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

A Clinical Trial to Determine the Therapeutic Benefit of an Investigational Over-The-Counter Cream on Dry, Itchy Skin of Adults and Children With Atopic Dermatitis.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02691507

Enrollment

Registered

2016-02-25

Start date

2016-02-29

Completion date

2016-04-30

Last updated

2017-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

Eczema, Itchy Skin

Brief summary

The objective of this 1 week trial is to evaluate the efficacy of an over-the-counter (OTC) 1% colloidal oatmeal skin protectant cream in adults and children with mild to moderate AD.

Detailed description

Approximately 60 subjects will be enrolled to ensure 52 subjects complete the study (39 subjects: active treatment and 13 subjects: positive control). Adults and children (ages 12 and over) will receive either a marketed or not yet marketed investigational product for the treatment of eczema. Subjects will be asked to stop use of prescription and all eczema treatments 2 days before the start of the study and during the study. Subjects will apply study product as indicated for 7 days to affected areas. Subjects will record treatment use in a daily diary and complete questionnaires. A dermatologist will examine and score the eczema and symptoms. Skin moisture levels will also be tested.

Interventions

DEVICEEpiCeram Skin Barrier Emulsion

EpiCeram Skin Barrier Emulsion

DRUGExperimental Product 1% Colloidal Oatmeal Balm

Experimental Product 1% Colloidal Oatmeal Balm

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) 2. Male or female of any race or ethnicity, ages 12 and older 3. Diagnosed as having eczema 4. Willing to stop use of all non-assigned moisturizers and/or creams for the entire duration of the study

Exclusion criteria

1. Known sensitivity to any investigational product ingredient 2. Females who are pregnant , breastfeeding , or planning on becoming pregnant during the study 3. Individuals with a history of skin cancer 4. Use of a therapeutic (over-the-counter or prescription) body wash that contains an active ingredient for eczema 5. Participation in any clinical study within 30 days of Visit 1 6. Active infection of any type at the start of the study 7. Diagnosed as having severe eczema 8. Has a compromised immune system 9. Individuals with any planned surgeries and/or invasive medical procedures during the course of the study 10. Requires greater than 2.0mg/day inhaled or intranasal corticosteroids

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in the Itch Assessment Score Immediately Following Treatment	Baseline to immediately following treatment	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.
Change From Baseline in the Itch Assessment Score 1 Hour After Treatment	Baseline to one hour after treatment	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.
Change From Baseline in the Itch Assessment Score 2 Hours After Treatment	Baseline to two hours after treatment	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.
Change From Baseline in the Itch Assessment Score 3 Hours After Treatment	Baseline to three hours after treatment	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.
Change From Baseline in the Itch Assessment Score 4 Hours After Treatment	Baseline to four hours after treatment	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.
Change From Baseline in the Itch Assessment Score 5 Hours After Treatment	Baseline to five hours after treatment	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.
Change From Baseline in the Itch Assessment Score 6 Hours After Treatment	Baseline to six hours after treatment	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.
Change From Baseline in the Itch Assessment Score 7 Days After Treatment	Baseline to seven days after treatment	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.

Secondary

Measure	Time frame	Description
Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment	Baseline to Immediately following treatment	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.
Change From Baseline in Mean Corneometer Measurement 1 Hour After Treatment	Baseline to one hour after treatment	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.
Change From Baseline in Mean Corneometer Measurement 2 Hours After Treatment	Baseline to two hours after treatment	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.
Change From Baseline in Mean Corneometer Measurement 3 Hours After Treatment	Baseline to three hours after treatment	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.
Change From Baseline in Mean Corneometer Measurement 4 Hours After Treatment	Baseline to four hours after treatment	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.
Change From Baseline in Mean Corneometer Measurement 5 Hours After Treatment	Baseline to five hours after treatment	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.
Change From Baseline in Mean Corneometer Measurement 6 Hours After Treatment	Baseline to six hours after treatment	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.
Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment	Baseline to seven days after treatment	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.
Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin	0 Days - Pre-treatment	Questions were answered before treatment by the participant. The question is I wake up to calmer skin
Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin	0 Days - Pre-treatment	Questions were answered before treatment by the participant. The question is My skin feels smooth
Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin	0 Days - Pre-treatment	Questions were answered before treatment by the participant. The question is I feel comfortable showing my skin
Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin	0 Days - Pre-treatment	Questions were answered before treatment by the participant. The question is I'm less distracted by my itchy skin
Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin	0 Days - Pre-treatment	Questions were answered before treatment by the participant. The question is My skin feels moisturized
Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin	0 Days - Pre-treatment	Questions were answered before treatment by the participant. The question is My skin feels touchable
Participant Questionnaire on Day 0 Pre-treatment - Soft Skin	0 Days - Pre-treatment	Questions were answered before treatment by the participant. The question is My skin feels soft
Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days	0 Days - Pre-treatment	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
Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days	0 Days - Pre-treatment	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?
Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days	0 Days - Pre-treatment	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?
Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days	0 Days - Pre-treatment	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
Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture	Six hours after treatment	Questions were answered six hours after treatment by the participant. The question is This product provides long lasting moisture
Participant Questionnaire 6 Hours After Treatment - Calms Skin	Six hours after treatment	Questions were answered six hours after treatment by the participant. The question is This product calms my skin
Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin	Six hours after treatment	Questions were answered six hours after treatment by the participant. The question is I'm less distracted by my itchy skin
Participant Questionnaire Immediately After Treatment - Product Fast Absorbing	0 Days - Immediately after treatment	Questions were answered immediately after treatment by the participant. The question is This product is fast absorbing
Participant Questionnaire Immediately After Treatment - Calm Skin	0 Days - Immediately after treatment	Questions were answered immediately after treatment by the participant. The question is This product calms my skin
Participant Questionnaire Immediately After Treatment - Moisturized Skin	0 Days - Immediately after treatment	Questions were answered immediately after treatment by the participant. The question is This product leaves my skin feeling immediately moisturized
Participant Questionnaire Immediately After Treatment - Product Does Not Sting	0 Days - Immediately after treatment	Questions were answered immediately after treatment by the participant. The question is This product does not sting when applied
Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture	Four hours after treatment	Questions were answered four hours after treatment by the participant. The question is This product provides long lasting moisture
Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft	Four hours after treatment	Questions were answered four hours after treatment by the participant. The question is This product leaves my skin feeling soft
Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture	Five hours after treatment	Questions were answered five hours after treatment by the participant. The question is This product provides long lasting moisture
Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft	Five hours after treatment	Questions were answered five hours after treatment by the participant. The question is This product leaves my skin feeling soft
Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin	Six hours after treatment	Questions were answered six hours after treatment by the participant. The question is I feel comfortable showing my skin
Participant Questionnaire 6 Hours After Treatment - Shield for Skin	Six hours after treatment	Questions were answered six hours after treatment by the participant. The question is This product feels like a shield for my skin
Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized	Six hours after treatment	Questions were answered six hours after treatment by the participant. The question is This product leaves my skin feeling moisturized
Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable	Six hours after treatment	Questions were answered six hours after treatment by the participant. The question is This product makes my skin feel touchable
Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft	Six hours after treatment	Questions were answered six hours after treatment by the participant. The question is This product makes my skin feel soft
Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth	Six hours after treatment	Questions were answered six hours after treatment by the participant. The question is This product leaves my skin feeling smooth
Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin	Six hours after treatment	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
Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin	Six hours after treatment	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
Participant Questionnaire 7 Days After Treatment - Skin Feels Calm	Seven days after treatment	Questions were answered seven days after treatment by the participant. The question is This product calms my skin
Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin	Seven days after treatment	Questions were answered seven days after treatment by the participant. The question is I'm less distracted by my itchy skin
Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking	Seven days after treatment	Questions were answered seven days after treatment by the participant. The question is I wake up to calmer skin
Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin	Seven days after treatment	Questions were answered seven days after treatment by the participant. The question is I feel comfortable showing my skin
Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture	Seven days after treatment	Questions were answered seven days after treatment by the participant. The question is This product provides long lasting moisture to my skin
Participant Questionnaire 7 Days After Treatment - Shield for Skin	Seven days after treatment	Questions were answered seven days after treatment by the participant. The question is This product feels like a shield for my skin
Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized	Seven days after treatment	Questions were answered seven days after treatment by the participant. The question is This product leaves my skin feeling moisturized
Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable	Seven days after treatment	Questions were answered seven days after treatment by the participant. The question is This product makes my skin feel touchable
Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets	Seven days after treatment	Questions were answered seven days after treatment by the participant. The question is This product does not rub off on sheets
Participant Questionnaire 7 Days After Treatment - Skin Feels Soft	Seven days after treatment	Questions were answered seven days after treatment by the participant. The question is This product makes my skin feel soft
Participant Questionnaire 7 Days After Treatment - Moisturized All Day	Seven days after treatment	Questions were answered seven days after treatment by the participant. The question is This product leaves my skin feeling moisturized all day
Participant Questionnaire 7 Days After Treatment - Slept Better	Seven days after treatment	Questions were answered seven days after treatment by the participant. The question is I slept better due to less itching or skin discomfort
Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth	Seven days after treatment	Questions were answered seven days after treatment by the participant. The question is This product leaves my skin feeling smooth
Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin	Seven days after treatment	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
Participant Questionnaire 7 Days After Treatment - Skin on Waking	Seven days after treatment	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?
Participant Questionnaire 7 Days After Treatment - Degree of Sleep	7 days after treatment	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?
Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin	Seven days after treatment	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

Countries

United States

Participant flow

Participants by arm

Arm	Count
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)	40
EpiCeram Skin Barrier Emulsion EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)	13
Total	53

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Missed Visit 3	0	1

Baseline characteristics

Characteristic	1% Colloidal Oatmeal Balm	EpiCeram Skin Barrier Emulsion	Total
Age, Continuous	43.0 years STANDARD_DEVIATION 17.43	45.5 years STANDARD_DEVIATION 18.51	43.6 years STANDARD_DEVIATION 17.55
Gender Female	25 Participants	9 Participants	34 Participants
Gender Male	15 Participants	4 Participants	19 Participants
Region of Enrollment United States	40 participants	13 participants	53 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	6 / 40	1 / 13
serious Total, serious adverse events	0 / 40	0 / 13

Outcome results

Primary

Change From Baseline in the Itch Assessment Score 1 Hour After Treatment

The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

Time frame: Baseline to one hour after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Value (MEAN)	Dispersion
1% Colloidal Oatmeal Balm	Change From Baseline in the Itch Assessment Score 1 Hour After Treatment	3.00 units on a scale	Standard Deviation 2.624
EpiCeram Skin Barrier Emulsion	Change From Baseline in the Itch Assessment Score 1 Hour After Treatment	3.08 units on a scale	Standard Deviation 2.559

Comparison: The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.p-value: <0.001Paired t-test

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.29795% CI: [-0.767, 2.46]ANCOVA

Primary

Change From Baseline in the Itch Assessment Score 2 Hours After Treatment

The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

Time frame: Baseline to two hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Value (MEAN)	Dispersion
1% Colloidal Oatmeal Balm	Change From Baseline in the Itch Assessment Score 2 Hours After Treatment	3.46 units on a scale	Standard Deviation 2.849
EpiCeram Skin Barrier Emulsion	Change From Baseline in the Itch Assessment Score 2 Hours After Treatment	3.65 units on a scale	Standard Deviation 2.236

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.39495% CI: [-0.973, 2.426]ANCOVA

Primary

Change From Baseline in the Itch Assessment Score 3 Hours After Treatment

The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

Time frame: Baseline to three hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Value (MEAN)	Dispersion
1% Colloidal Oatmeal Balm	Change From Baseline in the Itch Assessment Score 3 Hours After Treatment	3.93 units on a scale	Standard Deviation 2.635
EpiCeram Skin Barrier Emulsion	Change From Baseline in the Itch Assessment Score 3 Hours After Treatment	4.88 units on a scale	Standard Deviation 2.094

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.6995% CI: [-1.14, 1.709]ANCOVA

Primary

Change From Baseline in the Itch Assessment Score 4 Hours After Treatment

The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

Time frame: Baseline to four hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Value (MEAN)	Dispersion
1% Colloidal Oatmeal Balm	Change From Baseline in the Itch Assessment Score 4 Hours After Treatment	3.85 units on a scale	Standard Deviation 2.58
EpiCeram Skin Barrier Emulsion	Change From Baseline in the Itch Assessment Score 4 Hours After Treatment	4.92 units on a scale	Standard Deviation 2.048

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.91495% CI: [-1.556, 1.397]ANCOVA

Primary

Change From Baseline in the Itch Assessment Score 5 Hours After Treatment

The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

Time frame: Baseline to five hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Value (MEAN)	Dispersion
1% Colloidal Oatmeal Balm	Change From Baseline in the Itch Assessment Score 5 Hours After Treatment	4.06 units on a scale	Standard Deviation 2.721
EpiCeram Skin Barrier Emulsion	Change From Baseline in the Itch Assessment Score 5 Hours After Treatment	5.25 units on a scale	Standard Deviation 1.846

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.75795% CI: [-1.796, 1.314]ANCOVA

Primary

Change From Baseline in the Itch Assessment Score 6 Hours After Treatment

The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

Time frame: Baseline to six hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Value (MEAN)	Dispersion
1% Colloidal Oatmeal Balm	Change From Baseline in the Itch Assessment Score 6 Hours After Treatment	4.07 units on a scale	Standard Deviation 2.824
EpiCeram Skin Barrier Emulsion	Change From Baseline in the Itch Assessment Score 6 Hours After Treatment	5.55 units on a scale	Standard Deviation 1.884

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.55695% CI: [-2.075, 1.129]ANCOVA

Primary

Change From Baseline in the Itch Assessment Score 7 Days After Treatment

The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

Time frame: Baseline to seven days after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Value (MEAN)	Dispersion
1% Colloidal Oatmeal Balm	Change From Baseline in the Itch Assessment Score 7 Days After Treatment	4.22 units on a scale	Standard Deviation 2.815
EpiCeram Skin Barrier Emulsion	Change From Baseline in the Itch Assessment Score 7 Days After Treatment	6.53 units on a scale	Standard Deviation 1.432

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.10695% CI: [-2.824, 0.278]ANCOVA

Primary

Change From Baseline in the Itch Assessment Score Immediately Following Treatment

The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

Time frame: Baseline to immediately following treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Value (MEAN)	Dispersion
1% Colloidal Oatmeal Balm	Change From Baseline in the Itch Assessment Score Immediately Following Treatment	1.93 units on a scale	Standard Deviation 2.753
EpiCeram Skin Barrier Emulsion	Change From Baseline in the Itch Assessment Score Immediately Following Treatment	2.64 units on a scale	Standard Deviation 2.482

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.61695% CI: [-1.196, 1.998]ANCOVA

Secondary

Change From Baseline in Mean Corneometer Measurement 1 Hour After Treatment

Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.

Time frame: Baseline to one hour after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Value (MEAN)	Dispersion
1% Colloidal Oatmeal Balm	Change From Baseline in Mean Corneometer Measurement 1 Hour After Treatment	27.00 arbitrary units	Standard Deviation 14.998
EpiCeram Skin Barrier Emulsion	Change From Baseline in Mean Corneometer Measurement 1 Hour After Treatment	7.84 arbitrary units	Standard Deviation 7.881

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [11.301, 27.352]ANCOVA

Secondary

Change From Baseline in Mean Corneometer Measurement 2 Hours After Treatment

Time frame: Baseline to two hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Value (MEAN)	Dispersion
1% Colloidal Oatmeal Balm	Change From Baseline in Mean Corneometer Measurement 2 Hours After Treatment	23.20 arbitrary units	Standard Deviation 14.418
EpiCeram Skin Barrier Emulsion	Change From Baseline in Mean Corneometer Measurement 2 Hours After Treatment	7.32 arbitrary units	Standard Deviation 8.525

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [7.829, 24.187]ANCOVA

Secondary

Change From Baseline in Mean Corneometer Measurement 3 Hours After Treatment

Time frame: Baseline to three hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Value (MEAN)	Dispersion
1% Colloidal Oatmeal Balm	Change From Baseline in Mean Corneometer Measurement 3 Hours After Treatment	21.05 arbitrary units	Standard Deviation 13.373
EpiCeram Skin Barrier Emulsion	Change From Baseline in Mean Corneometer Measurement 3 Hours After Treatment	8.07 arbitrary units	Standard Deviation 7.706

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [5.684, 20.82]ANCOVA

Secondary

Change From Baseline in Mean Corneometer Measurement 4 Hours After Treatment

Time frame: Baseline to four hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Value (MEAN)	Dispersion
1% Colloidal Oatmeal Balm	Change From Baseline in Mean Corneometer Measurement 4 Hours After Treatment	19.65 arbitrary units	Standard Deviation 15.249
EpiCeram Skin Barrier Emulsion	Change From Baseline in Mean Corneometer Measurement 4 Hours After Treatment	5.75 arbitrary units	Standard Deviation 9.491

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.00195% CI: [5.766, 22.387]ANCOVA

Secondary

Change From Baseline in Mean Corneometer Measurement 5 Hours After Treatment

Time frame: Baseline to five hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Value (MEAN)	Dispersion
1% Colloidal Oatmeal Balm	Change From Baseline in Mean Corneometer Measurement 5 Hours After Treatment	21.48 arbitrary units	Standard Deviation 15.98
EpiCeram Skin Barrier Emulsion	Change From Baseline in Mean Corneometer Measurement 5 Hours After Treatment	7.31 arbitrary units	Standard Deviation 10.205

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.00495% CI: [4.862, 23.66]ANCOVA

Secondary

Change From Baseline in Mean Corneometer Measurement 6 Hours After Treatment

Time frame: Baseline to six hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Value (MEAN)	Dispersion
1% Colloidal Oatmeal Balm	Change From Baseline in Mean Corneometer Measurement 6 Hours After Treatment	18.71 arbitrary units	Standard Deviation 14.882
EpiCeram Skin Barrier Emulsion	Change From Baseline in Mean Corneometer Measurement 6 Hours After Treatment	6.05 arbitrary units	Standard Deviation 7.687

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.00495% CI: [4.291, 21.252]ANCOVA

Secondary

Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment

Time frame: Baseline to seven days after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Value (MEAN)	Dispersion
1% Colloidal Oatmeal Balm	Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment	21.01 arbitrary units	Standard Deviation 19.743
EpiCeram Skin Barrier Emulsion	Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment	7.99 arbitrary units	Standard Deviation 11.404

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.03795% CI: [0.805, 24.621]ANCOVA

Secondary

Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment

Time frame: Baseline to Immediately following treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Value (MEAN)	Dispersion
1% Colloidal Oatmeal Balm	Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment	48.26 arbitrary units	Standard Deviation 24.913
EpiCeram Skin Barrier Emulsion	Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment	21.71 arbitrary units	Standard Deviation 13.665

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [13.407, 40.247]ANCOVA

Secondary

Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture

Questions were answered four hours after treatment by the participant. The question is This product provides long lasting moisture

Time frame: Four hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture	Strongly agree	55.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture	Somewhat agree	25.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture	Neither agree or disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture	Somewhat disagree	10.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture	Strongly disagree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture	I don't have an opinion	2.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture	Strongly disagree	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture	Strongly agree	38.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture	Somewhat disagree	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture	Somewhat agree	46.2 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft

Questions were answered four hours after treatment by the participant. The question is This product leaves my skin feeling soft

Time frame: Four hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft	Strongly agree	40.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft	Somewhat agree	45.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft	Neither agree or disagree	7.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft	Somewhat disagree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft	Strongly disagree	0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft	I don't have an opinion	2.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft	Strongly disagree	15.4 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft	Strongly agree	46.2 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft	Somewhat disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft	Somewhat agree	38.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture

Questions were answered five hours after treatment by the participant. The question is This product provides long lasting moisture

Time frame: Five hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture	Strongly agree	60.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture	Somewhat agree	27.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture	Neither agree or disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture	Somewhat disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture	Strongly disagree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture	I don't have an opinion	2.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture	Strongly disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture	Strongly agree	61.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture	Somewhat disagree	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture	Somewhat agree	30.8 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft

Questions were answered five hours after treatment by the participant. The question is This product leaves my skin feeling soft

Time frame: Five hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft	Strongly agree	47.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft	Somewhat agree	35.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft	Neither agree or disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft	Somewhat disagree	7.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft	Strongly disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft	I don't have an opinion	5.0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft	Strongly disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft	Strongly agree	53.8 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft	Somewhat disagree	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft	Somewhat agree	30.8 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft	Neither agree or disagree	7.7 percentage of participants

Secondary

Participant Questionnaire 6 Hours After Treatment - Calms Skin

Questions were answered six hours after treatment by the participant. The question is This product calms my skin

Time frame: Six hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Calms Skin	Strongly agree	47.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Calms Skin	Somewhat agree	35.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Calms Skin	Neither agree or disagree	7.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Calms Skin	Somewhat disagree	7.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Calms Skin	Strongly disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Calms Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Calms Skin	Strongly disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Calms Skin	Strongly agree	61.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Calms Skin	Somewhat disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Calms Skin	Somewhat agree	30.8 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Calms Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Calms Skin	Neither agree or disagree	7.7 percentage of participants

Secondary

Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin

Questions were answered six hours after treatment by the participant. The question is I feel comfortable showing my skin

Time frame: Six hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin	Strongly agree	35.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin	Somewhat agree	30.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin	Neither agree or disagree	15.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin	Somewhat disagree	12.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin	Strongly disagree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin	I don't have an opinion	2.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin	Strongly disagree	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin	Strongly agree	38.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin	Somewhat disagree	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin	Somewhat agree	38.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin	Neither agree or disagree	7.7 percentage of participants

Secondary

Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin

Questions were answered six hours after treatment by the participant. The question is Thinking about how comfortable you felt showing your skin after using this product, would you say that you were

Time frame: Six hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin	Extremely comfortable	22.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin	Very comfortable	27.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin	Moderately comfortable	40.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin	Slightly comfortable	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin	Not at all comfortable	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin	I don't have an opinion	5.0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin	Not at all comfortable	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin	Extremely comfortable	23.1 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin	Slightly comfortable	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin	Very comfortable	30.8 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin	Moderately comfortable	30.8 percentage of participants

Secondary

Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin

Questions were answered six hours after treatment by the participant. The question is Thinking about your experience after using this product, please describe your degree of being distracted by your itchy, eczema skin. Would you say you were

Time frame: Six hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin	Not at all distracted	35.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin	Slightly distracted	40.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin	Moderately distracted	17.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin	Very distracted	7.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin	Extremely distracted	0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin	Extremely distracted	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin	Not at all distracted	23.1 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin	Very distracted	15.4 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin	Slightly distracted	46.2 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin	Moderately distracted	15.4 percentage of participants

Secondary

Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin

Questions were answered six hours after treatment by the participant. The question is I'm less distracted by my itchy skin

