Trial Outcomes & Findings for Test to Determine the Effectiveness of Moisturizing Balm Used on Babies With Dry, Itchy Skin (NCT NCT02404493)

NCT ID: NCT02404493

Last Updated: 2017-03-24

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: Day 0 - Pretreatment (Baseline) to Day 0 - immediately post treatment
• Results posted on: 2017-03-24

Participant Flow

Participant milestones

Measure	1% Colloidal Oatmeal Balm 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Overall Study STARTED	17	6
Overall Study COMPLETED	16	5
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	1% Colloidal Oatmeal Balm 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Overall Study Adverse Event	1	1

Baseline Characteristics

Test to Determine the Effectiveness of Moisturizing Balm Used on Babies With Dry, Itchy Skin

Baseline characteristics by cohort

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed	Total n=23 Participants Total of all reporting groups
Age, Continuous	21.8 months STANDARD_DEVIATION 9.66 • n=5 Participants	22.5 months STANDARD_DEVIATION 10.78 • n=7 Participants	22.0 months STANDARD_DEVIATION 9.72 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment USA	17 participants n=5 Participants	6 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 - Pretreatment (Baseline) to Day 0 - immediately post treatment

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

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

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment	656.31 arbitrary units Standard Deviation 273.322	234.72 arbitrary units Standard Deviation 176.566

PRIMARY outcome

Timeframe: Day 0 - Pretreatment (Baseline) to 12 Hours After treatment

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

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

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Change From Baseline in Mean Corneometer Measurement 12 Hours After Treatment	55.12 arbitrary units Standard Deviation 47.124	2.11 arbitrary units Standard Deviation 15.629

SECONDARY outcome

Timeframe: Day 0 - Pretreatment (Baseline) to 24 Hours After treatment

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

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

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Change From Baseline in Mean Corneometer Measurement 24 Hours After Treatment	178.35 arbitrary units Standard Deviation 138.651	14.83 arbitrary units Standard Deviation 29.347

SECONDARY outcome

Timeframe: Day 0 - Pretreatment (Baseline) to 3 Days After treatment

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

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

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Change From Baseline in Mean Corneometer Measurement 3 Days After Treatment	226.85 arbitrary units Standard Deviation 244.028	8.17 arbitrary units Standard Deviation 15.769

SECONDARY outcome

Timeframe: Day 0 - Pretreatment (Baseline) to 7 Days After treatment

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

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

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment	208.52 arbitrary units Standard Deviation 169.098	17.50 arbitrary units Standard Deviation 30.615

SECONDARY outcome

Timeframe: Day 0 - Pretreatment (Baseline) to 14 Days After treatment

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

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

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Change From Baseline in Mean Corneometer Measurement 14 Days After Treatment	158.65 arbitrary units Standard Deviation 170.627	23.60 arbitrary units Standard Deviation 20.298

SECONDARY outcome

Timeframe: Day 0 - Pretreatment (Baseline) to Day 1

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

The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline	0.04 units on a scale Standard Deviation 0.434	-0.12 units on a scale Standard Deviation 0.436

SECONDARY outcome

Timeframe: Day 0 - Pretreatment (Baseline) to Day 3

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

The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline	-0.54 units on a scale Standard Deviation 0.802	-0.48 units on a scale Standard Deviation 0.852

SECONDARY outcome

Timeframe: Day 0 - Pretreatment (Baseline) to Day 7

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

The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline	-0.73 units on a scale Standard Deviation 0.884	-0.15 units on a scale Standard Deviation 1.544

SECONDARY outcome

Timeframe: Day 0 - Pretreatment (Baseline) to Day 14

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

The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline	-0.74 units on a scale Standard Deviation 0.962	-0.85 units on a scale Standard Deviation 0.814

SECONDARY outcome

Timeframe: Day 0 - Pretreatment (Baseline) to Day 1

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

The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline	-0.1 units on a scale Standard Deviation 0.44	-0.2 units on a scale Standard Deviation 0.41

SECONDARY outcome

Timeframe: Day 0 - Pretreatment (Baseline) to Day 3

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

The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline	-0.3 units on a scale Standard Deviation 0.60	-0.5 units on a scale Standard Deviation 0.55

SECONDARY outcome

Timeframe: Day 0 - Pretreatment (Baseline) to Day 7

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

The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline	-0.4 units on a scale Standard Deviation 0.51	-0.7 units on a scale Standard Deviation 0.52

SECONDARY outcome

Timeframe: Day 0 - Pretreatment (Baseline) to Day 14

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

The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline	-0.6 units on a scale Standard Deviation 0.51	-1.0 units on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: Day 0 - Pretreatment (Baseline) to Day 1

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

An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=9 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=4 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Dryness Scale Score on Day 1 - Change From Baseline	-0.2 units on a scale Standard Deviation 0.44	0.0 units on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: Day 0 - Pretreatment (Baseline) to Day 3

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

An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=9 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=4 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Dryness Scale Score on Day 3 - Change From Baseline	-0.9 units on a scale Standard Deviation 0.33	-0.5 units on a scale Standard Deviation 0.58

SECONDARY outcome

Timeframe: Day 0 - Pretreatment (Baseline) to Day 7

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

An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=9 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=4 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Dryness Scale Score on Day 7 - Change From Baseline	-1.2 units on a scale Standard Deviation 0.44	-1.3 units on a scale Standard Deviation 0.96

SECONDARY outcome

Timeframe: Day 0 - Pretreatment (Baseline) to Day 14

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

An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=9 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=4 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Dryness Scale Score on Day 14 - Change From Baseline	-1.2 units on a scale Standard Deviation 0.44	-1.5 units on a scale Standard Deviation 1.00

SECONDARY outcome

Timeframe: Day 0 - Pretreatment (Baseline) to Day 3

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

An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=15 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver's Itch Assessment on Day 3 - Change From Baseline	-0.73 units on a scale Standard Deviation 0.884	-1.00 units on a scale Standard Deviation 0.632

SECONDARY outcome

Timeframe: Day 0 - Pretreatment (Baseline) to Day 7

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

An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=15 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver's Itch Assessment on Day 7 - Change From Baseline	-0.87 units on a scale Standard Deviation 0.915	-1.17 units on a scale Standard Deviation 0.408

SECONDARY outcome

Timeframe: Day 0 - Pretreatment (Baseline) to Day 14

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

An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=15 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver's Itch Assessment on Day 14 - Change From Baseline	-1.00 units on a scale Standard Deviation 0.845	-1.20 units on a scale Standard Deviation 0.447

SECONDARY outcome

Timeframe: 0 Days Pretreatment (Baseline)

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

Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role Father	0 percentage of participants	0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role Mother	100 percentage of participants	100 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role Grandparent	0 percentage of participants	0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role Other	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 0 Days Pretreatment (Baseline)

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

Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement Infant crib separate room	23.5 percentage of participants	33.3 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement Infant crib parent's room	41.2 percentage of participants	0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement In parent's bed	17.6 percentage of participants	50.0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement Infant crib in room with sibling	0 percentage of participants	0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement Other	17.6 percentage of participants	16.7 percentage of participants

SECONDARY outcome

Timeframe: 0 Days Pretreatment (Baseline)

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

Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time Child Usually Put to Bed	9.04 hours.minutes Standard Deviation 1.16	9.10 hours.minutes Standard Deviation 0.35

SECONDARY outcome

Timeframe: 0 Days Pretreatment (Baseline)

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

Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime Very easy	5.9 percentage of participants	16.7 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime Somewhat easy	52.9 percentage of participants	50.0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime Somewhat difficult	17.6 percentage of participants	16.7 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime Moderately difficult	17.6 percentage of participants	0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime Very difficult	5.9 percentage of participants	16.7 percentage of participants

SECONDARY outcome

Timeframe: 0 Days Pretreatment (Baseline)

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

Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time for Child to Fall Asleep	27.6 minutes Standard Deviation 11.74	27.5 minutes Standard Deviation 15.08

SECONDARY outcome

Timeframe: 0 Days Pretreatment (Baseline)

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

Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Times Child Awakes During the Night	1.6 number of times Standard Deviation 1.00	2.3 number of times Standard Deviation 1.03

SECONDARY outcome

Timeframe: 0 Days Pretreatment (Baseline)

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

Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Awake During the Night	26.0 minutes Standard Deviation 21.85	44.2 minutes Standard Deviation 48.21

SECONDARY outcome

Timeframe: 0 Days Pretreatment (Baseline)

