drugset / Trial / NCT00809172

Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients

NCT00809172

Phase 3 Completed 100 enrolled Hospices Civils de Lyon
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2008-12
Primary completion
2011-10
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclosporine Peptide 2.5 mg/kg Oral
Comparator Cyclosporine Peptide 5 mg/kg Oral
Subject Methotrexate Small molecule 15 mg Oral
Subject Methotrexate Small molecule 25 mg Oral

Indications