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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
400
Pimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily
twice daily administration
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
Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation)
Incidence of all other adverse events
Time to relapse of atopic dermatitis
Time to treatment success according to the Investigators Global Assessment (IGA - a measure of disease severity)
Efficacy measured by IGA (treatment success and improvement)
Efficacy measured by improvement in Eczema Area and Severity Index (EASI - a measure of disease severity and extent
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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
...and 3 more locations