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

Borderline Lepromatous Leprosy research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Borderline Lepromatous Leprosy

Lepromatous Leprosy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:ClofazimineClofazimine 100mg daily for 12 months after completion of MDT.

Drug:PlaceboDaily for 12 months

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Completed

Start Date: August 2010

Completed Date: March 2015

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Incidence of ENL reactions

Secondary Outcome: Severity of ENL reactions

Study sponsors, principal investigator, and references

Principal Investigator: Marivic Balagon, MD

Lead Sponsor: Paul Saunderson

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01290744

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