Effect of Additional Clofazimine on Erythema Nodosum Leprosum (ENL) Reactions in Leprosy

Phase 4

Completed

• Conditions: Borderline Lepromatous Leprosy; Lepromatous Leprosy
• Interventions: Drug: Placebo; Drug: Clofazimine

• Registration Number: NCT01290744
• Lead Sponsor: Paul Saunderson

Brief Summary

This study is a double-blind, randomized controlled trial examining the effect on ENL reactions of giving an additional year of clofazimine after completion of MDT in leprosy.

Detailed Description

Clofazimine is an anti-bacterial agent used to treat leprosy; it is a normal component of WHO-recommended multi-drug therapy (MDT). It is also known to have a beneficial effect in one of the common immunological reactions that occur in leprosy, known as erythema nodosum leprosum, or ENL. When MDT was reduced in length from 24 to 12 months, evidence suggests that ENL became worse. This study is a double-blind, randomized controlled trial examining the effect of giving an additional year of clofazimine after completion of MDT. The endpoints are the incidence and severity of ENL over a period of 3 years in the 2 groups.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-02-02
• Study First Submitted QC: 2011-02-03
• Study First Posted: 2011-02-07
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 15 to 70 years of age
• MB leprosy
• Pretreatment BI of 4 or more at any site
• Consent

Exclusion Criteria

• Presence of another serious illness
• Refusal of informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	These patients will receive placebo for 12 months after completion of MDT.
Clofazimine for 12 months after MDT	Clofazimine	Patients will be given clofazimine (100mg daily) for 12 months after completion of MDT.

Primary Outcome Measures

Name	Time	Method
Incidence of ENL reactions	2 years of follow-up	The hypothesis is that additional clofazimine will reduce the incidence of ENL reactions in the two years following completion of MDT.

Secondary Outcome Measures

Name	Time	Method
Severity of ENL reactions	2 years of follow-up	The hypothesis is that additional clofazimine will reduce severity of ENL reactions, as well as incidence. Severity will be monitored by three indicators: 1. a rather crude clinical score (mild, moderate or severe), 2. the total dose of prednisolone given to treat ENL reactions, 3. the total duration of ENL symptoms.

Trial Locations

Locations (1)

Cebu Skin Clinic; 🇵🇭 Cebu, Vesayas, Philippines