A study to compare the usefulness and safety of Clofazimine and Minocycline in patients with repeated episodes of erythema nodosum Leprosum

Not Applicable

Completed

• Conditions: Health Condition 1: null- clinically diagnosed cases of erythema nodosum leprosumHealth Condition 2: A305- Lepromatous leprosy

• Registration Number: CTRI/2018/07/014965
• Lead Sponsor: one

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-08-14
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 57

Inclusion Criteria

1. Chronic and recurrent ENL cases of leprosy regardless of age, sex and treatment status with MDT

2.Patients not on treatment with paracetamol, pentoxifylline, colchicine, methotrexate, azathioprine, TNF inhibitors etc.,

3.Patients who can give valid consent.

4.Willing for monthly follow-up visits for at least 6 months

Exclusion Criteria

1.Pregnant and lactating mothers

2.Patients allergic to tetracyclines, clofazimine

3.Patients with HIV, Hepatitis B and Hepatitis C

4.Inability to come for monthly follow up visits for 6 months

5.Those who cannot provide consent for the study

6.Patients with cardiac, hepatic, renal disease, neurological diseases, bleeding disorder, mental diseases, cerebrovascular diseases and showing abnormal baseline laboratory parameters

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure will be the number of ENL recurrence episodes per patient for each treatment arm, both during treatment period (week 1â??12) and the follow-up period (6 months). An episode of ENL will be defined as the occurrence of ENL requiring the institution or change of treatment (such as an increase in dosage or frequency of treatment or the addition of or switching to another drug).Timepoint: At the end of 6 months follow up

Secondary Outcome Measures

Name	Time	Method
1.Mean time to ENL recurrence after initial control; <br/ ><br>2.Severity of ENL at recurrence; <br/ ><br>3.Amount of additional prednisolone required by patients over the study period; <br/ ><br>4.Frequency of adverse events for patients in each treatment arm; and <br/ ><br>5.The difference in score in Quality of Life assessment (SF36) between start and end for patients in each treatment arm <br/ ><br>Timepoint: At the end of 6 months follow up