NCT01290744

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

Effect of Additional Clofazimine on ENL Reactions in Leprosy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Paul Saunderson · Academic / Other
• Sex: All
• Age: 15 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Borderline Lepromatous Leprosy
• Lepromatous Leprosy

Interventions

Type	Name	Description
DRUG	Clofazimine	Clofazimine 100mg daily for 12 months after completion of MDT.
DRUG	Placebo	Daily for 12 months

Timeline

• Start date: 2010-08-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2011-02-07
• Last updated: 2015-06-04

Locations

1 site across 1 country: Philippines