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

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: All

Summary

A study to compare efficacy of Protopic Ointment to that of Elidel Cream in treating 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 rated at least mild using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body surface area

• Negative pregnancy test and agrees to practice effective birth control during the study

Exclusion Criteria:

• Skin disorder other than Atopic Dermatitis in the areas to be treated

• Extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters

• Clinically infected Atopic Dermatitis at baseline

• Likely to require systemic corticosteroids; or likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug

• Known hypersensitivity to macrolides or any excipient of either study medication

• Chronic condition which is either not stable or not well controlled

• Pregnant or breast feeding an infant