Time frame: Six hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin	Strongly agree	52.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin	Somewhat agree	27.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin	Neither agree or disagree	12.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin	Somewhat disagree	7.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin	Strongly disagree	0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin	Strongly disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin	Strongly agree	53.8 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin	Somewhat disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin	Somewhat agree	38.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin	Neither agree or disagree	7.7 percentage of participants

Secondary

Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture

Questions were answered six hours after treatment by the participant. The question is This product provides long lasting moisture

Time frame: Six hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture	Strongly agree	60.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture	Somewhat agree	27.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture	Neither agree or disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture	Somewhat disagree	10.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture	Strongly disagree	0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture	Strongly disagree	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture	Strongly agree	38.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture	Somewhat disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture	Somewhat agree	53.8 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire 6 Hours After Treatment - Shield for Skin

Questions were answered six hours after treatment by the participant. The question is This product feels like a shield for my skin

Time frame: Six hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Shield for Skin	Strongly agree	37.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Shield for Skin	Somewhat agree	37.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Shield for Skin	Neither agree or disagree	17.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Shield for Skin	Somewhat disagree	7.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Shield for Skin	Strongly disagree	0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Shield for Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Shield for Skin	Strongly disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Shield for Skin	Strongly agree	38.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Shield for Skin	Somewhat disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Shield for Skin	Somewhat agree	61.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Shield for Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Shield for Skin	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized

Questions were answered six hours after treatment by the participant. The question is This product leaves my skin feeling moisturized

Time frame: Six hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized	Strongly agree	57.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized	Somewhat agree	27.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized	Neither agree or disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized	Somewhat disagree	10.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized	Strongly disagree	0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized	I don't have an opinion	2.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized	Strongly disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized	Strongly agree	46.2 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized	Somewhat disagree	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized	Somewhat agree	38.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized	Neither agree or disagree	7.7 percentage of participants

Secondary

Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth

Questions were answered six hours after treatment by the participant. The question is This product leaves my skin feeling smooth

Time frame: Six hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth	Strongly agree	45.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth	Somewhat agree	32.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth	Neither agree or disagree	7.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth	Somewhat disagree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth	Strongly disagree	7.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth	I don't have an opinion	2.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth	Strongly disagree	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth	Strongly agree	53.8 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth	Somewhat disagree	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth	Somewhat agree	30.8 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft

Questions were answered six hours after treatment by the participant. The question is This product makes my skin feel soft

Time frame: Six hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft	Strongly agree	50.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft	Somewhat agree	30.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft	Neither agree or disagree	10.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft	Somewhat disagree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft	Strongly disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft	I don't have an opinion	2.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft	Strongly disagree	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft	Strongly agree	53.8 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft	Somewhat disagree	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft	Somewhat agree	30.8 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable

Questions were answered six hours after treatment by the participant. The question is This product makes my skin feel touchable

Time frame: Six hours after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable	Strongly agree	42.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable	Somewhat agree	35.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable	Neither agree or disagree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable	Somewhat disagree	12.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable	Strongly disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable	I don't have an opinion	2.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable	Strongly disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable	Strongly agree	61.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable	Somewhat disagree	15.4 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable	Somewhat agree	15.4 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable	Neither agree or disagree	7.7 percentage of participants

Secondary

Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking

Questions were answered seven days after treatment by the participant. The question is I wake up to calmer skin

Time frame: Seven days after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking	Strongly agree	65.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking	Somewhat agree	20.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking	Neither agree or disagree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking	Somewhat disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking	Strongly disagree	7.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking	Strongly disagree	8.3 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking	Strongly agree	66.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking	Somewhat disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking	Somewhat agree	25.0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin

Questions were answered seven days after treatment by the participant. The question is I feel comfortable showing my skin

Time frame: Seven days after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin	Strongly agree	42.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin	Somewhat agree	32.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin	Neither agree or disagree	7.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin	Somewhat disagree	12.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin	Strongly disagree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin	Strongly disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin	Strongly agree	50.0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin	Somewhat disagree	8.3 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin	Somewhat agree	41.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin

Questions were answered seven days after treatment by the participant. The question is Thinking about how comfortable you felt showing your skin while using this product, would you say that you were

Time frame: Seven days after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin	Extremely comfortable	25.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin	Very comfortable	37.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin	Moderately comfortable	17.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin	Slightly comfortable	17.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin	Not at all comfortable	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin	Not at all comfortable	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin	Extremely comfortable	25.0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin	Slightly comfortable	8.3 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin	Very comfortable	33.3 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin	Moderately comfortable	33.3 percentage of participants

Secondary

Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin

Questions were answered seven days after treatment by the participant. The question is Thinking about your experience while using this product, please describe your degree of being distracted by your itchy, eczema skin. Would you say you were

Time frame: Seven days after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin	Not at all distracted	33.3 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin	Slightly distracted	56.4 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin	Moderately distracted	5.1 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin	Very distracted	0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin	Extremely distracted	5.1 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin	Extremely distracted	16.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin	Not at all distracted	33.3 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin	Very distracted	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin	Slightly distracted	50.0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin	Moderately distracted	0 percentage of participants

Secondary

Participant Questionnaire 7 Days After Treatment - Degree of Sleep

Questions were answered seven days after treatment by the participant. The question is Thinking about how well you slept when using this product, would you say your sleep was?

