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
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