Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum
Information source: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leprosy
Intervention: prednisolone (Drug); ciclosporin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: London School of Hygiene and Tropical Medicine Official(s) and/or principal investigator(s): Diana NJ Lockwood, MBChB, Principal Investigator, Affiliation: London School of Hygiene and Tropical Medicine
Summary
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.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: number of ENL recurrence episodes per patient
Secondary outcome: Mean time to ENL recurrence after initial controlSeverity of ENL at recurrence Amount of additional prednisolone required by patients Frequency of adverse events for patients in each treatment arm Difference in score in Quality of Life assessment between start and end for patients in each treatment arm
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Alert Hospital, Addis Abeba, Ethiopia
Additional Information
Starting date: August 2010
Last updated: March 25, 2015
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