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

June 3, 2015 updated by: Paul Saunderson

Effect of Additional Clofazimine on ENL Reactions in Leprosy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
    • Vesayas
      • Cebu, Vesayas, Philippines, 6000
        • Cebu Skin Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paul Saunderson

Investigators

  • Principal Investigator: Marivic Balagon, MD, LWM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

February 2, 2011

First Submitted That Met QC Criteria

February 3, 2011

First Posted (Estimate)

February 7, 2011

Study Record Updates

Last Update Posted (Estimate)

June 4, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LWM-2010-ENL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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