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Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by London School of Hygiene and Tropical Medicine.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Homes and Hospitals of St Giles
Alert Hospital, Ethiopia
Armauer Hansen Research Institute, Ethiopia
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00919776
First received: June 11, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  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:

U.S. FDA Resources

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

Estimated Enrollment: 12
Study Start Date: August 2009
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)
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919776

Contacts
Contact: Saba M Lambert, MBChB +447921266473 saba.lambert@lshtm.ac.uk
Contact: Diana NJ Lockwood, MBChB +44 20 7927 2457 diana.lockwood@lshtm.ac.uk

Locations
Ethiopia
Alert Hospital Not yet recruiting
Addis Abeba, Ethiopia
Contact: Saba M Lambert, MBChB     +447921266473     saba.lambert@lshtm.ac.uk    
Contact: Diana NJ Lockwood, MBChB     +44 20 7927 2457     diana.lockwood@lshtm.ac.uk    
Principal Investigator: Diana NJ Lockwood, MBChB            
Principal Investigator: Saba M Lambert, MBChB            
Principal Investigator: Elisabeth Bizuneh, MD            
Principal Investigator: Wim Brandsma            
Sub-Investigator: Fasil Tesfaye, MD            
Sub-Investigator: Ahmed Bedru, MD            
Sub-Investigator: Jemal Hussein, MD            
Sub-Investigator: Lawrence Yamuah            
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

No publications provided

Responsible Party: Professor Diana Lockwood, 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: June 11, 2009
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
Drug Eruptions
Dermatitis
Skin Diseases
Erythema
Drug Hypersensitivity
Hypersensitivity
Immune System Diseases
Drug Toxicity
Poisoning
Substance-Related Disorders
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
 Bacterial Infections
Cyclosporins
Cyclosporine
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 16, 2013