A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin
Condition: Eczema
MeSH terms: Eczema
Intervention: EpiCeram® Skin Barrier Emulsion; Colloidal Oatmeal Cream
Intervention description: 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 (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.
Intervention MeSH terms: Decanoic acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 2 Months
Maximum age: 35 Months
Healthy volunteers: No
Keywords: Atopic Dermatitis

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.
    

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.