Trial | NCT01290744  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    clofazimine ...

  • Study Participants

    100
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.
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 Started
Aug 31
2010
Primary Completion
Mar 31
2015
Study Completion
Mar 31
2015
Last Update
Jun 04
2015
Estimate

Drug Clofazimine

Clofazimine 100mg daily for 12 months after completion of MDT.

  • Other names: Lamprene

Drug Placebo

Daily for 12 months

  • Other names: Vitamin capsule

Placebo group Placebo Comparator

These patients will receive placebo for 12 months after completion of MDT.

Clofazimine for 12 months after MDT Experimental

Patients will be given clofazimine (100mg daily) for 12 months after completion of MDT.

Criteria 

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
No Results Posted