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Trial to Determine the Therapeutic Benefit of an OTC Cream on Dry, Itchy Skin of Adults and Children With Eczema

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: NCT02691507
Recruitment Status : Completed
First Posted : February 25, 2016
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Interventions Device: EpiCeram Skin Barrier Emulsion
Drug: Experimental Product 1% Colloidal Oatmeal Balm
Enrollment 53
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed) EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Period Title: Overall Study
Started 40 13
Completed 40 12
Not Completed 0 1
Reason Not Completed
Missed Visit 3             0             1
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion Total
Hide Arm/Group Description 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed) EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed) Total of all reporting groups
Overall Number of Baseline Participants 40 13 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 13 participants 53 participants
43.0  (17.43) 45.5  (18.51) 43.6  (17.55)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 13 participants 53 participants
Female
25
  62.5%
9
  69.2%
34
  64.2%
Male
15
  37.5%
4
  30.8%
19
  35.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 13 participants 53 participants
40 13 53
1.Primary Outcome
Title Change From Baseline in the Itch Assessment Score Immediately Following Treatment
Hide Description The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Time Frame Baseline to immediately following treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.93  (2.753) 2.64  (2.482)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm
Comments The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
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 between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm, 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 0.616
Comments The significance level threshold level was 0.05.
Method ANCOVA
Comments Change from baseline as response, baseline score as covariate and treatment as factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
-1.196 to 1.998
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.795
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in the Itch Assessment Score 1 Hour After Treatment
Hide Description The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Time Frame Baseline to one hour after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.00  (2.624) 3.08  (2.559)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm
Comments The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
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 between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm, 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 0.297
Comments The significance level threshold level was 0.05.
Method ANCOVA
Comments Change from baseline as response, baseline score as covariate and treatment as factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
-0.767 to 2.460
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.803
Estimation Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline in the Itch Assessment Score 2 Hours After Treatment
Hide Description The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Time Frame Baseline to two hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.46  (2.849) 3.65  (2.236)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm
Comments The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
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 between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm, 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 0.394
Comments The significance level threshold level was 0.05.
Method ANCOVA
Comments Change from baseline as response, baseline score as covariate and treatment as factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
-0.973 to 2.426
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.846
Estimation Comments [Not Specified]
4.Primary Outcome
Title Change From Baseline in the Itch Assessment Score 3 Hours After Treatment
Hide Description The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Time Frame Baseline to three hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 38 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.93  (2.635) 4.88  (2.094)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm
Comments The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
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 between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm, 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 0.690
Comments The significance level threshold level was 0.05.
Method ANCOVA
Comments Change from baseline as response, baseline score as covariate and treatment as factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
-1.140 to 1.709
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.708
Estimation Comments [Not Specified]
5.Primary Outcome
Title Change From Baseline in the Itch Assessment Score 4 Hours After Treatment
Hide Description The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Time Frame Baseline to four hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.85  (2.580) 4.92  (2.048)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm
Comments The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
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 between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm, 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 0.914
Comments The significance level threshold level was 0.05.
Method ANCOVA
Comments Change from baseline as response, baseline score as covariate and treatment as factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-1.556 to 1.397
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.735
Estimation Comments [Not Specified]
6.Primary Outcome
Title Change From Baseline in the Itch Assessment Score 5 Hours After Treatment
Hide Description The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Time Frame Baseline to five hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.06  (2.721) 5.25  (1.846)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm
Comments The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
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 between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm, 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 0.757
Comments The significance level threshold level was 0.05.
Method ANCOVA
Comments Change from baseline as response, baseline score as covariate and treatment as factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-1.796 to 1.314
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.774
Estimation Comments [Not Specified]
7.Primary Outcome
Title Change From Baseline in the Itch Assessment Score 6 Hours After Treatment
Hide Description The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Time Frame Baseline to six hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.07  (2.824) 5.55  (1.884)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm
Comments The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
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 between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm, 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 0.556
Comments The significance level threshold level was 0.05.
Method ANCOVA
Comments Change from baseline as response, baseline score as covariate and treatment as factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-2.075 to 1.129
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.798
Estimation Comments [Not Specified]
8.Primary Outcome
Title Change From Baseline in the Itch Assessment Score 7 Days After Treatment
Hide Description The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.
Time Frame Baseline to seven days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.22  (2.815) 6.53  (1.432)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm
Comments The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
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 between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm, 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 0.106
Comments The significance level threshold level was 0.05.
