Ciclosporin in the Management of New 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:
NCT00919542
First received: June 11, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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

Objective: A pilot (double blind controlled) study randomizing patientsto 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).


Condition Intervention Phase
Leprosy
Drug: Ciclosporin
Drug: prednisolone
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 With New Acute ENL to Treatment Either With Ciclosporin or Prednisolone.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • time to relapse of ENL after initial control of symptoms [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time, in hours, to control initial episode of ENL relapse from time of starting anti-reactional medication [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • time, in days, to ENL relapse from date of stopping anti-reactional medication [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: July 2009
Arms Assigned Interventions
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
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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919542

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
  More Information

No publications provided

Responsible Party: Professor Diana Lockwood, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00919542     History of Changes
Other Study ID Numbers: ITCRBY24-ENLA
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:
Erythema Nodosum
Leprosy
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 April 17, 2014