Health Condition 1: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Intervention1: Cyclosporine: oral Cyclosporine at a dose of 3 to 3.5 mg/kg daily upto maximum dose of 5 mg/kg/day for 6 months
Control Intervention1: Oral cyclosporine: 3 to 3.5 mg/kg daily
Control In
Sponsors
IMS and SUM Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with severe AD 2. EASI more than 21 3. Objective SCORAD more than 40 4. Chronic relapsing eczema for more than 3months
Exclusion criteria
Exclusion criteria: 1. Patients with deranged liver function test (LFT) 2. Patients with deranged renal function test (RFT) 3. Patients with deranged Complete Blood Counts (CBC) 4. Known case of cardiac disease 5. Known case of hypertension 6. Known case of chronic or recurrent infections 7. Known case / family or contact history of tuberculosis 8. Known case of immunodeficiency syndrome 9. Known case of malignancy 10. Patients with known hypersensitivity to cyclosporine and methotrexate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of the drugs by the reduction in EASI, SCORAD and increase in DLQI and improvement in the clinical presentation of the childTimepoint: at baseline, then a monthly follow up for 6 months when on medication and then for 3 months after stopping medication | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the drugs by the adverse effects caused in study populationTimepoint: at the end of follow up, that is at 9 months | — |
Countries
India
Contacts
Public ContactAnanya Pramanik
IMS and SUM Hospital
Outcome results
None listed