This study is not being conducted in the United States of America (USA). Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety and efficacy of pimecrolimus cream 1% in atopic dermatitis of the face in patients intolerant of, or dependent on, topical corticosteroids.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
Pimecrolimus 1 % cream
Pimecrolimus vehicle cream (placebo)
This study is not being conducted in the United States
Novartis Pharmaceuticals, New Jersey, United States
The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear)
Percentage of patients who responded to treatment assessed by overall Eczema Area and Severity Index (EASI) and head and neck EASI score
The percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score
The percentage of patients achieving a score of 0 or 1 for pruritus (absent or mild)
Time to clearance of facial IGA (score of 0 or 1)
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