Status:
COMPLETED
A Comparison Study Between Protopic (Tacrolimus) Ointment and Elidel (Pimecrolimus) Cream in Treating Subjects With Atopic Dermatitis
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
A study to compare efficacy of Protopic Ointment to that of Elidel Cream in treating patients with Atopic Dermatitis
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2003
Estimated Enrollment :
413 Patients enrolled
Trial Details
Trial ID
NCT00666302
Start Date
October 1 2002
End Date
November 1 2003
Last Update
September 18 2014
Active Locations (15)
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1
Birmingham, Alabama, United States, 35205
2
San Francisco, California, United States, 94118
3
Kansas City, Kansas, United States, 66160
4
Ann Arbor, Michigan, United States, 48109