Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis
NCT ID: NCT00121381
Last Updated: 2008-01-15
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
400 participants
INTERVENTIONAL
2005-05-31
2007-01-31
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
DOUBLE
Study Groups
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1
Pimecrolimus 1 % cream plus topical corticosteroid (TCS)
Pimecrolimus plus topical corticosteroid (TCS)
Pimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily
2
Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
twice daily administration
Interventions
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Pimecrolimus plus topical corticosteroid (TCS)
Pimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily
Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
twice daily administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 5% of total body surface area (TBSA) affected
Exclusion Criteria
* Immunocompromised
* Recently received phototherapy or systemic therapy
2 Years
17 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_CHAIR
Novartis Pharmaceuticals
Locations
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Pediatric Care Medical Group, Inc.
Huntington Beach, California, United States
Children's Hospital -San Diego
San Diego, California, United States
National Jewish Medical and Research Center
Denver, Colorado, United States
Dermatology Associates and Research
Coral Gables, Florida, United States
Medical College of Georgia - Clinical Investigative Services
Augusta, Georgia, United States
Dartmouth Hitchcock Medical Center Section of Dermatology
Lebanon, New Hampshire, United States
Wake Forest University School of Medicine Dept. of Dermatology
Winston-Salem, North Carolina, United States
Calcagno Research and Development
Gresham, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
520 Trinity Creek Cove
Cordova, Tennessee, United States
Virginia Commonwealth University
Richmond, Virginia, United States
A.S.T.H.M.A., Inc
Seattle, Washington, United States
Countries
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Other Identifiers
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CASM981C2439
Identifier Type: -
Identifier Source: org_study_id
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