Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Alert Hospital, Ethiopia; Armauer Hansen Research Institute, Ethiopia; Homes and Hospitals of St Giles
• Treatments: Cyclosporine; Cyclosporins; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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