Clinical trial NCT00919815: Ciclosporin in the Management of New Type 1 Reactions in Leprosy
Official title: A Randomised Double Blind Controlled Trial Comparing Ciclosporin and Prednisolone in the Treatment of New Leprosy Type 1 Reactions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Leprosy
Keywords: Leprosy
Type 1 Reactions
Prednisolone
Ciclosporin
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Homes and Hospitals of St Giles
name: Alert Hospital, Ethiopia
name: Armauer Hansen Research Institute, Ethiopia
First posted: 2009-06-12
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: improvement in nerve function and Clinical Severity Score
timeFrame: at week 4, 20, 28
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: up to 36 weeks
measure: Number of T1R recurrence episodes per patient in each treatment arm
timeFrame: up to 36 weeks
measure: Severity of T1R recurrence for patients in each treatment arm
timeFrame: up to 36 weeks
measure: extra prednisolone needed to control reaction
timeFrame: up to 36 weeks
measure: 6. Difference in score in Quality of Life assessment between start and end of treatment for patients in each treatment arm
timeFrame: 36 weeks
measure: Mean time to recurrence of T1R for patients in each treatment arm
timeFrame: up to 36 weeks
Other outcomes:
Locations:
city: Addis Abeba
country: Ethiopia
facility: Alert Hospital
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Diana Lockwood, MBChB
role: PRINCIPAL_INVESTIGATOR
References: