Human Testing of an Over-the-Counter (OTC) Cream in Children With Eczema

• Interim Eczema Area and Severity Index (EASI) [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  Number of subjects improved at Week 2 compared to Baseline in EASI. Improved is defined as post baseline EASI score smaller than baseline score.
• Assessment of Itch [ Time Frame: through Week 3 ] [ Designated as safety issue: No ]
  Subject's or caregiver's assessment of itch, on a 10-cm Visual Analogue Scale (VAS), where 0-no itch, 10-worst itch imaginable
• Investigator's Global Atopic Dermatitis Assessment (IGADA) [ Time Frame: through Week 3 ] [ Designated as safety issue: No ]
  An assessment of Atopic Dermatitis based on a 4 point scale where 0 (none) and 3 (severe) are 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 will be 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe, or 5-very severe.

• Interim Eczema Area and Severity Index (EASI) [ Time Frame: through Week 2 ] [ Designated as safety issue: No ]
  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
• Assessment of Itch [ Time Frame: through Week 3 ] [ Designated as safety issue: No ]
  Subject's or caregiver's assessment of itch, on a 10-cm Visual Analogue Scale (VAS)
• Investigator's Global Atopic Dermatitis Assessment (IGADA) [ Time Frame: through Week 3 ] [ Designated as safety issue: No ]
  An assessment of Atopic Dermatitis based on a 4 point scale where 0 (none) and 3 (severe) are 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 will be clear, almost clear, mild, moderate, severe, or very severe.

This three week study will be conducted to determine the safety and efficacy of an over-the-counter (OTC) cream in children with mild to moderate atopic dermatitis.

The objective of this trial is to evaluate the efficacy and safety of an OTC colloidal oatmeal skin protectant cream in children with mild to moderate AD in comparison to that of EpiCeram®

• Drug: Colloidal Oatmeal
  Topical cream applied twice daily (or as needed)
  Other Name: Not yet marketed
• Device: Topical Cream
  Topical cream applied twice daily (or as needed)
  Other Name: EpiCeram

• Experimental: 19306-127
  Experimental Topical cream applied twice daily (or as needed)
  Intervention: Drug: Colloidal Oatmeal
• 19306-137
  Marketed Topical cream applied twice daily (or as needed)
  Intervention: Device: Topical Cream

Inclusion Criteria:

• Children ages 6 mo- 18 years
• Any ethnicity
• Diagnosed with atopic dermatitis (AD) per Hanifin-Rajka criteria
• Mild to moderate atopic dermatitis per Rajka-Langeland severity index
• Willing to use only provided cream and body wash for duration of study

Exclusion Criteria:

• Known sensitivity to investigational products
• Pregnant or breastfeeding
• Severe AD per Rajka-Langeland severity index
• AD requiring class I (super potent) or class II or III (potent) topical steroids
• Requires greater than 2.0 g inhaled or intranasal corticosteroids
• Other skin conditions which may interfere with the scoring of AD