Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02120833
Recruitment Status : Completed
First Posted : April 23, 2014
Results First Posted : September 7, 2015
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

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.


Condition or disease Intervention/treatment Phase
Eczema Device: EpiCeram® Skin Barrier Emulsion Drug: Colloidal Oatmeal Cream Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Active Comparator: EPI 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.

Experimental: NEE 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.




Primary Outcome Measures :
  1. Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline [ Time Frame: Baseline to Day 3 ]
    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.

  2. Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline [ Time Frame: Baseline to Day 3 ]
    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.


Secondary Outcome Measures :
  1. Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline [ Time Frame: Baseline to Day 1 ]
    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.

  2. Eczema Area and Severity Index (EASI) on Day 2 - Change From Baseline [ Time Frame: Baseline to Day 2 ]
    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.

  3. Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline [ Time Frame: Baseline to Day 7 ]
    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.

  4. Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline [ Time Frame: Baseline to Day 14 ]
    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.

  5. Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline [ Time Frame: Baseline to Day 1 ]
    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.

  6. Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 2 - Change From Baseline [ Time Frame: Baseline to Day 2 ]
    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.

  7. Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline [ Time Frame: Baseline to Day 7 ]
    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.

  8. Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline [ Time Frame: Baseline to Day 14 ]
    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.

  9. Corneometer Measurement on Day 0 - Post-Treatment - Change From Baseline [ Time Frame: Baseline to Post -Treatment on Day 0 ]
    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.

  10. Corneometer Measurement on Day 1 - Change From Baseline [ Time Frame: Baseline to Day 1 ]
    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.

  11. Corneometer Measurement on Day 2 - Change From Baseline [ Time Frame: Baseline to Day 2 ]
    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.

  12. Corneometer Measurement on Day 3 - Change From Baseline [ Time Frame: Baseline to Day 3 ]
    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.

  13. Corneometer Measurement on Day 7 - Change From Baseline [ Time Frame: Baseline to Day 7 ]
    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.

  14. Corneometer Measurement on Day 14 - Change From Baseline [ Time Frame: Baseline to Day 14 ]
    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.

  15. Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth [ Time Frame: 0 Days - Pre-Treatment ]
    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.'

  16. Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy [ Time Frame: 0 Days - Pre-Treatment ]
    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.'

  17. Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft [ Time Frame: 0 Days - Pre-Treatment ]
    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.'

  18. Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth [ Time Frame: 0 Days - Pre-Treatment ]
    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.'

  19. 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 ]
    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.'

  20. 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 ]
    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.'

  21. 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 ]
    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.'

  22. 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 ]
    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.'

  23. Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth [ Time Frame: 0 Days - Post-Treatment ]
    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.'

  24. Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy [ Time Frame: 0 Days - Post-Treatment ]
    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.'

  25. Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft [ Time Frame: 0 Days - Post-Treatment ]
    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.'

  26. Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth [ Time Frame: 0 Days - Post-Treatment ]
    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.'

  27. Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly [ Time Frame: 0 Days - Post-Treatment ]
    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.'

  28. Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth [ Time Frame: 0 Days - Post-Treatment ]
    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.'

  29. Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy [ Time Frame: 0 Days - Post-Treatment ]
    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.'

  30. Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft [ Time Frame: 0 Days - Post-Treatment ]
    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.'

  31. Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth [ Time Frame: 0 Days - Post-Treatment ]
    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.'

  32. Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly [ Time Frame: 0 Days - Post-Treatment ]
    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.'

  33. Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth [ Time Frame: 1 Day ]
    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.'

  34. Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy [ Time Frame: 1 Day ]
    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.'

  35. Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft [ Time Frame: 1 Day ]
    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.'

  36. Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth [ Time Frame: 1 Day ]
    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.'

  37. Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth [ Time Frame: 1 Day ]
    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.'

  38. Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy [ Time Frame: 1 Day ]
    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.'

  39. Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft [ Time Frame: 1 Day ]
    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.'

  40. Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth [ Time Frame: 1 Day ]
    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.'

  41. Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth [ Time Frame: 2 Days ]
    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.'

  42. Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy [ Time Frame: 2 Days ]
    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.'

  43. Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft [ Time Frame: 2 Days ]
    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.'

  44. Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth [ Time Frame: 2 Days ]
    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.'

  45. Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth [ Time Frame: 2 Days ]
    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.'

  46. Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy [ Time Frame: 2 Days ]
    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.'

  47. Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft [ Time Frame: 2 Days ]
    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.'

  48. Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth [ Time Frame: 2 Days ]
    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.'

  49. Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth [ Time Frame: 3 Days ]
    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.'

  50. Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy [ Time Frame: 3 Days ]
    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.'

  51. Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft [ Time Frame: 3 Days ]
    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.'

  52. Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth [ Time Frame: 3 Days ]
    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.'

  53. Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth [ Time Frame: 3 Days ]
    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.'

  54. Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy [ Time Frame: 3 Days ]
    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.'

  55. Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft [ Time Frame: 3 Days ]
    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.'

  56. Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth [ Time Frame: 3 Days ]
    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.'

  57. Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth [ Time Frame: 7 Days ]
    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.'

  58. Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy [ Time Frame: 7 Days ]
    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.'

  59. Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft [ Time Frame: 7 Days ]
    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.'

  60. Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth [ Time Frame: 7 Days ]
    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.'

  61. Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth [ Time Frame: 7 Days ]
    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.'

  62. Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy [ Time Frame: 7 Days ]
    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.'

  63. Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft [ Time Frame: 7 Days ]
    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.'

  64. Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth [ Time Frame: 7 Days ]
    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.'

  65. Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth [ Time Frame: 14 Days ]
    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.'

  66. Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy [ Time Frame: 14 Days ]
    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.'

  67. Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft [ Time Frame: 14 Days ]
    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.'

  68. Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth [ Time Frame: 14 Days ]
    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.'

  69. Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth [ Time Frame: 14 Days ]
    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.'

  70. Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy [ Time Frame: 14 Days ]
    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.'

  71. Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft [ Time Frame: 14 Days ]
    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.'

  72. Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth [ Time Frame: 14 Days ]
    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.'

  73. Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent. [ Time Frame: 14 Days ]
    Questions were answered immediately post-treatment by participant's caregiver. Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120833


Locations
Layout table for location information
United States, Colorado
Thomas J. Stephens and Associates, Colorado Research Center
Colorado Springs, Colorado, United States, 80915
United States, Texas
Thomas J. Stephens and Associates, Dallas Research Center
Richardson, Texas, United States, 75081
Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
Layout table for investigator information
Study Director: Christopher Nunez Johnson & Johnson Consumer and Personal Products Worldwide

Layout table for additonal information
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT02120833     History of Changes
Other Study ID Numbers: CO-140206110636-SBCT
First Posted: April 23, 2014    Key Record Dates
Results First Posted: September 7, 2015
Last Update Posted: January 13, 2017
Last Verified: January 2017

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Atopic Dermatitis