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

NCT ID: NCT01290744

Last Updated: 2015-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2015-03-31

Brief Summary

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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

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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

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Borderline Lepromatous Leprosy Lepromatous Leprosy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Daily for 12 months

Clofazimine for 12 months after MDT

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

Group Type EXPERIMENTAL

Clofazimine

Intervention Type DRUG

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

Interventions

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Clofazimine

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

Intervention Type DRUG

Placebo

Daily for 12 months

Intervention Type DRUG

Other Intervention Names

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Lamprene Vitamin capsule

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paul Saunderson

OTHER

Sponsor Role lead

Responsible Party

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Paul Saunderson

Scientific Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Marivic Balagon, MD

Role: PRINCIPAL_INVESTIGATOR

LWM

Locations

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Cebu Skin Clinic

Cebu, Vesayas, Philippines

Site Status

Countries

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Philippines

Other Identifiers

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LWM-2010-ENL

Identifier Type: -

Identifier Source: org_study_id

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