A Randomized, Investigator Blinded Study of Protopic (Tacrolimus) Ointment Vs. Elidel (Pimecrolimus) Cream in Pediatric Patients With Mild Atopic Dermatitis

Astellas Pharma Inc0 sites426 target enrollmentDecember 2002

Overview

A study to compare the safety and efficacy of Protopic and Elidel in treating mild Atopic Dermatitis in pediatric patients

Registry

clinicaltrials.gov

Start Date

December 2002

End Date

November 2003

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Patient has a diagnosis of Atopic Dermatitis rated mild using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body surface area, and the maximum of 20% of the body surface area
•If female, and of childbearing potential, patient has a negative pregnancy test and agrees to practice effective birth control during the study

•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