Somewhat agree 4 0
Strongly agree 0 0
Missing 0 0
23.Secondary Outcome
Title Caregiver Questionnaire on Day 0 Pre-treatment – In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Hide Description 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.’
Time Frame 0 Days - Pre-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 21 8
Somewhat disagree 10 4
Neither agree nor disagree 3 0
Somewhat agree 4 0
Strongly agree 1 0
Missing 0 0
24.Secondary Outcome
Title Caregiver Questionnaire on Day 0 Pre-treatment – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Hide Description 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.’
Time Frame 0 Days - Pre-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 21 8
Somewhat disagree 13 4
Neither agree nor disagree 0 0
Somewhat agree 5 0
Strongly agree 0 0
Missing 0 0
25.Secondary Outcome
Title Caregiver Questionnaire on Day 0 Post-treatment – Overall, my Baby’s Skin Looks Smooth
Hide Description 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.’
Time Frame 0 Days - Post-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 2 1
Somewhat disagree 11 2
Neither agree nor disagree 4 3
Somewhat agree 14 4
Strongly agree 8 2
Missing 0 0
26.Secondary Outcome
Title Caregiver Questionnaire on Day 0 Post-treatment – Overall, my Baby’s Skin Looks Healthy
Hide Description 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.’
Time Frame 0 Days - Post-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 1 1
Somewhat disagree 11 3
Neither agree nor disagree 4 1
Somewhat agree 19 5
Strongly agree 4 2
Missing 0 0
27.Secondary Outcome
Title Caregiver Questionnaire on Day 0 Post-treatment – Overall, my Baby’s Skin Feels Soft
Hide Description 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.’
Time Frame 0 Days - Post-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 2 1
Somewhat disagree 10 2
Neither agree nor disagree 3 3
Somewhat agree 15 4
Strongly agree 9 2
Missing 0 0
28.Secondary Outcome
Title Caregiver Questionnaire on Day 0 Post-treatment – Overall, my Baby’s Skin Feels Smooth
Hide Description 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.’
Time Frame 0 Days - Post-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 3 1
Somewhat disagree 7 3
Neither agree nor disagree 4 3
Somewhat agree 18 3
Strongly agree 7 2
Missing 0 0
29.Secondary Outcome
Title Caregiver Questionnaire on Day 0 Post-treatment – Overall, my Baby’s Skin Feels Soft and Smooth Instantly
Hide Description 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.’
Time Frame 0 Days - Post-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 2 1
Somewhat disagree 5 2
Neither agree nor disagree 7 4
Somewhat agree 17 3
Strongly agree 8 2
Missing 0 0
30.Secondary Outcome
Title Caregiver Questionnaire on Day 0 Post-treatment – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Hide Description 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.’
Time Frame 0 Days - Post-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 9 3
Somewhat disagree 9 3
Neither agree nor disagree 4 4
Somewhat agree 15 2
Strongly agree 2 0
Missing 0 0
31.Secondary Outcome
Title Caregiver Questionnaire on Day 0 Post-treatment – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Hide Description 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.’
Time Frame 0 Days - Post-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 8 1
Somewhat disagree 9 8
Neither agree nor disagree 8 2
Somewhat agree 11 1
Strongly agree 3 0
Missing 0 0
32.Secondary Outcome
Title Caregiver Questionnaire on Day 0 Post-treatment – In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Hide Description 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.’
Time Frame 0 Days - Post-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 8 2
Somewhat disagree 7 6
Neither agree nor disagree 4 1
Somewhat agree 13 3
Strongly agree 7 0
Missing 0 0
33.Secondary Outcome
Title Caregiver Questionnaire on Day 0 Post-treatment – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Hide Description 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.’
Time Frame 0 Days - Post-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 7 2
Somewhat disagree 9 6
Neither agree nor disagree 3 1
Somewhat agree 12 3
Strongly agree 8 0
Missing 0 0
34.Secondary Outcome
Title Caregiver Questionnaire on Day 0 Post-treatment – In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly
Hide Description 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.’
Time Frame 0 Days - Post-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 6 1
Somewhat disagree 7 4
Neither agree nor disagree 6 4
Somewhat agree 10 3
Strongly agree 10 0
Missing 0 0
35.Secondary Outcome
Title Caregiver Questionnaire on Day 1 – Overall, my Baby’s Skin Looks Smooth
Hide Description 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.’
Time Frame 1 Day
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 1 1
Somewhat disagree 9 1
Neither agree nor disagree 3 1
Somewhat agree 15 6
Strongly agree 9 1
Missing 2 2
36.Secondary Outcome
Title Caregiver Questionnaire on Day 1 – Overall, my Baby’s Skin Looks Healthy
Hide Description 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.’
Time Frame 1 Day
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 1 1
Somewhat disagree 8 1
Neither agree nor disagree 5 0
Somewhat agree 16 7
Strongly agree 7 1
Missing 2 2
37.Secondary Outcome
Title Caregiver Questionnaire on Day 1 – Overall, my Baby’s Skin Feels Soft
Hide Description 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.’
Time Frame 1 Day
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 1 1
Somewhat disagree 10 1
Neither agree nor disagree 3 2
Somewhat agree 17 5
Strongly agree 6 1
Missing 2 2
38.Secondary Outcome
Title Caregiver Questionnaire on Day 1 – Overall, my Baby’s Skin Feels Smooth
Hide Description 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.’
Time Frame 1 Day
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 1 1
Somewhat disagree 9 1
Neither agree nor disagree 5 3
Somewhat agree 17 4
Strongly agree 5 1
Missing 2 2
39.Secondary Outcome
Title Caregiver Questionnaire on Day 1 – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Hide Description 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.’
Time Frame 1 Day
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 4 1
Somewhat disagree 13 5
Neither agree nor disagree 3 2
Somewhat agree 14 2
Strongly agree 3 0
Missing 2 2
40.Secondary Outcome
Title Caregiver Questionnaire on Day 1 – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Hide Description 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.’
Time Frame 1 Day
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 5 1
Somewhat disagree 11 6
Neither agree nor disagree 7 0
Somewhat agree 11 3
Strongly agree 3 0
Missing 2 2
41.Secondary Outcome
Title Caregiver Questionnaire on Day 1 – In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Hide Description 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.’
Time Frame 1 Day
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 4 1
Somewhat disagree 11 4
Neither agree nor disagree 1 1
Somewhat agree 16 4
Strongly agree 5 0
Missing 2 2
42.Secondary Outcome
Title Caregiver Questionnaire on Day 1 – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Hide Description 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.’
Time Frame 1 Day
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 5 1
Somewhat disagree 10 3
Neither agree nor disagree 4 2
Somewhat agree 13 4
Strongly agree 5 0
Missing 2 2
43.Secondary Outcome
Title Caregiver Questionnaire on Day 2 – Overall, my Baby’s Skin Looks Smooth
Hide Description 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.’
Time Frame 2 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 1 1
Somewhat disagree 5 2
Neither agree nor disagree 2 0
Somewhat agree 16 6
Strongly agree 12 2
Missing 3 1
44.Secondary Outcome
Title Caregiver Questionnaire on Day 2 – Overall, my Baby’s Skin Looks Healthy
Hide Description 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.’
Time Frame 2 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 1 1
Somewhat disagree 3 2
Neither agree nor disagree 5 1
Somewhat agree 18 5
Strongly agree 9 2
Missing 3 1
45.Secondary Outcome
Title Caregiver Questionnaire on Day 2 – Overall, my Baby’s Skin Feels Soft
Hide Description 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.’
Time Frame 2 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 1 1
Somewhat disagree 4 1
Neither agree nor disagree 1 1
Somewhat agree 23 6
Strongly agree 7 2
Missing 3 1
46.Secondary Outcome
Title Caregiver Questionnaire on Day 2 – Overall, my Baby’s Skin Feels Smooth
Hide Description 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.’
Time Frame 2 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 1 1
Somewhat disagree 6 2
Neither agree nor disagree 1 0
Somewhat agree 21 6
Strongly agree 7 2
Missing 3 1
47.Secondary Outcome
Title Caregiver Questionnaire on Day 2 – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Hide Description 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.’
Time Frame 2 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 3 2
Somewhat disagree 9 3
Neither agree nor disagree 1 1
Somewhat agree 17 4
Strongly agree 6 1
Missing 3 1
48.Secondary Outcome
Title Caregiver Questionnaire on Day 2 – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Hide Description 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.’
Time Frame 2 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 3 2
Somewhat disagree 8 4
Neither agree nor disagree 5 0
Somewhat agree 16 4
Strongly agree 4 1
Missing 3 1
49.Secondary Outcome
Title Caregiver Questionnaire on Day 2 – In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Hide Description 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.’
Time Frame 2 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 2 2
Somewhat disagree 10 2
Neither agree nor disagree 4 1
Somewhat agree 13 5
Strongly agree 7 1
Missing 3 1
50.Secondary Outcome
Title Caregiver Questionnaire on Day 2 – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Hide Description 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.’
