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Ciclosporin in the Management of New Type 1 Reactions in Leprosy

Information source: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leprosy

Intervention: Ciclosporin (Drug); Prednisolone (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: London School of Hygiene and Tropical Medicine

Official(s) and/or principal investigator(s):
Diana Lockwood, MBChB, Principal Investigator, Affiliation: London School of Hygiene and Tropical Medicine


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.

Clinical Details

Official title: A Randomised Double Blind Controlled Trial Comparing Ciclosporin and Prednisolone in the Treatment of New Leprosy Type 1 Reactions

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: improvement in nerve function and Clinical Severity Score

Secondary outcome:

Incidence of adverse events

Number of T1R recurrence episodes per patient in each treatment arm

Severity of T1R recurrence for patients in each treatment arm

extra prednisolone needed to control reaction

6. Difference in score in Quality of Life assessment between start and end of treatment for patients in each treatment arm

Mean time to recurrence of T1R for patients in each treatment arm

Detailed 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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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

Locations and Contacts

Alert Hospital, Addis Abeba, Ethiopia
Additional Information

Starting date: August 2010
Last updated: March 21, 2015

Page last updated: August 23, 2015

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