Clinical Trial: Ciclosporin in the Management of New Erythema Nodosum Leprosum

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

Official Title: A Pilot (Double Blind Controlled) Study Randomizing Patients With New Acute ENL to Treatment Either With Ciclosporin or Prednisolone.

Brief Summary:

Study 2A: Ciclosporin in the management of new Erythema Nodosum Leprosum

Objective: A pilot (double blind controlled) study randomizing patients to treatment either with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).


Detailed Summary: A pilot (double blind controlled) study randomizing patients to treatment either with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).
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: time to relapse of ENL after initial control of symptoms [ Time Frame: up to 2 years ]

Current Secondary Outcome:

  • Mean time to ENL recurrence after initial control [ 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:

  • time, in hours, to control initial episode of ENL relapse from time of starting anti-reactional medication [ Time Frame: 48 hours ]
  • time, in days, to ENL relapse from date of stopping anti-reactional medication [ Time Frame: up to 2 years ]


Information By: London School of Hygiene and Tropical Medicine

Dates:
Date Received: June 11, 2009
Date Started: July 2010
Date Completion:
Last Updated: March 21, 2015
Last Verified: March 2015