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

A Double-Blind, Randomized, Active-Controlled Clinical Trial to Evaluate the Efficacy and Safety of an Over-the-Counter Cream in the Management of Mild to Moderate Atopic Dermatitis in Children

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®

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