A Comparison Study Between Protopic (Tacrolimus) Ointment and Elidel (Pimecrolimus) Cream in Treating Subjects With Atopic Dermatitis
NCT ID: NCT00666302
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
413 participants
INTERVENTIONAL
2002-10-31
2003-11-30
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
* Negative pregnancy test and agrees to practice effective birth control during the study
Exclusion Criteria
* 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
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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Birmingham, Alabama, United States
San Francisco, California, United States
Kansas City, Kansas, United States
Ann Arbor, Michigan, United States
St Louis, Missouri, United States
New York, New York, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Halifax, Nova Scotia, Canada
Halifax, Nova Scotia, Canada
Countries
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References
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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.
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.
Fleischer AB Jr, Abramovits W, Breneman D, Jaracz E; US/Canada tacrolimus ointment study group. Tacrolimus ointment is more effective than pimecrolimus cream in adult patients with moderate to very severe atopic dermatitis. J Dermatolog Treat. 2007;18(3):151-7. doi: 10.1080/09546630701287332.
Other Identifiers
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20-02-004
Identifier Type: -
Identifier Source: org_study_id
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