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

Sponsor
Paul Saunderson (Other)
Overall Status
Completed
CT.gov ID
NCT01290744
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
55
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
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 :
Aug 1, 2010
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

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 Names:
  • 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 Names:
  • Lamprene

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of ENL reactions [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 [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

    Criteria

    Ages Eligible for Study:
    15 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Cebu Skin Clinic Cebu Vesayas Philippines 6000

    Sponsors and Collaborators

    • Paul Saunderson

    Investigators

    • Principal Investigator: Marivic Balagon, MD, LWM

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Paul Saunderson, Scientific Director, Leonard Wood Memorial
    ClinicalTrials.gov Identifier:
    NCT01290744
    Other Study ID Numbers:
    • LWM-2010-ENL
    First Posted:
    Feb 7, 2011
    Last Update Posted:
    Jun 4, 2015
    Last Verified:
    Jun 1, 2015
    Keywords provided by Paul Saunderson, Scientific Director, Leonard Wood Memorial
    leprosy
    ENL
    clofazimine
    Additional relevant MeSH terms:
    Leprosy
    Leprosy, Lepromatous
    Leprosy, Multibacillary
    Clofazimine

    Study Results

    No Results Posted as of Jun 4, 2015