Trial Outcomes & Findings for Trial to Determine the Therapeutic Benefit of an OTC Cream on Dry, Itchy Skin of Adults and Children With Eczema (NCT NCT02691507)
NCT ID: NCT02691507
Last Updated: 2017-03-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Baseline to immediately following treatment
Results posted on
2017-03-06
Participant Flow
Participant milestones
| Measure |
1% Colloidal Oatmeal Balm
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
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
13
|
|
Overall Study
COMPLETED
|
40
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
1% Colloidal Oatmeal Balm
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
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Overall Study
Missed Visit 3
|
0
|
1
|
Baseline Characteristics
Trial to Determine the Therapeutic Benefit of an OTC Cream on Dry, Itchy Skin of Adults and Children With Eczema
Baseline characteristics by cohort
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.0 years
STANDARD_DEVIATION 17.43 • n=5 Participants
|
45.5 years
STANDARD_DEVIATION 18.51 • n=7 Participants
|
43.6 years
STANDARD_DEVIATION 17.55 • n=5 Participants
|
|
Gender
Female
|
25 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Gender
Male
|
15 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
13 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to immediately following treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Change From Baseline in the Itch Assessment Score Immediately Following Treatment
|
1.93 units on a scale
Standard Deviation 2.753
|
2.64 units on a scale
Standard Deviation 2.482
|
PRIMARY outcome
Timeframe: Baseline to one hour after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Change From Baseline in the Itch Assessment Score 1 Hour After Treatment
|
3.00 units on a scale
Standard Deviation 2.624
|
3.08 units on a scale
Standard Deviation 2.559
|
PRIMARY outcome
Timeframe: Baseline to two hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Change From Baseline in the Itch Assessment Score 2 Hours After Treatment
|
3.46 units on a scale
Standard Deviation 2.849
|
3.65 units on a scale
Standard Deviation 2.236
|
PRIMARY outcome
Timeframe: Baseline to three hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=38 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Change From Baseline in the Itch Assessment Score 3 Hours After Treatment
|
3.93 units on a scale
Standard Deviation 2.635
|
4.88 units on a scale
Standard Deviation 2.094
|
PRIMARY outcome
Timeframe: Baseline to four hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Change From Baseline in the Itch Assessment Score 4 Hours After Treatment
|
3.85 units on a scale
Standard Deviation 2.580
|
4.92 units on a scale
Standard Deviation 2.048
|
PRIMARY outcome
Timeframe: Baseline to five hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Change From Baseline in the Itch Assessment Score 5 Hours After Treatment
|
4.06 units on a scale
Standard Deviation 2.721
|
5.25 units on a scale
Standard Deviation 1.846
|
PRIMARY outcome
Timeframe: Baseline to six hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Change From Baseline in the Itch Assessment Score 6 Hours After Treatment
|
4.07 units on a scale
Standard Deviation 2.824
|
5.55 units on a scale
Standard Deviation 1.884
|
PRIMARY outcome
Timeframe: Baseline to seven days after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=12 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Change From Baseline in the Itch Assessment Score 7 Days After Treatment
|
4.22 units on a scale
Standard Deviation 2.815
|
6.53 units on a scale
Standard Deviation 1.432
|
SECONDARY outcome
Timeframe: Baseline to Immediately following treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment
|
48.26 arbitrary units
Standard Deviation 24.913
|
21.71 arbitrary units
Standard Deviation 13.665
|
SECONDARY outcome
Timeframe: Baseline to one hour after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Change From Baseline in Mean Corneometer Measurement 1 Hour After Treatment
|
27.00 arbitrary units
Standard Deviation 14.998
|
7.84 arbitrary units
Standard Deviation 7.881
|
SECONDARY outcome
Timeframe: Baseline to two hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Change From Baseline in Mean Corneometer Measurement 2 Hours After Treatment
|
23.20 arbitrary units
Standard Deviation 14.418
|
7.32 arbitrary units
Standard Deviation 8.525
|
SECONDARY outcome
Timeframe: Baseline to three hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=38 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Change From Baseline in Mean Corneometer Measurement 3 Hours After Treatment
|
21.05 arbitrary units
Standard Deviation 13.373
|
8.07 arbitrary units
Standard Deviation 7.706
|
SECONDARY outcome
Timeframe: Baseline to four hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Change From Baseline in Mean Corneometer Measurement 4 Hours After Treatment
|
19.65 arbitrary units
Standard Deviation 15.249
|
5.75 arbitrary units
Standard Deviation 9.491
|
SECONDARY outcome
Timeframe: Baseline to five hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Change From Baseline in Mean Corneometer Measurement 5 Hours After Treatment
|
21.48 arbitrary units
Standard Deviation 15.980
|
7.31 arbitrary units
Standard Deviation 10.205
|
SECONDARY outcome
Timeframe: Baseline to six hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Change From Baseline in Mean Corneometer Measurement 6 Hours After Treatment
|
18.71 arbitrary units
Standard Deviation 14.882
|
6.05 arbitrary units
Standard Deviation 7.687
|
SECONDARY outcome
Timeframe: Baseline to seven days after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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.
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=12 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment
|
21.01 arbitrary units
Standard Deviation 19.743
|
7.99 arbitrary units
Standard Deviation 11.404
|
SECONDARY outcome
Timeframe: 0 Days - Pre-treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered before treatment by the participant. The question is "I'm less distracted by my itchy skin"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin
Somewhat agree
|
7.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin
Neither agree or disagree
|
7.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin
Strongly agree
|
7.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin
Somewhat disagree
|
37.5 percentage of participants
|
38.5 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin
Strongly disagree
|
40.0 percentage of participants
|
61.5 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 0 Days - Pre-treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered before treatment by the participant. The question is "I wake up to calmer skin"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin
Strongly agree
|
10.0 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin
Somewhat agree
|
10.0 percentage of participants
|
23.1 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin
Neither agree or disagree
|
5.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin
Somewhat disagree
|
37.5 percentage of participants
|
23.1 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin
Strongly disagree
|
37.5 percentage of participants
|
46.2 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 0 Days - Pre-treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered before treatment by the participant. The question is "My skin feels smooth"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin
Strongly agree
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin
Somewhat agree
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin
Neither agree or disagree
|
10.0 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin
Somewhat disagree
|
32.5 percentage of participants
|
23.1 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin
Strongly disagree
|
52.5 percentage of participants
|
69.2 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 0 Days - Pre-treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered before treatment by the participant. The question is "I feel comfortable showing my skin"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin
Strongly agree
|
15.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin
Somewhat agree
|
5.0 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin
Neither agree or disagree
|
12.5 percentage of participants
|
30.8 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin
Somewhat disagree
|
25.0 percentage of participants
|
15.4 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin
Strongly disagree
|
37.5 percentage of participants
|
46.2 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin
I don't have an opinion
|
5.0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 0 Days - Pre-treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered before treatment by the participant. The question is "My skin feels moisturized"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin
Strongly agree
|
0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin
Somewhat agree
|
5.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin
Neither agree or disagree
|
7.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin
Somewhat disagree
|
27.5 percentage of participants
|
23.1 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin
Strongly disagree
|
60.0 percentage of participants
|
76.9 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 0 Days - Pre-treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered before treatment by the participant. The question is "My skin feels touchable"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin
Strongly agree
|
7.5 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin
Somewhat agree
|
10.0 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin
Neither agree or disagree
|
7.5 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin
Somewhat disagree
|
40.0 percentage of participants
|
38.5 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin
Strongly disagree
|
30.0 percentage of participants
|
38.5 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin
I don't have an opinion
|
5.0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 0 Days - Pre-treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered before treatment by the participant. The question is "My skin feels soft"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire on Day 0 Pre-treatment - Soft Skin
Strongly agree
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Soft Skin
Somewhat agree
|
2.5 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Soft Skin
Neither agree or disagree
|
10.0 percentage of participants
|
15.4 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Soft Skin
Somewhat disagree
|
30.0 percentage of participants
|
15.4 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Soft Skin
Strongly disagree
|
50.0 percentage of participants
|
61.5 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Soft Skin
I don't have an opinion
|
5.0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 0 Days - Pre-treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days
Not at all distracted
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days
Slightly distracted
|
7.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days
Moderately distracted
|
35.0 percentage of participants
|
23.1 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days
Very distracted
|
37.5 percentage of participants
|
61.5 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days
Extremely distracted
|
17.5 percentage of participants
|
15.4 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 0 Days - Pre-treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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?"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days
Extremely calm
|
2.5 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days
Very calm
|
0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days
Moderately calm
|
22.5 percentage of participants
|
15.4 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days
Slightly calm
|
30.0 percentage of participants
|
23.1 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days
Not at all calm
|
35.0 percentage of participants
|
53.8 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days
