Status:
COMPLETED
Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Treating Pediatric Patients With Atopic Dermatitis
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
2-16 years
Phase:
PHASE4
Brief Summary
Comparison of Protopic Ointment to Elidel Cream to assess the safety and efficacy in pediatric patients with Atopic Dermatitis
Detailed Description
This is a two arm, randomized, investigator blinded study to compare Protopic Ointment to Elidel Cream in treating pediatric patients with moderate to severe Atopic Dermatitis
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2003
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT00666159
Start Date
December 1 2002
End Date
May 1 2003
Last Update
September 18 2014
Active Locations (12)
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1
New Haven, Connecticut, United States, 06519
2
Miami, Florida, United States, 33136
3
Miami, Florida, United States, 33155
4
Chicago, Illinois, United States, 60614