drugset / Trial / NCT00809172
Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |