Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Treating Pediatric Patients With Atopic Dermatitis

Launched by ASTELLAS PHARMA INC · Apr 23, 2008

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility criteria

• 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