A Phase 4 interventional study of Clofazimine and Placebo in Borderline Lepromatous Leprosy and Lepromatous Leprosy, sponsored by Paul Saunderson. Completed at 1 site in Philippines. Open to participants aged 15 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-06-04.
Sponsored by Paul Saunderson · Phase 4, Interventional, and Prevention
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.
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.
52 studies on the registry are indexed under Leprosy; 13 are open to participants now.
This study's enrollment of 100 is above the median of 70 across 41 interventional studies indexed under Leprosy.
Browse Leprosy studies →This is the only study on the registry with Paul Saunderson as lead sponsor.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
These patients will receive placebo for 12 months after completion of MDT.
Drug: Placebo
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.
Also known as: Lamprene
Daily for 12 months
Also known as: Vitamin capsule
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.
Time frame: 2 years of follow-up
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.
Time frame: 2 years of follow-up
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Clofazimine