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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | These patients will receive placebo for 12 months after completion of MDT. |
|
| Clofazimine for 12 months after MDT | Experimental | Patients will be given clofazimine (100mg daily) for 12 months after completion of MDT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clofazimine | Drug | Clofazimine 100mg daily for 12 months after completion of MDT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years of follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marivic Balagon, MD | LWM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cebu Skin Clinic | Cebu | Vesayas | 6000 | Philippines |
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| ID | Term |
|---|---|
| D015440 | Leprosy, Lepromatous |
| D007918 | Leprosy |
| ID | Term |
|---|---|
| D056006 | Leprosy, Multibacillary |
| D009165 | Mycobacterium Infections, Nontuberculous |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
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| ID | Term |
|---|---|
| D002991 | Clofazimine |
| D014815 | Vitamins |
| ID | Term |
|---|---|
| D010619 | Phenazines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Daily for 12 months |
|
|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000078622 | Nutrients |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |