Study 1A: Ciclosporin in the management of new Type 1 Reactions in Leprosy Objective: A randomised double blind controlled trial comparing Ciclosporin and Prednisolone,to determine whether treatment with Ciclosporin gives the same outcome in the treatment of new Type 1 Reactions as Prednisolone.
We tested our hypothesis that ciclosporin would be as effective as prednisolone in the treatment of patients with leprosy reactions and nerve function impairment and that patients treated with ciclosporin would have fewer side effects than patients treated with prednisolone. A randomised controlled trial comparing ciclosporin and prednisolone in the treatment of acute leprosy T1R was conducted.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
73
Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)
prednisolone 40mg daily then reducing regimen over 24 weeks
Alert Hospital
Addis Ababa, Ethiopia
improvement in nerve function and Clinical Severity Score
Time frame: at week 4, 20, 28
Incidence of adverse events
Time frame: up to 36 weeks
Number of T1R recurrence episodes per patient in each treatment arm
Time frame: up to 36 weeks
Severity of T1R recurrence for patients in each treatment arm
Time frame: up to 36 weeks
extra prednisolone needed to control reaction
Time frame: up to 36 weeks
6. Difference in score in Quality of Life assessment between start and end of treatment for patients in each treatment arm
Time frame: 36 weeks
Mean time to recurrence of T1R for patients in each treatment arm
Time frame: up to 36 weeks
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