Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum

This study has been completed.
Sponsor:
Collaborators:
Homes and Hospitals of St Giles
Alert Hospital, Ethiopia
Armauer Hansen Research Institute, Ethiopia
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00919776
First received: June 11, 2009
Last updated: March 25, 2015
Last verified: March 2015
  Purpose

Study 2B: Ciclosporin in the management of chronic or recurrent Erythema Nodosum Leprosum Aim: To assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients whose ENL is not controlled with standard Prednisolone.

Objective: A pilot double blind controlled study randomizing patients whose ENL is not controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a group treated with additional steroid only.


Condition Intervention Phase
Leprosy
Drug: prednisolone
Drug: ciclosporin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Double Blind Controlled Study Randomizing Patients Whose ENL is Not Controlled With Standard Prednisolone, and Comparing a Group Treated With Ciclosporin to a Group Treated With Additional Steroid Only.

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • number of ENL recurrence episodes per patient [ Time Frame: up to 32 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean time to ENL recurrence after initial control [ Time Frame: up to 32 weeks ] [ Designated as safety issue: No ]
  • Severity of ENL at recurrence [ Time Frame: up to 32 weeks ] [ Designated as safety issue: No ]
  • Amount of additional prednisolone required by patients [ Time Frame: up to 32 weeks ] [ Designated as safety issue: No ]
  • Frequency of adverse events for patients in each treatment arm [ Time Frame: up to 32 weeks ] [ Designated as safety issue: No ]
  • Difference in score in Quality of Life assessment between start and end for patients in each treatment arm [ Time Frame: up to 32 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: August 2010
Study Completion Date: July 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ciclosporin
ciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks)
Drug: ciclosporin
Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)
Other Names:
  • Cyclosporine
  • Cyclosporin A
Active Comparator: Prednisolone
standard course of prednisolone given in a reducing regimen over 16 weeks
Drug: prednisolone
prednisolone 40mg daily then reducing regimen over 16 weeks
Other Name: corticosteroids

Detailed Description:
A pilot double blind controlled study randomizing patients whose ENL is not controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a group treated with additional steroid only.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals with clinical evidence of recurrent or chronic 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919776

Locations
Ethiopia
Alert Hospital
Addis Abeba, Ethiopia
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Homes and Hospitals of St Giles
Alert Hospital, Ethiopia
Armauer Hansen Research Institute, Ethiopia
Investigators
Principal Investigator: Diana NJ Lockwood, MBChB London School of Hygiene and Tropical Medicine
  More Information

Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00919776     History of Changes
Other Study ID Numbers: ITCCRBY24-ENLB 
Study First Received: June 11, 2009
Last Updated: March 25, 2015
Health Authority: United Kingdom: London School of Hygiene and Tropical Medicine Ethics Committee
Ethiopia: AHRI/ALERT Ethical Review Committee
Ethiopia: National Science and Technology Committee of Ethiopia
Ethiopia: Drug Administration and Control Authority

Keywords provided by London School of Hygiene and Tropical Medicine:
Leprosy
ENL
Erythema Nodosum Leprosum
Prednisolone
Ciclosporin

Additional relevant MeSH terms:
Leprosy
Erythema Nodosum
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Drug Eruptions
Dermatitis
Skin Diseases
Erythema
Drug Hypersensitivity
Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Cyclosporins
Cyclosporine
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents

ClinicalTrials.gov processed this record on August 25, 2016