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Ciclosporin in the Management of Steroid Resistant Type 1 Reactions in Leprosy

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ClinicalTrials.gov Identifier: NCT00919451
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : March 25, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:

Study 1B: Ciclosporin in the management of steroid resistant Type 1 Reactions in Leprosy

Objective: A pilot study assessing the efficacy and safety of Ciclosporin as a second -line drug in patients with Type 1 Reactions who have not responded to a 12 week course of Prednisolone.

Condition or disease Intervention/treatment Phase
Leprosy Drug: ciclosporin Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Assessing the Efficacy and Safety of Ciclosporin as a Second -Line Drug in Patients With Type 1 Reactions Who Have Not Responded to a 12 Week Course of Prednisolone.
Study Start Date : August 2010
Primary Completion Date : June 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Ciclosporin
ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)
Drug: ciclosporin
Ciclosporin 7.5mg/kg - reducing regimen over 24 weeks (additional prednisolone given for the first four weeks)

Outcome Measures

Primary Outcome Measures :
  1. improvement in nerve function [ Time Frame: at 24 weeks and 32 weeks ]

Secondary Outcome Measures :
  1. incidence of adverse effects [ Time Frame: throughout 32 weeks ]
  2. Skin lesion inflammation improvement [ Time Frame: up to 36 weeks ]
  3. rate of improvement of reaction [ Time Frame: up to 36 weeks ]
  4. Time to next reactional episode [ Time Frame: up to 2 years ]
  5. extra prednisolone needed to control reaction [ Time Frame: up to 36 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Individuals with clinical evidence of Type 1 Reaction who have not responded to 3 months Prednisolone Treatment
  • 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
Contacts and Locations

Information from the National Library of Medicine

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): NCT00919451

Alert Hospital
Addis Abeba, Ethiopia
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Homes and Hospitals of St Giles
Alert Hospital, Ethiopia
Armauer Hansen Research Institute, Ethiopia
Principal Investigator: Diana NJ Lockwood, MBChB London SHTM
More Information

Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00919451     History of Changes
Other Study ID Numbers: ITCRBY24-T1RB
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: September 2014

Keywords provided by London School of Hygiene and Tropical Medicine:
Type 1 Reaction

Additional relevant MeSH terms:
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
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
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents