A Multi-Center Study of Short and Long-term Use of Protopic Ointment in Patients With Atopic Dermatitis
NCT ID: NCT00106496
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
410 participants
INTERVENTIONAL
2004-10-31
2006-07-31
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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1A
Protopic
topical
1B
Corticosteroid
topical
2
Open label
Protopic
topical
3A
Protopic
topical
3B
placebo
topical
4
Open label
Protopic
topical
Interventions
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Protopic
topical
Corticosteroid
topical
placebo
topical
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient must be at least 2 years of age
Exclusion Criteria
2 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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Investigational Site
Birmingham, Alabama, United States
Investigational Site
Irvine, California, United States
Investigational Site
Loma Linda, California, United States
Investigational Site
San Diego, California, United States
New Haven, Connecticut, United States
Miami, Florida, United States
Investigational Site
Atlanta, Georgia, United States
Investigational Site
Chicago, Illinois, United States
Chicago, Illinois, United States
Investigational Site
Chicago, Illinois, United States
Lexington, Kentucky, United States
Baltimore, Maryland, United States
Investigational Site
Ann Arbor, Michigan, United States
Investigational Site
Detroit, Michigan, United States
Investigational Site
St Louis, Missouri, United States
Investigational Site
Lebanon, New Hampshire, United States
Investigational Site
New York, New York, United States
Investigational Site
Winston-Salem, North Carolina, United States
Investigational Site
Cincinnati, Ohio, United States
Investigational Site
Portland, Oregon, United States
Investigational Site
Philadelphia, Pennsylvania, United States
Investigational Site
Nashville, Tennessee, United States
Investigational Site
Dallas, Texas, United States
Investigational Site
Dallas, Texas, United States
Countries
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References
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Breneman D, Fleischer AB Jr, Abramovits W, Zeichner J, Gold MH, Kirsner RS, Shull TF, Crowe AW, Jaracz E, Hanifin JM; Tacrolimus Ointment Study Group. Intermittent therapy for flare prevention and long-term disease control in stabilized atopic dermatitis: a randomized comparison of 3-times-weekly applications of tacrolimus ointment versus vehicle. J Am Acad Dermatol. 2008 Jun;58(6):990-9. doi: 10.1016/j.jaad.2008.02.008. Epub 2008 Mar 21.
Paller AS, Eichenfield LF, Kirsner RS, Shull T, Jaracz E, Simpson EL; US Tacrolimus Ointment Study Group. Three times weekly tacrolimus ointment reduces relapse in stabilized atopic dermatitis: a new paradigm for use. Pediatrics. 2008 Dec;122(6):e1210-8. doi: 10.1542/peds.2008-1343. Epub 2008 Nov 17.
Other Identifiers
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20-04-002
Identifier Type: -
Identifier Source: org_study_id
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