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

This study is currently recruiting participants.
Verified February 2011 by Leonard Wood Memorial
Sponsor:
Information provided by:
Leonard Wood Memorial
ClinicalTrials.gov Identifier:
NCT01290744
First received: February 2, 2011
Last updated: February 3, 2011
Last verified: February 2011
History of Changes

February 2, 2011
February 3, 2011
August 2010
August 2013   (final data collection date for primary outcome measure)
Incidence of ENL reactions [ Time Frame: 2 years of follow-up ] [ Designated as safety issue: No ]
The hypothesis is that additional clofazimine will reduce the incidence of ENL reactions in the two years following completion of MDT.
Same as current
Complete list of historical versions of study NCT01290744 on ClinicalTrials.gov Archive Site
Severity of ENL reactions [ Time Frame: 2 years of follow-up ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Effect of Additional Clofazimine on Erythema Nodosum Leprosum (ENL) Reactions in Leprosy
Effect of Additional Clofazimine on ENL Reactions in Leprosy

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Borderline Lepromatous Leprosy
  • Lepromatous Leprosy
  • Drug: Clofazimine
    Clofazimine 100mg daily for 12 months after completion of MDT.
  • Drug: Vitamin capsule
    Daily for 12 months
  • Placebo Comparator: Placebo group
    These patients will receive placebo for 12 months after completion of MDT.
    Intervention: Drug: Vitamin capsule
  • Experimental: Clofazimine for 12 months after MDT
    Patients will be given clofazimine (100mg daily) for 12 months after completion of MDT.
    Intervention: Drug: Clofazimine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
15 Years to 70 Years
No
Contact: Marivic Balagon, MD csc_epi@yahoo.com
Contact: Paul Saunderson, MD psaunderson@leprosy.org
Philippines
 
NCT01290744
LWM-2010-ENL
No
Dr Paul Saunderson, American Leprosy Missions
Leonard Wood Memorial
Not Provided
Principal Investigator: Marivic Balagon, MD LWM
Leonard Wood Memorial
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP