Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification
NCT ID: NCT00124709
Last Updated: 2011-03-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
1091 participants
INTERVENTIONAL
2003-10-31
2008-11-30
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
DOUBLE
Study Groups
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1
Pimecrolimus
Pimecrolimus
Pimecrolimus cream 1 %
2
Corticosteroid
Corticosteroid
conventional corticosteroid-based treatment
Interventions
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Pimecrolimus
Pimecrolimus cream 1 %
Corticosteroid
conventional corticosteroid-based treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Family history of atopy
* 3 to 18 months of age at baseline
* At least mild atopic dermatitis at baseline (investigator global assessment \[IGA\] greater or equal to 2)
* Clinical evidence of atopic dermatitis for no longer than 3 months
Exclusion Criteria
Other protocol related criteria may apply
3 Months
18 Months
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_CHAIR
Novartis Pharmaceuticals
Locations
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Alabama Allergy and Asthma Center
Birmingham, Alabama, United States
Northwest Arkansas Pediatric Clinic, P.A.
Fayetteville, Arkansas, United States
The Children's Clinic of Jonesboro
Jonesboro, Arkansas, United States
Southern California Research
Mission Viejo, California, United States
Children's Hospital of Orange County
Orange, California, United States
Stanford Dermatology Clinic and Clinical Trials Dept
Redwood City, California, United States
Capital Allergy Respiratory Disease Center
Sacramento, California, United States
Children's Hospital San Diego
San Diego, California, United States
Allergy and Asthma Medical Group of Diablo Valley, Inc./ Clinical Research Division
Walnut Creek, California, United States
National Jewish Medical and Research Center
Denver, Colorado, United States
Dermatology Associates and Research
Coral Gables, Florida, United States
Emerald Coast Clinical Research
Pensacola, Florida, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Indiana University Outpatient Clinical Research
Indianapolis, Indiana, United States
Central Kentucky Research Associates
Lexington, Kentucky, United States
Dermatology Specialists
Louisville, Kentucky, United States
Rx R & D
Metarie, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Children's Hospital - Boston
Boston, Massachusetts, United States
Dermatology, PLLC
Ann Arbor, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Central Dermatology
St Louis, Missouri, United States
Skin Specialists, P.C.
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center/Dermatology Section
Lebanon, New Hampshire, United States
Children's Medical Group
Hopewell Junction, New York, United States
Dermatology Associates of St. Luke's - Roosevelt
New York, New York, United States
Calcagno Research and Development
Gresham, Oregon, United States
Oregon Health Science University - Dermatology Dept.
Portland, Oregon, United States
The Childrens' Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Texas Children's Hospital, BCM
Houston, Texas, United States
Alpine Medical Group, LLC
Salt Lake City, Utah, United States
Granger Medical Clinic
West Valley City, Utah, United States
Virginia Clinical Research
Norfolk, Virginia, United States
Asthma Inc
Seattle, Washington, United States
Countries
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References
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Spergel JM, Boguniewicz M, Schneider L, Hanifin JM, Paller AS, Eichenfield LF. Food Allergy in Infants With Atopic Dermatitis: Limitations of Food-Specific IgE Measurements. Pediatrics. 2015 Dec;136(6):e1530-8. doi: 10.1542/peds.2015-1444.
Other Identifiers
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CASM981CUS09
Identifier Type: -
Identifier Source: org_study_id
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