Health Condition 1: L308- Other specified dermatitis
Conditions
Interventions
Intervention1: Methotrexate: All patients who meet the eligibility criteria during the screening visit will be randomly assigned to one of the two treatment groups of 40 patients each and one group wi
Sponsors
Postgraduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: Patients diagnosed as moderate to severe hand eczema (HECSI score >12). Age >18 years.
Exclusion criteria
Exclusion criteria: 1. Patients with hepatic/ renal disease/pulmonary fibrosis. 2. Severe anaemia, leucopenia or thrombocytopenia. 3. Active infectious disease or immune system deficiency including AIDS. 4. Pregnant or lactating women. 5. Significant abnormalities in liver function (serum bilirubin, AST, ALT, and ALP > 1.5 times the upper limit of normal), viral hepatitis or cirrhosis. 6. H/o excessive alcohol consumption. 7. H/o intolerance/hypersensitivity to azathioprine and/or methotrexate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the clinical and functional outcome in each group, as assessed by HECSI and DLQI. To compare the safety and tolerability of each drug by regular evaluation of clinical and biochemical parameters.Timepoint: week 2, 4, 8 and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| ã?? Evaluate the clinicodemographic factors predicting response in each group. To study the MOAHLFA index for demographic characteristics of patients.Timepoint: week 2,4,8 and 12 | — |
Countries
India
Contacts
Public ContactSanjeev Handa
Postgraduate Institute of Medical education and Research
Outcome results
None listed