Clinical Trial: Ciclosporin in the Management of New Type 1 Reactions in Leprosy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomised Double Blind Controlled Trial Comparing Ciclosporin and Prednisolone in the Treatment of New Leprosy Type 1 Reactions

Brief Summary:

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.


Detailed Summary: 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.
Sponsor: London School of Hygiene and Tropical Medicine

Current Primary Outcome: improvement in nerve function and Clinical Severity Score [ Time Frame: at week 4, 20, 28 ]

Original Primary Outcome: improvement in nerve function [ Time Frame: at 24 weeks and 36 weeks ]

Current Secondary Outcome:

  • 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 ]


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: 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 21, 2015
Last Verified: March 2015