Health Condition 1: A305- Lepromatous leprosy
Conditions
Interventions
Intervention1: Methotrexate: The patients will receive prednisolone 1mg/kg/day or a maximum dose of 60mg at baseline along with methotrexate.
Methotrexate 15 mg once weekly will be continued till the
Sponsors
Dr Bhini Ameta
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with severe ENL of any gender and age more than 18 years 2.Patients willing to participate and willing to follow up for six months Definitions: Erythema nodosum leprosum (ENL): It is defined as the sudden appearance of transient painful erythematous cutaneous nodules mostly on the extensor aspects of legs and arms, face along with occasional involvement of the trunk. New ENL: is defined as ENL occurring 1st time in a patient. Nature of ENL classified as: Acute ENL- one ENL episode lasting for less than 24 weeks while the patient is on corticosteroid treatment. Recurrent ENL- if a patient develops ENL again after 28 days of stoppage of treatment. Chronic ENL- ENL lesions persist for greater than or 24 weeks while the patient is on treatment continuously/having treatment free period for 27 days or less Mild ENL: It affects only the skin along with low grade fever and ENLIST ENL severity score is less than or equal to 8. Severe ENL: It is characterized by multiple cutaneous nodules which may ulcerate, along with the inflammation of other organs such as the nerves, eyes, joints, testes, and lymph nodes. The ENLIST ENL score more than 8.
Exclusion criteria
Exclusion criteria: 1.Patients with known immunosuppression or on immunosuppressive therapy 2.Patients with severe ENL on any steroid-sparing agents within the last one month 3.Pregnancy and lactation 4.Patients with a history of hypersensitivity to thalidomide or methotrexate. 5.Patients with haemoglobin less than 10 gm/dl, Leukopenia (total leukocyte count less than 4000/mm3), or thrombocytopenia (Platelets less than 1lakh/mm3), active liver disease (AST, ALT more han 35 IU/L), eGFR less than 30 ml/min/1.73 m2 6.Patients with HIV 1 and or 2, Hepatitis B and C infection. 7.Patients on therapy that interacts with interventional drugs 8.Patients with a self-declared history of alcohol consumption. 9.Patients who will deny giving consent to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the proportion of patients achieving remission at three and six months (Remission is defined as subsidence of all features of ENL with ENL International Study Group Severity Scale score of zero when the patient is off prednisolone or minimal prednisolone dose of 10mg or less) between the Thalidomide group and Methotrexate groupTimepoint: Baseline, 3 month, 6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| i. The number of ENL flares ii. The mean time for ENL flare iii. Cumulative dose of steroids in both groups iv. Percentage change in DLQI v. The correlation between ENLIST ENL severity score and serum IL 6 levels vi. The correlation between ENLIST ENL severity score and pretibial tenderness vii. Histopathological-dermoscopic correlation of skin lesions Timepoint: 6 month | — |
Countries
India
Contacts
Public ContactDr Biswanath Behera
All India Institute of Medical Sciences, Bhubaneswar
Outcome results
None listed