NCT00919542

Ciclosporin in the Management of New Erythema Nodosum Leprosum

A Pilot (Double Blind Controlled) Study Randomizing Patients With New Acute ENL to Treatment Either With Ciclosporin or Prednisolone.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: London School of Hygiene and Tropical Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Study 2A: Ciclosporin in the management of new Erythema Nodosum Leprosum Objective: A pilot (double blind controlled) study randomizing patients to 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).

Detailed description

A pilot (double blind controlled) study randomizing patients to 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).

Conditions

• Leprosy

Interventions

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

Timeline

• Start date: 2010-07-01
• 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