Clinical trial NCT02120833: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Eczema
Keywords: Atopic Dermatitis
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2014-04-23
Enrollment: 51
Sex: ALL
Minimum age (years): 2
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline
timeFrame: Baseline to Day 3
measure: Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline
timeFrame: Baseline to Day 3
Secondary outcomes:
measure: Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline
timeFrame: Baseline to Day 1
measure: Eczema Area and Severity Index (EASI) on Day 2 - Change From Baseline
timeFrame: Baseline to Day 2
measure: Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline
timeFrame: Baseline to Day 7
measure: Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline
timeFrame: Baseline to Day 14
measure: Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline
timeFrame: Baseline to Day 1
measure: Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 2 - Change From Baseline
timeFrame: Baseline to Day 2
measure: Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline
timeFrame: Baseline to Day 7
measure: Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline
timeFrame: Baseline to Day 14
measure: Corneometer Measurement on Day 0 - Post-Treatment - Change From Baseline
timeFrame: Baseline to Post -Treatment on Day 0
measure: Corneometer Measurement on Day 1 - Change From Baseline
timeFrame: Baseline to Day 1
measure: Corneometer Measurement on Day 2 - Change From Baseline
timeFrame: Baseline to Day 2
measure: Corneometer Measurement on Day 3 - Change From Baseline
timeFrame: Baseline to Day 3
measure: Corneometer Measurement on Day 7 - Change From Baseline
timeFrame: Baseline to Day 7
measure: Corneometer Measurement on Day 14 - Change From Baseline
timeFrame: Baseline to Day 14
measure: Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth
timeFrame: 0 Days - Pre-Treatment
measure: Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy
timeFrame: 0 Days - Pre-Treatment
measure: Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft
timeFrame: 0 Days - Pre-Treatment
measure: Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth
timeFrame: 0 Days - Pre-Treatment
measure: Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
timeFrame: 0 Days - Pre-Treatment
measure: Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
timeFrame: 0 Days - Pre-Treatment
measure: Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
timeFrame: 0 Days - Pre-Treatment
measure: Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
timeFrame: 0 Days - Pre-Treatment
measure: Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth
timeFrame: 0 Days - Post-Treatment
measure: Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy
timeFrame: 0 Days - Post-Treatment
measure: Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft
timeFrame: 0 Days - Post-Treatment
measure: Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth
timeFrame: 0 Days - Post-Treatment
measure: Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly
timeFrame: 0 Days - Post-Treatment
measure: Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
timeFrame: 0 Days - Post-Treatment
measure: Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
timeFrame: 0 Days - Post-Treatment
measure: Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
timeFrame: 0 Days - Post-Treatment
measure: Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
timeFrame: 0 Days - Post-Treatment
measure: Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly
timeFrame: 0 Days - Post-Treatment
measure: Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth
timeFrame: 1 Day
measure: Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy
timeFrame: 1 Day
measure: Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft
timeFrame: 1 Day
measure: Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth
timeFrame: 1 Day
measure: Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
timeFrame: 1 Day
measure: Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
timeFrame: 1 Day
measure: Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
timeFrame: 1 Day
measure: Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
timeFrame: 1 Day
measure: Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth
timeFrame: 2 Days
measure: Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy
timeFrame: 2 Days
measure: Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft
timeFrame: 2 Days
measure: Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth
timeFrame: 2 Days
measure: Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
timeFrame: 2 Days
measure: Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
timeFrame: 2 Days
measure: Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
timeFrame: 2 Days
measure: Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
timeFrame: 2 Days
measure: Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth
timeFrame: 3 Days
measure: Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy
timeFrame: 3 Days
measure: Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft
timeFrame: 3 Days
measure: Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth
timeFrame: 3 Days
measure: Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
timeFrame: 3 Days
measure: Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
timeFrame: 3 Days
measure: Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
timeFrame: 3 Days
measure: Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
timeFrame: 3 Days
measure: Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
timeFrame: 7 Days
measure: Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth
timeFrame: 14 Days
measure: Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent.
timeFrame: 14 Days
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Thomas J. Stephens and Associates, Colorado Research Center
state: Colorado
city: Richardson
country: United States
facility: Thomas J. Stephens and Associates, Dallas Research Center
state: Texas
Study officials:
affiliation: Johnson & Johnson Consumer and Personal Products Worldwide
name: Christopher Nunez
role: STUDY_DIRECTOR
References: