Comparison of Protopic Ointment to Elidel Cream to assess the safety and efficacy in pediatric patients with Atopic Dermatitis

This is a two arm, randomized, investigator blinded study to compare Protopic Ointment to Elidel Cream in treating pediatric patients with moderate to severe Atopic Dermatitis

Inclusion Criteria:

• Diagnosis of Atopic Dermatitis which is rated moderate, severe or very severe using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body's surface area
• If female, and of childbearing potential, patient has a negative pregnancy test and agrees to practice effective birth control during the study

Exclusion Criteria:

• Patient has a skin disorder other than Atopic Dermatitis in the areas to be treated
• Patient has extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters
• Patient has clinically infected Atopic Dermatitis at baseline
• Patient is likely to require systemic corticosteroids, or the patient is likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug
• Patient has a known hypersensitivity to macrolides or any excipient of either study medication
• Patient has a chronic condition which is either not stable or not well controlled
• Patient is pregnant or breast feeding an infant