The systemic treatments for moderate to severe atopic dermatitis (AD) are limited to phototherapy and cyclosporine with the risks respectively of either carcinoma, or hypertension or nephropathy. Methotrexate was effective in 75% of moderate to severe AD patients with good tolerance in an open retrospective study. We want to confirm our observations: a non inferiority multicenter clinical trial, methotrexate versus cyclosporine, will be conducted in 100 patients for 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
5 mg/kg/day per os during 8 weeks after the posology will be changed according to clinical response during the next 16 weeks
15 mg/week per os in one tablet during 8 weeks after the posology will be changed according to clinical response during the next 16 weeks
Hospices Civils de Lyon
Lyon, France
proportion of patients with a 50% decrease of scorad ( scorad 50) after 8 weeks of treatment
Time frame: 36 months
Decrease of scorad by 50% at week4,12,16,20 and 24
Time frame: at week4,12,16,20 and 24
Decrease of scorad by 75% and 90 % at week 8 and 24
Time frame: at week 8 and 24
quality of life at week 8 and 24
Time frame: at week 8 and 24
Concentration of cytokines CCL17 and CCL18
Time frame: at week 8 and 24
number of adverse events
Time frame: 36 months
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