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

Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Longest Time Child is Asleep During the Night	6.28 hours Standard Deviation 2.296	5.58 hours Standard Deviation 3.105

SECONDARY outcome

Timeframe: 0 Days Pretreatment (Baseline)

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

Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child is Asleep During the Night	8.46 hours Standard Deviation 1.921	9.08 hours Standard Deviation 1.908

SECONDARY outcome

Timeframe: 0 Days Pretreatment (Baseline)

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

Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Naps Child Takes During the Day	1.2 number of naps Standard Deviation 0.56	1.0 number of naps Standard Deviation 0.89

SECONDARY outcome

Timeframe: 0 Days Pretreatment (Baseline)

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

Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Sleeps During the Day	2.32 hours Standard Deviation 0.642	1.57 hours Standard Deviation 1.023

SECONDARY outcome

Timeframe: 0 Days Pretreatment (Baseline)

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

Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem I don't have an opinion	0 percentage of participants	0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem Not a problem at all	11.8 percentage of participants	0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem A very small problem	41.2 percentage of participants	16.7 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem A small problem	23.5 percentage of participants	33.3 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem A moderate problem	23.5 percentage of participants	33.3 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem A serious problem	0 percentage of participants	16.7 percentage of participants

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role Father	0 percentage of participants	0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role Mother	100 percentage of participants	100 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role Grandparent	0 percentage of participants	0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role Other	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement Other	12.5 percentage of participants	16.7 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement Infant crib separate room	12.5 percentage of participants	33.3 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement Infant crib parent's room	37.5 percentage of participants	0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement In parent's bed	18.8 percentage of participants	50.0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement Infant crib in room with sibling	18.8 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time Child Usually Put to Bed	8.46 hours.minutes Standard Deviation 1.05	9.27 hours.minutes Standard Deviation 0.40

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime Very easy	6.3 percentage of participants	0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime Somewhat easy	43.8 percentage of participants	50.0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime Somewhat difficult	31.3 percentage of participants	33.3 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime Moderately difficult	12.5 percentage of participants	16.7 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime Very difficult	6.3 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time for Child to Fall Asleep	28.8 minutes Standard Deviation 14.20	22.5 minutes Standard Deviation 12.94

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Times Child Awakes During the Night	1.1 number of times Standard Deviation 0.81	1.8 number of times Standard Deviation 1.47

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Awake During the Night	17.8 minutes Standard Deviation 11.97	44.2 minutes Standard Deviation 53.61

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Longest Time Child is Asleep During the Night	7.70 hours Standard Deviation 2.206	6.58 hours Standard Deviation 2.764

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child is Asleep During the Night	8.81 hours Standard Deviation 1.410	9.17 hours Standard Deviation 1.633

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Naps Child Takes During the Day	1.3 number of naps Standard Deviation 0.60	1.2 number of naps Standard Deviation 0.75

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Sleeps During the Day	2.10 hours Standard Deviation 0.649	2.29 hours Standard Deviation 2.421

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem I don't have an opinion	0 percentage of participants	0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem Not a problem at all	18.8 percentage of participants	16.7 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem A very small problem	50.0 percentage of participants	50.0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem A small problem	18.8 percentage of participants	0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem A moderate problem	6.3 percentage of participants	16.7 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem A serious problem	6.3 percentage of participants	16.7 percentage of participants

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Responder Role Father	0 percentage of participants	0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Responder Role Mother	100 percentage of participants	100 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Responder Role Grandparent	0 percentage of participants	0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Responder Role Other	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement Infant crib separate room	18.8 percentage of participants	20.0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement Infant crib parent's room	37.5 percentage of participants	0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement In parent's bed	18.8 percentage of participants	60.0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement Infant crib in room with sibling	12.5 percentage of participants	0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement Other	12.5 percentage of participants	20.0 percentage of participants

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time Child Usually Put to Bed	8.48 hours.minutes Standard Deviation 1.02	9.14 hours.minutes Standard Deviation 0.31

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime Very easy	12.5 percentage of participants	0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime Somewhat easy	56.3 percentage of participants	60.0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime Somewhat difficult	25.0 percentage of participants	40.0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime Moderately difficult	6.3 percentage of participants	0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime Very difficult	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time for Child to Fall Asleep	23.8 minutes Standard Deviation 12.85	27.0 minutes Standard Deviation 11.51

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Times Child Awakes During the Night	1.1 number of times Standard Deviation 0.93	1.6 number of times Standard Deviation 1.14

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Awake During the Night	14.7 minutes Standard Deviation 9.91	37.0 minutes Standard Deviation 47.64

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Longest Time Child is Asleep During the Night	8.19 hours Standard Deviation 2.237	4.90 hours Standard Deviation 2.966

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child is Asleep During the Night	8.99 hours Standard Deviation 1.300	9.00 hours Standard Deviation 2.236

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Naps Child Takes During the Day	1.2 number of naps Standard Deviation 0.54	1.2 number of naps Standard Deviation 0.84

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Sleeps During the Day	2.06 hours Standard Deviation 0.722	1.55 hours Standard Deviation 2.095

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem I don't have an opinion	0 percentage of participants	0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem Not a problem at all	31.3 percentage of participants	0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem A very small problem	31.3 percentage of participants	60.0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem A small problem	25.0 percentage of participants	20.0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem A moderate problem	6.3 percentage of participants	20.0 percentage of participants
Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem A serious problem	6.3 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 0 Days - Pre-treatment

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

Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks smooth".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall Strongly disagree	29.4 percentage of participants	33.3 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall Somewhat disagree	41.2 percentage of participants	50.0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall Neither agree nor disagree	11.8 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall Somewhat agree	17.6 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall Strongly agree	0 percentage of participants	16.7 percentage of participants

SECONDARY outcome

Timeframe: 0 Days - Pre-treatment

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

Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks healthy".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall Strongly disagree	5.9 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall Somewhat disagree	58.8 percentage of participants	66.7 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall Neither agree nor disagree	5.9 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall Somewhat agree	23.5 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall Strongly agree	5.9 percentage of participants	16.7 percentage of participants

SECONDARY outcome

Timeframe: 0 Days - Pre-treatment

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

Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin feels soft".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall Strongly disagree	23.5 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall Somewhat disagree	41.2 percentage of participants	50.0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall Neither agree nor disagree	17.6 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall Somewhat agree	17.6 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall Strongly agree	0 percentage of participants	33.3 percentage of participants

SECONDARY outcome

Timeframe: 0 Days - Pre-treatment

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

Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks smooth".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema Strongly disagree	41.2 percentage of participants	33.3 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema Somewhat disagree	41.2 percentage of participants	50.0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema Neither agree nor disagree	5.9 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema Somewhat agree	5.9 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema Strongly agree	5.9 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 0 Days - Pre-treatment

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

Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks healthy".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema Strongly disagree	11.8 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema Somewhat disagree	70.6 percentage of participants	83.3 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema Neither agree nor disagree	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema Somewhat agree	11.8 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema Strongly agree	5.9 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 0 Days - Pre-treatment

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

Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin feels soft".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema Strongly disagree	41.2 percentage of participants	50.0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema Somewhat disagree	29.4 percentage of participants	33.3 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema Neither agree nor disagree	11.8 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema Somewhat agree	11.8 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema Strongly agree	5.9 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 0 Days - Pre-treatment

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

Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, what has your child's mood been?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week Very happy	35.3 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week Somewhat happy	17.6 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week No change	17.6 percentage of participants	50.0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week Somewhat fussy	29.4 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week Very fussy	0 percentage of participants	16.7 percentage of participants

SECONDARY outcome

Timeframe: 0 Days - Pre-treatment

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

Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Typically, how would you rate your child's mood when he/she wakes up in the morning?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning Very happy	23.5 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning Somewhat happy	35.3 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning No change	11.8 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning Somewhat fussy	17.6 percentage of participants	50.0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning Very fussy	11.8 percentage of participants	16.7 percentage of participants

SECONDARY outcome

Timeframe: 0 Days - Pre-treatment

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

Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much has your child wanted to play?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week Less than last week	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week No difference	64.7 percentage of participants	33.3 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week A little more	11.8 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week A lot more	0 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week All the time	23.5 percentage of participants	50.0 percentage of participants

SECONDARY outcome

Timeframe: 0 Days - Pre-treatment

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

Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much sleep did you get at night?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 0 Pre-treatment - Amount of Sleep Caregiver Got Over Past Week	6.48 hours Standard Deviation 1.169	6.19 hours Standard Deviation 1.956

