A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin
Condition: Eczema
MeSH terms: Eczema
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): EpiCeram® Skin Barrier Emulsion; Colloidal Oatmeal Cream
Intervention type(s): Device; Drug
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atopic Dermatitis