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

Information source: Leonard Wood Memorial
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Borderline Lepromatous Leprosy; Lepromatous Leprosy

Intervention: Clofazimine (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Paul Saunderson

Official(s) and/or principal investigator(s):
Marivic Balagon, MD, Principal Investigator, Affiliation: LWM

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.

Clinical Details

Official title: Effect of Additional Clofazimine on ENL Reactions in Leprosy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Incidence of ENL reactions

Secondary outcome: Severity of ENL reactions

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.

Eligibility

Minimum age: 15 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Cebu Skin Clinic, Cebu, Vesayas 6000, Philippines
Additional Information

Starting date: August 2010
Last updated: June 3, 2015

Page last updated: August 23, 2015

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