A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin | RxWiki

A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin

Overview[ - collapse ][ - ]

Purpose	This study is for infants with mild to moderate dry and itchy skin. This study will involve going to the doctor for 6 visits over 2 weeks. All participants' skin will be examined by a dermatologist to determine if they have atopic dermatitis and have an active mild to moderate eczema wound. Participant's parents/guardians will be asked a few questions to determine if their child qualifies for the study. Then all participants' caregivers will complete a questionnaire at the beginning of the study. The child's skin will be examined to rate the level of their eczema and a trained examiner will grade the looks and symptoms of their eczema. All parents or guardians will be instructed how to apply the test product and how to record usage on a diary card and then apply the test product. The test product will be applied at least 2 times per day or more as needed on all body areas, including the face affected throughout the study. One digital picture will be taken of one eczema wound. Another digital picture will be taken of the area around this wound. These pictures will be taken on Day 0 (Baseline), Day 3, and Day 14. Once product is applied the skin will be examined for any adverse events and all participants' caregivers will complete a questionnaire on study day 1, 3, 7 and 14.
Condition	Eczema
Intervention	Device: EpiCeram® Skin Barrier Emulsion Drug: Colloidal Oatmeal Cream
Phase	Phase 3
Sponsor	Johnson & Johnson Consumer and Personal Products Worldwide
Responsible Party	Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier	NCT02120833
First Received	March 28, 2014
Last Updated	April 21, 2014
Last verified	April 2014

Tracking Information[ + expand ][ + ]

First Received Date	March 28, 2014
Last Updated Date	April 21, 2014
Start Date	March 2014
Estimated Primary Completion Date	May 2014
Current Primary Outcome Measures	Eczema Area and Severity Index (EASI) [Time Frame: Study Day 3] [Designated as safety issue: No]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 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72. Investigator's Global Atopic Dermatitis Assessment (IGADA) [Time Frame: Study Day 3] [Designated as safety issue: No]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 where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number signs and symptoms, the final rating will be clear, almost clear, mild, moderate, severe, or very severe.
Current Secondary Outcome Measures	Eczema Area and Severity Index (EASI) [Time Frame: Study Day 1] [Designated as safety issue: No]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 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72. Eczema Area and Severity Index (EASI) [Time Frame: Study Day 2] [Designated as safety issue: No]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 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72. Eczema Area and Severity Index (EASI) [Time Frame: Study Day 4] [Designated as safety issue: No]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 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72. Eczema Area and Severity Index (EASI) [Time Frame: Study Day 7] [Designated as safety issue: No]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 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72. Investigator's Global Atopic Dermatitis Assessment (IGADA) [Time Frame: Study Day 1] [Designated as safety issue: No]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 where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number signs and symptoms, the final rating will be clear, almost clear, mild, moderate, severe, or very severe. Investigator's Global Atopic Dermatitis Assessment (IGADA) [Time Frame: Study Day 2] [Designated as safety issue: No]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 where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number signs and symptoms, the final rating will be clear, almost clear, mild, moderate, severe, or very severe. Investigator's Global Atopic Dermatitis Assessment (IGADA) [Time Frame: Study Day 4] [Designated as safety issue: No]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 where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number signs and symptoms, the final rating will be clear, almost clear, mild, moderate, severe, or very severe. Investigator's Global Atopic Dermatitis Assessment (IGADA) [Time Frame: Study Day 7] [Designated as safety issue: No]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 where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number signs and symptoms, the final rating will be clear, almost clear, mild, moderate, severe, or very severe. Investigator's Global Atopic Dermatitis Assessment (IGADA) [Time Frame: Study Day 14] [Designated as safety issue: No]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 where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number signs and symptoms, the final rating will be clear, almost clear, mild, moderate, severe, or very severe. Corneometer measurements [Time Frame: Study Day 1] [Designated as safety issue: No]Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer will be placed at a site adjacent to eczema-affected skin areas. Corneometer measurements [Time Frame: Study Day 2] [Designated as safety issue: No]Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer will be placed at a site adjacent to eczema-affected skin areas. Corneometer measurements [Time Frame: Study Day 3] [Designated as safety issue: No]Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer will be placed at a site adjacent to eczema-affected skin areas. Corneometer measurements [Time Frame: Study Day 4] [Designated as safety issue: No]Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer will be placed at a site adjacent to eczema-affected skin areas. Corneometer measurements [Time Frame: Study Day 7] [Designated as safety issue: No]Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer will be placed at a site adjacent to eczema-affected skin areas. Corneometer measurements [Time Frame: Study Day 14] [Designated as safety issue: No]Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer will be placed at a site adjacent to eczema-affected skin areas. Caregiver questionnaire data assessing product experience [Time Frame: Study Day 0] [Designated as safety issue: No]Questions to be answered immediately post-treatment by participants' caregivers. Questions include overall look (smooth, healthy) and feel (soft, smooth) of participants' skin; and affected area's look (smooth, healthy) and feel (soft, smooth). Caregivers will answer based on a 6 point system from 'I don't have an opinion' to 'Strongly Disagree'. Caregiver questionnaire data assessing product experience [Time Frame: Study Day 1] [Designated as safety issue: No]Questions to be answered immediately post-treatment by participants' caregivers. Questions include overall look (smooth, healthy) and feel (soft, smooth) of participants' skin; and affected area's look (smooth, healthy) and feel (soft, smooth). Caregivers will answer based on a 6 point system from 'I don't have an opinion' to 'Strongly Disagree'. Caregiver questionnaire data assessing product experience [Time Frame: Study Day 2] [Designated as safety issue: No]Questions to be answered immediately post-treatment by participants' caregivers. Questions include overall look (smooth, healthy) and feel (soft, smooth) of participants' skin; and affected area's look (smooth, healthy) and feel (soft, smooth). Caregivers will answer based on a 6 point system from 'I don't have an opinion' to 'Strongly Disagree'. Caregiver questionnaire data assessing product experience [Time Frame: Study Day 3] [Designated as safety issue: No]Questions to be answered immediately post-treatment by participants' caregivers. Questions include overall look (smooth, healthy) and feel (soft, smooth) of participants' skin; and affected area's look (smooth, healthy) and feel (soft, smooth). Caregivers will answer based on a 6 point system from 'I don't have an opinion' to 'Strongly Disagree'. Caregiver questionnaire data assessing product experience [Time Frame: Study Day 7] [Designated as safety issue: No]Questions to be answered immediately post-treatment by participants' caregivers. Questions include overall look (smooth, healthy) and feel (soft, smooth) of participants' skin; and affected area's look (smooth, healthy) and feel (soft, smooth). Caregivers will answer based on a 6 point system from 'I don't have an opinion' to 'Strongly Disagree'. Caregiver questionnaire data assessing product experience [Time Frame: Study Day 14] [Designated as safety issue: No]Questions to be answered immediately post-treatment by participants' caregivers. Questions include overall look (smooth, healthy) and feel (soft, smooth) of participants' skin; and affected area's look (smooth, healthy) and feel (soft, smooth). Caregivers will answer based on a 6 point system from 'I don't have an opinion' to 'Strongly Disagree'. Eczema Area and Severity Index (EASI) [Time Frame: Study Day 14] [Designated as safety issue: No]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 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.

Descriptive Information[ + expand ][ + ]

