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