Ciclosporin in the Management of New Type 1 Reactions in Leprosy
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ClinicalTrials.gov Identifier: NCT00919815 |
Recruitment Status :
Completed
First Posted : June 12, 2009
Last Update Posted : March 24, 2015
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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.
Condition or disease | Intervention/treatment | Phase |
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Leprosy | Drug: Ciclosporin Drug: Prednisolone | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 73 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomised Double Blind Controlled Trial Comparing Ciclosporin and Prednisolone in the Treatment of New Leprosy Type 1 Reactions |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | July 2013 |

Arm | Intervention/treatment |
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Experimental: ciclosporin arm
ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)
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Drug: Ciclosporin
Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)
Other Names:
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Active Comparator: prednisolone
standard course of prednisolone given in a reducing regimen over 24 weeks
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Drug: Prednisolone
prednisolone 40mg daily then reducing regimen over 24 weeks
Other Name: corticosteroids |
- improvement in nerve function and Clinical Severity Score [ Time Frame: at week 4, 20, 28 ]
- Incidence of adverse events [ Time Frame: up to 36 weeks ]
- Number of T1R recurrence episodes per patient in each treatment arm [ Time Frame: up to 36 weeks ]
- Severity of T1R recurrence for patients in each treatment arm [ Time Frame: up to 36 weeks ]
- extra prednisolone needed to control reaction [ Time Frame: up to 36 weeks ]
- 6. Difference in score in Quality of Life assessment between start and end of treatment for patients in each treatment arm [ Time Frame: 36 weeks ]
- Mean time to recurrence of T1R for patients in each treatment arm [ Time Frame: up to 36 weeks ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00919815
Ethiopia | |
Alert Hospital | |
Addis Abeba, Ethiopia |
Principal Investigator: | Diana Lockwood, MBChB | London School of Hygiene and Tropical Medicine |
Responsible Party: | Saba Lambert, Clinical Research Fellow, London School of Hygiene and Tropical Medicine |
ClinicalTrials.gov Identifier: | NCT00919815 |
Other Study ID Numbers: |
ITCRBY24-T1RA |
First Posted: | June 12, 2009 Key Record Dates |
Last Update Posted: | March 24, 2015 |
Last Verified: | March 2015 |
Leprosy Type 1 Reactions Prednisolone Ciclosporin |
Leprosy Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Cyclosporine Prednisolone Cyclosporins Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Dermatologic Agents Antirheumatic Agents Calcineurin Inhibitors Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |