Trial | NCT00919542  Report issue

Title

Ciclosporin in the Management of New Erythema Nodosum Leprosum
A Pilot (Double Blind Controlled) Study Randomizing Patients With New Acute ENL to Treatment Either With Ciclosporin or Prednisolone.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    12
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).
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).
Study Started
Jul 31
2010
Primary Completion
Dec 31
2012
Study Completion
Jul 31
2013
Last Update
Mar 24
2015
Estimate

Drug Ciclosporin

Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)

  • Other names: cyclosporin, Cyclosporin A

Drug prednisolone

prednisolone 40mg daily then reducing regimen over 16 weeks

  • Other names: corticosteroids

prednisolone Active Comparator

standard course of prednisolone given in a reducing regimen over 16 weeks

Ciclosporin Experimental

ciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks)

Criteria 

Inclusion Criteria:

Individuals with clinical evidence of new ENL
Aged 18-65
Weigh more than 30Kg

Exclusion Criteria:

Unwillingness to give informed consent
Patients with severe active infections such as tuberculosis
Pregnant or breastfeeding women (see Appendix II)
Those with renal failure, abnormal renal function, hypertensive
Patients taking thalidomide currently or within the last 3 months
Patients not willing to return for follow-up
Women of reproductive age not willing to use contraception for the duration of the study ( see Appendix II)
HIV positive patients
No Results Posted