The purpose of this study is to determine if Raptiva will have beneficial effects in the treatment of patients with moderate to severe atopic dermatitis.
Atopic dermatitis is a common, highly pruritic, inflammatory skin disease that affects up to 17% of school-aged children. Most cases of childhood atopic dermatitis improve or resolve by adulthood. However, the majority of patients retain some features of atopic dermatitis and some continue to have severe disease that continues to adulthood. Moderate to severe atopic dermatitis cannot be adeuately controlled with topical agents. Consequently many patients are treated with systemic corticosteroids, cyclosporine, azathioprine, methotrexate, and other immunosuppressants that carry the risk of severe atopic dermatitis is greatly needed. The chronic use of current immunosuppressive agents is limited by cumulative end-organ toxicities. We propose inhibition of T cell trafficking to the skin with Raptiva will have beneficial effects in the treatment of patients with moderate to severe atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Open Label
Evaluate the safety and effectiveness of Raptiva in patients with moderate to severe atopic dermatitis
The primary efficacy outcome measure will be the change in mean Eczema Area and Severity Index (EASI) score from baseline
Time frame: EASI Score collected at 12 weeks following baseline
Improvement in EASI score
Total percent of patients reaching 50% improvement in EASI score
Time frame: Assessed 12 weeks after baseline
Improvement in IGA score
Numbers of patient reaching clear, almost clear or mild disease on the Investigator Global Assessment (IGA) Score
Time frame: Assessed 12 weeks after baseline
Subject's assessment of overall response
Subject's assessment of overall response
Time frame: End of study
Change in serum IgE level
Change in serum IgE Level
Time frame: Serum IgE collected at 12 weeks following baseline
Pruritis (0-10 VAS Scale) change
Pruritis (0-10 VAS Scale) change
Time frame: VAS scale collected at 12 weeks following baseline
Time to first response
Time to first response as defined by a decrease of 25% in EASI score
Time frame: Assessed on Days 28,56, and 84
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