A Comparison Study Between Protopic (Tacrolimus) Ointment and Elidel (Pimecrolimus) Cream in Treating Subjects With Atopic Dermatitis
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dermatitis, Atopic
Intervention: tacrolimus ointment (Drug); pimecrolimus cream (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Use central contact, Study Director, Affiliation: Astellas Pharma US, Inc.
Summary
A study to compare efficacy of Protopic Ointment to that of Elidel Cream in treating patients
with Atopic Dermatitis
Clinical Details
Official title: A Randomized, Investigator Blinded Study of Protopic (Tacrolimus) Ointment Vs. Elidel (Pimecrolimus) Cream in Patients With Atopic Dermatitis
Study design: Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in Eczema Area and Severity Index (EASI)
Secondary outcome: Investigator's Global Atopic Dermatitis Assessment (IGADA)Patient's evaluation of itch Body surface area affected
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Birmingham, Alabama 35205, United States
San Francisco, California 94118, United States
Kansas City, Kansas 66160, United States
Ann Arbor, Michigan 48109, United States
St Louis, Missouri 63110, United States
New York, New York 10029, United States
Winston-Salem, North Carolina 27157, United States
Halifax, Nova Scotia B3H 1Z4, Canada
Halifax, Nova Scotia B3H 1V7, Canada
Cincinnati, Ohio 45219, United States
Philadelphia, Pennsylvania 19107, United States
San Antonio, Texas 78229, United States
Dallas, Texas 75230, United States
Salt Lake City, Utah 84124, United States
Norfolk, Virginia 23507, United States
Additional Information
Starting date: October 2002
Ending date: November 2003
Last updated: April 23, 2008
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