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

Primary Purpose

Borderline Lepromatous Leprosy, Lepromatous Leprosy

Status
Completed
Phase
Phase 4
Locations
Philippines
Study Type
Interventional
Intervention
Clofazimine
Placebo
Sponsored by
Paul Saunderson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Borderline Lepromatous Leprosy focused on measuring leprosy, ENL, clofazimine

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cebu Skin Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo group

Clofazimine for 12 months after MDT

Arm Description

These patients will receive placebo for 12 months after completion of MDT.

Patients will be given clofazimine (100mg daily) for 12 months after completion of MDT.

Outcomes

Primary Outcome Measures

Incidence of ENL reactions
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
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.

Full Information

First Posted
February 2, 2011
Last Updated
June 3, 2015
Sponsor
Paul Saunderson
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1. Study Identification

Unique Protocol Identification Number
NCT01290744
Brief Title
Effect of Additional Clofazimine on Erythema Nodosum Leprosum (ENL) Reactions in Leprosy
Official Title
Effect of Additional Clofazimine on ENL Reactions in Leprosy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Paul Saunderson

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Lepromatous Leprosy, Lepromatous Leprosy
Keywords
leprosy, ENL, clofazimine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
These patients will receive placebo for 12 months after completion of MDT.
Arm Title
Clofazimine for 12 months after MDT
Arm Type
Experimental
Arm Description
Patients will be given clofazimine (100mg daily) for 12 months after completion of MDT.
Intervention Type
Drug
Intervention Name(s)
Clofazimine
Other Intervention Name(s)
Lamprene
Intervention Description
Clofazimine 100mg daily for 12 months after completion of MDT.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Vitamin capsule
Intervention Description
Daily for 12 months
Primary Outcome Measure Information:
Title
Incidence of ENL reactions
Description
The hypothesis is that additional clofazimine will reduce the incidence of ENL reactions in the two years following completion of MDT.
Time Frame
2 years of follow-up
Secondary Outcome Measure Information:
Title
Severity of ENL reactions
Description
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.
Time Frame
2 years of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marivic Balagon, MD
Organizational Affiliation
LWM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cebu Skin Clinic
City
Cebu
State/Province
Vesayas
ZIP/Postal Code
6000
Country
Philippines

12. IPD Sharing Statement

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

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