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

Completed · Phase 4

Conditions studied: Dermatitis, Atopic

In brief

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

Key facts

Study ID

NCT00666159

Run by

Astellas Pharma Inc

People needed

226

Starts

2002-12-01

Expected to finish

2003-05-01

Last updated by the study team

2014-09-18

Who can join

Age: 2 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — New Haven, Connecticut, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Boston, Massachusetts, United States
• Study site — Clinton Township, Michigan, United States
• Study site — Omaha, Nebraska, United States
• Study site — Reno, Nevada, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Wilmington, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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