Time frame: 7 days after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Degree of Sleep	Very good	45.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Degree of Sleep	Moderately good	30.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Degree of Sleep	Neither bad nor good	20.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Degree of Sleep	Moderately bad	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Degree of Sleep	Very bad	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Degree of Sleep	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Degree of Sleep	Very bad	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Degree of Sleep	Very good	50.0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Degree of Sleep	Moderately bad	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Degree of Sleep	Moderately good	50.0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Degree of Sleep	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Degree of Sleep	Neither bad nor good	0 percentage of participants

Secondary

Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin

Questions were answered seven days after treatment by the participant. The question is I'm less distracted by my itchy skin

Time frame: Seven days after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin	Strongly agree	55.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin	Somewhat agree	32.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin	Neither agree or disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin	Somewhat disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin	Strongly disagree	7.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin	Strongly disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin	Strongly agree	83.3 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin	Somewhat disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin	Somewhat agree	16.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture

Questions were answered seven days after treatment by the participant. The question is This product provides long lasting moisture to my skin

Time frame: Seven days after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture	Strongly agree	65.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture	Somewhat agree	22.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture	Neither agree or disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture	Somewhat disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture	Strongly disagree	7.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture	Strongly disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture	Strongly agree	50.0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture	Somewhat disagree	8.3 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture	Somewhat agree	41.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire 7 Days After Treatment - Moisturized All Day

Questions were answered seven days after treatment by the participant. The question is This product leaves my skin feeling moisturized all day

Time frame: Seven days after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Moisturized All Day	Strongly agree	67.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Moisturized All Day	Somewhat agree	17.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Moisturized All Day	Neither agree or disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Moisturized All Day	Somewhat disagree	7.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Moisturized All Day	Strongly disagree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Moisturized All Day	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Moisturized All Day	Strongly disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Moisturized All Day	Strongly agree	33.3 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Moisturized All Day	Somewhat disagree	16.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Moisturized All Day	Somewhat agree	50.0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Moisturized All Day	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Moisturized All Day	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets

Questions were answered seven days after treatment by the participant. The question is This product does not rub off on sheets

Time frame: Seven days after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets	Strongly agree	42.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets	Somewhat agree	25.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets	Neither agree or disagree	10.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets	Somewhat disagree	10.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets	Strongly disagree	12.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets	Strongly disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets	Strongly agree	83.3 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets	Somewhat disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets	Somewhat agree	16.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire 7 Days After Treatment - Shield for Skin

Questions were answered seven days after treatment by the participant. The question is This product feels like a shield for my skin

Time frame: Seven days after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Shield for Skin	Strongly agree	52.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Shield for Skin	Somewhat agree	30.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Shield for Skin	Neither agree or disagree	12.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Shield for Skin	Somewhat disagree	0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Shield for Skin	Strongly disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Shield for Skin	I don't have an opinion	2.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Shield for Skin	Strongly disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Shield for Skin	Strongly agree	66.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Shield for Skin	Somewhat disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Shield for Skin	Somewhat agree	25.0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Shield for Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Shield for Skin	Neither agree or disagree	8.3 percentage of participants

Secondary

Participant Questionnaire 7 Days After Treatment - Skin Feels Calm

Questions were answered seven days after treatment by the participant. The question is This product calms my skin

Time frame: Seven days after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Calm	Somewhat agree	32.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Calm	Somewhat disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Calm	Strongly agree	60.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Calm	Strongly disagree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Calm	Neither agree or disagree	0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Calm	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Calm	Neither agree or disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Calm	Strongly agree	66.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Calm	Somewhat agree	33.3 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Calm	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Calm	Somewhat disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Calm	Strongly disagree	0 percentage of participants

Secondary

Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized

Questions were answered seven days after treatment by the participant. The question is This product leaves my skin feeling moisturized

Time frame: Seven days after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized	Strongly agree	72.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized	Somewhat agree	22.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized	Neither agree or disagree	0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized	Somewhat disagree	0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized	Strongly disagree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized	Strongly disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized	Strongly agree	50.0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized	Somewhat disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized	Somewhat agree	50.0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth

Questions were answered seven days after treatment by the participant. The question is This product leaves my skin feeling smooth

Time frame: Seven days after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth	Strongly agree	60.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth	Somewhat agree	27.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth	Neither agree or disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth	Somewhat disagree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth	Strongly disagree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth	Strongly disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth	Strongly agree	66.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth	Somewhat disagree	8.3 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth	Somewhat agree	25.0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire 7 Days After Treatment - Skin Feels Soft

Questions were answered seven days after treatment by the participant. The question is This product makes my skin feel soft

Time frame: Seven days after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Soft	Strongly agree	65.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Soft	Somewhat agree	27.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Soft	Neither agree or disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Soft	Somewhat disagree	0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Soft	Strongly disagree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Soft	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Soft	Strongly disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Soft	Strongly agree	50.0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Soft	Somewhat disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Soft	Somewhat agree	50.0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Soft	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Soft	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable

Questions were answered seven days after treatment by the participant. The question is This product makes my skin feel touchable

Time frame: Seven days after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable	Strongly agree	57.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable	Somewhat agree	22.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable	Neither agree or disagree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable	Somewhat disagree	10.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable	Strongly disagree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable	Strongly disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable	Strongly agree	41.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable	Somewhat disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable	Somewhat agree	58.3 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire 7 Days After Treatment - Skin on Waking

Questions were answered seven days after treatment by the participant. The question is Thinking about your experience when using this product, how would you describe your skin upon awakening?

Time frame: Seven days after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin on Waking	Extremely calm	32.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin on Waking	Very calm	30.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin on Waking	Moderately calm	27.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin on Waking	Slightly calm	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin on Waking	Not at all calm	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Skin on Waking	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin on Waking	Not at all calm	8.3 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin on Waking	Extremely calm	8.3 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin on Waking	Slightly calm	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin on Waking	Very calm	58.3 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin on Waking	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Skin on Waking	Moderately calm	25.0 percentage of participants

Secondary

Participant Questionnaire 7 Days After Treatment - Slept Better

Questions were answered seven days after treatment by the participant. The question is I slept better due to less itching or skin discomfort

Time frame: Seven days after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Slept Better	Strongly agree	45.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Slept Better	Somewhat agree	30.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Slept Better	Neither agree or disagree	17.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Slept Better	Somewhat disagree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Slept Better	Strongly disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire 7 Days After Treatment - Slept Better	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Slept Better	Strongly disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Slept Better	Strongly agree	41.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Slept Better	Somewhat disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Slept Better	Somewhat agree	58.3 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Slept Better	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire 7 Days After Treatment - Slept Better	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire Immediately After Treatment - Calm Skin

Questions were answered immediately after treatment by the participant. The question is This product calms my skin

Time frame: 0 Days - Immediately after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Calm Skin	Strongly agree	30.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Calm Skin	Somewhat agree	37.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Calm Skin	Neither agree or disagree	15.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Calm Skin	Somewhat disagree	12.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Calm Skin	Strongly disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Calm Skin	I don't have an opinion	2.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Calm Skin	Strongly disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Calm Skin	Strongly agree	53.8 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Calm Skin	Somewhat disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Calm Skin	Somewhat agree	38.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Calm Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Calm Skin	Neither agree or disagree	7.7 percentage of participants

Secondary

Participant Questionnaire Immediately After Treatment - Moisturized Skin

Questions were answered immediately after treatment by the participant. The question is This product leaves my skin feeling immediately moisturized

Time frame: 0 Days - Immediately after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Moisturized Skin	Strongly agree	42.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Moisturized Skin	Somewhat agree	40.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Moisturized Skin	Neither agree or disagree	15.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Moisturized Skin	Somewhat disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Moisturized Skin	Strongly disagree	0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Moisturized Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Moisturized Skin	Strongly disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Moisturized Skin	Strongly agree	38.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Moisturized Skin	Somewhat disagree	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Moisturized Skin	Somewhat agree	46.2 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Moisturized Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Moisturized Skin	Neither agree or disagree	7.7 percentage of participants

Secondary

Participant Questionnaire Immediately After Treatment - Product Does Not Sting

Questions were answered immediately after treatment by the participant. The question is This product does not sting when applied

Time frame: 0 Days - Immediately after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Product Does Not Sting	Strongly agree	50.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Product Does Not Sting	Somewhat agree	32.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Product Does Not Sting	Neither agree or disagree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Product Does Not Sting	Somewhat disagree	10.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Product Does Not Sting	Strongly disagree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Product Does Not Sting	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Product Does Not Sting	Strongly disagree	15.4 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Product Does Not Sting	Strongly agree	53.8 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Product Does Not Sting	Somewhat disagree	23.1 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Product Does Not Sting	Somewhat agree	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Product Does Not Sting	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Product Does Not Sting	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire Immediately After Treatment - Product Fast Absorbing

Questions were answered immediately after treatment by the participant. The question is This product is fast absorbing

Time frame: 0 Days - Immediately after treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Product Fast Absorbing	Strongly agree	22.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Product Fast Absorbing	Somewhat agree	42.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Product Fast Absorbing	Neither agree or disagree	15.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Product Fast Absorbing	Somewhat disagree	12.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Product Fast Absorbing	Strongly disagree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire Immediately After Treatment - Product Fast Absorbing	I don't have an opinion	2.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Product Fast Absorbing	Strongly disagree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Product Fast Absorbing	Strongly agree	53.8 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Product Fast Absorbing	Somewhat disagree	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Product Fast Absorbing	Somewhat agree	38.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Product Fast Absorbing	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire Immediately After Treatment - Product Fast Absorbing	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin

Questions were answered before treatment by the participant. The question is I wake up to calmer skin

Time frame: 0 Days - Pre-treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin	Strongly agree	10.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin	Somewhat agree	10.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin	Neither agree or disagree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin	Somewhat disagree	37.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin	Strongly disagree	37.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin	Strongly disagree	46.2 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin	Strongly agree	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin	Somewhat disagree	23.1 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin	Somewhat agree	23.1 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin

Questions were answered before treatment by the participant. The question is I feel comfortable showing my skin

Time frame: 0 Days - Pre-treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin	Strongly agree	15.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin	Somewhat agree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin	Neither agree or disagree	12.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin	Somewhat disagree	25.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin	Strongly disagree	37.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin	I don't have an opinion	5.0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin	Strongly disagree	46.2 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin	Strongly agree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin	Somewhat disagree	15.4 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin	Somewhat agree	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin	Neither agree or disagree	30.8 percentage of participants

Secondary

Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days

Questions were answered before treatment by the participant. The question is Thinking about how comfortable you felt showing your skin during the last two days, would you say that you were

Time frame: 0 Days - Pre-treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days	Extremely comfortable	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days	Very comfortable	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days	Moderately comfortable	27.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days	Slightly comfortable	30.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days	Not at all comfortable	32.5 percentage of participants
1% Colloidal Oatmeal Balm	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
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days	Not at all comfortable	69.2 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days	Extremely comfortable	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days	Slightly comfortable	23.1 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days	Very comfortable	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days	Moderately comfortable	7.7 percentage of participants

Secondary

Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days

Questions were answered before treatment by the participant. The question is Thinking about your experience over the past two days, please describe your degree of being distracted by your itchy, eczema skin. Would you say you were

Time frame: 0 Days - Pre-treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	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
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days	Slightly distracted	7.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days	Moderately distracted	35.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days	Very distracted	37.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days	Extremely distracted	17.5 percentage of participants
1% Colloidal Oatmeal Balm	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
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days	Extremely distracted	15.4 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days	Not at all distracted	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days	Very distracted	61.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days	Slightly distracted	0 percentage of participants
EpiCeram Skin Barrier Emulsion	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
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days	Moderately distracted	23.1 percentage of participants

Secondary

Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin

Questions were answered before treatment by the participant. The question is I'm less distracted by my itchy skin

Time frame: 0 Days - Pre-treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin	Strongly agree	7.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin	Somewhat agree	7.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin	Neither agree or disagree	7.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin	Somewhat disagree	37.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin	Strongly disagree	40.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin	Strongly disagree	61.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin	Strongly agree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin	Somewhat disagree	38.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin	Somewhat agree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin

Questions were answered before treatment by the participant. The question is My skin feels moisturized

Time frame: 0 Days - Pre-treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin	Strongly agree	0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin	Somewhat agree	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin	Neither agree or disagree	7.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin	Somewhat disagree	27.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin	Strongly disagree	60.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin	Strongly disagree	76.9 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin	Strongly agree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin	Somewhat disagree	23.1 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin	Somewhat agree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin	Neither agree or disagree	0 percentage of participants

Secondary

Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days

Questions were answered before treatment by the participant. The question is Thinking about your experience over the past two days, how would you describe your skin upon awakening?