Method ANCOVA
Comments Change from baseline as response, baseline score as covariate and treatment as factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.27
Confidence Interval (2-Sided) 95%
-2.824 to 0.278
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.772
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment
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 affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time Frame Baseline to Immediately following treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Mean (Standard Deviation)
Unit of Measure: arbitrary units
48.26  (24.913) 21.71  (13.665)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm
Comments The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
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 between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm, 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 <0.001
Comments The significance level threshold level was 0.05.
Method ANCOVA
Comments Change from baseline as response, baseline score as covariate and treatment as factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 26.83
Confidence Interval (2-Sided) 95%
13.407 to 40.247
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.681
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Mean Corneometer Measurement 1 Hour After Treatment
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 affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time Frame Baseline to one hour after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Mean (Standard Deviation)
Unit of Measure: arbitrary units
27.00  (14.998) 7.84  (7.881)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm
Comments The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
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 between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm, 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 <0.001
Comments The significance level threshold level was 0.05.
Method ANCOVA
Comments Change from baseline as response, baseline score as covariate and treatment as factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 19.33
Confidence Interval (2-Sided) 95%
11.301 to 27.352
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.996
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Mean Corneometer Measurement 2 Hours After Treatment
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 affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time Frame Baseline to two hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Mean (Standard Deviation)
Unit of Measure: arbitrary units
23.20  (14.418) 7.32  (8.525)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm
Comments The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
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 between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm, 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 <0.001
Comments The significance level threshold level was 0.05.
Method ANCOVA
Comments Change from baseline as response, baseline score as covariate and treatment as factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 16.01
Confidence Interval (2-Sided) 95%
7.829 to 24.187
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.072
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Mean Corneometer Measurement 3 Hours After Treatment
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 affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time Frame Baseline to three hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 38 13
Mean (Standard Deviation)
Unit of Measure: arbitrary units
21.05  (13.373) 8.07  (7.706)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm
Comments The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
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 between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm, 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 <0.001
Comments The significance level threshold level was 0.05.
Method ANCOVA
Comments Change from baseline as response, baseline score as covariate and treatment as factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 13.25
Confidence Interval (2-Sided) 95%
5.684 to 20.820
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.764
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Mean Corneometer Measurement 4 Hours After Treatment
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 affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time Frame Baseline to four hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Mean (Standard Deviation)
Unit of Measure: arbitrary units
19.65  (15.249) 5.75  (9.491)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm
Comments The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
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 between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm, 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 0.001
Comments The significance level threshold level was 0.05.
Method ANCOVA
Comments Change from baseline as response, baseline score as covariate and treatment as factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14.08
Confidence Interval (2-Sided) 95%
5.766 to 22.387
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.138
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Mean Corneometer Measurement 5 Hours After Treatment
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 affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time Frame Baseline to five hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Mean (Standard Deviation)
Unit of Measure: arbitrary units
21.48  (15.980) 7.31  (10.205)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm
Comments The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
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 between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm, 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 0.004
Comments The significance level threshold level was 0.05.
Method ANCOVA
Comments Change from baseline as response, baseline score as covariate and treatment as factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14.26
Confidence Interval (2-Sided) 95%
4.862 to 23.660
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.679
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Mean Corneometer Measurement 6 Hours After Treatment
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 affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time Frame Baseline to six hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Mean (Standard Deviation)
Unit of Measure: arbitrary units
18.71  (14.882) 6.05  (7.687)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm
Comments The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
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 between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm, 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 0.004
Comments The significance level threshold level was 0.05.
Method ANCOVA
Comments Change from baseline as response, baseline score as covariate and treatment as factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 12.77
Confidence Interval (2-Sided) 95%
4.291 to 21.252
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.222
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment
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 affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.
Time Frame Baseline to seven days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 12
Mean (Standard Deviation)
Unit of Measure: arbitrary units
21.01  (19.743) 7.99  (11.404)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm
Comments The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
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 between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments The significance level threshold level was 0.05.
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1% Colloidal Oatmeal Balm, 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 0.037
Comments The significance level threshold level was 0.05.
Method ANCOVA
Comments Change from baseline as response, baseline score as covariate and treatment as factor.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 12.71
Confidence Interval (2-Sided) 95%
0.805 to 24.621
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.925
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Participant Questionnaire on Day 0 Pre-treatment – Distracted by Itchy Skin
Hide Description Questions were answered before treatment by the participant. The question is "I'm less distracted by my itchy skin"
Time Frame 0 Days - Pre-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 7.5 0
Somewhat agree 7.5 0
Neither agree or disagree 7.5 0
Somewhat disagree 37.5 38.5
Strongly disagree 40.0 61.5
I don't have an opinion 0 0
18.Secondary Outcome
Title Participant Questionnaire on Day 0 Pre-treatment – Calmer Skin
Hide Description Questions were answered before treatment by the participant. The question is "I wake up to calmer skin"
Time Frame 0 Days - Pre-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 10.0 7.7
Somewhat agree 10.0 23.1
Neither agree or disagree 5.0 0
Somewhat disagree 37.5 23.1
Strongly disagree 37.5 46.2
I don't have an opinion 0 0
19.Secondary Outcome
Title Participant Questionnaire on Day 0 Pre-treatment – Smooth Skin
Hide Description Questions were answered before treatment by the participant. The question is "My skin feels smooth"
Time Frame 0 Days - Pre-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 2.5 0
Somewhat agree 2.5 0
Neither agree or disagree 10.0 7.7
Somewhat disagree 32.5 23.1
Strongly disagree 52.5 69.2
I don't have an opinion 0 0
20.Secondary Outcome
Title Participant Questionnaire on Day 0 Pre-treatment – Comfortable Showing Skin
Hide Description Questions were answered before treatment by the participant. The question is "I feel comfortable showing my skin"
Time Frame 0 Days - Pre-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 15.0 0
Somewhat agree 5.0 7.7
Neither agree or disagree 12.5 30.8
Somewhat disagree 25.0 15.4
Strongly disagree 37.5 46.2
I don't have an opinion 5.0 0
21.Secondary Outcome
Title Participant Questionnaire on Day 0 Pre-treatment – Moisturized Skin
Hide Description Questions were answered before treatment by the participant. The question is "My skin feels moisturized"
Time Frame 0 Days - Pre-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 0 0
Somewhat agree 5.0 0
Neither agree or disagree 7.5 0
Somewhat disagree 27.5 23.1
Strongly disagree 60.0 76.9
I don't have an opinion 0 0
22.Secondary Outcome
Title Participant Questionnaire on Day 0 Pre-treatment – Touchable Skin
Hide Description Questions were answered before treatment by the participant. The question is "My skin feels touchable"
Time Frame 0 Days - Pre-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 7.5 7.7
Somewhat agree 10.0 7.7
Neither agree or disagree 7.5 7.7
Somewhat disagree 40.0 38.5
Strongly disagree 30.0 38.5
I don't have an opinion 5.0 0
23.Secondary Outcome
Title Participant Questionnaire on Day 0 Pre-treatment – Soft Skin
Hide Description Questions were answered before treatment by the participant. The question is "My skin feels soft"
Time Frame 0 Days - Pre-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 2.5 0
Somewhat agree 2.5 7.7
Neither agree or disagree 10.0 15.4
Somewhat disagree 30.0 15.4
Strongly disagree 50.0 61.5
I don't have an opinion 5.0 0
24.Secondary Outcome
Title Participant Questionnaire on Day 0 Pre-treatment – Distracted by Itchy Eczema Skin Over Past 2 Days
Hide Description Questions were answered before treatment by the participant. The question is "Thinking about your experience over the past two days, please describe your degree of being distracted by your itchy, eczema skin. Would you say you were"
Time Frame 0 Days - Pre-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Not at all distracted 2.5 0
Slightly distracted 7.5 0
Moderately distracted 35.0 23.1
Very distracted 37.5 61.5
Extremely distracted 17.5 15.4
I don't have an opinion 0 0
25.Secondary Outcome
Title Participant Questionnaire on Day 0 Pre-treatment – Skin Upon Waking Over Past 2 Days
Hide Description Questions were answered before treatment by the participant. The question is "Thinking about your experience over the past two days, how would you describe your skin upon awakening?"
Time Frame 0 Days - Pre-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Extremely calm 2.5 7.7
Very calm 0 0
Moderately calm 22.5 15.4
Slightly calm 30.0 23.1
Not at all calm 35.0 53.8
I don't have an opinion 10.0 0
26.Secondary Outcome
Title Participant Questionnaire on Day 0 Pre-treatment – Sleep During Past 2 Days
Hide Description Questions were answered before treatment by the participant. The question is "Thinking about how well you slept during the past two days, would you say your sleep was?"
