Clinical Trial: Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Pilot Double Blind Controlled Study Randomizing Patients Whose ENL is Not Controlled With Standard Prednisolone, and Comparing a Group Treated With Ciclosporin to a Group Treated With Additional Ste
Brief Summary:
Study 2B: Ciclosporin in the management of chronic or recurrent Erythema Nodosum Leprosum Aim: To assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients whose ENL is not controlled with standard Prednisolone.
Objective: A pilot double blind controlled study randomizing patients whose ENL is not controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a group treated with additional steroid only.
Detailed Summary: A pilot double blind controlled study randomizing patients whose ENL is not controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a group treated with additional steroid only.
Sponsor: London School of Hygiene and Tropical Medicine
Current Primary Outcome: number of ENL recurrence episodes per patient [ Time Frame: up to 32 weeks ]
Original Primary Outcome:
Current Secondary Outcome:
- Mean time to ENL recurrence after initial control [ Time Frame: up to 32 weeks ]
- Severity of ENL at recurrence [ Time Frame: up to 32 weeks ]
- Amount of additional prednisolone required by patients [ Time Frame: up to 32 weeks ]
- Frequency of adverse events for patients in each treatment arm [ Time Frame: up to 32 weeks ]
- Difference in score in Quality of Life assessment between start and end for patients in each treatment arm [ Time Frame: up to 32 weeks ]
Original Secondary Outcome:
Information By: London School of Hygiene and Tropical Medicine
Dates:
Date Received: June 11, 2009
Date Started: August 2010
Date Completion:
Last Updated: March 25, 2015
Last Verified: March 2015
