Study 1B: Ciclosporin in the management of steroid resistant Type 1 Reactions in Leprosy Objective: A pilot study assessing the efficacy and safety of Ciclosporin as a second -line drug in patients with Type 1 Reactions who have not responded to a 12 week course of Prednisolone.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)
Alert Hospital
Addis Ababa, Ethiopia
improvement in nerve function
Time frame: at 24 weeks and 32 weeks
incidence of adverse effects
Time frame: throughout 32 weeks
Skin lesion inflammation improvement
Time frame: up to 36 weeks
rate of improvement of reaction
Time frame: up to 36 weeks
Time to next reactional episode
Time frame: up to 2 years
extra prednisolone needed to control reaction
Time frame: up to 36 weeks
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