Time Frame 0 Days - Pre-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Very good 5.0 0
Moderately good 25.0 23.1
Neither bad nor good 15.0 15.4
Moderately bad 37.5 46.2
Very bad 17.5 15.4
I don't have an opinion 0 0
27.Secondary Outcome
Title Participant Questionnaire on Day 0 Pre-treatment – Comfortable Showing Skin Over Past 2 Days
Hide Description Questions were answered before treatment by the participant. The question is "Thinking about how comfortable you felt showing your skin during the last two days, would you say that you were"
Time Frame 0 Days - Pre-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Extremely comfortable 2.5 0
Very comfortable 2.5 0
Moderately comfortable 27.5 7.7
Slightly comfortable 30.0 23.1
Not at all comfortable 32.5 69.2
I don't have an opinion 5.0 0
28.Secondary Outcome
Title Participant Questionnaire Immediately After Treatment - Product Fast Absorbing
Hide Description Questions were answered immediately after treatment by the participant. The question is "This product is fast absorbing"
Time Frame 0 Days - Immediately after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 22.5 53.8
Somewhat agree 42.5 38.5
Neither agree or disagree 15.0 0
Somewhat disagree 12.5 7.7
Strongly disagree 5.0 0
I don't have an opinion 2.5 0
29.Secondary Outcome
Title Participant Questionnaire Immediately After Treatment - Calm Skin
Hide Description Questions were answered immediately after treatment by the participant. The question is "This product calms my skin"
Time Frame 0 Days - Immediately after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 30.0 53.8
Somewhat agree 37.5 38.5
Neither agree or disagree 15.0 7.7
Somewhat disagree 12.5 0
Strongly disagree 2.5 0
I don't have an opinion 2.5 0
30.Secondary Outcome
Title Participant Questionnaire Immediately After Treatment - Moisturized Skin
Hide Description Questions were answered immediately after treatment by the participant. The question is "This product leaves my skin feeling immediately moisturized"
Time Frame 0 Days - Immediately after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 42.5 38.5
Somewhat agree 40.0 46.2
Neither agree or disagree 15.0 7.7
Somewhat disagree 2.5 7.7
Strongly disagree 0 0
I don't have an opinion 0 0
31.Secondary Outcome
Title Participant Questionnaire Immediately After Treatment - Product Does Not Sting
Hide Description Questions were answered immediately after treatment by the participant. The question is "This product does not sting when applied"
Time Frame 0 Days - Immediately after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 50.0 53.8
Somewhat agree 32.5 7.7
Neither agree or disagree 2.5 0
Somewhat disagree 10.0 23.1
Strongly disagree 5.0 15.4
I don't have an opinion 0 0
32.Secondary Outcome
Title Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture
Hide Description Questions were answered four hours after treatment by the participant. The question is "This product provides long lasting moisture"
Time Frame Four hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 55.0 38.5
Somewhat agree 25.0 46.2
Neither agree or disagree 2.5 0
Somewhat disagree 10.0 7.7
Strongly disagree 5.0 7.7
I don't have an opinion 2.5 0
33.Secondary Outcome
Title Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft
Hide Description Questions were answered four hours after treatment by the participant. The question is "This product leaves my skin feeling soft"
Time Frame Four hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 40.0 46.2
Somewhat agree 45.0 38.5
Neither agree or disagree 7.5 0
Somewhat disagree 5.0 0
Strongly disagree 0 15.4
I don't have an opinion 2.5 0
34.Secondary Outcome
Title Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture
Hide Description Questions were answered five hours after treatment by the participant. The question is "This product provides long lasting moisture"
Time Frame Five hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 60.0 61.5
Somewhat agree 27.5 30.8
Neither agree or disagree 2.5 0
Somewhat disagree 2.5 7.7
Strongly disagree 5.0 0
I don't have an opinion 2.5 0
35.Secondary Outcome
Title Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft
Hide Description Questions were answered five hours after treatment by the participant. The question is "This product leaves my skin feeling soft"
Time Frame Five hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 47.5 53.8
Somewhat agree 35.0 30.8
Neither agree or disagree 2.5 7.7
Somewhat disagree 7.5 7.7
Strongly disagree 2.5 0
I don't have an opinion 5.0 0
36.Secondary Outcome
Title Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture
Hide Description Questions were answered six hours after treatment by the participant. The question is "This product provides long lasting moisture"
Time Frame Six hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 60.0 38.5
Somewhat agree 27.5 53.8
Neither agree or disagree 2.5 0
Somewhat disagree 10.0 0
Strongly disagree 0 7.7
I don't have an opinion 0 0
37.Secondary Outcome
Title Participant Questionnaire 6 Hours After Treatment - Calms Skin
Hide Description Questions were answered six hours after treatment by the participant. The question is "This product calms my skin"
Time Frame Six hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 47.5 61.5
Somewhat agree 35.0 30.8
Neither agree or disagree 7.5 7.7
Somewhat disagree 7.5 0
Strongly disagree 2.5 0
I don't have an opinion 0 0
38.Secondary Outcome
Title Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin
Hide Description Questions were answered six hours after treatment by the participant. The question is "I'm less distracted by my itchy skin"
Time Frame Six hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 52.5 53.8
Somewhat agree 27.5 38.5
Neither agree or disagree 12.5 7.7
Somewhat disagree 7.5 0
Strongly disagree 0 0
I don't have an opinion 0 0
39.Secondary Outcome
Title Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin
Hide Description Questions were answered six hours after treatment by the participant. The question is "I feel comfortable showing my skin"
Time Frame Six hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 35.0 38.5
Somewhat agree 30.0 38.5
Neither agree or disagree 15.0 7.7
Somewhat disagree 12.5 7.7
Strongly disagree 5.0 7.7
I don't have an opinion 2.5 0
40.Secondary Outcome
Title Participant Questionnaire 6 Hours After Treatment - Shield for Skin
Hide Description Questions were answered six hours after treatment by the participant. The question is "This product feels like a shield for my skin"
Time Frame Six hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 37.5 38.5
Somewhat agree 37.5 61.5
Neither agree or disagree 17.5 0
Somewhat disagree 7.5 0
Strongly disagree 0 0
I don't have an opinion 0 0
41.Secondary Outcome
Title Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized
Hide Description Questions were answered six hours after treatment by the participant. The question is "This product leaves my skin feeling moisturized"
Time Frame Six hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 57.5 46.2
Somewhat agree 27.5 38.5
Neither agree or disagree 2.5 7.7
Somewhat disagree 10.0 7.7
Strongly disagree 0 0
I don't have an opinion 2.5 0
42.Secondary Outcome
Title Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable
Hide Description Questions were answered six hours after treatment by the participant. The question is "This product makes my skin feel touchable"
Time Frame Six hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 42.5 61.5
Somewhat agree 35.0 15.4
Neither agree or disagree 5.0 7.7
Somewhat disagree 12.5 15.4
Strongly disagree 2.5 0
I don't have an opinion 2.5 0
43.Secondary Outcome
Title Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft
Hide Description Questions were answered six hours after treatment by the participant. The question is "This product makes my skin feel soft"
Time Frame Six hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 50.0 53.8
Somewhat agree 30.0 30.8
Neither agree or disagree 10.0 0
Somewhat disagree 5.0 7.7
Strongly disagree 2.5 7.7
I don't have an opinion 2.5 0
44.Secondary Outcome
Title Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth
Hide Description Questions were answered six hours after treatment by the participant. The question is "This product leaves my skin feeling smooth"
Time Frame Six hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 45.0 53.8
Somewhat agree 32.5 30.8
Neither agree or disagree 7.5 0
Somewhat disagree 5.0 7.7
Strongly disagree 7.5 7.7
I don't have an opinion 2.5 0
45.Secondary Outcome
Title Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin
Hide Description Questions were answered six hours after treatment by the participant. The question is "Thinking about your experience after using this product, please describe your degree of being distracted by your itchy, eczema skin. Would you say you were"
Time Frame Six hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Not at all distracted 35.0 23.1
Slightly distracted 40.0 46.2
Moderately distracted 17.5 15.4
Very distracted 7.5 15.4
Extremely distracted 0 0
I don't have an opinion 0 0
46.Secondary Outcome
Title Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin
Hide Description Questions were answered six hours after treatment by the participant. The question is "Thinking about how comfortable you felt showing your skin after using this product, would you say that you were"
Time Frame Six hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 13
Measure Type: Number
Unit of Measure: percentage of participants
Extremely comfortable 22.5 23.1
Very comfortable 27.5 30.8
Moderately comfortable 40.0 30.8
Slightly comfortable 2.5 7.7
Not at all comfortable 2.5 7.7
I don't have an opinion 5.0 0
47.Secondary Outcome
Title Participant Questionnaire 7 Days After Treatment - Skin Feels Calm
Hide Description Questions were answered seven days after treatment by the participant. The question is "This product calms my skin"
Time Frame Seven days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 12
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 60.0 66.7
