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

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

EpiCeram Skin Barrier Emulsion

Experimental Product 1% Colloidal Oatmeal Balm

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Eczema, Itchy Skin

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Stephens & Associates (Colorado Research Center)
Stephens & Associates (Texas Reserach Center)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Positive Control

Experimental

Arm Description

Marketed - EpiCeram(R) Skin Barrier Emulsion: Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin.

Not Yet Marketed - 1% Colloidal Oatmeal Balm: Apply at least once per night or more if needed.

Outcomes

Primary Outcome Measures

Change From Baseline in the Itch Assessment Score Immediately Following Treatment

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Secondary Outcome Measures

Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment

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

Change From Baseline in Mean Corneometer Measurement 1 Hour After Treatment

Change From Baseline in Mean Corneometer Measurement 2 Hours After Treatment

Change From Baseline in Mean Corneometer Measurement 3 Hours After Treatment

Change From Baseline in Mean Corneometer Measurement 4 Hours After Treatment

Change From Baseline in Mean Corneometer Measurement 5 Hours After Treatment

Change From Baseline in Mean Corneometer Measurement 6 Hours After Treatment

Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment

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

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

Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin

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

Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin

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

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

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

Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin

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

Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin

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

Participant Questionnaire on Day 0 Pre-treatment - Soft Skin

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

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

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

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

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

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

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

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

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

Participant Questionnaire Immediately After Treatment - Product Fast Absorbing

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

Participant Questionnaire Immediately After Treatment - Calm Skin

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

Participant Questionnaire Immediately After Treatment - Moisturized Skin

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

Participant Questionnaire Immediately After Treatment - Product Does Not Sting

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

Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture

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

Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft

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

Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture

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

Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft

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

Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture

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

Participant Questionnaire 6 Hours After Treatment - Calms Skin

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

Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin

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

Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin

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

Participant Questionnaire 6 Hours After Treatment - Shield for Skin

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

Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized

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

Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable

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

Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft

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

Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth

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

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

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

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

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

Participant Questionnaire 7 Days After Treatment - Skin Feels Calm

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

Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin

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

Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking

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

Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin

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

Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture

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

Participant Questionnaire 7 Days After Treatment - Shield for Skin

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

Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized

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

Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable

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

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

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

Participant Questionnaire 7 Days After Treatment - Skin Feels Soft

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

Participant Questionnaire 7 Days After Treatment - Moisturized All Day

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

Participant Questionnaire 7 Days After Treatment - Slept Better

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

Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth

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

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

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

Participant Questionnaire 7 Days After Treatment - Skin on Waking

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

Participant Questionnaire 7 Days After Treatment - Degree of Sleep

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

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

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

Full Information

NCT ID

NCT02691507

First Posted

February 22, 2016

Last Updated

January 16, 2017

Sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

1. Study Identification

Unique Protocol Identification Number

NCT02691507

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

February 2016 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

Eczema, Itchy Skin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Positive Control

Arm Type

Active Comparator

Arm Description

Marketed - EpiCeram(R) Skin Barrier Emulsion: Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin.

Arm Title

Experimental

Arm Type

Experimental

Arm Description

Not Yet Marketed - 1% Colloidal Oatmeal Balm: Apply at least once per night or more if needed.

Intervention Type

Device

Intervention Name(s)

EpiCeram Skin Barrier Emulsion

Intervention Description

EpiCeram Skin Barrier Emulsion

Intervention Type

Drug

Intervention Name(s)

Experimental Product 1% Colloidal Oatmeal Balm

Other Intervention Name(s)

Eczema Moisturizing Balm

Intervention Description

Experimental Product 1% Colloidal Oatmeal Balm

Primary Outcome Measure Information:

Title

Change From Baseline in the Itch Assessment Score Immediately Following Treatment

Description

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

Time Frame

Baseline to immediately following treatment

Title

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

Description

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

Time Frame

Baseline to one hour after treatment

Title

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

Description

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

Time Frame

Baseline to two hours after treatment

Title

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

Description

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

Time Frame

Baseline to three hours after treatment

Title

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

Description

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

Time Frame

Baseline to four hours after treatment

Title

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

Description

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

Time Frame

Baseline to five hours after treatment

Title

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

Description

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

Time Frame

Baseline to six hours after treatment

Title

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

Description

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

Time Frame

Baseline to seven days after treatment

Secondary Outcome Measure Information:

Title

Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment

Description

Time Frame

Baseline to Immediately following treatment

Title

Change From Baseline in Mean Corneometer Measurement 1 Hour After Treatment

Description

Time Frame

Baseline to one hour after treatment

Title

Change From Baseline in Mean Corneometer Measurement 2 Hours After Treatment

Description

Time Frame

Baseline to two hours after treatment

Title

Change From Baseline in Mean Corneometer Measurement 3 Hours After Treatment

Description

Time Frame

Baseline to three hours after treatment

Title

Change From Baseline in Mean Corneometer Measurement 4 Hours After Treatment

Description

Time Frame

Baseline to four hours after treatment

Title

Change From Baseline in Mean Corneometer Measurement 5 Hours After Treatment

Description

Time Frame

Baseline to five hours after treatment

Title

Change From Baseline in Mean Corneometer Measurement 6 Hours After Treatment

Description

Time Frame

Baseline to six hours after treatment

Title

Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment

Description

Time Frame

Baseline to seven days after treatment

Title

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

Description

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

Time Frame

0 Days - Pre-treatment

Title

Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin

Description

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

Time Frame

0 Days - Pre-treatment

Title

Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin

Description

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

Time Frame

0 Days - Pre-treatment

Title

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

Description

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

Time Frame

0 Days - Pre-treatment

Title

Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin

Description

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

Time Frame

0 Days - Pre-treatment

Title

Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin

Description

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

Time Frame

0 Days - Pre-treatment

Title

Participant Questionnaire on Day 0 Pre-treatment - Soft Skin

Description

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

Time Frame

0 Days - Pre-treatment

Title

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

Description

Time Frame

0 Days - Pre-treatment

Title

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

Description

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

Time Frame

0 Days - Pre-treatment

Title

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

Description

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

Time Frame

0 Days - Pre-treatment

Title

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

Description

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

Time Frame

0 Days - Pre-treatment

Title

Participant Questionnaire Immediately After Treatment - Product Fast Absorbing

Description

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

Time Frame

0 Days - Immediately after treatment

Title

Participant Questionnaire Immediately After Treatment - Calm Skin

Description

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

Time Frame

0 Days - Immediately after treatment

Title

Participant Questionnaire Immediately After Treatment - Moisturized Skin

Description

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

Time Frame

0 Days - Immediately after treatment

Title

Participant Questionnaire Immediately After Treatment - Product Does Not Sting

Description

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

Time Frame

0 Days - Immediately after treatment

Title

Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture

Description

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

Time Frame

Four hours after treatment

Title

Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft

Description

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

Time Frame

Four hours after treatment

Title

Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture

Description

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

Time Frame

Five hours after treatment

Title

Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft

Description

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

Time Frame

Five hours after treatment

Title

Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture

Description

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

Time Frame

Six hours after treatment

Title

Participant Questionnaire 6 Hours After Treatment - Calms Skin

Description

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

Time Frame

Six hours after treatment

Title

Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin

Description

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

Time Frame

Six hours after treatment

Title

Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin

Description

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

Time Frame

Six hours after treatment

Title

Participant Questionnaire 6 Hours After Treatment - Shield for Skin

Description

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

Time Frame

Six hours after treatment

Title

Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized

Description

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

Time Frame

Six hours after treatment

Title

Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable

Description

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

Time Frame

Six hours after treatment

Title

Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft

Description

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

Time Frame

Six hours after treatment

Title

Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth

Description

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

Time Frame

Six hours after treatment

Title

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

Description

Time Frame

Six hours after treatment

Title

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

Description

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

Time Frame

Six hours after treatment

Title

Participant Questionnaire 7 Days After Treatment - Skin Feels Calm

Description

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

Time Frame

Seven days after treatment

Title

Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin

Description

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

Time Frame

Seven days after treatment

Title

Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking

Description

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

Time Frame

Seven days after treatment

Title

Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin

Description

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

Time Frame

Seven days after treatment

Title

Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture

Description

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

Time Frame

Seven days after treatment

Title

Participant Questionnaire 7 Days After Treatment - Shield for Skin

Description

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

Time Frame

Seven days after treatment

Title

Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized

Description

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

Time Frame

Seven days after treatment

Title

Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable

Description

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

Time Frame

Seven days after treatment

Title

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

Description

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

Time Frame

Seven days after treatment

Title

Participant Questionnaire 7 Days After Treatment - Skin Feels Soft

Description

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

Time Frame

Seven days after treatment

Title

Participant Questionnaire 7 Days After Treatment - Moisturized All Day

Description

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

Time Frame

Seven days after treatment

Title

Participant Questionnaire 7 Days After Treatment - Slept Better

Description

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

Time Frame

Seven days after treatment

Title

Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth

Description

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

Time Frame

Seven days after treatment

Title

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

Description

Time Frame

Seven days after treatment

Title

Participant Questionnaire 7 Days After Treatment - Skin on Waking

Description

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

Time Frame

Seven days after treatment

Title

Participant Questionnaire 7 Days After Treatment - Degree of Sleep

Description

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

Time Frame

7 days after treatment

Title

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

Description

Time Frame

Seven days after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) Male or female of any race or ethnicity, ages 12 and older Diagnosed as having eczema Willing to stop use of all non-assigned moisturizers and/or creams for the entire duration of the study Exclusion Criteria: Known sensitivity to any investigational product ingredient Females who are pregnant , breastfeeding , or planning on becoming pregnant during the study Individuals with a history of skin cancer Use of a therapeutic (over-the-counter or prescription) body wash that contains an active ingredient for eczema Participation in any clinical study within 30 days of Visit 1 Active infection of any type at the start of the study Diagnosed as having severe eczema Has a compromised immune system Individuals with any planned surgeries and/or invasive medical procedures during the course of the study Requires greater than 2.0mg/day inhaled or intranasal corticosteroids

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amisha Parikh-Das, PhD

Organizational Affiliation

Johnson & Johnson Consumer Inc. (J&JCI)

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Lily Jiang, PhD

Organizational Affiliation

Stephens & Associates, Inc (Texas Research Center)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kun M Qian, MD

Organizational Affiliation

Stephens & Associates, Inc (Colorado Research Center)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stephens & Associates (Colorado Research Center)

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80915

Country

United States

Facility Name

Stephens & Associates (Texas Reserach Center)

City

Richardson

State/Province

Texas

ZIP/Postal Code

75081

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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