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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00919542

Enrollment

Registered

2009-06-12

Start date

2010-07-31

Completion date

2013-07-31

Last updated

2015-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leprosy

Keywords

Leprosy, ENL, Erythema Nodosum Leprosum, Prednisolone, Ciclosporin

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).

Interventions

DRUGCiclosporin

Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)

DRUGprednisolone

prednisolone 40mg daily then reducing regimen over 16 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of ENL recurrence episodes per patient	up to 32 weeks

Secondary

Measure	Time frame
Mean time to ENL recurrence after initial control	up to 32 weeks
Amount of additional prednisolone required by patients	up to 32 weeks
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

Countries

Ethiopia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026