Phase
Condition
Hives (Urticaria)
Warts
Skin Wounds
Treatment
Placebo
Methotrexate
Prednisolone
Clinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:: ALL OF THE FOLLOWING SIX CRITERIA MUST BE MET IN ORDER FOR AN INDIVIDUAL TO BE ELIGIBLE (ONLY ONE OF 6A TO 6D NEED BE MET):
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 doseOR
Thalidomide or other non-steroidal anti-ENL medication OR
A combination of prednisolone (up to 30mg) and another non-steroidal anti-ENLmedication (thalidomide, clofazimine, azathioprine, pentoxifylline,ciclosporin, minocycline)
Exclusion
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 adequatecontraception and men who decline to use two forms of adequate contraception
Pregnant or breastfeeding women
Individuals with recurrent or chronic ENL who deteriorate on a dose of prednisoloneless than 10 mg or more than 30 mg
Individuals who have taken methotrexate by any route for the last 12 weeks
Individuals with a hypersensitivity to methotrexate or a recognised contraindication ( please see Methotrexate information sheet)
Individuals currently diagnosed with Type 1 reaction or Lucio's phenomenon
Individuals with the severe abnormalities in screening investigations
Positive serology for HIV, Hepatitis B or C
Evidence of tuberculosis or pulmonary fibrosis
A history of chronic liver disease or excessive alcohol or illicit substanceconsumption
Individuals with severe inter-current infections, uncontrolled diabetes, activepeptic ulcer disease, untreated malignancy
Individuals unable to attend regularly for assessment or monitoring
Study Design
Study Description
Connect with a study center
TMLI Bangladesh/ DBLM hospital
Dhaka,
BangladeshSite Not Available
FIOCRUZ
Rio De Janeiro,
BrazilSite Not Available
ALERT
Addis Ababa,
EthiopiaSite Not Available
The Leprosy Mission Trust
Delhi,
IndiaActive - Recruiting
Bombay Leprosy Project
Mumbai,
IndiaActive - Recruiting
Soetomo Hospital
Surabaya,
IndonesiaSite Not Available
Anandaban Hospital
Kathmandu,
NepalSite Not Available
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