Somewhat agree 32.5 33.3
Neither agree or disagree 0 0
Somewhat disagree 2.5 0
Strongly disagree 5.0 0
I don't have an opinion 0 0
48.Secondary Outcome
Title Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin
Hide Description Questions were answered seven days after treatment by the participant. The question is "I'm less distracted by my itchy skin"
Time Frame Seven days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 12
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 55.0 83.3
Somewhat agree 32.5 16.7
Neither agree or disagree 2.5 0
Somewhat disagree 2.5 0
Strongly disagree 7.5 0
I don't have an opinion 0 0
49.Secondary Outcome
Title Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking
Hide Description Questions were answered seven days after treatment by the participant. The question is "I wake up to calmer skin"
Time Frame Seven days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 12
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 65.0 66.7
Somewhat agree 20.0 25.0
Neither agree or disagree 5.0 0
Somewhat disagree 2.5 0
Strongly disagree 7.5 8.3
I don't have an opinion 0 0
50.Secondary Outcome
Title Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin
Hide Description Questions were answered seven days after treatment by the participant. The question is "I feel comfortable showing my skin"
Time Frame Seven days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 12
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 42.5 50.0
Somewhat agree 32.5 41.7
Neither agree or disagree 7.5 0
Somewhat disagree 12.5 8.3
Strongly disagree 5.0 0
I don't have an opinion 0 0
51.Secondary Outcome
Title Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture
Hide Description Questions were answered seven days after treatment by the participant. The question is "This product provides long lasting moisture to my skin"
Time Frame Seven days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 12
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 65.0 50.0
Somewhat agree 22.5 41.7
Neither agree or disagree 2.5 0
Somewhat disagree 2.5 8.3
Strongly disagree 7.5 0
I don't have an opinion 0 0
52.Secondary Outcome
Title Participant Questionnaire 7 Days After Treatment - Shield for Skin
Hide Description Questions were answered seven days after treatment by the participant. The question is "This product feels like a shield for my skin"
Time Frame Seven days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 12
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 52.5 66.7
Somewhat agree 30.0 25.0
Neither agree or disagree 12.5 8.3
Somewhat disagree 0 0
Strongly disagree 2.5 0
I don't have an opinion 2.5 0
53.Secondary Outcome
Title Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized
Hide Description Questions were answered seven days after treatment by the participant. The question is "This product leaves my skin feeling moisturized"
Time Frame Seven days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 12
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 72.5 50.0
Somewhat agree 22.5 50.0
Neither agree or disagree 0 0
Somewhat disagree 0 0
Strongly disagree 5.0 0
I don't have an opinion 0 0
54.Secondary Outcome
Title Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable
Hide Description Questions were answered seven days after treatment by the participant. The question is "This product makes my skin feel touchable"
Time Frame Seven days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 12
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 57.5 41.7
Somewhat agree 22.5 58.3
Neither agree or disagree 5.0 0
Somewhat disagree 10.0 0
Strongly disagree 5.0 0
I don't have an opinion 0 0
55.Secondary Outcome
Title Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets
Hide Description Questions were answered seven days after treatment by the participant. The question is "This product does not rub off on sheets"
Time Frame Seven days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 12
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 42.5 83.3
Somewhat agree 25.0 16.7
Neither agree or disagree 10.0 0
Somewhat disagree 10.0 0
Strongly disagree 12.5 0
I don't have an opinion 0 0
56.Secondary Outcome
Title Participant Questionnaire 7 Days After Treatment - Skin Feels Soft
Hide Description Questions were answered seven days after treatment by the participant. The question is "This product makes my skin feel soft"
Time Frame Seven days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 12
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 65.0 50.0
Somewhat agree 27.5 50.0
Neither agree or disagree 2.5 0
Somewhat disagree 0 0
Strongly disagree 5.0 0
I don't have an opinion 0 0
57.Secondary Outcome
Title Participant Questionnaire 7 Days After Treatment - Moisturized All Day
Hide Description Questions were answered seven days after treatment by the participant. The question is "This product leaves my skin feeling moisturized all day"
Time Frame Seven days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 12