I don't have an opinion
|
10.0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 0 Days - Pre-treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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?"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days
Very good
|
5.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days
Moderately good
|
25.0 percentage of participants
|
23.1 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days
Neither bad nor good
|
15.0 percentage of participants
|
15.4 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days
Moderately bad
|
37.5 percentage of participants
|
46.2 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days
Very bad
|
17.5 percentage of participants
|
15.4 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 0 Days - Pre-treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days
Not at all comfortable
|
32.5 percentage of participants
|
69.2 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days
I don't have an opinion
|
5.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days
Extremely comfortable
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days
Very comfortable
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days
Moderately comfortable
|
27.5 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days
Slightly comfortable
|
30.0 percentage of participants
|
23.1 percentage of participants
|
SECONDARY outcome
Timeframe: 0 Days - Immediately after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered immediately after treatment by the participant. The question is "This product is fast absorbing"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire Immediately After Treatment - Product Fast Absorbing
Strongly agree
|
22.5 percentage of participants
|
53.8 percentage of participants
|
|
Participant Questionnaire Immediately After Treatment - Product Fast Absorbing
Somewhat agree
|
42.5 percentage of participants
|
38.5 percentage of participants
|
|
Participant Questionnaire Immediately After Treatment - Product Fast Absorbing
Neither agree or disagree
|
15.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire Immediately After Treatment - Product Fast Absorbing
Somewhat disagree
|
12.5 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire Immediately After Treatment - Product Fast Absorbing
Strongly disagree
|
5.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire Immediately After Treatment - Product Fast Absorbing
I don't have an opinion
|
2.5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 0 Days - Immediately after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered immediately after treatment by the participant. The question is "This product calms my skin"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire Immediately After Treatment - Calm Skin
Strongly agree
|
30.0 percentage of participants
|
53.8 percentage of participants
|
|
Participant Questionnaire Immediately After Treatment - Calm Skin
Somewhat agree
|
37.5 percentage of participants
|
38.5 percentage of participants
|
|
Participant Questionnaire Immediately After Treatment - Calm Skin
Neither agree or disagree
|
15.0 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire Immediately After Treatment - Calm Skin
Somewhat disagree
|
12.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire Immediately After Treatment - Calm Skin
Strongly disagree
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire Immediately After Treatment - Calm Skin
I don't have an opinion
|
2.5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 0 Days - Immediately after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered immediately after treatment by the participant. The question is "This product leaves my skin feeling immediately moisturized"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire Immediately After Treatment - Moisturized Skin
Somewhat disagree
|
2.5 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire Immediately After Treatment - Moisturized Skin
Strongly agree
|
42.5 percentage of participants
|
38.5 percentage of participants
|
|
Participant Questionnaire Immediately After Treatment - Moisturized Skin
Somewhat agree
|
40.0 percentage of participants
|
46.2 percentage of participants
|
|
Participant Questionnaire Immediately After Treatment - Moisturized Skin
Neither agree or disagree
|
15.0 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire Immediately After Treatment - Moisturized Skin
Strongly disagree
|
0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire Immediately After Treatment - Moisturized Skin
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 0 Days - Immediately after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered immediately after treatment by the participant. The question is "This product does not sting when applied"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire Immediately After Treatment - Product Does Not Sting
Somewhat agree
|
32.5 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire Immediately After Treatment - Product Does Not Sting
Strongly agree
|
50.0 percentage of participants
|
53.8 percentage of participants
|
|
Participant Questionnaire Immediately After Treatment - Product Does Not Sting
Neither agree or disagree
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire Immediately After Treatment - Product Does Not Sting
Somewhat disagree
|
10.0 percentage of participants
|
23.1 percentage of participants
|
|
Participant Questionnaire Immediately After Treatment - Product Does Not Sting
Strongly disagree
|
5.0 percentage of participants
|
15.4 percentage of participants
|
|
Participant Questionnaire Immediately After Treatment - Product Does Not Sting
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Four hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered four hours after treatment by the participant. The question is "This product provides long lasting moisture"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture
Strongly agree
|
55.0 percentage of participants
|
38.5 percentage of participants
|
|
Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture
Somewhat agree
|
25.0 percentage of participants
|
46.2 percentage of participants
|
|
Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture
Neither agree or disagree
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture
Somewhat disagree
|
10.0 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture
Strongly disagree
|
5.0 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture
I don't have an opinion
|
2.5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Four hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered four hours after treatment by the participant. The question is "This product leaves my skin feeling soft"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft
Somewhat agree
|
45.0 percentage of participants
|
38.5 percentage of participants
|
|
Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft
Neither agree or disagree
|
7.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft
Somewhat disagree
|
5.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft
Strongly disagree
|
0 percentage of participants
|
15.4 percentage of participants
|
|
Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft
Strongly agree
|
40.0 percentage of participants
|
46.2 percentage of participants
|
|
Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft
I don't have an opinion
|
2.5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Five hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered five hours after treatment by the participant. The question is "This product provides long lasting moisture"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture
Strongly agree
|
60.0 percentage of participants
|
61.5 percentage of participants
|
|
Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture
Somewhat agree
|
27.5 percentage of participants
|
30.8 percentage of participants
|
|
Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture
Neither agree or disagree
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture
Somewhat disagree
|
2.5 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture
Strongly disagree
|
5.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture
I don't have an opinion
|
2.5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Five hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered five hours after treatment by the participant. The question is "This product leaves my skin feeling soft"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft
Strongly agree
|
47.5 percentage of participants
|
53.8 percentage of participants
|
|
Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft
Somewhat agree
|
35.0 percentage of participants
|
30.8 percentage of participants
|
|
Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft
Neither agree or disagree
|
2.5 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft
Somewhat disagree
|
7.5 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft
Strongly disagree
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft
I don't have an opinion
|
5.0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Six hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered six hours after treatment by the participant. The question is "This product provides long lasting moisture"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture
Somewhat disagree
|
10.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture
Strongly agree
|
60.0 percentage of participants
|
38.5 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture
Somewhat agree
|
27.5 percentage of participants
|
53.8 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture
Neither agree or disagree
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture
Strongly disagree
|
0 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Six hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered six hours after treatment by the participant. The question is "This product calms my skin"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 6 Hours After Treatment - Calms Skin
Strongly agree
|
47.5 percentage of participants
|
61.5 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Calms Skin
Somewhat agree
|
35.0 percentage of participants
|
30.8 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Calms Skin
Neither agree or disagree
|
7.5 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Calms Skin
Somewhat disagree
|
7.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Calms Skin
Strongly disagree
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Calms Skin
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Six hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered six hours after treatment by the participant. The question is "I'm less distracted by my itchy skin"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin
Strongly agree
|
52.5 percentage of participants
|
53.8 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin
Somewhat agree
|
27.5 percentage of participants
|
38.5 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin
Neither agree or disagree
|
12.5 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin
Somewhat disagree
|
7.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin
Strongly disagree
|
0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Six hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered six hours after treatment by the participant. The question is "I feel comfortable showing my skin"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin
Strongly agree
|
35.0 percentage of participants
|
38.5 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin
Somewhat agree
|
30.0 percentage of participants
|
38.5 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin
Neither agree or disagree
|
15.0 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin
Somewhat disagree
|
12.5 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin
Strongly disagree
|
5.0 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin
I don't have an opinion
|
2.5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Six hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered six hours after treatment by the participant. The question is "This product feels like a shield for my skin"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 6 Hours After Treatment - Shield for Skin
Strongly agree
|
37.5 percentage of participants
|
38.5 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Shield for Skin
Somewhat agree
|
37.5 percentage of participants
|
61.5 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Shield for Skin
Neither agree or disagree
|
17.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Shield for Skin
Somewhat disagree
|
7.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Shield for Skin
Strongly disagree
|
0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Shield for Skin
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Six hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered six hours after treatment by the participant. The question is "This product leaves my skin feeling moisturized"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized
Strongly agree
|
57.5 percentage of participants
|
46.2 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized
Somewhat agree
|
27.5 percentage of participants
|
38.5 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized
Neither agree or disagree
|
2.5 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized
Somewhat disagree
|
10.0 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized
Strongly disagree
|
0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized
I don't have an opinion
|
2.5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Six hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered six hours after treatment by the participant. The question is "This product makes my skin feel touchable"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable
Somewhat agree
|
35.0 percentage of participants
|
15.4 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable
Neither agree or disagree
|
5.0 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable
Strongly agree
|
42.5 percentage of participants
|
61.5 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable
Somewhat disagree
|
12.5 percentage of participants
|
15.4 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable
Strongly disagree
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable
I don't have an opinion
|
2.5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Six hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered six hours after treatment by the participant. The question is "This product makes my skin feel soft"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft
Strongly agree
|
50.0 percentage of participants
|
53.8 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft
Somewhat agree
|
30.0 percentage of participants
|
30.8 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft
I don't have an opinion
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft
Neither agree or disagree
|
10.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft
Somewhat disagree
|
5.0 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft
Strongly disagree
|
2.5 percentage of participants
|
7.7 percentage of participants
|
SECONDARY outcome
Timeframe: Six hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered six hours after treatment by the participant. The question is "This product leaves my skin feeling smooth"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth
Strongly agree
|
45.0 percentage of participants
|
53.8 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth
Somewhat agree
|
32.5 percentage of participants
|
30.8 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth
Neither agree or disagree
|
7.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth
Somewhat disagree
|
5.0 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth
Strongly disagree
|
7.5 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth
I don't have an opinion
|
2.5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Six hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin
Extremely distracted
|
0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin
Not at all distracted
|
35.0 percentage of participants
|
23.1 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin
Slightly distracted
|
40.0 percentage of participants
|
46.2 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin
Moderately distracted
|
17.5 percentage of participants
|
15.4 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin
Very distracted
|
7.5 percentage of participants
|
15.4 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Six hours after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=13 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin
Extremely comfortable
|
22.5 percentage of participants
|
23.1 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin
Very comfortable
|
27.5 percentage of participants
|
30.8 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin
Moderately comfortable
|
40.0 percentage of participants
|
30.8 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin
Slightly comfortable
|
2.5 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin
Not at all comfortable
|
2.5 percentage of participants
|
7.7 percentage of participants
|
|
Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin
I don't have an opinion
|
5.0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Seven days after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered seven days after treatment by the participant. The question is "This product calms my skin"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=12 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Calm
Neither agree or disagree
|
0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Calm
Somewhat disagree
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Calm
Strongly agree
|
60.0 percentage of participants
|
66.7 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Calm
Somewhat agree
|
32.5 percentage of participants
|
33.3 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Calm
Strongly disagree
|
5.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Calm
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Seven days after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered seven days after treatment by the participant. The question is "I'm less distracted by my itchy skin"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=12 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin
Somewhat disagree
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin
Strongly disagree
|
7.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin
Strongly agree
|
55.0 percentage of participants
|
83.3 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin
Somewhat agree
|
32.5 percentage of participants
|
16.7 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin
Neither agree or disagree
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Seven days after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered seven days after treatment by the participant. The question is "I wake up to calmer skin"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=12 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking
Strongly agree
|
65.0 percentage of participants
|
66.7 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking
Somewhat agree
|
20.0 percentage of participants
|
25.0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking
Neither agree or disagree
|
5.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking
Somewhat disagree
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking
Strongly disagree
|
7.5 percentage of participants
|
8.3 percentage of participants
|
SECONDARY outcome
Timeframe: Seven days after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered seven days after treatment by the participant. The question is "I feel comfortable showing my skin"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=12 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin
Strongly agree
|
42.5 percentage of participants
|
50.0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin
Somewhat agree
|
32.5 percentage of participants
|
41.7 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin
Neither agree or disagree
|
7.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin
Somewhat disagree
|
12.5 percentage of participants
|
8.3 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin
Strongly disagree
|
5.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Seven days after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered seven days after treatment by the participant. The question is "This product provides long lasting moisture to my skin"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=12 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture
Strongly disagree
|
7.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture
Strongly agree
|
65.0 percentage of participants
|
50.0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture
Somewhat agree
|
22.5 percentage of participants
|
41.7 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture
Neither agree or disagree
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture
Somewhat disagree
|
2.5 percentage of participants
|
8.3 percentage of participants
|
SECONDARY outcome
Timeframe: Seven days after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered seven days after treatment by the participant. The question is "This product feels like a shield for my skin"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=12 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 7 Days After Treatment - Shield for Skin
Strongly agree
|
52.5 percentage of participants
|
66.7 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Shield for Skin
Somewhat agree
|
30.0 percentage of participants
|
25.0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Shield for Skin
Neither agree or disagree
|
12.5 percentage of participants
|
8.3 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Shield for Skin
Somewhat disagree
|
0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Shield for Skin
Strongly disagree
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Shield for Skin
I don't have an opinion
|
2.5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Seven days after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered seven days after treatment by the participant. The question is "This product leaves my skin feeling moisturized"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=12 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized
Strongly agree
|
72.5 percentage of participants
|
50.0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized
Somewhat agree
|
22.5 percentage of participants
|
50.0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized
Neither agree or disagree
|
0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized
Somewhat disagree
|
0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized
Strongly disagree
|
5.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Seven days after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered seven days after treatment by the participant. The question is "This product makes my skin feel touchable"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=12 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable
Somewhat disagree
|
10.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable
Strongly disagree
|
5.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable
Strongly agree
|
57.5 percentage of participants
|
41.7 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable
Somewhat agree
|
22.5 percentage of participants
|
58.3 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable
Neither agree or disagree
|
5.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Seven days after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered seven days after treatment by the participant. The question is "This product does not rub off on sheets"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=12 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets
Strongly agree
|
42.5 percentage of participants
|
83.3 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets
Somewhat agree
|
25.0 percentage of participants
|
16.7 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets
Neither agree or disagree
|
10.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets
Somewhat disagree
|
10.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets
Strongly disagree
|
12.5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Seven days after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered seven days after treatment by the participant. The question is "This product makes my skin feel soft"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=12 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Soft
Strongly agree
|
65.0 percentage of participants
|
50.0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Soft
Somewhat agree
|
27.5 percentage of participants
|
50.0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Soft
Neither agree or disagree
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Soft
Somewhat disagree
|
0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Soft
Strongly disagree
|
5.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Soft
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Seven days after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered seven days after treatment by the participant. The question is "This product leaves my skin feeling moisturized all day"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=12 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 7 Days After Treatment - Moisturized All Day
Strongly agree
|
67.5 percentage of participants
|
33.3 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Moisturized All Day
Somewhat agree
|
17.5 percentage of participants
|
50.0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Moisturized All Day
Neither agree or disagree
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Moisturized All Day
Somewhat disagree
|
7.5 percentage of participants
|
16.7 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Moisturized All Day
Strongly disagree
|
5.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Moisturized All Day
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Seven days after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered seven days after treatment by the participant. The question is "I slept better due to less itching or skin discomfort"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=12 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 7 Days After Treatment - Slept Better
Strongly agree
|
45.0 percentage of participants
|
41.7 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Slept Better
Somewhat agree
|
30.0 percentage of participants
|
58.3 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Slept Better
Neither agree or disagree
|
17.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Slept Better
Somewhat disagree
|
5.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Slept Better
Strongly disagree
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Slept Better
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Seven days after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Questions were answered seven days after treatment by the participant. The question is "This product leaves my skin feeling smooth"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=12 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth
Strongly agree
|
60.0 percentage of participants
|
66.7 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth
Somewhat agree
|
27.5 percentage of participants
|
25.0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth
Neither agree or disagree
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth
Somewhat disagree
|
5.0 percentage of participants
|
8.3 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth
Strongly disagree
|
5.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Seven days after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=39 Participants
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
n=12 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin
Slightly distracted
|
56.4 percentage of participants
|
50.0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin
Moderately distracted
|
5.1 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin
Not at all distracted
|
33.3 percentage of participants
|
33.3 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin
Very distracted
|
0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin
Extremely distracted
|
5.1 percentage of participants
|
16.7 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Seven days after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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?"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=12 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 7 Days After Treatment - Skin on Waking
Extremely calm
|
32.5 percentage of participants
|
8.3 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin on Waking
Very calm
|
30.0 percentage of participants
|
58.3 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin on Waking
Moderately calm
|
27.5 percentage of participants
|
25.0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin on Waking
Slightly calm
|
5.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin on Waking
Not at all calm
|
5.0 percentage of participants
|
8.3 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Skin on Waking
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 7 days after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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?"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=12 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 7 Days After Treatment - Degree of Sleep
Moderately bad
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Degree of Sleep
Very bad
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Degree of Sleep
Very good
|
45.0 percentage of participants
|
50.0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Degree of Sleep
Moderately good
|
30.0 percentage of participants
|
50.0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Degree of Sleep
Neither bad nor good
|
20.0 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Degree of Sleep
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Seven days after treatmentPopulation: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
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"
Outcome measures
| Measure |
1% Colloidal Oatmeal Balm
n=40 Participants
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
n=12 Participants
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin
Extremely comfortable
|
25.0 percentage of participants
|
25.0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin
Very comfortable
|
37.5 percentage of participants
|
33.3 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin
Moderately comfortable
|
17.5 percentage of participants
|
33.3 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin
Slightly comfortable
|
17.5 percentage of participants
|
8.3 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin
Not at all comfortable
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin
I don't have an opinion
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
1% Colloidal Oatmeal Balm
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
EpiCeram Skin Barrier Emulsion
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1% Colloidal Oatmeal Balm
n=40 participants at risk
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
n=13 participants at risk
EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
|
|---|---|---|
|
General disorders
Application Site Pain
|
15.0%
6/40 • Day 7 ± 1 day, +30 days for serious adverse events.
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.
|
0.00%
0/13 • Day 7 ± 1 day, +30 days for serious adverse events.
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.
|
|
General disorders
Pain
|
0.00%
0/40 • Day 7 ± 1 day, +30 days for serious adverse events.
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.
|
7.7%
1/13 • Day 7 ± 1 day, +30 days for serious adverse events.
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.
|
|
Nervous system disorders
Headache
|
0.00%
0/40 • Day 7 ± 1 day, +30 days for serious adverse events.
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.
|
7.7%
1/13 • Day 7 ± 1 day, +30 days for serious adverse events.
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.
|
Additional Information
Amisha Parikh-Das, PhD/Study Director
Johnson & Johnson Consumer, Inc
Phone: 973-255-8701 USA EST
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Principal investigators agreed not to publish the study results without prior sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER