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

Paul Saunderson

Status and phase: Completed; Phase 4

Conditions: Borderline Lepromatous Leprosy; Lepromatous Leprosy

Treatments: Drug: Clofazimine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01290744

LWM-2010-ENL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 15 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Clofazimine for 12 months after MDT

Experimental group

Description:

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

Treatment:

Drug: Clofazimine