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

Completed · Phase 4

Conditions studied: Dermatitis, Atopic

In brief

A study to compare efficacy of Protopic Ointment to that of Elidel Cream in treating patients with Atopic Dermatitis

Key facts

Study ID

NCT00666302

Run by

Astellas Pharma Inc

People needed

413

Starts

2002-10-01

Expected to finish

2003-11-01

Last updated by the study team

2014-09-18

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — San Francisco, California, United States
• Study site — Kansas City, Kansas, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — New York, New York, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Dallas, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Norfolk, Virginia, United States
• Study site — Halifax, Nova Scotia, Canada
• Study site — Halifax, Nova Scotia, Canada

Full record on ClinicalTrials.gov

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