Time Frame 2 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 3 2
Somewhat disagree 13 2
Neither agree nor disagree 0 1
Somewhat agree 13 5
Strongly agree 7 1
Missing 3 1
51.Secondary Outcome
Title Caregiver Questionnaire on Day 3 – Overall, my Baby’s Skin Looks Smooth
Hide Description 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.’
Time Frame 3 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 1 1
Somewhat disagree 2 1
Neither agree nor disagree 3 1
Somewhat agree 19 5
Strongly agree 9 3
Missing 5 1
52.Secondary Outcome
Title Caregiver Questionnaire on Day 3 – Overall, my Baby’s Skin Looks Healthy
Hide Description 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.’
Time Frame 3 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 1 1
Somewhat disagree 3 1
Neither agree nor disagree 5 1
Somewhat agree 18 5
Strongly agree 7 3
Missing 5 1
53.Secondary Outcome
Title Caregiver Questionnaire on Day 3 – Overall, my Baby’s Skin Feels Soft
Hide Description 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.’
Time Frame 3 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 1 1
Somewhat disagree 6 0
Neither agree nor disagree 1 1
Somewhat agree 18 6
Strongly agree 8 3
Missing 5 1
54.Secondary Outcome
Title Caregiver Questionnaire on Day 3 – Overall, my Baby’s Skin Feels Smooth
Hide Description 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.’
Time Frame 3 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 1 1
Somewhat disagree 5 1
Neither agree nor disagree 1 1
Somewhat agree 19 5
Strongly agree 8 3
Missing 5 1
55.Secondary Outcome
Title Caregiver Questionnaire on Day 3 – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Hide Description 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.’
Time Frame 3 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 2 1
Somewhat disagree 8 2
Neither agree nor disagree 2 1
Somewhat agree 15 5
Strongly agree 7 2
Missing 5 1
56.Secondary Outcome
Title Caregiver Questionnaire on Day 3 – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
Hide Description 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.’
Time Frame 3 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 2 1
Somewhat disagree 7 2
Neither agree nor disagree 4 2
Somewhat agree 16 5
Strongly agree 5 1
Missing 5 1
57.Secondary Outcome
Title Caregiver Questionnaire on Day 3 – In the Areas Affected by Eczema, my Baby's Skin Feels Soft
Hide Description 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.’
Time Frame 3 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 2 1
Somewhat disagree 8 3
Neither agree nor disagree 4 1
Somewhat agree 10 5
Strongly agree 10 1
Missing 5 1
58.Secondary Outcome
Title Caregiver Questionnaire on Day 3 – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
Hide Description 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.’
Time Frame 3 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 2 1
Somewhat disagree 9 3
Neither agree nor disagree 2 1
Somewhat agree 12 5
Strongly agree 9 1
Missing 5 1
59.Secondary Outcome
Title Caregiver Questionnaire on Day 7 – Overall, my Baby’s Skin Looks Smooth
Hide Description 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.’
Time Frame 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 2 1
Somewhat disagree 1 1
Neither agree nor disagree 2 0
Somewhat agree 13 5
Strongly agree 17 4
Missing 4 1
60.Secondary Outcome
Title Caregiver Questionnaire on Day 7 – Overall, my Baby’s Skin Looks Healthy
Hide Description 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.’
Time Frame 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 2 1
Somewhat disagree 1 1
Neither agree nor disagree 3 1
Somewhat agree 15 3
Strongly agree 14 5
Missing 4 1
61.Secondary Outcome
Title Caregiver Questionnaire on Day 7 – Overall, my Baby’s Skin Feels Soft
Hide Description 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.’
Time Frame 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 2 1
Somewhat disagree 0 2
Neither agree nor disagree 3 0
Somewhat agree 16 4
Strongly agree 14 4
Missing 4 1
62.Secondary Outcome
Title Caregiver Questionnaire on Day 7 – Overall, my Baby’s Skin Feels Smooth
Hide Description 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.’
Time Frame 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion
Hide Arm/Group Description:
1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
EpiCeram® Skin Barrier Emulsion, thin layer twice a day
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: participants
I don't have an opinion 0 0
Strongly disagree 2 1
Somewhat disagree 2 2
Neither agree nor disagree 1 0
Somewhat agree 19 4
Strongly agree 11 4
Missing 4 1
63.Secondary Outcome
Title Caregiver Questionnaire on Day 7 – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
Hide Description 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.’
Time Frame 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.
Arm/Group Title 1% Colloidal Oatmeal Eczema Cream EpiCeram® Skin Barrier Emulsion