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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Leonard Wood Memorial.
Recruitment status was  Recruiting
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
  Purpose

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.


Condition Intervention
Borderline Lepromatous Leprosy
Lepromatous Leprosy
Drug: Clofazimine
Drug: Vitamin capsule

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Additional Clofazimine on ENL Reactions in Leprosy

Resource links provided by NLM:


Further study details as provided by Leonard Wood Memorial:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: August 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo group
These patients will receive placebo for 12 months after completion of MDT.
Drug: Vitamin capsule
Daily for 12 months
Experimental: Clofazimine for 12 months after MDT
Patients will be given clofazimine (100mg daily) for 12 months after completion of MDT.
Drug: Clofazimine
Clofazimine 100mg daily for 12 months after completion of MDT.

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290744

Contacts
Contact: Marivic Balagon, MD csc_epi@yahoo.com
Contact: Paul Saunderson, MD psaunderson@leprosy.org

Locations
Philippines
Cebu Skin Clinic Recruiting
Cebu, Vesayas, Philippines, 6000
Contact: Marivic Balagon, MD       csc_epi@yahoo.com   
Principal Investigator: Marivic Balagon, MD         
Sponsors and Collaborators
Leonard Wood Memorial
Investigators
Principal Investigator: Marivic Balagon, MD LWM
  More Information

No publications provided

Responsible Party: Dr Paul Saunderson, American Leprosy Missions
ClinicalTrials.gov Identifier: NCT01290744     History of Changes
Other Study ID Numbers: LWM-2010-ENL
Study First Received: February 2, 2011
Last Updated: February 3, 2011
Health Authority: Philippines: Department of Health

Keywords provided by Leonard Wood Memorial:
leprosy
ENL
clofazimine

Additional relevant MeSH terms:
Drug Hypersensitivity
Erythema Nodosum
Leprosy
Leprosy, Lepromatous
Leprosy, Borderline
Leprosy, Multibacillary
Drug Eruptions
Dermatitis
Skin Diseases
Erythema
Hypersensitivity
Immune System Diseases
Drug Toxicity
Poisoning
Substance-Related Disorders
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Leprosy, Paucibacillary
Clofazimine
Vitamins
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

ClinicalTrials.gov processed this record on July 24, 2014