NCT00919776

Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: London School of Hygiene and Tropical Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Leprosy

Interventions

Type	Name	Description
DRUG	prednisolone	prednisolone 40mg daily then reducing regimen over 16 weeks
DRUG	ciclosporin	Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-12-01
• Completion: 2013-07-01
• First posted: 2009-06-12
• Last updated: 2015-03-26

Locations

1 site across 1 country: Ethiopia