Brief Title	A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin
Official Title	A Multi-Center Clinical Trial to Evaluate the Efficacy of an Over-the-Counter Cream in the Management of Mild to Moderate Atopic Dermatitis in Infants and Toddlers
Brief Summary	This study is for infants with mild to moderate dry and itchy skin. This study will involve going to the doctor for 6 visits over 2 weeks. All participants' skin will be examined by a dermatologist to determine if they have atopic dermatitis and have an active mild to moderate eczema wound. Participant's parents/guardians will be asked a few questions to determine if their child qualifies for the study. Then all participants' caregivers will complete a questionnaire at the beginning of the study. The child's skin will be examined to rate the level of their eczema and a trained examiner will grade the looks and symptoms of their eczema. All parents or guardians will be instructed how to apply the test product and how to record usage on a diary card and then apply the test product. The test product will be applied at least 2 times per day or more as needed on all body areas, including the face affected throughout the study. One digital picture will be taken of one eczema wound. Another digital picture will be taken of the area around this wound. These pictures will be taken on Day 0 (Baseline), Day 3, and Day 14. Once product is applied the skin will be examined for any adverse events and all participants' caregivers will complete a questionnaire on study day 1, 3, 7 and 14.
Detailed Description	This is a multi-center, two-arm clinical trial in participants aged 2 - 35 months with mild to moderate Atopic Dermatitis (AD) as determined by the study physician. A sufficient number of participants will be enrolled in this study to yield 40 participants who complete the trial, 30 in the investigational product group and 10 in the active control group. The investigational and control (EpiCeram®) products will be used topically. Participant caregivers will be instructed to gently massage the assigned product into the participant's skin. The treatments will be applied at least 2 times per day on all body areas, including areas of the body and face affected by AD. No product should be applied within 4 hours of a site visit. These treatments will be used in place of the participant's current moisturizers and/or emollients. Diaries will be completed by the participants' caregivers each day, beginning upon initiation of therapy and continuing until trial completion/discontinuation, and will include information on product application and use of rescue medication. All participants will visit the clinical site for assessments at baseline (Day 0) and on Days 1, 2, 3, 7 and 14. Clinical assessments include the Eczema Area and Severity index (EASI) and Investigator's Global Atopic Dermatitis Assessment (IGADA). Instrumental assessment of hydration will be done using a Corneometer (Courage & Khazaka, Germany). Caregivers will also complete a questionnaire to assess product experience. The final visit will occur on Day 14 or on the day of participant withdrawal from the trial.
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Eczema
Intervention	Device: EpiCeram® Skin Barrier Emulsion Device (including sham) Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin as directed. Drug: Colloidal Oatmeal Cream Drug (including placebo) Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin as directed.
Study Arm (s)	Active Comparator: EPI Experimental: NEE

Recruitment Information[ + expand ][ + ]

Recruitment Status	Enrolling by invitation
Estimated Enrollment	40
Estimated Completion Date	May 2014
Estimated Primary Completion Date	May 2014
Eligibility Criteria	Inclusion Criteria 1. Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment; 2. Caregiver is able and willing to provide written informed consent for the participant to participate in the trial; 3. Male or female of any race or ethnicity, 2 months to 35 months of age; 4. Diagnosed as having Atopic Dermatitis (AD) on the basis of the criteria defined by Hanifin and Rajka 5. Rated as having mild to moderate AD (graded between 3.0 and 7.5 inclusive) as per Rajka-Langeland severity index 6. Willing to stop all emollients, moisturizers and/or other skin barrier cream or emulsion treatments for the AD condition during the test period. If using corticosteroids (not Class I, II, or III) or immunomodulators at study entry, must be on a stable dose for a minimum of 1 month; 7. Willing to undergo a washout period of 2 days before the trial initiation where no use of moisturizers or emollients will be allowed; and 8. Willing and able to comply with scheduled visits, treatment plan, and other trial procedures. Exclusion Criteria: 1. Known sensitivity to any investigational product ingredient; 2. Use of a therapeutic (over the counter or prescription) body wash that contains an active ingredient for eczema; 3. Participation in any clinical study within 30 days of Visit 1; 4. Relative, partner or staff of any clinical research site personnel; 5. Active infection of any type at the start of the study; 6. Severe AD as determined by the Rajka-Langeland Severity Index 7. AD requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids. If a participant requires any of these medications as rescue therapy during the study, the participant will be discontinued from the trial; 8. Requires any inhaled or intranasal corticosteroids; 9. Other medical condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Gender	Both
Ages	2 Months
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT02120833
Other Study ID Numbers	CO-140206110636-SBCT
Has Data Monitoring Committee	No
Information Provided By	Johnson & Johnson Consumer and Personal Products Worldwide
Study Sponsor	Johnson & Johnson Consumer and Personal Products Worldwide
Collaborators	Not Provided
Investigators	Study Director: Christopher Nunez Johnson & Johnson Consumer and Personal Products Worldwide
Verification Date	April 2014

Locations[ + expand ][ + ]

Thomas J. Stephens and Associates, Colorado Research Center	Colorado Springs, Colorado, United States, 80915
Thomas J. Stephens and Associates, Dallas Research Center	Carrollton, Texas, United States, 75006