Ciclosporin in the Management of New Type 1 Reactions in Leprosy

London School of Hygiene and Tropical Medicine

Status and phase

Completed

Phase 3

Phase 2

Conditions

Leprosy

Treatments

Drug: Ciclosporin

Drug: Prednisolone

Study type

Interventional

Funder types

Other

Identifiers

NCT00919815

ITCRBY24-T1RA

Details and patient eligibility

About

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.

Full 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.

Enrollment

73 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Individuals with clinical evidence of T1R with new nerve function impairment (NFI).
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