SECONDARY outcome

Timeframe: 0 Days - Pre-treatment

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

Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "How many times did you wake up during the night?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 0 Pre-treatment - Number of Times Caregiver Woke Up	2.2 number of times Standard Deviation 0.90	5.7 number of times Standard Deviation 7.06

SECONDARY outcome

Timeframe: 0 Days - Pre-treatment

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

Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "If you did wake up during the night, how much time were you awake (on average) before falling back asleep?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 0 Pre-treatment - Amount of Time Caregiver Awake	0.79 hours Standard Deviation 0.807	1.36 hours Standard Deviation 0.645

SECONDARY outcome

Timeframe: 0 Days - Pre-treatment

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

Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much energy have you had to engage with your family?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week I don't have an opinion	5.9 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week Less than last week	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week No difference	76.5 percentage of participants	83.3 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week A little more	5.9 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week A lot more	5.9 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week All the time	5.9 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 0 Days - Pre-treatment

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

Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how rested have you felt?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week I don't have an opinion	5.9 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week Less than last week	17.6 percentage of participants	50.0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week No difference	64.7 percentage of participants	50.0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week A little more	5.9 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week A lot more	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week All the time	5.9 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 0 Days - Pre-treatment

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

Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how alert have you felt?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week A lot more	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week All the time	11.8 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week I don't have an opinion	5.9 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week Less than last week	11.8 percentage of participants	33.3 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week No difference	47.1 percentage of participants	66.7 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week A little more	23.5 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 0 Days - Pre-treatment

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

Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how productive have you been at work?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week I don't have an opinion	23.5 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week Less than last week	0 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week No difference	64.7 percentage of participants	66.7 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week A little more	5.9 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week A lot more	5.9 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week All the time	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 0 Days - Post-treatment

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

Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks smooth".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall Strongly disagree	5.9 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall Somewhat disagree	35.3 percentage of participants	66.7 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall Neither agree nor disagree	17.6 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall Somewhat agree	23.5 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall Strongly agree	17.6 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 0 Days - Post-treatment

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

Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks healthy".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall Strongly disagree	5.9 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall Somewhat disagree	35.3 percentage of participants	83.3 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall Neither agree nor disagree	11.8 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall Somewhat agree	35.3 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall Strongly agree	11.8 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 0 Days - Post-treatment

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

Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin feels soft".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall Strongly disagree	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall Somewhat disagree	23.5 percentage of participants	33.3 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall Neither agree nor disagree	11.8 percentage of participants	33.3 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall Somewhat agree	41.2 percentage of participants	33.3 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall Strongly agree	23.5 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 0 Days - Post-treatment

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

Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks smooth".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema Strongly disagree	11.8 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema Somewhat disagree	41.2 percentage of participants	66.7 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema Neither agree nor disagree	5.9 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema Somewhat agree	23.5 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema Strongly agree	17.6 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 0 Days - Post-treatment

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

Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks healthy".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema Strongly disagree	5.9 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema Somewhat disagree	41.2 percentage of participants	66.7 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema Neither agree nor disagree	17.6 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema Somewhat agree	23.5 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema Strongly agree	11.8 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 0 Days - Post-treatment

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

Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin feels soft".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=17 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema Strongly disagree	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema Somewhat disagree	29.4 percentage of participants	50.0 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema Neither agree nor disagree	5.9 percentage of participants	33.3 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema Somewhat agree	41.2 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema Strongly agree	23.5 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 3 Days

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

Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks smooth".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall Strongly disagree	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall Somewhat disagree	18.8 percentage of participants	50.0 percentage of participants
Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall Neither agree nor disagree	12.5 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall Somewhat agree	50.0 percentage of participants	50.0 percentage of participants
Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall Strongly agree	18.8 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 3 Days

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

Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks healthy".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall Somewhat agree	87.5 percentage of participants	66.7 percentage of participants
Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall Strongly agree	6.3 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall Strongly disagree	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall Somewhat disagree	6.3 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall Neither agree nor disagree	0 percentage of participants	16.7 percentage of participants

SECONDARY outcome

Timeframe: 3 Days

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

Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin feels soft".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall Strongly disagree	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall Somewhat disagree	0 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall Neither agree nor disagree	18.8 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall Somewhat agree	56.3 percentage of participants	50.0 percentage of participants
Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall Strongly agree	25.0 percentage of participants	16.7 percentage of participants

SECONDARY outcome

Timeframe: 3 Days

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

Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks smooth".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema Strongly disagree	0 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema Somewhat disagree	6.3 percentage of participants	33.3 percentage of participants
Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema Neither agree nor disagree	12.5 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema Somewhat agree	75.0 percentage of participants	50.0 percentage of participants
Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema Strongly agree	6.3 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 3 Days

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

Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks healthy".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema Strongly disagree	0 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema Somewhat disagree	6.3 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema Neither agree nor disagree	6.3 percentage of participants	33.3 percentage of participants
Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema Somewhat agree	75.0 percentage of participants	33.3 percentage of participants
Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema Strongly agree	12.5 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 3 Days

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

Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin feels soft".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema Strongly disagree	0 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema Somewhat disagree	0 percentage of participants	33.3 percentage of participants
Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema Neither agree nor disagree	12.5 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema Somewhat agree	68.8 percentage of participants	33.3 percentage of participants
Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema Strongly agree	18.8 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks smooth".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall Strongly disagree	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall Somewhat disagree	6.3 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall Neither agree nor disagree	0 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall Somewhat agree	56.3 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall Strongly agree	37.5 percentage of participants	50.0 percentage of participants

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks healthy".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall Somewhat disagree	6.3 percentage of participants	33.3 percentage of participants
Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall Strongly disagree	6.3 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall Neither agree nor disagree	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall Somewhat agree	50.0 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall Strongly agree	37.5 percentage of participants	50.0 percentage of participants

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin feels soft".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall Strongly disagree	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall Somewhat disagree	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall Neither agree nor disagree	12.5 percentage of participants	33.3 percentage of participants
Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall Somewhat agree	43.8 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall Strongly agree	43.8 percentage of participants	66.7 percentage of participants

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks smooth".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema Strongly disagree	0 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema Somewhat disagree	6.3 percentage of participants	33.3 percentage of participants
Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema Neither agree nor disagree	6.3 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema Somewhat agree	68.8 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema Strongly agree	18.8 percentage of participants	50.0 percentage of participants

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks healthy".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema Strongly disagree	0 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema Somewhat disagree	6.3 percentage of participants	33.3 percentage of participants
Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema Neither agree nor disagree	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema Somewhat agree	62.5 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema Strongly agree	31.3 percentage of participants	33.3 percentage of participants

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin feels soft".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema Neither agree nor disagree	12.5 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema Somewhat agree	62.5 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema Strongly disagree	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema Somewhat disagree	0 percentage of participants	50.0 percentage of participants
Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema Strongly agree	25.0 percentage of participants	50.0 percentage of participants

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, what has your child's mood been?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week Very happy	37.5 percentage of participants	33.3 percentage of participants
Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week Somewhat happy	37.5 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week No change	25.0 percentage of participants	50.0 percentage of participants
Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week Somewhat fussy	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week Very fussy	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Typically, how would you rate your child's mood when he/she wakes up in the morning?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning Very happy	25.0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning Somewhat happy	50.0 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning No change	12.5 percentage of participants	66.7 percentage of participants
Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning Somewhat fussy	12.5 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning Very fussy	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much has your child wanted to play?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week Less than last week	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week No difference	56.3 percentage of participants	50.0 percentage of participants
Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week A little more	18.8 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week A lot more	12.5 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week All the time	12.5 percentage of participants	16.7 percentage of participants

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much sleep did you get at night?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 7 - Amount of Sleep Caregiver Got Over Past Week	7.89 hours Standard Deviation 1.626	7.42 hours Standard Deviation 2.154

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "How many times did you wake up during the night?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 7 - Number of Times Caregiver Woke Up	1.1 number of times Standard Deviation 0.89	1.7 number of times Standard Deviation 1.63

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "If you did wake up during the night, how much time were you awake (on average) before falling back asleep?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 7 - Amount of Time Caregiver Awake	0.32 hours Standard Deviation 0.298	0.74 hours Standard Deviation 0.754

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much energy have you had to engage with your family?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week Less than last week	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week No difference	37.5 percentage of participants	66.7 percentage of participants
Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week A little more	37.5 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week A lot more	18.8 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week All the time	6.3 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how rested have you felt?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week Less than last week	6.3 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week No difference	31.3 percentage of participants	50.0 percentage of participants
Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week A little more	43.8 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week A lot more	12.5 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week All the time	6.3 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how alert have you felt?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week Less than last week	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week No difference	50.0 percentage of participants	66.7 percentage of participants
Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week A little more	37.5 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week A lot more	6.3 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week All the time	6.3 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 7 Days

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

Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how productive have you been at work?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week All the time	6.3 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week I don't have an opinion	12.5 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week Less than last week	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week No difference	43.8 percentage of participants	66.7 percentage of participants
Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week A little more	31.3 percentage of participants	16.7 percentage of participants
Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week A lot more	6.3 percentage of participants	16.7 percentage of participants

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks smooth".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall Strongly disagree	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall Somewhat disagree	0 percentage of participants	20.0 percentage of participants
Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall Neither agree nor disagree	6.3 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall Somewhat agree	62.5 percentage of participants	20.0 percentage of participants
Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall Strongly agree	31.3 percentage of participants	60.0 percentage of participants

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin looks healthy".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall Strongly disagree	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall Somewhat disagree	0 percentage of participants	20.0 percentage of participants
Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall Neither agree nor disagree	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall Somewhat agree	68.8 percentage of participants	40.0 percentage of participants
Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall Strongly agree	31.3 percentage of participants	40.0 percentage of participants

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Overall, my baby's skin feels soft".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall Strongly disagree	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall Somewhat disagree	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall Neither agree nor disagree	6.3 percentage of participants	20.0 percentage of participants
Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall Somewhat agree	31.3 percentage of participants	20.0 percentage of participants
Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall Strongly agree	62.5 percentage of participants	60.0 percentage of participants

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks smooth".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema Strongly agree	31.3 percentage of participants	40.0 percentage of participants
Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema Strongly disagree	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema Somewhat disagree	6.3 percentage of participants	20.0 percentage of participants
Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema Neither agree nor disagree	0 percentage of participants	20.0 percentage of participants
Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema Somewhat agree	62.5 percentage of participants	20.0 percentage of participants

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin looks healthy".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema Strongly disagree	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema Somewhat disagree	0 percentage of participants	20.0 percentage of participants
Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema Neither agree nor disagree	6.3 percentage of participants	20.0 percentage of participants
Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema Somewhat agree	56.3 percentage of participants	20.0 percentage of participants
Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema Strongly agree	37.5 percentage of participants	40.0 percentage of participants

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "In the areas affected by eczema, my baby's skin feels soft".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema Strongly disagree	6.3 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema Somewhat disagree	0 percentage of participants	20.0 percentage of participants
Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema Neither agree nor disagree	6.3 percentage of participants	20.0 percentage of participants
Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema Somewhat agree	37.5 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema Strongly agree	50.0 percentage of participants	60.0 percentage of participants

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, what has your child's mood been?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week Very happy	12.5 percentage of participants	20.0 percentage of participants
Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week Somewhat happy	25.0 percentage of participants	40.0 percentage of participants
Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week No change	56.3 percentage of participants	40.0 percentage of participants
Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week Somewhat fussy	6.3 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week Very fussy	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Typically, how would you rate your child's mood when he/she wakes up in the morning?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning Very happy	18.8 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning Somewhat happy	37.5 percentage of participants	40.0 percentage of participants
Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning No change	31.3 percentage of participants	40.0 percentage of participants
Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning Somewhat fussy	6.3 percentage of participants	20.0 percentage of participants
Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning Very fussy	6.3 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much has your child wanted to play?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week Less than last week	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week No difference	43.8 percentage of participants	40.0 percentage of participants
Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week A little more	18.8 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week A lot more	18.8 percentage of participants	20.0 percentage of participants
Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week All the time	18.8 percentage of participants	40.0 percentage of participants

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much sleep did you get at night?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 14 - Amount of Sleep Caregiver Got Over Past Week	7.99 hours Standard Deviation 1.543	7.40 hours Standard Deviation 1.710

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "How many times did you wake up during the night?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=15 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 14 - Number of Times Caregiver Woke Up	1.0 number of times Standard Deviation 1.07	1.6 number of times Standard Deviation 1.14

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "If you did wake up during the night, how much time were you awake (on average) before falling back asleep?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 14 - Amount of Time Caregiver Awake	0.22 hours Standard Deviation 0.385	0.87 hours Standard Deviation 1.048

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how much energy have you had to engage with your family?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week All the time	12.5 percentage of participants	20.0 percentage of participants
Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week Less than last week	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week No difference	43.8 percentage of participants	60.0 percentage of participants
Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week A little more	31.3 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week A lot more	12.5 percentage of participants	20.0 percentage of participants

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how rested have you felt?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=15 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week A lot more	13.3 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week Less than last week	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week No difference	40.0 percentage of participants	60.0 percentage of participants
Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week A little more	40.0 percentage of participants	20.0 percentage of participants
Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week All the time	6.7 percentage of participants	20.0 percentage of participants

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how alert have you felt?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week Less than last week	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week No difference	50.0 percentage of participants	60.0 percentage of participants
Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week All the time	6.3 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week A little more	37.5 percentage of participants	20.0 percentage of participants
Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week A lot more	6.3 percentage of participants	20.0 percentage of participants

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "Over this past week, how productive have you been at work?"

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week I don't have an opinion	6.3 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week Less than last week	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week No difference	50.0 percentage of participants	60.0 percentage of participants
Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week A little more	31.3 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week A lot more	6.3 percentage of participants	40.0 percentage of participants
Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week All the time	6.3 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 14 Days

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

Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is "I would recommend this product to another parent".

Outcome measures

Measure	1% Colloidal Oatmeal Balm n=16 Participants 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=5 Participants EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Caregiver Questionnaire on Day 14 - Recommend Product I don't have an opinion	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Recommend Product Strongly disagree	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Recommend Product Somewhat disagree	0 percentage of participants	20.0 percentage of participants
Caregiver Questionnaire on Day 14 - Recommend Product Neither agree nor disagree	0 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Recommend Product Somewhat agree	43.8 percentage of participants	0 percentage of participants
Caregiver Questionnaire on Day 14 - Recommend Product Strongly agree	56.3 percentage of participants	80.0 percentage of participants

Adverse Events

1% Colloidal Oatmeal Balm

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

EpiCeram Skin Barrier Emulsion

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	1% Colloidal Oatmeal Balm n=17 participants at risk 1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed	EpiCeram Skin Barrier Emulsion n=6 participants at risk EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
Skin and subcutaneous tissue disorders Dermatitis Diaper	5.9% 1/17 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.	0.00% 0/6 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
Ear and labyrinth disorders Motion Sickness	0.00% 0/17 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.	16.7% 1/6 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
Gastrointestinal disorders Diarrhoea	5.9% 1/17 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.	0.00% 0/6 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
Gastrointestinal disorders Frequent Bowel Movements	5.9% 1/17 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.	0.00% 0/6 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
Gastrointestinal disorders Teething	11.8% 2/17 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.	16.7% 1/6 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
Gastrointestinal disorders Vomiting	0.00% 0/17 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.	16.7% 1/6 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
General disorders Pyrexia	11.8% 2/17 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.	16.7% 1/6 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
Infections and infestations Ear Infection	5.9% 1/17 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.	0.00% 0/6 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
Infections and infestations Gastroenteritis Viral	5.9% 1/17 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.	0.00% 0/6 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
Infections and infestations Nasopharyngitis	5.9% 1/17 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.	16.7% 1/6 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
Infections and infestations Upper Respiratory Tract Infection	5.9% 1/17 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.	0.00% 0/6 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
Injury, poisoning and procedural complications Excoriation	11.8% 2/17 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.	0.00% 0/6 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
Injury, poisoning and procedural complications Scratch	5.9% 1/17 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.	0.00% 0/6 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
Respiratory, thoracic and mediastinal disorders Cough	5.9% 1/17 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.	16.7% 1/6 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	11.8% 2/17 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.	0.00% 0/6 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
Skin and subcutaneous tissue disorders Keratosis Pilaris	0.00% 0/17 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.	16.7% 1/6 • 14 ± 2 days, +30 days for serious adverse events. Adverse events were systematically collected beginning with the signing of the informed consent form and continuing at each study visit through Visit 7 (14 ± 2 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.

Additional Information

Amisha Parikh-Das, PhD/Study Director

Johnson & Johnson Consumer, Inc

Phone: 973-255-8701 USA EST

Email: AParikh1@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee Principal investigators agreed not to publish the study results without prior sponsor approval.
• Publication restrictions are in place

Restriction type: OTHER