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

Phase 3CompletedNCT02120833

Johnson & Johnson Consumer and Personal Products Worldwide51 enrolled

Overview

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.

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.

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 35 Months

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline

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.

Time frame: Baseline to Day 3

Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline

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 (none) and 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.

Time frame: Baseline to Day 3

Secondary Outcomes

Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline

Time frame: Baseline to Day 1

Eczema Area and Severity Index (EASI) on Day 2 - Change From Baseline

Time frame: Baseline to Day 2

Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline

Time frame: Baseline to Day 7

Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline

Time frame: Baseline to Day 14

Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline

Time frame: Baseline to Day 1

Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 2 - Change From Baseline

Time frame: Baseline to Day 2

Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline

Time frame: Baseline to Day 7

Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline

Time frame: Baseline to Day 14

Corneometer Measurement on Day 0 - Post-Treatment - Change From Baseline

Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. Post-treatment on Day 0, corneometer readings ranged from 10.3 to 86.3.

Time frame: Baseline to Post -Treatment on Day 0

Corneometer Measurement on Day 1 - Change From Baseline

Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 1, corneometer readings ranged from 5.5 to 84.0.

Time frame: Baseline to Day 1

Corneometer Measurement on Day 2 - Change From Baseline

Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 2, corneometer readings ranged from 8.5 to 74.0.

Time frame: Baseline to Day 2

Corneometer Measurement on Day 3 - Change From Baseline

Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 3, corneometer readings ranged from 8.0 to 65.3.

Time frame: Baseline to Day 3

Corneometer Measurement on Day 7 - Change From Baseline

Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 7, corneometer readings ranged from 6.8 to 65.0.

Time frame: Baseline to Day 7

Corneometer Measurement on Day 14 - Change From Baseline

Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 14, corneometer readings ranged from 5.7 to 73.1.

Time frame: Baseline to Day 14

Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth

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). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'

Time frame: 0 Days - Pre-Treatment

Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy

Time frame: 0 Days - Pre-Treatment

Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft

Time frame: 0 Days - Pre-Treatment

Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth

Time frame: 0 Days - Pre-Treatment

Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth

Time frame: 0 Days - Pre-Treatment

Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy

Time frame: 0 Days - Pre-Treatment

Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft

Time frame: 0 Days - Pre-Treatment

Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth

Time frame: 0 Days - Pre-Treatment

Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth

Questions were answered immediately post-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). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'