Study of the Safety and Efficacy of Tacrolimus Ointment in Treating Chronic Allergic Contact Dermatitis
NCT ID: NCT00667056
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
98 participants
INTERVENTIONAL
2004-07-31
2004-12-31
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
QUADRUPLE
Study Groups
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1
tacrolimus ointment
topical
2
placebo ointment
topical
Interventions
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tacrolimus ointment
topical
placebo ointment
topical
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subject fails to react to the nickel disks (grade 0), reacts with a questionable (grade 1) or extreme (grade 4) reaction or the subject's reactions on the left and right arms are not of the same grade of intensity
* Subject has a known hypersensitivity to any component of the test medications
* Subject has any other significant dermatological condition that affects \>10% of the body surface area or general medical condition that could interfere with the study evaluation
* Subject has any significant medical condition that could compromise immune responsiveness
17 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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Washington D.C., District of Columbia, United States
Kansas City, Kansas, United States
Shawnee, Kansas, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Minneapolis, Minnesota, United States
New York, New York, United States
Portland, Oregon, United States
Hershey, Pennsylvania, United States
Lynchburg, Virginia, United States
Countries
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References
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Belsito D, Wilson DC, Warshaw E, Fowler J, Ehrlich A, Anderson B, Strober BE, Willetts J, Rutledge ES. A prospective randomized clinical trial of 0.1% tacrolimus ointment in a model of chronic allergic contact dermatitis. J Am Acad Dermatol. 2006 Jul;55(1):40-6. doi: 10.1016/j.jaad.2006.03.025. Epub 2006 May 26.
Other Identifiers
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20-04-001
Identifier Type: -
Identifier Source: org_study_id
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