Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients (METHODA)
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|ClinicalTrials.gov Identifier: NCT00809172|
Recruitment Status : Completed
First Posted : December 17, 2008
Last Update Posted : May 14, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: Ciclosporin Drug: Methotrexate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Randomised Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients|
|Study Start Date :||December 2008|
|Primary Completion Date :||October 2011|
|Study Completion Date :||April 2012|
Active Comparator: 1
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
- 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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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00809172
|Hospices Civils de Lyon|
|Principal Investigator:||Jean-François Nicolas, Professor||Hospices Civils de Lyon|