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Completed

NCT Number: NCT01290744

Effect of Additional Clofazimine on Erythema Nodosum Leprosum (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.

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Key information

Conditions

Borderline Lepromatous Leprosy Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lepromatous Leprosy Leprosy Leprosy, Lepromatous Leprosy, Multibacillary Mycobacterium Infections Mycobacterium Infections, Nontuberculous

Age range

15 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cebu Skin Clinic

Cebu, Vesayas, 6000, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clofazimine

Drug

Clofazimine 100mg daily for 12 months after completion of MDT.

Other names: Lamprene

Placebo

Drug

Daily for 12 months

Other names: Vitamin capsule

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Paul Saunderson

Other

Registry information

Official study title

Effect of Additional Clofazimine on ENL Reactions in Leprosy

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Feb 7, 2011
Registry last updated
Jun 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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