NCT00919815

Ciclosporin in the Management of New Type 1 Reactions in Leprosy

A Randomised Double Blind Controlled Trial Comparing Ciclosporin and Prednisolone in the Treatment of New Leprosy Type 1 Reactions

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: London School of Hygiene and Tropical Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Study 1A: Ciclosporin in the management of new Type 1 Reactions in Leprosy Objective: A randomised double blind controlled trial comparing Ciclosporin and Prednisolone,to determine whether treatment with Ciclosporin gives the same outcome in the treatment of new Type 1 Reactions as Prednisolone.

Detailed description

We tested our hypothesis that ciclosporin would be as effective as prednisolone in the treatment of patients with leprosy reactions and nerve function impairment and that patients treated with ciclosporin would have fewer side effects than patients treated with prednisolone. A randomised controlled trial comparing ciclosporin and prednisolone in the treatment of acute leprosy T1R was conducted.

Conditions

• Leprosy

Interventions

Type	Name	Description
DRUG	Ciclosporin	Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)
DRUG	Prednisolone	prednisolone 40mg daily then reducing regimen over 24 weeks

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-12-01
• Completion: 2013-07-01
• First posted: 2009-06-12
• Last updated: 2015-03-24

Locations

1 site across 1 country: Ethiopia