Erythema Nodosum Leprosum (ENL) is a painful, debilitating complication of leprosy. Patients often require high doses of corticosteroids for prolonged periods. Thalidomide is expensive and not available in most countries. The use of corticosteroids for long periods is associated with adverse effects and mortality. It is a priority to identify alternative agents to treat ENL. Methotrexate (MTX) is a cheap, widely used medication which has been reported to be effective in ENL resistant to steroids and thalidomide.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Individuals who diagnosed with leprosy complicated by ENL
✓. Individuals with ENL aged 18-60 years old
✓. Individuals with ENL deteriorating symptoms
✓. Individuals with 10 or more tender, papular or nodular ENL skin lesions
✓. Individuals with an EESS score of at least 9
✓. Individuals with ENL on:
✓. No current anti- ENL treatment
✓. Prednisolone up to 30mg per day (if ACUTE) or Prednisolone 10-30mg (inclusive) per day (if RECURRENT/ CHRONIC) or equivalent alternative corticosteroid dose OR
Exclusion criteria
✕. Individuals who were first diagnosed with ENL more than 4 years prior to enrolment
✕. Individuals less than 18 years old or older than 60 years
✕. Individuals weighing less than 35kg
✕. Individuals with 9 or fewer tender, popular or nodular ENL skin lesions
✕. Individuals with an EESS score of 8 or less
✕. Women of child bearing capacity who decline to use two forms of adequate contraception and men who decline to use two forms of adequate contraception
What they're measuring
1
Proportion of individuals free from Erythema Nodosum Leprosum (ENL) flares in 24 weeks
Timeframe: During the first 24 weeks
2
Proportion of individuals free from ENL flares in 48 weeks
Timeframe: During first 48 weeks
Trial details
NCT IDNCT03775460
SponsorLondon School of Hygiene and Tropical Medicine