Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum

March 25, 2015 updated by: London School of Hygiene and Tropical Medicine

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
      • Addis Abeba, Ethiopia
        • ALERT Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • corticosteroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of ENL recurrence episodes per patient
Time Frame: up to 32 weeks
up to 32 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean time to ENL recurrence after initial control
Time Frame: up to 32 weeks
up to 32 weeks
Severity of ENL at recurrence
Time Frame: up to 32 weeks
up to 32 weeks
Amount of additional prednisolone required by patients
Time Frame: up to 32 weeks
up to 32 weeks
Frequency of adverse events for patients in each treatment arm
Time Frame: up to 32 weeks
up to 32 weeks
Difference in score in Quality of Life assessment between start and end for patients in each treatment arm
Time Frame: up to 32 weeks
up to 32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

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

Investigators

  • Principal Investigator: Diana NJ Lockwood, MBChB, London School of Hygiene and Tropical Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 11, 2009

First Submitted That Met QC Criteria

June 11, 2009

First Posted (Estimate)

June 12, 2009

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITCCRBY24-ENLB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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