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

• Status: Completed
• Trial end date: 2003-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Pimecrolimus; Tacrolimus

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