Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum

• ClinicalTrials.gov Identifier: NCT00919776
• Recruitment Status: Completed
• First Posted: June 12, 2009
• Last Update Posted: March 26, 2015
• Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Homes and Hospitals of St Giles; Alert Hospital, Ethiopia; Armauer Hansen Research Institute, Ethiopia
• Information provided by (Responsible Party): London School of Hygiene and Tropical Medicine

Study Description

Brief Summary:

Study 2B: Ciclosporin in the management of chronic or recurrent Erythema Nodosum Leprosum Aim: To assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients whose ENL is not controlled with standard Prednisolone.

Objective: A pilot double blind controlled study randomizing patients whose ENL is not controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a group treated with additional steroid only.

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

Detailed Description:

A pilot double blind controlled study randomizing patients whose ENL is not controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a group treated with additional steroid only.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Pilot Double Blind Controlled Study Randomizing Patients Whose ENL is Not Controlled With Standard Prednisolone, and Comparing a Group Treated With Ciclosporin to a Group Treated With Additional Steroid Only.
• Study Start Date: August 2010
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: July 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: ciclosporin; ciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks)	Drug: ciclosporin; Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks); Other Names: Cyclosporine; Cyclosporin A
Active Comparator: Prednisolone; standard course of prednisolone given in a reducing regimen over 16 weeks	Drug: prednisolone; prednisolone 40mg daily then reducing regimen over 16 weeks; Other Name: corticosteroids

Outcome Measures

Primary Outcome Measures :

1. number of ENL recurrence episodes per patient [ Time Frame: up to 32 weeks ]

Secondary Outcome Measures :

1. Mean time to ENL recurrence after initial control [ Time Frame: up to 32 weeks ]
2. Severity of ENL at recurrence [ Time Frame: up to 32 weeks ]
3. Amount of additional prednisolone required by patients [ Time Frame: up to 32 weeks ]
4. Frequency of adverse events for patients in each treatment arm [ Time Frame: up to 32 weeks ]
5. Difference in score in Quality of Life assessment between start and end for patients in each treatment arm [ Time Frame: up to 32 weeks ]

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Individuals with clinical evidence of recurrent or chronic 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

Contacts and Locations

Locations

Ethiopia

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

Investigators

• Principal Investigator: Diana NJ Lockwood, MBChB; London School of Hygiene and Tropical Medicine

More Information

• Responsible Party: London School of Hygiene and Tropical Medicine
• ClinicalTrials.gov Identifier: NCT00919776 History of Changes
• Other Study ID Numbers: ITCCRBY24-ENLB
• First Posted: June 12, 2009
• Last Update Posted: March 26, 2015
• Last Verified: March 2015

Keywords provided by London School of Hygiene and Tropical Medicine:

Leprosy; ENL; Erythema Nodosum Leprosum; Prednisolone; Ciclosporin

Additional relevant MeSH terms:

Leprosy; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Erythema Nodosum; Erythema; Skin Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Drug Eruptions; Dermatitis; Drug Hypersensitivity; Hypersensitivity; Immune System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Cyclosporine; Cyclosporins; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antifungal Agents