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

Effect of Additional Clofazimine on ENL Reactions in Leprosy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01290744

Enrollment

100

Registered

2011-02-07

Start date

2010-08-31

Completion date

2015-03-31

Last updated

2015-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Lepromatous Leprosy, Lepromatous Leprosy

Keywords

leprosy, ENL, clofazimine

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.

Interventions

DRUGClofazimine

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

DRUGPlacebo

Daily for 12 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

15 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Philippines

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026