Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Treating Pediatric Patients With Atopic Dermatitis
NCT ID: NCT00666159
Last Updated: 2014-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
226 participants
INTERVENTIONAL
2002-12-31
2003-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
tacrolimus ointment
topical
2
pimecrolimus cream
topical
Interventions
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tacrolimus ointment
topical
pimecrolimus cream
topical
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* If female, and of childbearing potential, patient has a negative pregnancy test and agrees to practice effective birth control during the study
Exclusion Criteria
* 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
2 Years
16 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use central contact
Role: STUDY_DIRECTOR
Astellas Pharma US, Inc.
Locations
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New Haven, Connecticut, United States
Miami, Florida, United States
Miami, Florida, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Clinton Township, Michigan, United States
Omaha, Nebraska, United States
Reno, Nevada, United States
Chapel Hill, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Houston, Texas, United States
Countries
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References
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Paller AS, Lebwohl M, Fleischer AB Jr, Antaya R, Langley RG, Kirsner RS, Blum RR, Rico MJ, Jaracz E, Crowe A, Linowski GJ; US/Canada Tacrolimus Ointment Study Group. Tacrolimus ointment is more effective than pimecrolimus cream with a similar safety profile in the treatment of atopic dermatitis: results from 3 randomized, comparative studies. J Am Acad Dermatol. 2005 May;52(5):810-22. doi: 10.1016/j.jaad.2004.12.038.
Kirsner RS, Heffernan MP, Antaya R. Safety and efficacy of tacrolimus ointment versus pimecrolimus cream in the treatment of patients with atopic dermatitis previously treated with corticosteroids. Acta Derm Venereol. 2010;90(1):58-64. doi: 10.2340/00015555-0748.
Other Identifiers
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20-02-005
Identifier Type: -
Identifier Source: org_study_id
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