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NCT Number: NCT00919542

Ciclosporin in the Management of New Erythema Nodosum Leprosum

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).

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Key information

Conditions

Leprosy Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Mycobacterium Infections, Nontuberculous

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Alert Hospital

Addis Ababa, Ethiopia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ciclosporin

Drug

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

Other names: cyclosporin, Cyclosporin A

Prednisolone

Drug

prednisolone 40mg daily then reducing regimen over 16 weeks

Other names: corticosteroids

Primary outcomes

  1. Number of ENL recurrence episodes per patient

    Time frame: up to 32 weeks

Secondary outcomes

  1. Mean time to ENL recurrence after initial control

    Time frame: up to 32 weeks

  2. Amount of additional prednisolone required by patients

    Time frame: up to 32 weeks

  3. Frequency of adverse events for patients in each treatment arm

    Time frame: up to 32 weeks

  4. Difference in score in Quality of Life assessment between start and end for patients in each treatment arm

    Time frame: up to 32 weeks

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • Alert Hospital, Ethiopia
  • Armauer Hansen Research Institute, Ethiopia
  • Homes and Hospitals of St Giles

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jun 12, 2009
Registry last updated
Mar 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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