Time frame: 0 Days - Pre-treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days	Extremely calm	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days	Very calm	0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days	Moderately calm	22.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days	Slightly calm	30.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days	Not at all calm	35.0 percentage of participants
1% Colloidal Oatmeal Balm	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
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days	Not at all calm	53.8 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days	Extremely calm	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days	Slightly calm	23.1 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days	Very calm	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days	Moderately calm	15.4 percentage of participants

Secondary

Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days

Questions were answered before treatment by the participant. The question is Thinking about how well you slept during the past two days, would you say your sleep was?

Time frame: 0 Days - Pre-treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days	Very good	5.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days	Moderately good	25.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days	Neither bad nor good	15.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days	Moderately bad	37.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days	Very bad	17.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days	Very bad	15.4 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days	Very good	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days	Moderately bad	46.2 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days	Moderately good	23.1 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days	Neither bad nor good	15.4 percentage of participants

Secondary

Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin

Questions were answered before treatment by the participant. The question is My skin feels smooth

Time frame: 0 Days - Pre-treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin	Strongly agree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin	Somewhat agree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin	Neither agree or disagree	10.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin	Somewhat disagree	32.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin	Strongly disagree	52.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin	Strongly disagree	69.2 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin	Strongly agree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin	Somewhat disagree	23.1 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin	Somewhat agree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin	Neither agree or disagree	7.7 percentage of participants

Secondary

Participant Questionnaire on Day 0 Pre-treatment - Soft Skin

Questions were answered before treatment by the participant. The question is My skin feels soft

Time frame: 0 Days - Pre-treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Soft Skin	Strongly agree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Soft Skin	Somewhat agree	2.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Soft Skin	Neither agree or disagree	10.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Soft Skin	Somewhat disagree	30.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Soft Skin	Strongly disagree	50.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Soft Skin	I don't have an opinion	5.0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Soft Skin	Strongly disagree	61.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Soft Skin	Strongly agree	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Soft Skin	Somewhat disagree	15.4 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Soft Skin	Somewhat agree	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Soft Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Soft Skin	Neither agree or disagree	15.4 percentage of participants

Secondary

Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin

Questions were answered before treatment by the participant. The question is My skin feels touchable

Time frame: 0 Days - Pre-treatment

Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.

Arm	Measure	Group	Value (NUMBER)
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin	Strongly agree	7.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin	Somewhat agree	10.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin	Neither agree or disagree	7.5 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin	Somewhat disagree	40.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin	Strongly disagree	30.0 percentage of participants
1% Colloidal Oatmeal Balm	Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin	I don't have an opinion	5.0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin	Strongly disagree	38.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin	Strongly agree	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin	Somewhat disagree	38.5 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin	Somewhat agree	7.7 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin	I don't have an opinion	0 percentage of participants
EpiCeram Skin Barrier Emulsion	Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin	Neither agree or disagree	7.7 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Change From Baseline in the Itch Assessment Score 1 Hour After Treatment

Change From Baseline in the Itch Assessment Score 2 Hours After Treatment

Change From Baseline in the Itch Assessment Score 3 Hours After Treatment

Change From Baseline in the Itch Assessment Score 4 Hours After Treatment

Change From Baseline in the Itch Assessment Score 5 Hours After Treatment

Change From Baseline in the Itch Assessment Score 6 Hours After Treatment

Change From Baseline in the Itch Assessment Score 7 Days After Treatment

Change From Baseline in the Itch Assessment Score Immediately Following Treatment

Change From Baseline in Mean Corneometer Measurement 1 Hour After Treatment

Change From Baseline in Mean Corneometer Measurement 2 Hours After Treatment

Change From Baseline in Mean Corneometer Measurement 3 Hours After Treatment

Change From Baseline in Mean Corneometer Measurement 4 Hours After Treatment

Change From Baseline in Mean Corneometer Measurement 5 Hours After Treatment

Change From Baseline in Mean Corneometer Measurement 6 Hours After Treatment

Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment

Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment

Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture

Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft

Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture

Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft

Participant Questionnaire 6 Hours After Treatment - Calms Skin

Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin

Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin

Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin

Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin

Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture

Participant Questionnaire 6 Hours After Treatment - Shield for Skin

Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized

Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth

Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft

Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable

Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking

Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin

Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin

Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin

Participant Questionnaire 7 Days After Treatment - Degree of Sleep

Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin

Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture

Participant Questionnaire 7 Days After Treatment - Moisturized All Day

Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets

Participant Questionnaire 7 Days After Treatment - Shield for Skin

Participant Questionnaire 7 Days After Treatment - Skin Feels Calm

Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized

Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth

Participant Questionnaire 7 Days After Treatment - Skin Feels Soft

Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable

Participant Questionnaire 7 Days After Treatment - Skin on Waking

Participant Questionnaire 7 Days After Treatment - Slept Better

Participant Questionnaire Immediately After Treatment - Calm Skin

Participant Questionnaire Immediately After Treatment - Moisturized Skin

Participant Questionnaire Immediately After Treatment - Product Does Not Sting

Participant Questionnaire Immediately After Treatment - Product Fast Absorbing

Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin

Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin

Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days

Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days

Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin

Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin