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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Additional Clofazimine on ENL Reactions in Leprosy

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 Summary: 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.
Sponsor: Paul Saunderson

Current Primary Outcome: Incidence of ENL reactions [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Severity of ENL reactions [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Leonard Wood Memorial

Dates:
Date Received: February 2, 2011
Date Started: August 2010
Date Completion:
Last Updated: June 3, 2015
Last Verified: June 2015