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Sponsored by: |
Novartis |
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00121381 |
Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety of pimecrolimus Cream 1% with topical corticosteroid treatment (commonly used in eczema) in patients with severe atopic dermatitis.
Condition | Intervention | Phase |
Dermatitis, Atopic |
Drug: Pimecrolimus plus topical corticosteroid (TCS) Drug: Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS) |
Phase IV |
MedlinePlus related topics: | Eczema |
Drug Information available for: | Corticosteroids Pimecrolimus |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis |
Estimated Enrollment: | 400 |
Study Start Date: | May 2005 |
Study Completion Date: | January 2007 |
Arms | Assigned Interventions |
1: Experimental
Pimecrolimus 1 % cream plus topical corticosteroid (TCS)
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Drug: Pimecrolimus plus topical corticosteroid (TCS)
Pimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily
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2: Placebo Comparator
Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
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Drug: Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
twice daily administration
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Ages Eligible for Study: | 2 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |||||
Pediatric Care Medical Group, Inc. | |||||
Huntington Beach, California, United States, 92647 | |||||
Children's Hospital -San Diego | |||||
San Diego, California, United States, 92123 | |||||
United States, Colorado | |||||
National Jewish Medical and Research Center | |||||
Denver, Colorado, United States, 80206 | |||||
United States, Florida | |||||
Dermatology Associates and Research | |||||
Coral Gables, Florida, United States, 33134 | |||||
United States, Georgia | |||||
Medical College of Georgia - Clinical Investigative Services | |||||
Augusta, Georgia, United States, 30912 | |||||
United States, New Hampshire | |||||
Dartmouth Hitchcock Medical Center Section of Dermatology | |||||
Lebanon, New Hampshire, United States, 03756 | |||||
United States, North Carolina | |||||
Wake Forest University School of Medicine Dept. of Dermatology | |||||
Winston-Salem, North Carolina, United States, 27157 | |||||
United States, Oregon | |||||
Calcagno Research and Development | |||||
Gresham, Oregon, United States, 97030 | |||||
United States, Pennsylvania | |||||
Children's Hospital of Philadelphia | |||||
Philadelphia, Pennsylvania, United States, 19104 | |||||
United States, Rhode Island | |||||
Rhode Island Hospital | |||||
Providence, Rhode Island, United States, 02903 | |||||
United States, Tennessee | |||||
520 Trinity Creek Cove | |||||
Cordova, Tennessee, United States, 38018 | |||||
United States, Virginia | |||||
Virginia Commonwealth University | |||||
Richmond, Virginia, United States, 23298 | |||||
United States, Washington | |||||
A.S.T.H.M.A., Inc | |||||
Seattle, Washington, United States, 98105 |
Novartis |
Study Chair: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CASM981C2439 |
First Received: | July 14, 2005 |
Last Updated: | January 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00121381 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Germany: Federal Institute for Drugs and Medical Devices; Italy: Ministry of Health; South Africa: Medicines Control Council |
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