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

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ClinicalTrials.gov Identifier: NCT01290744
Recruitment Status : Completed
First Posted : February 7, 2011
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
Paul Saunderson, Leonard Wood Memorial

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Borderline Lepromatous Leprosy Lepromatous Leprosy Drug: Clofazimine Drug: Placebo Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Additional Clofazimine on ENL Reactions in Leprosy
Study Start Date : August 2010
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo group
These patients will receive placebo for 12 months after completion of MDT.
 Drug: Placebo
Daily for 12 months
Other Name: Vitamin capsule
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.
Other Name: Lamprene


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of ENL reactions [ Time Frame: 2 years of follow-up ]
    The hypothesis is that additional clofazimine will reduce the incidence of ENL reactions in the two years following completion of MDT.


Secondary Outcome Measures :
  1. Severity of ENL reactions [ Time Frame: 2 years of follow-up ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290744


Locations
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Philippines
Cebu Skin Clinic
Cebu, Vesayas, Philippines, 6000
Sponsors and Collaborators
Paul Saunderson
Investigators
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Principal Investigator: Marivic Balagon, MD LWM
More Information
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Responsible Party: Paul Saunderson, Scientific Director, Leonard Wood Memorial
ClinicalTrials.gov Identifier: NCT01290744     History of Changes
Other Study ID Numbers: LWM-2010-ENL
First Posted: February 7, 2011    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015
Keywords provided by Paul Saunderson, Leonard Wood Memorial:
leprosy
ENL
clofazimine
Additional relevant MeSH terms:
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Leprosy
Leprosy, Lepromatous
Leprosy, Multibacillary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
 Bacterial Infections
Clofazimine
Anti-Inflammatory Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents