Clinical Trial: Ciclosporin in the Management of Steroid Resistant Type 1 Reactions in Leprosy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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.
Brief Summary:
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.
Detailed Summary:
Sponsor: London School of Hygiene and Tropical Medicine
Current Primary Outcome: improvement in nerve function [ Time Frame: at 24 weeks and 32 weeks ]
Original Primary Outcome: improvement in nerve function [ Time Frame: at 24 weeks and 36 weeks ]
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
- incidence of adverse effects [ Time Frame: throughout 24 weeks of treatment ]
- 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 ]
Information By: London School of Hygiene and Tropical Medicine
Dates:
Date Received: June 11, 2009
Date Started: August 2010
Date Completion:
Last Updated: March 24, 2015
Last Verified: September 2014