Ciclosporin in the Management of New Erythema Nodosum Leprosum

London School of Hygiene and Tropical Medicine

Status and phase

Completed

Phase 2

Conditions

Leprosy

Treatments

Drug: Ciclosporin

Drug: prednisolone

Study type

Interventional

Funder types

Other

Identifiers

NCT00919542

ITCRBY24-ENLA

Details and patient eligibility

About

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).

Full 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).

Enrollment

12 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No 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