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 67.5 33.3
Somewhat agree 17.5 50.0
Neither agree or disagree 2.5 0
Somewhat disagree 7.5 16.7
Strongly disagree 5.0 0
I don't have an opinion 0 0
58.Secondary Outcome
Title Participant Questionnaire 7 Days After Treatment - Slept Better
Hide Description Questions were answered seven days after treatment by the participant. The question is "I slept better due to less itching or skin discomfort"
Time Frame Seven days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 12
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 45.0 41.7
Somewhat agree 30.0 58.3
Neither agree or disagree 17.5 0
Somewhat disagree 5.0 0
Strongly disagree 2.5 0
I don't have an opinion 0 0
59.Secondary Outcome
Title Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth
Hide Description Questions were answered seven days after treatment by the participant. The question is "This product leaves my skin feeling smooth"
Time Frame Seven days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 12
Measure Type: Number
Unit of Measure: percentage of participants
Strongly agree 60.0 66.7
Somewhat agree 27.5 25.0
Neither agree or disagree 2.5 0
Somewhat disagree 5.0 8.3
Strongly disagree 5.0 0
I don't have an opinion 0 0
60.Secondary Outcome
Title Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin
Hide Description Questions were answered seven days after treatment by the participant. The question is "Thinking about your experience while using this product, please describe your degree of being distracted by your itchy, eczema skin. Would you say you were"
Time Frame Seven days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 39 12
Measure Type: Number
Unit of Measure: percentage of participants
Not at all distracted 33.3 33.3
Slightly distracted 56.4 50.0
Moderately distracted 5.1 0
Very distracted 0 0
Extremely distracted 5.1 16.7
I don't have an opinion 0 0
61.Secondary Outcome
Title Participant Questionnaire 7 Days After Treatment - Skin on Waking
Hide Description Questions were answered seven days after treatment by the participant. The question is "Thinking about your experience when using this product, how would you describe your skin upon awakening?"
Time Frame Seven days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 12
Measure Type: Number
Unit of Measure: percentage of participants
Extremely calm 32.5 8.3
Very calm 30.0 58.3
Moderately calm 27.5 25.0
Slightly calm 5.0 0
Not at all calm 5.0 8.3
I don't have an opinion 0 0
62.Secondary Outcome
Title Participant Questionnaire 7 Days After Treatment – Degree of Sleep
Hide Description Questions were answered seven days after treatment by the participant. The question is "Thinking about how well you slept when using this product, would you say your sleep was?"
Time Frame 7 days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 12
Measure Type: Number
Unit of Measure: percentage of participants
Very good 45.0 50.0
Moderately good 30.0 50.0
Neither bad nor good 20.0 0
Moderately bad 2.5 0
Very bad 2.5 0
I don't have an opinion 0 0
63.Secondary Outcome
Title Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin
Hide Description Questions were answered seven days after treatment by the participant. The question is "Thinking about how comfortable you felt showing your skin while using this product, would you say that you were"
Time Frame Seven days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description:
1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
Overall Number of Participants Analyzed 40 12
Measure Type: Number
Unit of Measure: percentage of participants
Extremely comfortable 25.0 25.0
Very comfortable 37.5 33.3
Moderately comfortable 17.5 33.3
Slightly comfortable 17.5 8.3
Not at all comfortable 2.5 0
I don't have an opinion 0 0
Time Frame Day 7 ± 1 day, +30 days for serious adverse events.
Adverse Event Reporting Description Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 3 (Day 7 ± 1 day). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
 
Arm/Group Title 1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Hide Arm/Group Description 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed) EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
All-Cause Mortality
1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1% Colloidal Oatmeal Balm EpiCeram Skin Barrier Emulsion
Affected / at Risk (%) Affected / at Risk (%)
Total   6/40 (15.00%)   1/13 (7.69%) 
General disorders     
Application Site Pain  1  6/40 (15.00%)  0/13 (0.00%) 
Pain  1  0/40 (0.00%)  1/13 (7.69%) 
Nervous system disorders     
Headache  1  0/40 (0.00%)  1/13 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Principal investigators agreed not to publish the study results without prior sponsor approval.
Results Point of Contact
Name/Title: Amisha Parikh-Das, PhD/Study Director
Organization: Johnson & Johnson Consumer, Inc
Phone: 973-255-8701 USA EST
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )
ClinicalTrials.gov Identifier: NCT02691507     History of Chang