Ciclosporin in the Management of New Erythema Nodosum Leprosum

Phase 2

Completed

• Conditions: Leprosy
• Interventions: Drug: prednisolone; Drug: Ciclosporin

• Registration Number: NCT00919542
• Lead Sponsor: London School of Hygiene and Tropical Medicine

Brief 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).

Study Timeline

• Study First Submitted: 2009-06-11
• Study First Submitted QC: 2009-06-11
• Study First Posted: 2009-06-12
• Study Start: 2010-07
• Primary Completion: 2012-12
• Study Completion: 2013-07
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-21
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

• Individuals with clinical evidence of new 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prednisolone	prednisolone	standard course of prednisolone given in a reducing regimen over 16 weeks
Ciclosporin	Ciclosporin	ciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks)

Primary Outcome Measures

Name	Time	Method
Number of ENL recurrence episodes per patient	up to 32 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Alert Hospital; 🇪🇹 Addis Abeba, Ethiopia